The Effectiveness of Family-based Weight Loss Treatment Implemented in Primary Care Centers
Phase: NA
Conditions: Pediatric Obesity
Sponsor: State University of New York at Buffalo

 
 
 
 
 
 
 
The Effectiveness of Family-based Weight Loss Treatment 
Implemented in Primary Care: A Randomized Control Trial 
Study Protocol 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Protocol Identifying Number: U01 HL131552 
Principal Investigator: Leonard H. Epstein, PhD 
IND/IDE Sponsor: National Heart, Lung and Blood 
Institutes (NHLBI) 
Funded by: NIH 
Draft or Version Number: v.16 11.17.2020. 
 

Page 1 of 305 
 
 
 
 
 
 
I. 
Contents 
II. 
6 
III. 
8 
IV. 
9 
Background Information 
9 
Study Summary 
9 
Scientific Rationale 
10 
V. 
10 
Description of Study Design 
10 
Outcome and Objectives 
11 
Study Organization and Roles and Responsibilities 
11 
1. 
12 
2. 
12 
3. 
13 
4. 
13 
5. 
13 
6. 
13 
Additional Committees 
14 
1. 
14 
2. 
14 
3. 
14 
4. 
14 
5. 
15 
6. 
15 
Study Timeline 
15 
II. 
16 
Recruitment 
16 
1. 
16 
Inclusion Criteria 
16 
Exclusion Criteria 
17 
2. 
18 

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Screening 
20 
Consenting Process 
21 
1. 
22 
2. 
22 
3. 
23 
Randomization 
23 
Assessments 
24 
Participant Timeline 
25 
1. 
25 
2. 
26 
3. 
26 
4. 
26 
5. 
26 
6. 
26 
II. 
28 
Usual Care (UC) 
28 
Family-based Behavioral Weight Loss Treatment (FBT) 
28 
1. 
28 
2. 
28 
Dietary Goals 
28 
Physical Activity Goals 
28 
Behavior Change Tools 
29 
Delay of Gratification 
29 
Social Facilitation Approaches 
29 
Educational Tools 
29 
3. 
30 
4. 
34 
Session Structure 
34 
Session Content 
35 
5. 
35 
III. 
36 
General Training in Study Procedures 
35 
PLAN Coach Training and Fidelity 
36 
1. 
36 
2. 
37 

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3. 
37 
4. 
37 
5. 
37 
6. 
37 
7. 
37 
8. 
38 
Assessment Training and Fidelity 
38 
1. 
39 
2. 
39 
II. 
39 
Practice Retention 
39 
1. 
39 
2. 
39 
Participant Retention 
40 
1. 
40 
2. 
40 
3. 
40 
Intervention Participation 
41 
Assessment Participation 
41 
4. 
41 
5. 
41 
Risks to Human Subjects 
42 
1. 
42 
2. 
43 
3. 
43 
Potential Benefits to Human Subjects and Others 
44 
II. 
44 
Safety Oversight 
44 
1. 
45 
Specification of Safety Parameters 
47 
1. 
48 
2. 
48 
3. 
48 
Classification of Adverse Events 
47 
1. 
48 

Page 4 of 305 
 
2. 
48 
3. 
48 
Adverse Event Assessment and Tracking 
49 
Adverse Event Reporting Procedures 
50 
Study Halting Rules for Participant Safety 
52 
II. 
54 
REDCap 
53 
Testing the Data Management System 
53 
Data Security and Confidentiality 
54 
Forms and Datasets Manual 
54 
Archiving Data 
54 
Quality Control 
54 
1. 
56 
2. 
57 
3. 
57 
4. 
57 
5. 
58 
III. 
58 
Measures to Minimize Bias 
67 
1. 
69 
2. 
69 
3. 
69 
Masking of Assessment Staff 
68 
Reducing Bias in Unmasked Groups 
69 
II. 
71 
Study Website 
69 
Conflicts of Interest 
70 
Publications and Presentations Policy 
70 
Protocol Amendments 
70 
Protocol Deviations 
70 
III. 
73 
IV. 
77 
A. 
77 
Addendum: Assessment Protocol in Response to Coronavirus Pandemic (COVID-19) 
186 
C. 
190 

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Assessment Measures 
236 
Remote assessments Protocol 
239 
FAMILY NUTRITION & PHYSICAL ACTIVITY (FNPA) 
255 
D.     Additional Forms 
300 
 
 
 

Page 6 of 305 
 
II. List of Abbreviations 
 
AAP 
American Academy of Pediatrics 
AE 
Adverse Event 
ANCOVA  
Analysis of Covariance 
BMI 
Body Mass Index 
BOV 
Percent over weight 
CCC 
Clinical Coordinating Center 
CFR 
Code of Federal Regulations 
CITI 
Collaborative Institutional Training Initiative  
COI 
Conflict of Interest 
CME 
Continuing Medical Education 
CMP 
Clinical Monitoring Plan 
CRO 
Clinical Research Office 
CTSI 
Clinical Translational Science Institute 
DCC 
Data Coordinating Center 
DD 
Delay Discounting 
DSMB 
Data Safety Monitoring Board 
DSMP 
Data Safety and Monitoring Plan 
UC 
Usual Care 
EMR 
Electronic Medical Records 
FBT 
Family-Based Treatment 
FDA 
Food and Drug Administration 
FDAAA  
Food and Drug Administration Amendments Act of 2007 
FRG 
Food Reference Guide 
FWA 
Federalwide Assurances 
GCP 
Good Clinical Practice 
GR-PBRN  
Greater Rochester Practice Based Research Network 
HIPAA 
Health Insurance Portability and Accountability Act 
IRB 
Institutional Review Board 
MOC 
Maintenance of Certification 
MOP 
Manual of Procedures 
NCH 
Nationwide Children’s Hospital 
NIH 
National Institutes of Health 
NPP 
Non-participating parent 
NHLBI 
National Heart, Lung and Blood Institutes 
OHRP 
Office for Human Research Protections 
PBRN 
Practice Based Research Network 
PC 
Project Coordinator 
PCN 
Primary Care Network 
PCP 
Primary Care Provider 
PLAN 
Primary Care Pediatrics, Learning, Activity, Nutrition 
PHI 
Private Health Information 
PI 
Principal Investigator  

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REDCap 
Research Electronic Data Capture 
RGH 
Rochester General Hospital 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SEC 
Study Executive Committee 
SMC 
Safety Monitoring Committee 
SMH 
Strong Memorial Hospital  
TFC 
Training and Fidelity Core 
UB 
University at Buffalo 
UBIRB 
University at Buffalo Institutional Review Board 
UP 
Unanticipated Problem 
URMC 
University at Rochester Medical Center 
US  
United States 
USPSTF 
United States Preventive Services Task Force 
WU 
Washington University in St. Louis 
 
 
 

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III. Statement of Compliance 
 
PLAN with Families will be conducted according to the study protocol developed to follow the Good 
Clinical Practice guidelines (GCP) set by the United States (US) Code of Federal Regulations (CFR) 
regarding clinical trials with the approval of the University at Buffalo Internal Review Board (UBIRB). All 
personnel responsible for conducting this trial will be trained through the Collaborative Institutional 
Training Initiative (CITI). The Principal Investigators agree that no deviation from, or changes to the 
protocol will take place without prior agreement from the sponsor and documented approval from the 
UBIRB, except where necessary to eliminate an immediate hazard(s) to the trial participants 
 
We agree to ensure that all staff members involved in the conduct of this study are informed about their 
obligations in meeting the above requirements. 
 
 
 
Principal Investigator: _______________________________________________________ 
 
 
 
Print/Type Name 
 
Signature: __________________________________ Date: _________________________ 
 
 
 
 
Principal Investigator: _______________________________________________________ 
 
 
 
Print/Type Name 
 
Signature: __________________________________ Date: _________________________ 
 
 

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IV. Introduction and Study Rationale 
 
Background Information 
Childhood obesity is associated with a risk for the development of adult obesity, with children with 
obesity at all ages at increased risk of becoming adults with obesity.1,2 In addition to the risk of 
becoming an adult with obesity, obesity during childhood is associated with cardio-metabolic 
changes including increases in blood pressure, cholesterol and triglyceride levels, and insulin 
resistance that initiate a trajectory of cardiovascular and metabolic disease as an adult.3 Childhood 
obesity is also associated with psychological and behavioral changes that negatively impact the 
child’s quality of life.4,5 Obesity is a familial disorder. The most reliable risk factor for childhood 
obesity is parental obesity.2 Beginning in infancy,6 and extending through adolescence,2 parents with 
obesity increase the risk of the child or adolescent experiencing obesity. Parents with obesity may 
also suffer from cardio-metabolic disease, initiating a cycle of both obesity and cardiovascular and 
metabolic disease that impacts both generations. Parental behaviors, such as modeling and support 
of child unhealthy behaviors, are associated with childhood obesity.7-10 Given the relationship 
between child and parental obesity and that parents arrange family eating and exercise 
environments, model behaviors for their children, and reinforce healthy or unhealthy behavior 
patterns, it is logical that targeting both the parent and child can have a positive impact on 
childhood weight control.  
 
Family-based childhood obesity treatment (FBT) was developed over 30 years ago and has proven 
effective in decreasing child and parent weight.11 FBT targets changes in eating and physical activity 
through child and parent behavior change. One implication of FBT is that it may be more cost-
effective than separate treatments of the child with obesity by his or her pediatrician and the parent 
with obesity by his or her primary care doctor. To test this, we randomized families to FBT or 
separate and simultaneous treatment for the parent and child with obesity. Results at 12 months 
showed FBT was associated with superior child and parent weight loss than separate treatment and 
was significantly more cost-effective per pound of weight loss.12 Family-based weight loss programs 
also convey additional health benefits beyond weight loss, such as improvements in cardio-
metabolic risk factors13 and health related quality of life.14,15 
 
Study Summary 
Family-based treatment (FBT) is a behavioral weight control intervention that targets children with 
overweight/obesity and their parents,16-18 and has the capacity to improve the weight status of non-
targeted family members such as siblings.19 FBT has significant positive effects on body weight in 
children for up to 10-years of follow-up,20,21 and a robust relationship is observed between child and 
parent outcomes.22,23 FBT’s concurrent care of two generations of obesity in the family is more 
efficacious and cost-effective than if parents and children are treated separately.12 Despite its 
recognized efficacy, FBT is mainly available in specialty clinics13,16,24 and many children fail to receive 
this evidence-based level of treatment,25-28 as recommended by the U.S. Preventive Services Task 
Force. 25-28 Primary care offers an optimal setting for delivery of FBT by capitalizing on the 
established relationship between primary care providers and families.29 Using behavioral 
interventionists co-located within the primary care setting overcomes barriers posed by 
fragmentation of care, and lack of provider time and training. One of the challenges to integrating 
childhood obesity treatment into primary care is optimizing limited health care resources. In 
behavioral weight loss programs, some individuals learn diet, physical activity, and behavior change 
information quickly, while others learn more slowly. Individuals also differ in their ability to 
implement treatment recommendations due to individual differences, such as problems with 

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delaying gratification. FBT accommodates these individual differences by using a personalized 
system of instruction, or a mastery model, in which the content and dose of treatment is calibrated 
to the needs of the family, ensuring that treatment effort is consistent with need. This multi-site, 
clinical trial aims to evaluate over a two-year period the effectiveness of FBT delivered by a trained 
behavioral interventionist co-located within primary care compared to usual care alone (UC). 
Participants will be a representative sample of 528 families with a 6-12-year-old child with 
overweight/obesity and a participating parent with overweight/obesity. Weight changes in 
approximately 228 siblings with overweight/obesity and between 2-18 years of age will also be 
studied. Additionally, this study provides the opportunity to explore factors important to successful 
implementation of FBT in a primary care setting. Provider attitudes, such as those related to 
evidence-based practices in general30 as well as their specific perceptions of FBT,31 may predict their 
intended use of co-located FBT,31 as intentions are reliable predictors for future behavior.32,33 
 
Scientific Rationale 
Obesity in youth has tripled in the last 30 years, a trend that is particularly disturbing because the 
majority of youth with obesity remain obese as adults. Because childhood obesity is associated with 
increased risk of adult cardiovascular diseases such as hypertension, hyperlipidemia, and type 2 
diabetes, improved access to evidence-based treatments is vital. Many organizations are responding 
to the demand for services by implementing programs for childhood obesity. However, obesity care 
is currently dominated by high-intensity behavioral treatment implemented in specialty clinics or by 
less effective, low- intensity treatments implemented in primary care. Effective family-based 
treatment delivered within primary care, matching national recommendations, has never been 
evaluated in a randomized, controlled trial. If we can demonstrate effectiveness in this setting, we 
will be establishing for the first time that childhood obesity can be addressed by trained behavioral 
interventionists in a setting that provides routine access to large numbers of children with obesity 
without requiring the intense environment of a specialty clinic. Moreover, by studying 
approximately 228 siblings with obesity in our initial secondary aim, we are asking a seminal 
question about whether the “family” component of FBT translates into benefits for family members 
not directly participating in the program. Affirmative evidence regarding this question will suggest 
multiple avenues of future research that have the potential to reorder our thinking about how best 
to implement cost-effective family-based obesity programs. The proposed study continues our 
efforts to translate FBT for widespread implementation and dissemination for treatment of children 
with overweight or obesity and families into primary care settings. It aims to shift current research 
and clinical practice paradigms by demonstrating the effectiveness of delivering FBT within primary 
care using a behavioral health provider who is co-located in a primary care setting. 
 
V. Study Design 
 
Description of Study Design 
The study is an individually randomized group treatment (IRGT) 34 trial such that the individual, in this 
case the family, is the unit of randomization. It differs from a classic individually randomized trial in that 
the intervention is either a group intervention or conducted by an agent responsible for implementing 
the intervention in a defined set of individuals. The PLAN study will evaluate the effectiveness of family 
based treatment (FBT) delivered by a coach versus usual care (UC) treatment delivered by primary care 
providers. Both FBT and UC will be delivered in pediatric offices. In PLAN, participants are randomized at 
the family level and only one eligible child (the index child) is included in the primary outcome analysis. 
The trial will enroll up to 1284 subjects from 528 randomized families at four sites, each having at least 
one overweight/obese participating child age 6-12 and at least one participating parent. Since the study 

Page 11 of 305 
 
has four sites with three coaches per site, the analysis plan involves a nesting of the coach within the site. 
Some sites have backup and floating coaches that are involved in delivering FBT to study participants, 
which will also be accounted for when outcome data is analyzed (This change was made on 12.4.18 
prior to review and approval by the DSMB, DSMB approved protocol addenda on 11.18.19). While this 
nesting suggests a classic cluster randomized trial, an IRGT trial is different because the nesting applies 
only to the intervention group.  Since the UC group has no nesting factor in this IRGT trial, a proper 
analysis must reflect the fact that the FBT group and the UC group must use different covariance 
structures. In addition to one participating child and parent from each family, the sample will also 
include up to 228 overweight/obese siblings and non-participating parents who will not be direct 
recipients of the intervention. There will be two years of follow-up with comprehensive assessments at 
baseline, 6, 12, 18 and 24 months. The primary outcome is percent over BMI at 24 months in the child. 
Our primary hypothesis is that the FBT intervention will be superior to UC alone in the participating child 
(DSMB approved protocol addenda, 11.2.18). 
 
Outcome and Objectives 
This study will test between-group differences in child (Primary Specific Aim 1) weight change, as well as 
weight change in parents (Secondary Aim 1), siblings with overweight/obesity (Secondary Aim 2), 
changes in parent and child delay of gratification and how changes in delay of gratification are related to 
parent and child weight changes (Secondary Aim 3), participant level predictors of treatment success 
(Secondary Aim 4), and how provider attitudes toward evidence-based treatment and perceptions of FBT 
may relate to their intention to use co-located FBT in their practices in the future (Exploratory Aim 1). 
Establishing that FBT can be effectively implemented within real world settings is crucial to creating a 
system by which children and their families who suffer from obesity can be treated in a centralized 
primary care setting (DSMB approved protocol addenda, 11.2.18). To investigate the discussions 
between PLAN FBT coaches and their PLAN FBT families regarding perception of food cost and food 
choices PRE and POST COVID. (Exploratory Aim 2) (DSMB requested protocol addenda, 9.22.20).  
 
 
Study Organization and Roles and Responsibilities 
This project continues long-standing collaborations between study PIs: Drs. Epstein, Wilfley, and 
Schechtman, and an enhanced partnership from prior professional associations with Drs. Cook and 
Eneli. The organizational structure includes a Clinical Coordinating Center, a Data Coordinating 
Center, and four clinical sites (see Figure 1 below). 
 

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FIGURE 1. Study Organization Chart 
 
1. 
Study Executive Committee (SEC)  
Members of the SEC will include Drs. Epstein, Schechtman, and Wilfley. The three PIs will 
alternate responsibility for the development of SEC meeting agendas and will co-lead regular 
meetings throughout the study. The SEC will be responsible for decision-making related to the 
overall scientific conduct of the study and monitoring the overall progress of the study to ensure 
timely study completion. In addition, the SEC will be responsible for final approval of the study 
protocol and for any changes to the developed protocol, all of which will be documented in 
writing as part of the SEC minutes. Throughout the study, the PIs will communicate weekly by 
teleconference to make decisions on the scientific direction of the grant (e.g., data collection, 
data analysis) and guidance regarding study procedures. Daily decisions about the project will be 
made by email and phone as needed. 
 
2. 
Steering Committee 
The PIs and Co-Is will form a Steering Committee (Drs. Epstein, Wilfley, Schechtman, Cook, Eneli, 
and Quattrin) that will manage the oversight and coordination of project management, research 
administration, publications and data sharing, and integration of all resources needed for the 
project. The University at Buffalo will subdivide the award funds and each PI will be responsible 
for their own budget. The Steering Committee will oversee decisions on minor changes in 
research direction and have the authority to reallocate funds and resources among PIs. Dr. 
Epstein will be first to serve as Chair of the Steering Committee and be responsible for 
communication among PIs and Co-Is, including meeting schedules and agendas. The position of 
Chair will rotate among the PIs on a yearly basis. Dr. Epstein will be designated the contact PI 

Page 13 of 305 
 
and be responsible for submitting all necessary documents to NIH, including IRB approvals and 
annual progress reports. The Steering Committee will meet as needed and at least on a 
quarterly basis by phone to discuss study-related decisions and to evaluate the overall scientific 
conduct of the study. 
 
3. 
Clinical Coordinating Center (CCC) 
Located within the University at Buffalo and directed by Dr. Epstein, PI, with Dr. Teresa Quattrin, 
Co-I, the CCC will be responsible for study oversight, including developing the treatment and 
assessment protocol, study website development, and coordination and monitoring of study 
procedures and progress across sites. Dr. Quattrin is experienced in overweight assessment and 
treatment in the primary care setting and will provide general medical guidance to the study as 
well as oversee the evaluation and adjudication of adverse event reports. 
 
4. 
Training and Fidelity Core (TFC) 
The TFC will be housed at Washington University in St. Louis. Dr. Wilfley will serve as PI for the 
TFC. Dr. Wilfley will provide leadership to the TFC and will be responsible for the content and 
integrity of behavioral interventionist training activities and implementation of the intervention 
across all clinical sites. The TFC will conduct the trainings and will supervise the interventionists 
to ensure adherence to the treatment protocol during the training and active treatment phases 
of the study. 
 
5. 
Data Coordinating Center (DCC) 
The DCC will also be housed at Washington University in St. Louis under the direction of Dr. 
Schechtman as PI. The DCC will provide scientific, organizational, statistical, quality control, and 
operational leadership in support of the present study. Dr. Schechtman has directed many NIH-
funded DCCs and has served as head of the DCC for a weight loss maintenance study for which 
Dr. Wilfley was PI and Dr. Epstein was Co-I. 
 
6. 
Clinical Sites 
Dr. Wilfley will serve as PI for the St. Louis, Missouri clinical site. Dr. Epstein, will serve as the PI 
for the Buffalo, New York clinical site with Dr. Teresa Quattrin serving as Co-I. Dr. Quattrin is 
experienced in overweight assessment and treatment in the primary care setting and will 
provide general medical guidance to the study team. She will also evaluate adverse event 
reports to determine appropriate disposition. Two additional clinical sites in Rochester, New 
York and Columbus, Ohio will be directed by Drs. Stephen Cook and Ihuoma Eneli, respectively. 
Drs. Cook and Eneli will serve as PIs for their clinical sites and will be primarily responsible for 
recruitment of practices and oversight of study-related processes within these practices (see 
Figure 2 below). 
 
 
 
 
 

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FIGURE  2. Clinical Site Organization 
 
Additional Committees 
 
1. 
Safety Monitoring Committee 
The Safety and Monitoring Committee (SMC), chaired by Dr. Teresa Quattrin, will oversee the 
assessment and reporting of adverse events (AE), serious adverse events (SAE), and 
unanticipated problems (UP). The SMC will be responsible for evaluating adverse event reports 
from the DCC and determining appropriate disposition.  Additional members include: Drs. 
Ihuoma Eneli and Rebecca Campo. 
 
2. 
Interventionist Committee 
The Interventionist Committee, co-chaired by Dr. Leonard Epstein and Colleen Kilanowski, will 
meet on a monthly basis to discuss participant progress in the intervention and to trouble-shoot 
areas of concern (e.g., non-compliance to treatment). Each clinical site will be represented by a 
lead interventionist who will summarize site progress with the project coordinators and chairs of 
the Interventionist Committee.   Additional members include: Dr. Rebecca Campo, Gracie 
Matychak, Megan Dahlman, Andrea Goard, and Sarah Kruger. 
 
3. 
Recruitment and Retention Committee 
The Recruitment and Retention Committee, chaired by Dr. Ihuoma Eneli, will oversee accrual 
milestones related to the recruitment and retention of families in the study. The Committee will 
monitor and communicate recruitment and retention strategies across sites and will make site-
specific recommendations based on recruitment reports from the DCC.  Additional members 
include: Drs. Charlotte Pratt and R. Robert Welch. 
 
4. 
Quality Control and Measurement Committee 
The Quality Control Committee, chaired by Dr. Denise Wilfley, will oversee the accuracy and 
completeness of computerized data, the common administration of protocols across sites, 
adherence to protocol requirements, and training and certification of study staff in assessment 
procedures and data collection.  Additional members include: Nasreen Moursi, and Peter Dore. 
 

Page 15 of 305 
 
5. 
Ancillary Study Committee 
The Ancillary Study Committee, chaired by Dr. Stephen Cook, will oversee the submission 
process for ancillary study proposals and will evaluate the feasibility of these proposals in regard 
to their cost, impact on IRB protocols, and burden to participants. The Committee will meet 
monthly to review proposals and will provide recommendations to the Steering Committee.  
Additional members include: Drs. Charlotte Pratt and Rebecca Campo. 
 
6. 
Publication and Presentations Committee 
The Publication and Presentation Committee, chaired by Dr. Kenneth Schechtman, will be 
responsible for defining publication policies, prioritizing if multiple papers and abstracts challenge 
resources, and encouraging the involvement of junior investigators in the dissemination of study 
results. This Committee will oversee the creation of a publications and presentations database that 
will facilitate the tracking of completed publications and the notification of abstract due dates and 
pending timelines for preparing material for publications and presentations.  Additional members 
include: Doctors Leonard Epstein, Denise Wilfley, Stephen Cook, Ihuoma Eneli, and Nancy Geller. All 
proposed publications will be disseminated to the Publication and Presentation Committee, and 
forwarded to Colleen Kilanowski and Alexandria Phipps for proper filing of documents.  
 
Study Timeline 
The first 12 months of the study will be devoted to study organization and training of staff in their 
research and clinical functions (see Table 1). Website development will occur in order to facilitate 
training and initiate recruitment and study implementation. Behavioral interventionists called PLAN 
coaches and study support staff will be hired and fully trained in their roles. PLAN coaches will 
attend a live training at WU led by the TFC and will also utilize online and printed materials. 
Recruitment of study participants utilizing the research match design will also begin, as it entails 
passive collection of information from families interested in participating in studies aimed at weight 
loss. Active recruitment will begin in month 16 and will continue through month 30. It is expected 
that all 528 families across all of the practices will be enrolled during this time period. Treatment 
initiation will also begin in month 17, as recruitment allows, and will continue through month 54. 
This will allow all participants recruited by month 31 to finish two years of treatment and final 
assessments. Months 55-60 will be used for study closeout and data analysis. 
 
TABLE 1. Study Timeline 
 
Study Activity 
Study Months 
Year 1 
Year 2 
Year 3 
Year 4 
Year 5 
1-6 
7-12 
13-18 
19-24 
25-30 
31-36 
37-42 
43-48 
49-54 
55-60 
Planning & Data Base 
Development 
X 
 
 
 
 
 
 
 
 
 
Web Development 
X 
X 
 
 
 
 
 
 
 
 
Interventionist Hiring & Training 
X 
X 
 
 
 
 
 
 
 
 
Piloting & Participant 
Recruitment  
 
 
X 
X 
X 
 
 
 
 
 
Treatment Delivery  
 
 
X 
X 
X 
X 
X 
X 
X 
 
Data Monitoring Reports 
 
 
 
X 
X 
X 
X 
X 
X 
X 
Data Analysis 
 
 
 
 
 
 
 
 
X 
X 
Study Closeout 
 
 
 
 
 
 
 
 
 
X 
 

Page 16 of 305 
 
II. Study Procedures and Schedule  
Study procedures will be carried out within primary care practices. The general roles and responsibilities 
of: 1) the PIs at the four clinical sites; 2) the administrators and providers at participating practices; 3) 
the PLAN coaches; and 4) the families randomized to the two conditions are summarized in the sections 
that follow. An overview of study flow is provided in following sections as well as in Figure 1 in Appendix 
D.  
 
Recruitment 
 
1. 
Participants  
Families will be recruited from pediatric practices in our Practice-based Research Networks 
(PBRNs) in several ways. Each practice will have children who meet age, height, and weight 
criteria flagged in their charts, and we will use multiple approaches to recruit families. First, we 
will establish a ResearchMatch approach to recruiting in each PBRN. ResearchMatch, an online 
recruitment tool, will accrue families in one of two ways. At intake for a well- or sick-child visit, 
forms designed to acquaint families with the study will be introduced by PLAN coaches, and 
families can sign up for additional information about this study. Their information will be 
entered into a database by the PLAN coaches, and they will be contacted if they meet criteria. In 
addition, we will set up a website that they will be directed to in a flyer, and they can sign up to 
participate from the website. Since the pediatrician generally will not have information on 
parental health, this will need to be collected prior to deciding study eligibility, and the family 
database will assist in this endeavor by including information about all family members after a 
phone screen is conducted by the PLAN coaches with the participating parent. Second, PBRN 
practices post study advertisement at offices for interested families to visit the study website to 
complete questionnaires to ensure they meet eligibility criteria. If the families meet eligibility 
criteria, a PLAN coach will follow up with the families to schedule their first appointment at their 
earliest convenience. At this appointment, the PLAN coach will confirm the families’ interest to 
participate and eligibility prior to participation. Third, Plan coaches will meet with families 
during well-child visits to introduce the study, assess their interest, and explain next steps. Each 
of these methods in collecting their information regarding interest and eligibility will be 
preceded by getting their verbal consent over the phone or a check box indicated on the web 
pages. 
 
During recruitment, PLAN coaches will explain that there is a 50/50 possibility of getting one 
treatment over the other treatment. This will be like a flip of the coin and no one can just pick 
one treatment or the other. This study is testing if the FBT is as good as the care provided by 
their doctors normally given or better. Randomization will occur after the first appointment. 
 
 
Inclusion Criteria 
The PLAN study inclusion criteria and methods for assessing these criteria are summarized in 
Table 2. The screening surveys and measures may be found in Appendix B. 
 
TABLE 2. PARTICIPANT INCLUSION CRITERIA 
Participant 
Inclusion Criteria 
Measurement 
Targeted Child 
Between the ages of 6 and 12 years1 
Initial Eligibility Survey2 
BMI above the 85th percentile for age and sex 
Initial Eligibility Survey3 

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At least one parent with overweight or obesity (BMI>25) 
who is willing to participate 
Initial Eligibility Survey 
Able to speak and comprehend English at a first grade 
level 
Eligibility Phone Screen (This 
change was made on 11.9.17 
prior to review and approval 
by the DSMB, DSMB approved 
protocol addenda on 11.2.18) 
Resides with targeted parent at least 50% of the time4 
Eligibility Phone Screen 
Supplemental evaluation of eligibility as needed 
PCP Medical Clearance Form 
Targeted Parent 
(DSMB approved protocol addenda, 11.2.18) 
Initial Eligibility Survey5 (DSMB 
approved protocol addenda, 
11.2.18) 
Agrees to attend all treatment meetings 
Eligibility Phone Screen  
Able to speak and comprehend English at a first grade 
level 
Eligibility Phone Screen, WRAT 
(This change was made on 
11.9.17 prior to review and 
approval by the DSMB, DSMB 
approved protocol addenda on 
11.2.18) 
Must be targeted child’s biological or adoptive parent or 
legal guardian 
Eligibility Phone Screen 
Supplemental evaluation of eligibility as needed 
PCP Medical Clearance Form 
Sibling (if 
applicable) 
Between the ages of 2 and 18 years6 
Eligibility Phone Screen 2 
BMI above the 85th percentile for age and sex 
Eligibility Phone Screen 3 
Must reside with targeted child and parent 
Eligibility Phone Screen 
(This change was made on 11.9.17 prior to review and approval by the DSMB, DSMB approved protocol 
addenda on 11.2.18) 1If family has two children between the ages of 6 and 12 years, it will be encouraged that 
the older sibling be the primary participant, as it is more likely the older sibling will serve as a role-model for the 
younger sibling; 2Calculate age using screen date and birth date; 3BMI Percentile Calculator: 
https://nccd.cdc.gov/dnpabmi/calculator.aspx; 4If 50/50 split, it will be encouraged that non-targeted parent sign 
an agreement to be supportive of study goals and to allow contact from study team; 5BMI: 
https://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/english_bmi_calculator/bmi_calculator.html; 6In 
families where more than one eligible sibling is available, we will enroll the sibling whose age is closest to that of 
the study child. 
 
Exclusion Criteria 
The PLAN study exclusion criteria and methods for assessing these criteria are summarized 
in Table 3. The screening surveys and measures, including a table of exclusionary 
medications, may be found in Appendix B. 
 
TABLE 3. PARTICIPANT EXCLUSION CRITERIA  
Participant 
Exclusion Criteria 
Measurement 
Targeted Child 
and/or Parent 
Concussion in the last 3 months1 
Initial Eligibility Survey 
 
Planning to move away from the area within the next 2 
years 
Initial Eligibility Survey 

Page 18 of 305 
 
Pregnant or is planning on becoming pregnant during the 
two-year study period 
Eligibility Phone Screen 
Participation to any degree in weight-
management/weight-loss program2 
Eligibility Phone Screen 
Weight-related surgeries (e.g., gastric bypass) within the 
last two years. (DSMB approved protocol addenda, 
11.2.18) 
Eligibility Phone Screen 
Weight-affecting medications known to cause weight gain 
or loss if at current dose for < 6 months 
Eligibility Phone Screen  
Medications affecting growth (e.g., systemic 
corticosteroids 2+ weeks in the past year, insulin, oral 
hypoglycemics, thyroid hormone, growth hormone) 
Eligibility Phone Screen  
Medical condition altering nutritional status or intestinal 
absorption (e.g., inflammatory bowel disease, diabetes 
and taking insulin) 
Eligibility Phone Screen 
Medical condition that affects growth (i.e., genetic or 
metabolic disease/syndrome associated with obesity) 
Eligibility Phone Screen  
Chronic medical conditions, including: Type 1 diabetes, 
heart disease or heart failure, HIV or AIDS, muscular 
dystrophy, renal diseases, hypothyroidism (if untreated or 
if treated with medication for <6 months) 
Eligibility Phone Screen 
Severe restriction of diet that would inhibit family from 
reasonably following the Traffic Light Eating Plan 
Eligibility Phone Screen  
Significant developmental delays, intellectual disabilities, 
or Autism Spectrum Disorder 
Eligibility Phone Screen  
Unmanaged/active psychiatric conditions (e.g., binge 
eating disorder or schizophrenia) meeting full DSM-5 
criteria or impairing clinical symptoms (e.g., suicidality) 
Child: PSC, QEWP-5 (Child 
Self-Report & Parent Report 
of Child), KSADS if warranted 
Parent: PHQ, SCID if 
warranted 
Disability that prevents performance of physical activity at 
the level of a brisk walk 
PCP Medical Clearance Form 
PSC=Pediatric Symptom Checklist; QEWP-5=Questionnaire on Eating and Weight Patterns; KSADS=Kiddie Schedule 
for Affective Disorders and Schizophrenia; PHQ=Patient Health Questionnaire; SCID=Structured Clinical Interview 
for DSM Disorders; 1Eligible once 3 months since concussion passes; 2Eligible if willing to stop program. 
 
2. 
Primary Care Pediatric Practices 
Practice recruitment will begin during the planning stage of the study (see Table 4. PLAN with families 
Study Gantt Chart). Each clinical site is responsible for recruiting appropriate numbers of practices to 
ensure participant recruitment goals can be met. Given differing practice and caseload sizes across sites, 
the number of practices recruited may vary across each site. As a minimum benchmark, by July 1 2017, 
all sites must have identified sufficient pediatric practices to give them access to a minimum of 3303 
children with overweight or obesity, or a minimum of 9714 total children study-wide (assuming a 34% 
prevalence rate of overweight/obesity). This number was identified assuming 57.1% of children with 
overweight/obesity will have a parent with overweight/obesity based upon 1286 families with an age-
eligible overweight/obese child in a screening database maintained by Dr. Epstein in Buffalo, in which 
734 (57.1%) had at least one obese parent. It is estimated that 10% of these families will express 

Page 19 of 305 
 
willingness to participate in the study. This estimate is based on previous experience of the former study 
Co-I Dr. Jane Garbutt as she ran a recent trial assessing an asthma intervention for families recruited 
from a primary care setting. Dr. Garbutt’s study was low intensity and she described a 20% uptake rate. 
Given the intensity of our intervention, a more conservative 10% is estimated. Additionally, after 
agreeing to be screened, it is estimated that only 70% of willing families will meet eligibility criteria 
and/or will decide they are interested in participating. This estimate is based on the recent COMPASS 
trial conducted by Dr. Wilfley, which found that approximately 66% of families that attended a study 
orientation meeting entered the study. It is believed our rate will be slightly higher, as participation in 
the study will begin soon after study orientation, whereas families in the COMPASS trial generally did 
not initiate treatment right away due to the cohort nature of the study.  
Gantt Chart Updated, (DSMB approved protocol addenda, 11.2.18). 
 
Additionally, given the recruitment goal for minority families, all sites must have access to a minimum of 
826 (30%) minority children with overweight or obesity, or 2,429 total minority children must be 
available study-wide. (Table 5. DCVS Accrual Milestones below).  
 
 
 
 
1
11
21
31
41
51
61
71
Study Website development
DCC designs and finalizes data forms
DCC develops and tests database
DCC trains and certifies personnel on data collection
Recruitment of Pediatric Practices
TFC trains & certifies interventionists
Planning & Data Base Development
DCC creates forms/dataset manual
Families are recruited and randomized
Treatment delivery/data/collection/quality control
DCC prepares regular study reports
DCC conducts data audits
Data Monitoring Reports
DCC conducts data audits
Data analysis
Study closeout
Time  from begininng of study(in months)
Study Activity
PLAN with Families Study Gantt Chart

Page 20 of 305 
 
 
MAP Updated, (DSMB approved protocol addenda, 11.2.18). 
 
Screening  
At the initiation of the screening process, the participating parent will complete the Initial Eligibility 
Survey in person, over the phone, or online via REDCap (Research Electronic Data Capture) with the 
assistance of the PLAN coach or Research Support Specialist. The survey will gather preliminary 
eligibility criteria including height, weight, and age. If eligible based on this survey, a PLAN coach will 
contact the parent to discuss the study in further detail and to answer any questions the parent may 
have. The PLAN coach will obtain the parent’s verbal consent to continue with the screening process 
and will then complete the Eligibility Phone Screen, which gathers additional information on medical 
and psychiatric history for both parent and child. For families found to meet eligibility criteria on 
both the Initial Eligibility Survey and the Eligibility Phone Screen, an orientation appointment will be 
scheduled following the Phone Screen, to complete the process of determining eligibility to 
participate in the study. 
 

Page 21 of 305 
 
Prior to the orientation appointment, the parent and child will complete survey questionnaires via 
REDCap, including the Patient Health Questionnaire (PHQ), Pediatric Symptom Checklist (PSC), and 
Questionnaire on Eating and Weight Patterns Parent Report of Child (QEWP-5). These 
questionnaires assess for symptoms of eating disorders and other psychiatric disorders (e.g., 
depression, anxiety, and substance abuse). If the respondent’s scores are above clinical cut-offs on 
these questionnaires, they will be flagged in REDCap and a PLAN coach will follow-up with the 
parent over the phone prior to the orientation appointment to further assess for the presence of 
eating disorders or other psychopathology by administering the relevant modules of the Structured 
Clinical Interview for DSM Disorders (SCID) and Kiddie Schedule for Affective Disorders and 
Schizophrenia (KSADS). A score of “Yes, present” for any of the psychiatric conditions assessed by 
these semi-structured clinical interviews will prompt the PLAN coach to inquire about any current or 
past treatment to gauge impairment level. This information will be entered into the Eligibility 
Tracking Form. 
 
Each week, the clinical site PI, with guidance from the doctoral-level psychologists on the study 
team as needed, will review participants flagged in this way and will make all final decisions 
regarding eligibility. If the parent or child only exhibits subthreshold symptoms of a disorder, the 
family will be eligible to participate assuming there are no impairing symptoms present (e.g., 
suicidality). If the parent or child meets full DSM-5 criteria for any psychiatric disorder, the family is 
ineligible to participate, and the PLAN coach will provide a referral for treatment to the family. Once 
the parent or child has been symptom-free for six months, the family is eligible to re-screen for 
enrollment into the study. The Eligibility Tracking Form (see Appendix B) will be completed to 
document the process by which each participant’s eligibility or ineligibility is determined  
 
 (This change was made on 11.9.17 prior to review and approval by the DSMB, DSMB approved 
protocol addenda on 11.2.18). The pediatrician or parent’s physician will be contacted if information 
about the family meeting inclusion or exclusion criteria is needed. Families will be asked to provide a 
standard form requesting information about the patient’s current specified medical condition, and 
to forward or have the PCP send the form to site clinical PI. 
 
Consenting Process 
 
All participants will meet with a trained study staff member and will be consented following the Manual 
of Procedures of the University at Buffalo Institutional Review Board (UBIRB), the IRB of Record for the 
study.  Coaches will file the paper consent forms in the following order: 
1. Child Assent 
2. Parental Permission for Child 
3. Parent Consent 
4. Sibling Assent 7-13 
5. Sibling Assent 14-17 
6. Adult Sibling Consent 
7. Parental Permission for Sibling 
8. Non-Participating Parent Consent 
9. Targeted Child – 7-13 Re-assent  
10. Targeted Child – 14-17 Re-assent 
11. Sibling – 7-13 Re-assent  
12. Sibling – 14-17 Re-assent 
13. Sibling – Adult – Re-consent 

Page 22 of 305 
 
14. Coronavirus Addendum  
 
a. Example consent/assent templates for all study participants are included in Appendix A. 
 
1. 
Family Consent 
Families who are eligible for the study will meet with a trained study staff member and will be 
given written and verbal information about the study. Full disclosure of the purpose of the 
study, the benefits and risks to individuals who participate, and the confidential nature of 
information obtained during the study will be explained to participants. Families will be aware 
from the outset that they will be randomly assigned to an active treatment condition (FBT) or a 
usual care control condition (UC) following baseline assessment completion. They will also be 
aware that their expected participation will be 2 years and may require anywhere from 26 to 96 
sessions of FBT. Families will be informed of alternative lifestyle change resources available to 
them, such as physical activity programs or sports teams for youth at the YMCA or other 
organizations, other commercially available child fitness or weight loss programs, or pediatric 
dieticians or fitness trainers, and if so desired, referrals will be made. Potential participants will 
also be informed that they may drop out at any time during the study and that their withdrawal 
from the study will in no way impact their ability to receive medical care through their primary 
care practice. The staff member will answer any questions the family has about the study, and 
then participants will be consented according to the policies and procedures of the UBIRB 
 
Each capable parent 18-years or older will sign the consent form for himself/herself and will also 
sign the parent permission form, which provides consent for his/her child age 6-12 to 
participate. In addition, the parent will sign a separate permission form that provides consent 
for participating siblings (i.e., a sibling who is overweight/obese) age 2-17 to participate. Older 
siblings will sign assent forms, which will be written and explained at a reading level appropriate 
for the child population. Non-participating parents and siblings who are 18 years of age will sign 
their own consent form. A copy of the signed consent, permission, and assent forms and study 
staff contact information will be given to the potential participants, and all original forms will be 
kept in the participant’s confidential research record. Participants will also be asked to give 
written consent for the PLAN coach to audio record their treatment sessions so the study team 
can assess adherence to the treatment protocol; however, participants will not be excluded 
from the study if they refuse audio recording. In our experience, less than 1% of participants 
refuse audio recording. 
 
Since the children involved directly (as targeted children) and indirectly (as siblings) will mature 
throughout the course of their time in the PLAN program, a PLAN Coach or Measurement Coach 
will re-assent and re-consent impacted children using assent and consent forms that explain 
their participation using age appropriate language. The re-assenting and consenting processes 
will take place at the next assessment appointment after they age into a new category. Example 
consent/re-assent templates for impacted children are included in Appendix A (This change was 
made on 7.25.19 prior to review and approval by the DSMB, DSMB approved protocol addenda, 
10.25.19). 
  
 
2. 
Primary Care Provider Consent 
Since we are interested in primary care providers’ knowledge of evidence-based treatments as 
well as their attitudes toward and their satisfaction with the treatment conditions implemented 

Page 23 of 305 
 
within their practices, we plan to collect basic demographic data (e.g., age, years in practice, 
highest degree obtained) and responses to self-report questionnaires from the physicians 
providing UC to the participating families. Primary care providers willing to participate in this 
research will sign a consent form that outlines the purpose of their participation in providing 
research data, the benefits and risks to individuals who participate, and the confidential nature 
of information obtained. Participation in the research portion is completely optional and a 
decision not to participate will in no way affect their role as a care provider on the study nor 
their current job status, which will be clearly outlined in the consent form. A trained study staff 
member will answer any questions the primary care provider has about his or her participation 
in the study (This change was made on 2.27.18 prior to review and approval by the DSMB, DSMB 
approved protocol addenda on 11.2.18). 
 
3. 
PLAN Coach Consent 
PLAN coaches will also be asked to participate in research designed to assess the delivery and 
implementation of FBT in the primary care setting through reporting of demographic data and 
responses to self-report questionnaires. As with the primary care providers, if they are willing 
participants, they will be asked to sign a consent form that outlines the purpose of their 
participation in providing research data, the benefits and risks to individuals who participate, 
and the confidential nature of information obtained. Additionally, a separate section of the 
consent form will allow researchers access to FBT session recordings for analysis and reporting 
in future publications. While the monitoring of audio-recordings for training and quality control 
purposes will be part of the expected duties of the PLAN coaches, participation in the research 
portion (e.g., providing demographic information, and the use of audio recordings for data 
analysis and scientific publication purposes) is completely optional, and a decision not to 
participate will in no way affect their role as a PLAN coach on the study, which will be clearly 
outlined in the consent form. This consent form will be administered by a trained study staff 
member who will answer any questions the PLAN coach has about his or her participation in the 
study prior to the on-site training seminar. 
Additionally, PLAN coaches will be asked to participate in an audio-recorded semi-structured 
interview; interested coaches will provide consent over the phone and will be asked a series of 
questions by a trained post-doctoral researcher on the study.  The questions are based on the 
coaches’ discussions with FBT families pre-COVID and amid-COVID regarding food cost, 
perception, and behaviors. The telephone interviews are voluntary and will be completed based 
on the coaches’ availability. (This change was made 7.13.20, DSMB approval 12.16.2020) 
  
 
 
Randomization 
The DCC will use the REDCap randomization module to create an online password protected 
randomization system that will facilitate the random assignment of families. When the website is 
entered, the user will provide information that establishes the eligibility of the family. Group 
assignments will be revealed only if all eligibility criteria are satisfied. To avoid temporal bias, 
randomization will be blocked within clinic using random block sizes in order to preclude the 
possibility that investigators might know in advance the assignment of the last family in a particular 
block. 

Page 24 of 305 
 
 
Families who enroll in the study will be scheduled for a baseline assessment to gather preliminary 
study data. Following this visit, the family will be randomized and then informed of the treatment 
condition to which they have been assigned. A PLAN coach will follow up with families randomized 
to FBT to schedule the first FBT visit (Session 0; This change was made on 9.18.17 prior to review and 
approval by the DSMB, DSMB approved protocol addenda on 11.2.18). Ideally, all treatment sessions 
will take place in the pediatric practices. If there are issues with space at the pediatric practices, FBT 
families can be seen at alternate locations (i.e., satellite office, university setting, etc.) for their 
weekly and assessment sessions. Usual care assessments can also be conducted at an alternate 
setting. (This change was made on 10.17.18 prior to review and approval by the DSMB, DSMB 
approved protocol addenda on 11.2.18) 
 
Participant randomization will begin November 2017 (This change was made on 11.9.2017 prior to 
review and approval by the DSMB, DSMB approved protocol addenda, 11.2.18) and will go through 
August 15th, 2019 (This change was made on 6.6.19 prior to review and approval by the DSMB, 
DSMB approved protocol addenda on 9.29.19). 
 
36 families will be randomized each month of this period (9 families per site) with the last three 
months (Sept. 2018-Nov. 2018) decreasing to 32 families each month (8 families per site) in order to 
reach 528 families (132 families per site). It is estimated that 43.2% of randomized families will have 
an age- and weight-eligible sibling; however, sibling recruitment goals will not be included in 
randomization benchmarks. This estimate is based upon unpublished data in which 163 of the 377 
screened families for a similar weight control program (43.2%) had at least one age and weight-
eligible sibling.  
 
Randomization benchmarks will be overseen by the Recruitment and Retention Committee. The DCC 
will prepare a recruitment report for review by the Recruitment and Retention Committee each 
month indicating the number of randomized total families and randomized minority families. If a 
clinical site is not meeting randomization benchmarks, the committee will make recommendations 
on how to improve their recruitment strategies such as identification of alternative sources of 
participants at the sites, the possible need for increased recruitment resources, more efficient use of 
existing resources, or the addition of new clinics at one or more site. An official review of 
randomization benchmarks will be conducted by the Study Executive Committee (SEC) and will occur 
quarterly at 20%, 40%, 60%, 80%, and 100% of the accrual period. At these time points, if sites are 
not at 100% or more of their randomization targets, despite remediation efforts, recommendations 
to redistribute funds across sites may be made at the discretion of the Study Executive Committee 
to ensure study recruitment milestones are met. 
 
Assessments 
 
Participating parent and child weight will be measured at each major assessment (at baseline and every 
6 months), and weight will be assessed throughout FBT as part of a goal setting and reinforcement 
system by the blind assessors. Child height will also be measured at each major assessment or as needed 
to determine progress (This change was made on 11.9.17 prior to review and approval by the DSMB, 
DSMB approved protocol addenda on 11.2.18).  Weight will be measured using a wireless, portable scale 
(SR Scales, Tonawanda NY), calibration certified. Two weights for each participant will be taken 
according to a uniform protocol and will be written on hard copy measurement sheets. The handwritten 
weights will be manually entered into the REDCap database by a blinded measurement coach, which will 

Page 25 of 305 
 
eliminate potential measurement bias and minimize errors in data entry (DSMB approved change, 
11.18.19). Height will be measured using the portable stadiometer HM200P PortStad by the Charder 
manufacturing company within the pediatric practices (This change was made on 4.6.17 prior to review 
and approval by the DSMB, DSMB approved protocol addenda on 11.2.18).  Hard copy height and weight 
measurement forms will be uploaded to the secure REDCap database to allow the CCC, DCC and TFC to 
check for transcription and/or unit of measurement errors. All assessors will be provided with the height 
and weight protocol (see Height and Weight Measurement in Appendix C) in order to ensure that 
participants are being measured accurately and consistently and we will retain the written record of 
participant height and weight, as well. On the basis of height and weight, BMI is calculated according to 
the following formula: BMI = kg/m2. Children will be considered overweight at or above the 85th BMI 
percentile for their age and sex.35 Parents will be considered overweight if their BMI is greater than or 
equal to 25 kg/m2, and obese if their BMI is greater than or equal to 30.36 
 
In line with Secondary Aim 1, overweight sibling height and weight will also be assessed at each 
major assessment time point in the same manner described above. Alternatively, parents also have 
the option to give consent for assessors to review the non-participating sibling(s)’s medical records 
to access height and weight data (DSMB approved protocol addenda, 11.2.18).  Additionally, non-
participating parent and other sibling heights and weights will be assessed at each major assessment 
time point if feasible. 
 
Delay discounting will be assessed at baseline and again at 12 and 24 months through use of a brief 
computer task administered via REDCap on a laptop. Additionally, baseline predictors of treatment 
outcome will be assessed, specifically, parental inconsistency in rewards and environmental 
enrichment of the home. Data will be collected using self-report questionnaires designed to assess 
these constructs administered on-line via REDCap (see Appendix C). Finally, for the FBT group, 
treatment adherence will be measured throughout the study by treatment session attendance and 
completion of diet and physical activity self-monitoring in habit books or specialized mobile 
applications. 
 
Participant Timeline 
 
1. 
Enrollment/Baseline 
Families who are eligible for the study will meet with a trained study staff member and will be 
given written and verbal information about the study. Full disclosure of the purpose of the 
study, the benefits and risks to individuals who participate, and the confidential nature of 
information obtained during the study will be explained to participants. Families will be aware 
from the onset that they will be randomly assigned to an active treatment condition (FBT) or a 
Usual Care (UC) control condition following baseline questionnaire completion. They will also be 
aware that their expected participation will be 2 years and may require anywhere from 26 
sessions to 96 sessions of FBT if randomized to that condition. The study staff member will 
answer any questions the family has about the study, and then participants will be consented 
according to the policies and procedures of the University at Buffalo Institutional Review Board 
(IRB), the IRB of Record for the study. Study staff will follow-up with families by phone to inform 
them of their randomization status and will schedule the first FBT visit for those families 
randomized to FBT. PLAN coaches will also send reminders for FBT visits to their families 
throughout the study to decrease missed appointments. 
 

Page 26 of 305 
 
2. 
Follow-up 
Following baseline, families will be assessed at months 6, 12, 18, and 24. Links to brief self-
report questionnaires via REDCap will be sent by study staff to all randomized families to 
complete prior to their assessment time point and families will be scheduled for assessment 
visits to collect height and weight measures and to complete the delay discounting task (DD; at 
12 and 24 months only). Families will be greeted by the blinded PLAN coach or assessor at the 
practices to complete the DD computer task and collect heights and weights according to the 
protocols. Families will also have the opportunity to complete the REDCap questionnaires if they 
were unable to do so prior to the in-person assessment. Blinded PLAN coaches and assessors 
will complete all necessary forms and submit them into REDCap following this appointment. 
Families will be reminded of their next assessment in the series until it is the final visit.  Home 
visits can be arranged for assessment appointments if necessary, and will be attended by two 
PLAN staff members.   
 
3. 
Final Study Visit 
The final study visit will be conducted similarly to the previous measurement appointments, 
although families will not be scheduled for any additional appointments.  
 
4. 
Early Termination Visit 
Families that are terminated early will be notified by phone or an in-person meeting to relay the 
reason(s) for the termination and provide any resources that would be available and 
appropriate. The families’ access to the website and data links will be eliminated. 
 
5. 
Unscheduled Visit 
PLAN coaches will be available to meet with families at the practices for scheduled 
appointments. Should a family arrive at the practice without an appointment, the office staff 
will be instructed to encourage the family to notify their PLAN coach or assessor. The PLAN 
coach or assessor will follow up with the family by phone, email or text to confirm their next 
appointment or to schedule an alternate visit time and will then record the contact in the 
participant tracking form in REDCap. 
 
6. 
Schedule of Events 
See Table 4 below for an outline of events for study participants. 
 
 
7.  
Remote Assessments  
Due to the serious nature of Covid-19 and instructed social distancing, in person assessments 
and sessions are halted. Assessments and sessions will be held through University and Hospital 
approved platforms such as Zoom, Webex, and Skype for business. An instructional video will be 
sent to all PLAN participating families to show how to correctly measure height and weight at 
home with supplies sent from PLAN. Supplies will include a foldable yard stick, a scale and 
carpenters edge if the families do not have access to one.  Remote assessment protocol and 
scripts have been included in Appendices on page 239.  
 
Table 4. Measurement Timeline 
Measures 
Method 
Time 
(min) 
Examinee 
Time point 
0 
6 
12 
18 
24 
Primary and Secondary Aim 1 Outcomes 

Page 27 of 305 
 
Weight1 & Height 
Scale and 
stadiometer 
5 
P,C,S, NPP 
X 
X 
X 
X 
X 
Delay Discounting (Secondary Aim 2) 
Delay of Gratification  
Computer Task 
20 
P,C 
X 
 
X 
 
X 
Participant Level Predictors (Secondary Aim 3) 
Parental Survey 
Questionnaire 
2 
C 
X 
 
 
 
 
Environmental Enrichment 
Questionnaire 
10 
P 
X 
 
 
 
 
SAE/AE Survey 
Questionnaire 
5 
P,C 
 
X 
X 
X 
X 
Provider Level Predictors (Exploratory Aim) 
Attitudes towards Evidence-
Based Treatments 
Questionnaire 
5 
PCP 
X 
 
 
 
 
Attributes of FBT2 
Survey Questions 
5 
PCP 
 
 
X 
 
 
Intended Adoption3 
Questionnaire 
1 
PCP 
 
 
 
 
X 
Participant and Provider Level Descriptors  
Family Demographics 
Questionnaire 
10 
P, Pc 
X 
 
 
 
 
Family Nutrition and 
Physical Activity (DSMB 
approved protocol addenda, 
9.29.19). 
Questionnaire 
10 
P 
X 
 
X 
 
X  
Participant Adherence to 
FBT 
Session Attendance1 
NA 
P,C 
X 
X 
X 
X 
X 
Participant Acceptability 
Client Satisfaction 
Questionnaire 
5 
P,C 
 
 
 
 
X 
24 Month Survey (DSMB 
approved protocol addenda, 
9.29.19). 
Questionnaire 
15 
P,C 
 
 
 
 
X 
Provider Demographics 
Questionnaire 
10 
PCP 
X 
 
 
 
 
Provider Usual Care Survey 
Questionnaire 
10 
PCP 
X 
 
 
 
X 
Chart review  
Questionnaire 
-- 
Plan Coach 
 
 
 
 
X 
Coach Demographics (This 
change was made on 
7.25.19 prior to review and 
approval by the DSMB, 
DSMB approved protocol 
addenda on 9.29.19). 
Questionnaire 
5 
PLAN 
Coach 
 
 
 
 
X 
Coach Treatment 
Knowledge (This change 
was made on 7.25.19 prior 
to review and approval by 
the DSMB, DSMB approved 
protocol addenda on 
9.29.19). 
Questionnaire 
10 
PLAN 
Coach 
 
 
 
 
X 
Coach Attitudes Toward 
Evidence Based Treatment 
(This change was made on 
Questionnaire 
10 
PLAN 
Coach 
 
 
 
 
X 

Page 28 of 305 
 
7.25.19 prior to review and 
approval by the DSMB, 
DSMB approved protocol 
addenda on 9.29.19). 
Coach Attributes of FBT 
(This change was made on 
7.25.19 prior to review and 
approval by the DSMB, 
DSMB approved protocol 
addenda on 9.29.19). 
Questionnaire 
5 
PLAN 
Coach 
 
 
 
 
X 
Total Time for Each Group 
Child 
12 
5 
10 
5 
10 
Parent 
55 
5 
10 
5 
15 
Provider 
25 
0 
5 
0 
11 
PLAN Coach (This change was made on 7.25.19 prior to review and approval 
by the DSMB, DSMB approved protocol addenda on 9.29.19). 
0 
0 
0 
0 
30 
 
II. Treatments 
 
Usual Care (UC) 
The usual care control group will consist of the care typically delivered by the family’s pediatrician 
for children with overweight or obesity. (This change was made on 11.9.17 prior to review and 
approval by the DSMB, DSMB approved protocol addenda on 11.2.18). The implementation of UC 
may vary between physicians but typically include an assessment of the child’s weight, help 
removing barriers to weight loss, and introduction of goals for better weight management. 
 
Family-based Behavioral Weight Loss Treatment (FBT) 
 
1. 
Introduction 
Each PLAN coach will provide FBT to families randomized to FBT. FBT utilizes behavior change 
techniques to target family-wide changes in diet and physical activity habits with the goal of 
promoting weight loss and subsequently healthy weight maintenance in both the participating 
child and his or her parent. Preliminary evidence demonstrates effects may even extend to 
other family members not enrolled in the program. Due to social distancing as a result of Covid-
19, all participating families will be shown an instructional video intended to aid in gathering 
reliable height measurements.  
 
2. 
Conceptual Components 
Dietary Goals 
Consume 1200-1800 kcal/day (This change was made on 4.6.17 prior to review and 
approval by the DSMB, DSMB approved protocol addenda on 11.2.18). Increase fruit and 
vegetable consumption and decrease consumption of high energy dense and/or low 
nutrition density foods and beverages to help shape food preferences. Calories will be 
adjusted according to weight change without reducing calories below 1000 to ensure 
essential calories are being met for a healthy diet 
(http://health.gov/dietaryguidelines/2015/guidelines/appendix-2/).  
 

Page 29 of 305 
 
Physical Activity Goals 
90 minutes of moderate to vigorous physical activity each day for children and 60 
minutes of moderate to vigorous physical activity 5 days per week for adults. Decrease 
time spent engaging in sedentary activities such as watching TV and playing computer 
games to two hours or less per day (This change was made on 4.7.2017 prior to review 
and approval by the DSMB, DSMB approved protocol addenda on 11.2.18). Information 
on achieving a healthy number of sleep hours each night will also be given. Moderate to 
vigorous physical activity goals will be shaped and mastered at different increments. 
 
Behavior Change Tools 
Self-monitoring, goal setting, problem solving, stimulus control, positive parenting 
techniques such as the provision of incentives for behavior change, assistance in 
reducing the need for immediate gratification using episodic future thinking (EFT) – a 
method for improving impulse control, and finding behavioral substitutes for highly 
reinforcing food. Families will have access to traditional paper and pencil self-
monitoring, and after self-monitoring skill is acquired, families can choose to use 
traditional or technology-based self-monitoring systems such as use of a FitBit or 
MyFitnessPal. 
 
Delay of Gratification 
The ability to delay gratification can be quantified by delay discounting (DD), or the 
tendency to discount large future rewards for smaller, immediate rewards.37 Research 
suggests that children with obesity are more likely to choose a small immediate food 
reward over a larger delayed food reward.38-40 Inconsistent parenting and less enriched 
environments also have a negative impact on ability to delay gratification. Thus, we use 
FBT to improve parental consistency to reduce DD, alter the shared family environment 
to reduce DD, and provide individual skills in parents and children to reduce DD. 
 
Social Facilitation Approaches 
Social facilitation approaches are designed to help families engage in social events and 
activities as alternate reinforcers to unhealthy eating and activity behaviors. Participants 
are taught assertion and communication skills to improve their social interactions within 
their existing social networks and participants are encouraged to form new relationships 
that serve to support and reinforce healthy behaviors. Additionally, children are 
coached on their abilities to deal with teasing to reduce negative social interactions. 
 
Educational Tools 
The Traffic Light Eating Plan and Food Reference Guide, which utilizes GREEN, YELLOW, 
and RED labels for food to guide families toward the goal of consuming low energy-
dense, high nutrient-dense foods will be used. Foods are assigned a traffic light color 
based on the average calories to obtain basic nutrients for each food group in the Food 
Guide Pyramid. For example, if a serving of a vegetable is less than 60 kcals/serving it is 
a GREEN food, if it is between 60-80 kcals/serving it is a YELLOW food, and if the 
vegetable is greater than 80 kcals/serving it is a RED food. Foods in the other food group 
categories are designated YELLOW or RED based on how many calories it takes to 
provide nutrients for foods in that food group (vegetables are the only food group with 
GREEN food designations) 
 

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The Traffic Light Activity Program and Activity Reference Guide also utilize GREEN, 
YELLOW, and RED labels for different levels of caloric expenditure to guide families 
toward increasing physical activity and reducing sedentary behaviors. Sedentary 
activities, those that are 1.9 3 METS (Metabolic Equivalents) or less, are considered RED 
activities, and the goal is to reduce them, particularly, screen time. YELLOW activities 
are 2.0 to 2.9 METS, equivalent to the lower end of MVPA (moderate to vigorous 
physical activity). Activities that are 3.0 METS or greater are considered GREEN 
activities. The goal is for child participants to obtain 90 minutes of MVPA per day and for 
parents to obtain 60 minutes of MVPA at least 5 days per week. Activities can include 
lifestyle behaviors (e.g., walking to school, biking with friends), or participating in 
organized sports, but must be engaged in for bouts of at least 10 minutes. 
 
3. 
Mastery-Based FBT Level System41,42 
FBT will be implemented on an individual basis to adapt the dose of treatment to the individual 
participant needs. While adaptable, FBT “dose” will be consistent with the USPSTF 
recommendation of 26 or more hours of individualized, intensive intervention.13,43 The minimal 
FBT dose includes 8 weekly visits, 8 two times per month visits, and 6 monthly visits for the first 
year, and 4 quarterly visits for the second year of intervention. A mastery system will be used to 
ensure parent and child are reading and understanding the program materials. Families are 
encouraged to initiate behavior change at their pace, and are rewarded for incremental 
changes. The goal for all families is for children to show a reduction of percent over BMI of at 
least 10 percent.  
 
Mastery of program information recognizes that not everyone learns at the same rate. Master 
of program content includes five areas: 1) changes in individual diet and activity; 2) changes in 
the family; 3) changes in peer networks; 4) changes in community; and 5) relapse prevention. 
Instruction on parenting will be given throughout each section. Progression through treatment 
topics will be based on mastery of treatment knowledge as demonstrated by scores of at least 
80% on quizzes related to the content of each unit. If scores of 80% are not achieved at the end 
of each unit, areas for remediation will be targeted and corrective feedback will be given until 
scores of 80% are obtained (multiple versions of unit quizzes will exist for this purpose). 
 
Changes in eating, activity and parenting are rewarded using a point system. Children and 
parents work independently toward their goals at their own pace.  They will focus on the 
behavioral goals in the areas in diet, physical activity and parent/child interactions as part of the 
reinforcement system.  The other supporting behaviors skills are encouraged through program 
materials, interactions with coaches, and parental praise.  Participants move toward the 
ultimate behavioral goals of FBT independently of each of the specific goals or other participant 
in the family (children and parents move at their own independent pace). The behavioral skills 
we are emphasizing have demonstrated success over traditional FBT through 1-year follow-up.42 
These behavioral skills have demonstrated associations with weight loss and weight loss 
maintenance (e.g., changes in diet, monitoring, sleep44; episodic future thinking45-48; skills related 
to the family/home and social environment49; relapse prevention skills50,51).  Table 5, displays the 
behavioral goals, and the frequency of sessions based on the families weight loss success. The 
bolded behaviors will be reinforced with points, all others will be reinforced by praise. 
 
 

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MASTERY-BASED FBT BEHAVIORAL SKILLS LEVEL SYSTEM 
Session Frequency 
Session frequency will be determined solely by weight change1, as measured in each treatment session. In order to reduce 
session frequency, both parent and child must meet weight loss goals for 2 consecutive weeks. Any subsequent weight 
gain will result in an increase in session frequency until pattern of loss has been restored. 
Weight 
 
Weekly 
Bi-Weekly 
Monthly 
Quarterly 
Reduction in Percent Over 
BMI (C) 
15% 
Weight loss 
≥20% 
Maintain weight 
loss ≥20% 
Maintain weight 
loss ≥20% 
 
 
Reduction in Percent of Total 
Body Weight (P) 
10% 
Maintain weight 
loss ≥10% 
Maintain weight 
loss ≥10% 
Maintain weight 
loss ≥10% 
Mastery Behaviors 
Mastery behaviors to be assigned by PLAN coach according to treatment protocol; families must demonstrate mastery 
(meeting goal 5 of 7 days) for 2 consecutive sessions in order to progress to next mastery level. Behaviors will be tracked 
via P & C Habit Books. 
Nutrition 
Calorie Range 
total per day 
1200-18002 (This change was made 
on 4.6.17 prior to review and 
approval by the DSMB, DSMB 
approved protocol addenda on 
11.2.18). 
Adjusted3 
 
GREEN Foods/Drinks 
total per day 
2 
3 
4 
≥5 
 
RED Foods/Drinks 
total per day 
≤10 
≤7 
≤4 
≤2 
Physical 
Activity 
(PA) 
GREEN PA (C) 
minutes X days per week 
(DSMB approved protocol 
addenda, 11.2.18). 
30x3 
45x4 
60x5 
90x5 
 
GREEN PA (P) 
minutes X days per week 
(DSMB approved protocol 
addenda, 11.2.18). 
20x3 
30x4 
45x4 
60x5 
Driving Behaviors 
Driving behaviors to be assigned by PLAN coach according to treatment protocol and individual needs. Targets listed reflect 
overall PLAN goals to be achieved through shaping; session goals will be assigned to progress from baseline to target. 
Parenting 
(This 
change was 
made on 
10.17.18 
prior to 
Praise 
times per day 
1 
2 
3 
4 
Stimulus Control 
times per week 
1 
2 
3 
4 
Daily Check In 
days per week 
4 
5 
6 
7 

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review and 
approval by 
the DSMB, 
DSMB 
approved 
protocol 
addenda on 
11.2.18) 
Meal Planning 
days per week 
2 
3 
4 
5 
Weight 
Graph* 
Graphing Weight (C) 
2 days per week 
Graphing Weight (P) 
7 days per week 
Nutrition 
Dinner Prepared at Home 
≥3 days per week 
Routines 
EFT Practice (P) 
≥5 times per week 
Recreational Screen Time 
≤2 hours per day or ≤15 hours per week (This change was made on 4.7.2017 
prior to review and approval by the DSMB, DSMB approved protocol 
addenda on 11.2.18) 
 
 
Healthy Sleep Routines (C) 
9-11 hours per night 
 
Healthy Sleep Routines (P) 
7-9 hours per night 
Social 
Engaging in PA with Family 
≥3 times per week 
Engaging in Healthy Eating & 
PA with Friends 
≥3 times per week 
Accessing Healthful 
Community Eating & PA 
Resources 
≥3 times per week 
 
NOTES ON MASTERY-BASED FBT BEHAVIORAL SKILLS LEVEL SYSTEM: 
● 
C = child; P = parent; PA = physical activity; EFT = episodic future thinking 
● 
Weight percentages are a guide 
o 
Weight loss will be individualized based on initial participant weight and subsequent weight loss 
o 
1Weight change will be assessed in reference to lowest measured weight (e.g., if loss in week 3 and gain in 
week 4, loss can only occur in week 5 if weight is below week 3 measurement) 
● 
Bolded behaviors will be reinforced by the point system 
● 
Calorie ranges individually assigned based on weight loss 
● 
2Calories for weight loss will range from 1200-1800 to promote 0.5 lb. loss for children and 1 lb. loss for parents 
each week 
● 
3Adjusted refers to adjustment of caloric intake (as monitored by coach) designed to maintain body weight in a 
healthier weight range  
● 
*Completing the weight graph involves having families weigh at home. If families do not have access to a home 
scale, the coach will lend them a commercial-grade scale for the duration of the study (This change was made on 
10.17.18 prior to review and approval by the DSMB, DSMB approved protocol addenda on 11.2.18).  
● 
Specific and timely praise statements 
o 
Verbal praise statements 
o 
Physical gestures such as hugs 

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● 
Stimulus control 
o 
Arranging the environment so triggers are less impactful (i.e., reducing cues for less healthy behaviors and 
increasing cues for healthy behaviors) 
o 
Number of stimulus control changes in the environment that were operating that week 
● 
Episodic future thinking practice 
o 
Practicing simulating future events when making decisions about small immediate rewards vs. larger 
delayed rewards 
 
Meeting behavioral goals is assessed by the FBT PLAN coach during sessions by reviewing parent 
and child daily habit books and a self- report FBT monitoring checklist completed by the parent 
that tracks behavioral goal progress over the previous week. Weight loss is conjointly required, 
in addition to self-reported habit changes, to increase assurance in the accuracy of self-reported 
behavior changes. Since weight loss is related to these self-reported behavioral changes, we do 
not want to reinforce participants who report making the changes but who are not losing 
weight. In this way, participants who report behavioral changes are not moved to the next 
phase of session frequency unless they show expected weight loss. Likewise, participants who 
show weight loss but who do not report behavioral change will remain at the same session 
frequency until behavioral change meets mastery criteria. This is to ensure that behavioral skills 
that are known to promote weight loss and weight maintenance are acquired and maintained 
over time. Weight loss goals were selected based on literature demonstrating a 5-10% loss in 
body weight yields clinically significant changes52,53; however, they may be individualized based 
on initial participant weight and subsequent weight loss. Participants will be moved from weekly 
sessions to biweekly sessions to monthly sessions to quarterly sessions when they have met the 
specified behavioral goals for at least 2 weeks and when they have met the weight loss criterion. 
Weight loss criteria for weekly, biweekly, and monthly sessions were designed for weight loss, 
and quarterly sessions for weight maintenance. 
 
Dosage will be based on mastery of program material, progress in behavior change, and weight 
change. Sessions will be weekly for at least 8 weeks and until at least a decrease of 10% percent 
over BMI is observed. Sessions will go to 2 times per month and will continue for at least 8 
weeks or until a new weight loss goal is attained. Treatment will transition to maintenance goals 
and less frequent meetings. If a family is able to reach the weight maintenance after 6 months, 
they will switch to quarterly meetings until the end of the study. If participants are unable to 
maintain behavioral goals or weight loss/maintenance goals of any level at any point, they will 
be returned to intensive weekly sessions to prevent relapse. This will occur until participants are 
able to maintain their weight loss for 2 weeks at the given level at which point they will continue 
to progress through the dosing schedule. See Table 6 for examples of different “dosing” based 
on rates of progress through the program. 
 

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TABLE 6. FBT Sessions Over 24 Months Based on Differential Rates of Mastery of FBT 
 
Maximum Dose 
Moderate Dose 
Minimum Dose 
Number of Weekly Sessions 
48 
24 
8 
Number of Biweekly Sessions 
24 
12 
8 
Number of Monthly Session 
 
12 
6 
Number of Quarterly Sessions 
 
 
4 
 
Total Number of Contacts Over 24 Months 
72* 
48 
26 
Note: *With the mastery model, it is possible that a family could be seen weekly for the duration of the 
study 
a. (approximately 96 visits over the course of the entire study). However, we have chosen to 
illustrate a more typical visit frequency for families slow to master behavioral skills of 72 
sessions over the course of the study. If a family is showing signs of becoming a retention risk, 
then we will adjust the frequency of FBT sessions to a treatment schedule that is acceptable to 
the family (This change was made on 3.18.19 prior to review and approval by the DSMB, DSMB 
approved protocol addenda on 9.29.19).  
 
4. 
Family Sessions  
 
Session Structure 
Each treatment session will be structured as follows: parents and children are first weighed 
and then have a 30-60-minute individual family meeting with their PLAN coach, during 
which time the family: 1) reviews habit books and self-report checklists with their PLAN 
coach; 2) receives feedback on behavioral skill acquisition, weight goals, and progression 
through the levels of FBT; 3) receives education on diet and physical activity (See Table 7 for 
a list of education topics); 4) is taught behavior change techniques; 5) sets behavioral goals 
for the week; and 6) reviews and addresses any barriers to goal attainment or to adherence 
with the weight loss behaviors. 
 
Table 7. Overview of FBT Education Topics 
Unit 
Chapter 
Topics 
1 
1 
Introduction to PLAN; Pediatric Care Practice, Learning, Activity and Nutrition 
2 
2 
Traffic Light Eating Plan  
3 
3 
Monitoring Food; Recording Daily Intake  
4 
Monitoring Red Foods 
4 
5 
Measuring Foods; Portions 
5 
6 
Recognizing Hunger and Satiety Cues 
6 
7 
Reading and Understanding Food Labels  
7 
8 
Pre-Planning  
8 
9 
Positive Parenting and Praise 
10 
Being a Good Model for Your Child  
11 
Encouragement; Daily Meetings 
9 
12 
Goal Setting; Cutting Calories 
10 
13 
Traffic Light Activity Program 
11 
14 
Energy Balance 

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12 
15 
Stimulus Control 
13 
16 
Healthy Shopping and Budgeting  
14 
17 
Healthy Routines: Behavior Chains; Meal Regulations  
18 
Healthy Routines: Sleep; Self-Weighing 
15 
19 
Reviewing Traffic Light Eating Plan Concepts 
16 
20 
Reinforcement and Rewards 
17 
21 
Prospection 
18 
22 
Problem Solving Skills  
19 
23 
High Risk Situations: Restaurants, Parties, Holidays and Vacations 
20 
24 
Recipes and Healthy Cooking  
21 
25 
Decreasing Red Activity 
22 
26 
Social Support and Making Social Networks Even Healthier 
27 
Planning Physically Active Social Gatherings 
23 
28 
Taking on Teasing 
29 
Stigma and Body 
24 
30 
Emotional Eating 
25 
31 
Focusing on Health at School, Work and Neighborhood 
26 
32 
Consolidating Healthy Living Skills 
33 
Maintaining Motivation and Relapse Prevention 
34 
Long-Term Maintenance   
 
Session Content 
FBT focuses on parents as the gatekeepers of health-related behaviors by improving 
parenting skills for the modification of child eating and activity behaviors as well as general 
child-parent interactions. Parents will be trained in general parenting methods to foster 
positive behavior change, such as learning to praise their child and implementing a parent-
delivered reinforcement system. Reinforcers, such as additional time spent with a parent 
engaging in a favorite activity or a sleepover with a friend can be earned for meeting dietary 
and activity goals.  Parents will be provided with strategies to modify the shared home 
environment in order to facilitate the behaviors that are targeted. Children and their 
parents will be taught problem solving and preplanning to deal with challenging situations, 
as well as techniques for coping with teasing. A unique aspect of FBT is the emphasis on 
creating an ecology that supports long-term change, which includes modifying the family 
environment, reshaping peer group networks, and ensuring that there are community 
resources available to the family to maintain behavior change. In this way, barriers to weight 
loss and maintenance of the loss are addressed across contexts, reinforcing healthy lifestyle 
changes and making them more readily sustainable. 
 
5. 
Technological Support 
A study website will provide information to families about FBT, provide downloadable versions 
of the Traffic Light Eating Plan and Food Reference Guide and the Traffic Light Activity Program 
and Activity Reference Guide, and provide links to handouts with information on healthy 
cooking and recipes, getting more physical activity, and positive parenting tips. All quizzes to 
assess mastery of educational materials will also be accessible via the study website, with 
multiple versions of quizzes on each topic available, recognizing that some participants will 
acquire mastery of the required behavior change information more slowly than others. 

Page 36 of 305 
 
 
III. Training and Fidelity Monitoring 
 
General Training in Study Procedures 
The DCC will work closely with clinic investigators to ensure the training and certification of all staff 
that perform study procedures. These efforts will focus on ensuring that (1) investigators, 
coordinators, and designated backups have appropriate familiarity with the details of the protocol; 
(2) all evaluations are carried out by individuals certified as being knowledgeable about and 
experienced with relevant study procedures; and (3) relevant staff are comfortable with data entry 
and management procedures. To accomplish these goals, the following procedures will be carried 
out. 
a. During the multisite FBT training at WU, the DCC will facilitate a meeting to discuss the 
details of the protocol and the standardization of data collection and to provide hands 
on experience with data collection procedures. During that meeting, staff will be 
certified to perform the task to which they are assigned by demonstrating the 
appropriate competencies and knowledge. 
b. Certification of data entry personnel will require that they establish familiarity with the 
system by entering data on at least four test subjects. 
c. At least two individuals will be certified to perform every task to ensure that backup is 
always available. 
d. ID numbers of individuals performing assessments will be included on data forms and 
will be computerized. Using a DCC maintained list of certified personnel, it will be 
routinely confirmed that assessments have been performed by certified individuals. 
e. Modified data on forms will be initialed and dated by the person making the change. 
f. When new personnel are hired during the study, individual clinics will be empowered to 
certify the new person as an alternative to less efficient centralized efforts. 
 
PLAN Coach Training and Fidelity 
FBT PLAN coaches will be hired by the clinical site PI. Clinical site PIs will be encouraged to hire 
individuals with at least a bachelor’s degree, and who possess, or are pursuing, an advanced degree 
in a related field of study such as dietetics, social work, or clinical psychology. Basic demographic 
information will be gathered regarding PLAN coach age, gender, educational background, 
race/ethnicity, prior experience with families or behavioral health interventions, etc. to help tailor 
training to their level of experience and to identify any PLAN coach level descriptors associated with 
ease of acquiring fidelity and competency in intervention delivery. These PLAN coaches will be 
trained using a combination of education, interactive role-playing, simulations, and treatment 
practice with pilot patients. 
 
https://buffalo.zoom.us/j/2320132211?pwd=VUJHMGRVSlU1NzYwUHZVMjh3MUYrdz09 
 
1. 
Multisite FBT Training 
PLAN coaches will attend a multisite FBT training at Washington University in St. Louis during 
the week of April 24-28, 2017 and at the University at Buffalo on July 11-12, 2017. All PLAN 
coaches will complete the on-site training workshops and must earn an 80% or above on the 
post-training assessment at the end of these trainings in order to be certified to initiate 
recruitment. If any coaches do not achieve this score, remedial instruction will occur and they 
may repeat the quiz. 
 

Page 37 of 305 
 
2. 
Educational Materials 
The study website will include articles on FBT for the PLAN coaches to read, and it will also 
provide a thorough training manual to teach behavioral, diet, and exercise principles used in the 
study, as well as other relevant readings. The website will also include web-based pre- and post-
assessments of FBT knowledge. PLAN coaches will need to demonstrate mastery of the material 
prior to working with families. 
 
3. 
Interactive Role Playing and Simulation 
Live and Skype training sessions will provide the opportunity to role play important behavioral 
skills. Training will conclude with a treatment session simulation, during which PLAN coaches 
will be rated on their utilization of FBT components to ensure competency. If the written and 
simulated assessments demonstrate lack of knowledge and skills, FBT concepts will be retaught 
until mastery is achieved. 
 
4. 
Pilot Patients 
PLAN coaches will practice delivering FBT to two families (at least 12 sessions each) not 
randomized to the study. They must demonstrate competency on at least four consecutive FBT 
sessions for each family, as determined by ratings of their audio- recorded treatment sessions, 
before they may begin treatment with a randomized family. 
 
5. 
Post-Training 
Training acceptability will be assessed using a 6-item self-report questionnaire adapted from 
Lyons and colleagues. PLAN coaches will receive supervision throughout their delivery of FBT. 
Manuals and checklists will be used during FBT treatment sessions, and each FBT session will be 
audio recorded. Supervision will be provided for all PLAN coaches by study staff experienced in 
FBT from the Training and Fidelity Core (TFC). Treatment fidelity will be evaluated by random 
audits of audio recordings using integrity checklists. Audits will be conducted by trained TFC 
raters who were not involved in training the PLAN coaches. The text below provides a summary 
of the PLAN coach training and quality control process for the present study. 
 
6. 
Alternate Training 
As some turnover in PLAN coach staffing is inevitable following the initial training workshop and 
piloting of families, an alternative method for training and certifying PLAN coaches has been 
developed. Within the first two weeks of hiring, new PLAN coaches must complete HIPAA and 
CITI training, watch the video recordings of the first training and pass the post-training quiz with 
a score of 80%. They will then role play four mock sessions with their fellow PLAN coaches, 
which will be audio recorded. FBT supervisors will review these sessions and provide feedback. 
The coaches will then schedule four simulations with the Training and Fidelity Core. After 
completing these simulations, the coach will begin seeing families randomized to FBT. All 
sessions will be audio recorded, reviewed by supervisors and feedback will be provided in 
writing and over the phone until 8 consecutive sessions have been rated 'competent'.  Once the 
replacement coach receives satisfactory ratings on at least eight consecutive sessions, they will 
be certified to work with randomized families (DSMB approved protocol addenda, 3.18.19). 
 
7. 
Summary of FBT Training Process: 
a. Complete HIPAA/CITI training as required by IRB of Record and/or participating clinical 
sites 
b. Read and become familiar with: 

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i. Study Protocol 
ii. General Articles Describing FBT 
iii. Treatment Manuals 
iv. Traffic Light Eating Plan and Food Reference Guide 
v. Traffic Light Activity Program and Activity Reference Guide 
c. Participate in on-site training workshops to be held prior to the randomization of the 
first participant 
d. Earn a score of 80% or greater on post-training assessment 
e. Engage in role plays and simulations with a TFC FBT expert to practice key behavioral 
intervention strategies (This change was made on 11.9.17 prior to review and approval 
by the DSMB, DSMB approved protocol addenda on 11.2.18). 
f. Conduct at least 12 treatment sessions with two pilot families 
g. Participate in regularly scheduled teleconference Clinical Case Review Groups for 
supervision with a TFC FBT expert and other PLAN coaches 
h. Provide audio recordings of the first four sessions with each pilot family and then two 
audio recordings from randomly selected visits with pilot patients for rating by the TFC 
FBT expert; if audits of any of these recordings result in competency ratings by the TFC 
FBT expert of less than “competent,” the PLAN coach will receive written and verbal 
corrective feedback and must submit audio recordings of all subsequent pilot sessions 
until two consecutive sessions (for each family) are rated as “competent” before 
working with families randomized to FBT 
i. 
“Certification of Interventionist” form signed by TFC FBT expert and returned to DCC 
prior to starting intervention with participants which confirms that: 
i. Appropriate human subjects training has been completed  
ii. Readings have been done and understood 
iii. Pilot training has been successfully completed 
iv. The PLAN coach agrees to uphold the highest ethical and professional standards 
while working with participants in the study 
 
8. 
Booster Training 
a. Booster training workshops will occur every 6 months; PLAN coaches must score 80% or 
greater on quizzes given after workshops. 
b. Two intervention session recordings will be randomly selected by the TFC FBT expert 
every 6 months to ensure PLAN coach adherence to the treatment protocol 
c. Recordings must receive a competency rating of “competent.” If rated “not competent,” 
corrective feedback is provided to the PLAN coach and session audio recording reviews 
will be repeated until two randomly selected recordings are rated as competent. 
 
Assessment Training and Fidelity 
Assessments will be performed only by trained and certified staff members. Details of the 
assessment protocol and the standardization of data collection procedures will be presented at the 
FBT training. Additionally, assessment staff will gain hands on experience with the relevant data 
collection procedures and will be certified to perform these tasks during the training. At least two 
individuals at each site will be certified to perform each task to ensure that backup is always 
available. The DCC will maintain lists of certified personnel. Individual clinics will be empowered to 
certify new personnel as an alternative to the initial centralized training session. Video-recordings of 
skilled assessors conducting the assessment procedures will be available following the training 
workshop to aid in standardization of training across sites. 

Page 39 of 305 
 
 
1. 
Initial Training 
All PLAN coaches and assessors will complete assessment training at the WU FBT training during 
the week of April 24-28, 2017 and the UB FBT training on July 11-12, 2017. During these 
trainings, staff will learn standardized procedures for collecting height and weight, (This change 
was made on 11.9.17 prior to review and approval by the DSMB, DSMB approved protocol 
addenda on 11.2.18), and collecting data via REDCap (including family surveys). Staff will have 
the opportunity to pilot these procedures on volunteer staff and study team members 
throughout the training. Additionally, all sites will be provided with the necessary educational 
materials to ensure adherence to assessment procedures following the training. 
 
Study tasks will be performed only by staff that are trained and certified to perform their 
assigned task. At the in-person trainings or video-taped instructional trainings, the 
standardization of data collection procedures will be discussed.  Additionally, staff will gain 
hands on experience with the relevant data collection procedures and will be certified to 
perform these tasks. The DCC will maintain lists of certified personnel, and individual sites will 
be empowered to certify new personnel as an alternative to the initial centralized training 
session. During the initial session, staff will be rigorously trained to certify new personnel that 
may be added during the implementation of the study via procedures detailed by the DCC. The 
DCC assessor training will be recorded, and video-recordings of skilled assessors conducting the 
assessment procedures will be available following the training workshop to aid in 
standardization of training across sites.  
 
2. 
Certification 
All PLAN coaches and assessors will be required to reach reliability for height and weight 
measurements (3mm for height, .25 lbs for weight, this change was made on 11.9.17 prior to 
review and approval by the DSMB, DSMB approved protocol addenda on 11.2.18).  Coaches will 
complete 10 different measurements according to the height procedures. If the reliable staff 
member and new staff member do not meet acceptable reliability criteria, additional 
participants should be measured by both staff members until adequate reliability is established. 
Additionally, they must prove competent in administering REDCap surveys as assessed by the 
clinical site project coordinator (This change was made on 11.9.17 prior to review and approval 
by the DSMB, DSMB approved protocol addenda on 11.2.18). When PLAN coaches and assessors 
reach reliability or competency for each of these measures, they will receive a “Certification of 
Assessment.”  
 
II. Research Procedures and Approach 
 
Practice Retention 
 
1. 
Expectations 
a. Create realistic expectations prior to recruitment. 
b. Provide practice with information regarding the study (e.g., recruitment, treatment, space 
considerations). 
c. Explain to practices how this study may impact their workflow. 
d. Keep clear and timely communication with the practices. 
2. 
Ongoing Strategies 
a. Prepare and post/distribute recruitment materials for practices. 

Page 40 of 305 
 
b. Remain friendly and open to answer any questions or concerns. 
c. Lend solutions to any issues that may arise in the practice concerning the study. 
d. Pay out incentive money  
e. Update progress of study and recruitment goals (This change was made on 3.23.18 prior to 
review and approval by the DSMB, DSMB approved protocol addenda on 11.2.18). 
 
Participant Retention 
Each of the sites has experience in subject retention, and both the University at Buffalo and 
Washington University have experience in retention in FBT. We will use a 3-step evidence-based 
approach to retention.54-56 First, we will gather names, addresses and phone numbers of at least two 
family members or friends who have regular contact with the participating families. Second, we will 
send greeting cards for birthdays and holidays to the participant over the course of the study. Third, 
we will provide personal and telephone contacts with the same staff over time whenever possible to 
facilitate familiarity and rapport. We will also provide continued emphasis on the importance of 
their contribution to their community and the legitimacy of the project. 
 
1. 
Expectations 
a. Emphasize up front the common challenges families face. 
i. 
Big time commitment 
ii. 
Family emergencies 
iii. 
Changes in routine 
iv. 
Resistance from family members 
v. 
Some difficulty reaching goals 
b. Discuss how the study is a big commitment. 
c. Discuss why participation in the study is worth it. 
i. 
State-of-the-art program that teaches the child and parent how to lose weight and 
maintain the loss 
ii. 
Decreased risk for health problems for the child and parent now and in the future 
iii. 
Prevention of heart disease and type 2 diabetes 
iv. 
Increased energy, better sleep, and better overall fitness from regular exercise 
v. 
Improvement in mood and sense of accomplishment from completing the program 
vi. 
Mastering skills earlier in life to reduce the social stigma of obesity  
d. Discuss commonality of resistance from child and how to handle it. 
e. Emphasize the expertise of the staff and their ability to help with this problem. 
 
2. 
Ongoing Strategies 
a. Always have a positive attitude and treat all participants in a caring, person-centered 
manner. 
b. Thank the families for coming and praise efforts from week to week. 
c. Treat each participant as an individual and demonstrate respect for cultural practices. 
d. Emphasize the potential importance of the study in conversations. 
e. Respect the family’s and school’s schedule and demonstrate appreciation for their efforts to 
attend. 
f. Show consideration for the family’s schedule by starting and ending on time. 
 
3. 
Participation and Retention Benchmarks 
 

Page 41 of 305 
 
Intervention Participation 
Participants are expected to attend at least 70% or more of their prescribed FBT meetings, 
as indicated by their level of mastery of program knowledge and skills. The study staff will 
use a “case management approach” to ensure that each participant’s active involvement is 
cultivated and tracked, which will include opportunities for make-up sessions, telephone 
sessions, and home visits to maintain participation. 
 
Families randomized into the UC group will attend medical appointments at the discretion 
of the physician according to their usual practices and availability, as well as the preferences 
of the participating family. As such, no benchmarks for usual care visits are specified. 
 
Assessment Participation 
Retention guidelines indicate that at least 80% of participants who are randomized will be 
retained at the 24-month assessment. It is estimated that drop-out rates will be higher in 
the first six months, as a steeper dropout rate was observed in the first four months of the 
recently completed, NIH funded COMPASS trial, than in the following 20 months. In order to 
maintain participation in assessment time points, we will offer flexible scheduling, make-up 
audio sessions, and home visits.  
 
4. 
Participant Tracking 
Participants will be tracked in REDCap in order to maximize retention in the study and, as 
necessary, to capture any drop-outs or withdrawals that occur during the study period. PLAN 
coaches can verify the status of their FBT families by accessing the REDCap Record Status 
Dashboard, which will list all existing records/responses and their status (i.e., incomplete or 
complete) for every data collection instrument in the study. PLAN coaches can verify that FBT 
families and UC families at their site have completed assessment time points as well as the 
family members that participated in these assessments. Additionally, PLAN coaches can utilize 
the REDCap calendar to manage participants and appointments, and they will complete Tracking 
Forms each week to document session attendance or absence of their FBT families. In order to 
ensure that families in both arms are captured at all necessary time points, the DCC will send 
regular reports to indicate participant status and subsequent required actions on behalf of the 
study team.  
 
5. 
Participant Withdrawal or Termination 
Children and parents can withdraw from the research at any time, and siblings and non-
participating parents can withdraw or be withdrawn without any consequences to the other 
family members’ status in the study. If participants withdraw, they will be debriefed about the 
nature of the study, asked permission to obtain data collection through medical records or brief 
appointments, and, if terminated, provided with the reason for their removal as well as a 
referral if deemed appropriate. Any information that had been provided may be retained by the 
researcher and analyzed. This includes permission to collect body composition information from 
their physicians at determined measurement time points (if not revoked upon their withdrawal). 
 
Participants who exhibit unhealthy weight loss, clinically concerning symptoms of disordered 
eating, or develop an illness or condition that would bias the data may be withdrawn from 
research analyses, as determined by the SEC, SMC, and the Data Safety and Monitoring board 
(see section IX) and referred to an appropriate professional (This change was made on 3.23.18 
prior to review and approval by the DSMB, DSMB approved protocol addenda on 11.2.18). 

Page 42 of 305 
 
 
Lost to Follow-Up for FBT Families (DSMB approved protocol addenda, 9.29.19): A designation of 
Lost to Follow-Up (LTF) is applied to intervention families that we have not had contact with for 
3 months (90 Days). 
  
a. During the 3 months after last contact the Coach should: 
i. Attempt all retention strategies outlined by the retention algorithm (Appendix Z 
of Manual of Procedures. 
1. For instance, handwritten note, text, call (day, evening, and weekend), 
email, etc. 
ii. Note: Families going on a scheduled hiatus are NOT LTF. 
b. Once the family is labeled lost to follow up, Coaches will attempt contact them monthly 
c. A family can come back to the study after being marked LTF. 
i. When an LTF family comes back, re-engagement will include: 
1. Review of contact info, alt. contacts, and best methods of contact and 
time of day. 
2. Review of initial motivation for study and link it to why they want to 
continue. 
3. Problem solving barriers to attendance and make plan for future 
a. Attempt to rebuild momentum. 
4. Review weight change during break. 
Risks to Human Subjects 
 
1. 
Potential Risks 
Safety of human participants is of utmost concern especially in a trial involving children. Efforts 
will be made to limit the use and disclosure of participants’ personal information, including 
research study and medical or education records, to people who have a need to review this 
information. We will collect information on changes in height and weight from medical records 
as needed if a family discontinues study participation or is unable to provide data at the 24-
month time point. The assessment process may carry potential risks. For example, some of the 
questions may be upsetting to participants, and some participants might feel uncomfortable 
having their height and weight measured. Other risks associated with participation in the 
intervention include possibly feeling hungry when dieting or sore after exercising. In addition, in 
select children, excessive attention paid to dieting may lead to an eating disorder or to growth 
problems. There are also several potential risks to family members in the course of therapy. 
First, there is a degree of inconvenience for family members who may miss work, school 
activities, meetings, etc. Second, there is the risk, as there is in any therapy, of a stress reaction 
occurring. Third, there may be some family disagreements during the implementation of the 
intervention as issues of family functioning, communication, and discipline may be discussed. 

Page 43 of 305 
 
Finally, there is the risk of a breach of confidentiality. Coach interviews are expected to be no or 
minimal risk of asking the interview questions. 
 
2. 
Adequacy of Protection Against Risks 
All key personnel involved in the design or conduct of research involving human subjects will 
receive the required education on the protection of human research participants prior to the 
start of the study. The PLAN coaches will collect and manage data collected from these 
participants and will not engage the pediatricians in the research. If required by a site’s 
individual IRB, PLAN coaches will complete Business Associate Agreements prior to their work 
within the practices. 
 
Individuals administering assessments will be made aware of the possibility of a participant’s 
discomfort about answering questions or having height and weight measured. Participants will 
be informed that they do not have to answer any questions that make them uncomfortable, and 
height and weight will be measured in private to minimize embarrassment. Participants will be 
advised of the possibility of hunger with dieting or soreness after exercise. In order to reduce 
the risk of exercise-related injury, all participants will be encouraged to follow their primary care 
physician’s instructions regarding exercise.  
 
On an ongoing basis, the family meetings will serve as the primary venue to detect and address 
any eating disturbance, and study PLAN coaches will be trained to monitor, recognize, and 
intervene if symptoms of disordered eating behaviors or attitudes emerge. If a PLAN coach 
notices that a participant is consuming a nutritionally inappropriate quantity or quality of foods, 
he or she will assist the participant in achieving appropriate intake. Should a participant show 
symptoms consistent with an eating disorder during treatment, the PLAN coach, in consultation 
with the treatment supervisor at the Training and Fidelity Core, will decide whether to 
recommend that the family be withdrawn from treatment and/or refer them for treatment 
elsewhere. This will be stated in the consent form.  
 
To the extent possible, flexibility in scheduling treatment sessions and assessments will help 
minimize the inconvenience of missing work, school activities, or meetings due to treatment 
obligations. Having expert and well-supervised PLAN coaches conduct treatments will mitigate 
the risk of a stress reaction occurring. The PLAN coaches will be aware of how to recognize such 
stress responses in their early form, and will conduct sessions in such a way as to reduce such 
responses. PLAN coaches will also be trained to deal with potential family disagreements. If any 
participant appears to be in crisis, appropriate action will be taken based on established suicide 
and crisis assessment protocols, and any adverse event will be reported promptly to NIMH and 
to the IRB of Record. 
 
3. 
Confidentiality 
Patient confidentiality will be maintained in compliance with HIPAA regulations. Any identifying 
information will be kept confidential, and patient records will be kept in locked files protected 
by two locks and accessible only by those directly involved with the implementation of the 
study. The locked files will be housed in the clinical site PI’s office at each site, and no data, files, 
or any other study participant information will leave these offices. Treatment session audio 
recordings will be securely stored at each center, and will be labeled by study ID, date and 
session number, without further identifiers. These recordings will be stored in locked cabinets 
with restricted access and will be destroyed three years after the end of the study, depending 

Page 44 of 305 
 
on the policy set by the Study Executive Committee and the IRB of record. Copies of selected 
session audio recordings, labeled as above, will be sent to the Training and Fidelity Center at WU 
for auditing. 
All coach interview audio files will be stored in a double password protected computer and a de-
identified file name. The audio files will be transcribed using Amazon Transcribe, once this is 
completed the audio files will be destroyed. The transcription file will be de-identified and also 
stored in a double password protected computer. 
 
All materials, discussions, and proceedings of the Data and Safety Monitoring Board (DSMB) are 
completely confidential, and members and other participants in DSMB meetings are expected to 
maintain confidentiality. All employees of the study with access to protected health information 
are required to complete HIPAA and CITI training and comply with the privacy procedures in 
place at their institutions. 
 
Potential Benefits to Human Subjects and Others 
The prevalence of overweight in both children and adults has been increasing at an alarming rate. 
Effective treatments for childhood obesity have the potential to provide substantial health benefits 
and to decrease the number of children tracking obesity into adulthood. Although we do not 
guarantee any benefits from this study, the intervention, if successful and if it replicates our 
previously completed studies, has several potential benefits. Potential benefits to participants 
include improved physical health, improvements in the quality of nutritional intake, increases in 
physical activity, reduction in body weight, and long-term maintenance of this reduced body weight. 
The treatment may also reduce the stress on the family posed by the burden of obesity. In addition, 
it is possible that skills to solve ongoing problems that perpetuate obesity may improve. The 
growing prevalence of obesity and its health-related consequences highlight the need to examine 
potential treatments that may help children to lose weight and sustain weight loss over time, and to 
investigate the effectiveness of providing these treatments within primary care settings. Therefore, 
the potential risks that are associated with this study are reasonable when considering the many 
health-related benefits that the participants and their families may gain. Coach interviews has no 
benefits to the coaches. Potential benefits to researchers include: detailed accounts of discussions 
of food cost and perception between PLAN FBT coaches and families, direct discussions with 
coaches (implementers of the treatment intervention), and a deeper understanding of 
when/how/why coaches tailor pieces of the treatment.   
 
 
II. Data Safety and Monitoring Plan 
 
Safety Oversight 
 
An independent panel of experts with experience in clinical trials, health services research, 
biostatistics, and pediatric and adult obesity, consisting of at least three members who are not 
affiliated with the study – including a clinician with expertise in childhood obesity, an 
epidemiologist, and a patient advocate – will be appointed to constitute a DSMB. Members 
named include study staff and a representative of NIH. In addition, the study PIs, Drs. Leonard 
Epstein and Denise Wilfley, the director of the DCC, Dr. Ken Schechtman, and designated staff 
will attend the DSMB meetings (as non-voting participants) and will be responsible for preparing 

Page 45 of 305 
 
and presenting data reports from the study. The DSMB will provide oversight and ongoing 
monitoring of participant safety, recruitment and retention rates, quality of data collection, and 
integrity of the study and will convene during the first 3 months of the study to allow for a full 
review of the study protocol. The study data will be reviewed by the DSMB every 6 months via 
teleconference or more frequently if preferred by the DSMB. The DSMB will receive a report 
from the study DCC approximately 4 weeks before each review date. These reports will include 
the major variables necessary for monitoring safety and quality of data collection and integrity 
of the study and will include otherwise blinded outcome data. Because study protocol and 
consent forms are relevant to the safety and quality of data, the DSMB will also review these 
documents before the onset of the study. Based on this review, the DSMB will possess the 
authority to prevent the study from starting or to recommend that the study be stopped after it 
has begun. The DSMB will prepare a report based on the material received from the DCC, which 
will be forwarded to the PIs to review at study executive committee meetings and also to be 
forwarded to the IRB of Record, as well as project officer, by Dr. Epstein. 
 
1. 
Safety Monitoring Committee 
First, we have established an internal Safety and Monitoring Committee (SMC) to oversee the 
assessment and reporting of adverse events (AE), serious adverse events (SAE), and 
unanticipated problems (UP). This committee, which will be chaired by Dr. Teresa Quattrin, will 
regularly review reports of AEs, SAEs, and unanticipated problems in collaboration with the 
DSMB.  Additional members include Rebecca Campo, PhD. 
 
Should a member of the study staff become aware of a possible AE, SAE, or UP (see section IX.D 
in the study protocol), s/he will notify the clinical site PI, local site PI, and PC with a detailed 
email summarizing the event (This change was made on 3.23.18 prior to review and approval by 
the DSMB, DSMB approved protocol addenda on 11.2.18), complete an Adverse Event Form or 
Serious Adverse Event Form, and as recommended by the site PI and PC contacts the SMC.  The 
local site PI will sign off on the AE/SAE and will forward this and a recommendation for action to 
the Safety Monitoring Committee (SMC). Each site PI will make sure that the AE/SAE is reported 
to the IRB within the allotted time frame (DSMB approved protocol addenda, 3.18.19). The SMC 
will then evaluate the severity of the event and determine the necessity for immediate action on 
behalf of the study group. If immediate action is necessary, the SMC will consult with the 
Steering Committee to recommend a course of action. If immediate action is not necessary, the 
event will be documented in the study database and discussed at the next scheduled DSMB 
meeting. The PC will review any recommendations from the SMC and/or local-site PI and 
forward them to the coach. The Coach will implement the recommendations with the family and 
report the outcome back to their site PC. The PC then informs the PI and SMC of the AE 
resolution. After the AE/SAE and event resolution is reviewed, the chair of the SMC will sign off 
on all AEs/SAEs (see Figure 1; DSMB approved protocol addenda, 9.29.19). Additionally, the DCC 
will prepare monthly reports that summarize adverse events and assess whether there is 
evidence of a between group difference in AE and SAE rates. 
 
All serious adverse events will follow an expedited reporting timeline, which includes 
immediately notifying all participating IRBs through the designated PIs in accordance with OHRP 
guidance. 
 
Lastly, all AEs, SAEs, UPs, and study withdrawals will be forwarded to the DSMB accompanied by 
a detailed explanation according to the timeline in Table 10 of the study protocol. The DSMB will 

Page 46 of 305 
 
ensure that all corrective and/or preventative action plans have been appropriately 
implemented.  
 
 
 

Page 47 of 305 
 
Figure 1. Internal AE/SAE Reporting Procedures (DSMB approved protocol addenda, 9.29.19) 
 
 
 
 
 
 Coach completes AE/SAE form 
 
 Coach updates PC/Clinical 
Supervisor about AE/SAE 
 
 Local-site PI and SMC are given 
the AE/SAE form to review 
 
 PI signs off on the AE/SAE form 
and makes recommendations 
 
 SMC makes recommendations 
 
 PC reviews recommendations 
and forwards them to the coach 
 
 
Coach implements the 
recommendations with the 
family and reports back to the PC 
 
 PC informs the PI and SMC of 
the AE/SAE resolution 
 
 
SMC evaluates the resolution 
and the SMC chair signs off on 
the AE/SAE 

Page 48 of 305 
 
 
Specification of Safety Parameters 
 
1. 
Adverse Events 
For the purpose of this study, an adverse event (AE) will be defined as any untoward or 
unfavorable occurrence (e.g., symptom, sign, or disease) that is temporally associated with a 
subject’s participation in the study, whether or not it is related to participation. 
 
2. 
Serious Adverse Events 
For the purpose of this study, a serious adverse event (SAE) will be defined as any untoward 
occurrence that results in death, is life threatening, requires hospitalization or prolongs existing 
hospitalization, or creates persistent and significant disability. 
 
3. 
Unanticipated Problems 
For the purpose of this study, an unanticipated problem (UP) will be defined as any event that is 
unexpected, is related or possibly related to participation in the research study, and suggests 
the research places participants or others at a greater risk of harm than was previously known 
or recognized. 
 
Classification of Adverse Events 
 
1. 
Severity 
AEs will be assessed for severity and can thereby be classified as mild, moderate, or severe in 
nature. Mild AEs require minimal or no treatment and do not interfere with the participant’s 
daily activities. Moderate AEs result in a low level of inconvenience or concern with the 
therapeutic measures and may cause some interference with functioning. Severe AEs interrupt a 
participant’s usual daily activity and may require systemic drug therapy or other treatment. 
Severe events are usually potentially life-threatening or incapacitating. 
 
2. 
Relatedness 
AEs will be assessed for their relatedness to the procedures involved in the research study and 
can thereby be classified as: (1) definitely related, (2) possibly related, or (3) not related (see 
Table 8 and 9; DSMB approved protocol addenda, 9.29.19). 
 
3. 
Expectedness 
Expectedness will be assessed in terms of the event’s nature, severity, and frequency. Events are 
considered unexpected when they are not listed in the protocol and consent forms or are not 
listed at the specificity or severity that has been observed (see Table 8 and 9; DSMB approved 
protocol addenda, 9.29.19). 
 
 
 

Page 49 of 305 
 
TABLE 8. Adverse Events Determination Table (DSMB approved protocol addenda, 9.29.19). 
 
Classification 
Adverse Events  
Expected 
Relatedness* 
Physical Activity  
Broken Bones/Fractures 
X 
(Possibly) 
Related 
 
Bruising 
X 
(Possibly) 
Related 
 
Concussion 
X 
(Possibly) 
Related 
 
Cuts 
X 
(Possibly) 
Related 
 
Joint Swelling/Pain/Sprain 
X 
(Possibly) 
Related 
 
Muscle Pulls  
X 
(Possibly) 
Related 
 
Tendonitis 
X 
(Possibly) 
Related 
 
Shin Splints 
X 
(Possibly) 
Related 
 
Sprains 
X 
(Possibly) 
Related 
 
Strains 
X 
(Possibly) 
Related 
 
Soreness 
X 
(Possibly) 
Related 
 
Asthma Exacerbated during PA 
X 
(Possibly) 
Related 
Mental Health  
Eating Disorders: Nor present 
before study enrollment 
X 
(Possibly 
Related) 
 
Loss of Control: Due to 
external causes 
 
Not Related 
 
Loss of Control: No external 
causes mentioned 
X 
(Possibly 
Related) 
 
Emotional outbursts during 
sessions 
X 
(Possibly 
Related) 
 
General anxiety or depression 
due to external causes 
 
Not Related 
 
Anxiety or Depression with any 
mention of the study 
X 
(Possibly 
Related) 
 
Extreme depression or suicidal 
idealization  
 
(Possibly 
Related)  
 
 
 

Page 50 of 305 
 
TABLE 9. Very Common Pediatric Events Table (DSMB approved protocol addenda, 9.29.19). 
 
Very Common Pediatric Events 
Expected 
Relatedness 
Abdominal pain and/or vomiting and/or 
diarrhea for <48 hours 
X 
Not Related 
Allergic/seasonal rhinitis 
X 
Not Related 
Cold or URI 
X 
Not Related 
Ear infection 
X 
Not Related 
Influenza and flu-like symptoms 
X 
Not Related 
Pharyngitis/tonsillitis 
X 
Not Related 
Worsening of asthma symptoms not related 
to physical activity in patient with known 
asthma or reactive airway Disease (RAD) and 
NOT requiring pediatrician or ED visit 
X 
Not Related 
Note: The SMC created a list of very 
common pediatric events to account for AEs 
that typically occur within the target 
population regardless of study participation. 
  
  
 
 
 
Adverse Event Assessment and Tracking 
The occurrence of an adverse event (AE), serious adverse event (SAE), or unanticipated problem 
(UP) may come to the attention of research staff during treatment sessions, assessment visits, or 
other participant contact (e.g., scheduling phone call or e-mail). PLAN coaches and assessors will be 
made aware of possible expected events, including: adverse emotional experiences (e.g., 
discomfort, embarrassment), or stress, hunger with dieting, soreness after exercise, and emergence 
of potential eating disordered attitudes or behaviors. As outlined in Adequacy of Protection Against 
Risks (VIII.C.2), measures will be in place to reduce the likelihood of these events occurring.  
 
To account for differences in the frequency of participant contact between the two study groups, 
blinded measurement staff will systematically assess for AEs in both the intervention and control 
groups through use of a standardized questionnaire (see MOP) that is administered at each major 
assessment time point.  If any items are endorsed on the questionnaire, the blinded measurement 
staff will gather additional information and, if necessary, follow the steps for recording and 
reporting adverse events outlined below and in section IX.E. AEs uncovered in the course of 
treatment will also be subject to the procedures below. Combining between visit and at visit AEs 
will result in an alternative count that the DSMB requested. This alternative count will be comprised 
of all AEs, whether reported at or between visits. Blinded coaches will be unaware if an AE was 
reported between visits, and any duplicates will be removed by an unblinded reviewer (DSMB 
Approval,12.16.2020) 
 
All AEs, including those not meeting the criteria for SAEs, will be captured on an Adverse Event Form 
or Serious Adverse Event Form (see Appendix D), which must be approved of and signed by the 
clinical site PI. Information to be collected includes event description, time of onset (and offset if 
applicable), assessment of severity, relationship to study treatment, expectedness, actions taken, 

Page 51 of 305 
 
and outcome of the event. Additionally, all SAEs will require categorization (e.g., death, 
hospitalization, permanent impairment, etc.) and documentation of any interventions implemented 
in response to the event.  
 
All AEs occurring during a participant’s study participation must be documented appropriately 
regardless of relationship. All AEs will be followed by the DSMB to adequate resolution and will be 
recorded in the data collection system. Any medical condition that is present at the time that the 
participant is screened will be considered as baseline and not reported as an AE. However, if the 
study participant’s condition deteriorates at any time during the study, it will be recorded as an AE. 
Changes in the severity of an AE will be documented to allow for an assessment of the duration of 
the event at each level of severity. AEs characterized as intermittent require documentation of 
onset and duration of each episode.  
 
The clinical site PIs will record all reportable events with start dates occurring any time after 
informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of 
study participation. Events will be followed by the DSMB for outcome information until resolution or 
stabilization. 
 
It is important to note that in previous similar clinical trials in the PIs’ respective laboratories, the 
procedures outlined above have been used to protect against and minimize potential risks to 
participants, and they have proved effective in preventing emotional and physical complaints as well 
as adverse events. 
 
Due to the fluid situation of COVID-19, 3 additional questions have been added to the AE 
questionnaire.  Asking these questions could give us data on the effects of the pandemic and could 
help explain changes in FBT attendance and assessment retention.  
 
i.  Do you have a positive COVID-19 test? 
ii.  Did you have exposure to someone with a known positive COVID-19 test? 
iii.  Did you need to get tested for COVID-19?  
 
(emergency status implemented 3.16.2020, DSMB approval, 5.7.2020)  
 
 
Adverse Event Reporting Procedures 
Upon initial receipt of information, all fatal or life-threatening suspected serious adverse events will 
be immediately reported to the IRB of Record, internal IRBs, NHLBI, SMC, and DCC via Dr. Epstein 
and the clinical site PIs. All non-fatal, non-life-threatening suspected SAEs will be reported within 15 
calendar days to the IRB of Record, internal IRBs, NHLBI, SMC, and DCC via Dr. Epstein and the 
clinical site PIs. Any unanticipated problems that do not classify as SAEs will be reported within 14 
days of the investigator becoming aware of the problem to the IRB of Record, internal IRBs, NHLBI, 
SMC, and DCC via Dr. Epstein and the clinical site PIs. All UPs will also be reported within 30 days of 
the IRB’s receipt of information to the Office for Human Research Protection via the IRB. Non-
serious adverse events will be documented in the study database following their occurrence and will 
be reported annually to the IRB of Record and internal IRBs via Dr. Epstein and the clinical site PIs. 
See Table 6 for a detailed outline of reporting timelines.  
 

Page 52 of 305 
 
Adverse event questionnaires and reporting forms are included in Appendix D of the study protocol. 
Once a site’s research staff becomes aware of an adverse event’s occurrence, that staff (i.e., PLAN 
coach or assessor) will consult with the clinical site PI or project coordinator to complete the 
appropriate event form and notify the SMC. Adverse event questionnaires will only be administered 
after assessment measurement by blinded measurement staff, who will correspondingly complete 
an adverse event log (10.12.20; DSMB approval,12.16.2020). The SMC will then evaluate the severity 
of the event and determine the necessity for immediate action on behalf of the study group. If 
immediate action is necessary, the SMC will consult with the Steering Committee to recommend a 
course of action (e.g., discontinuation of treatment, referral to higher level care). If immediate 
action is not necessary, the event will be documented in the study database and discussed at the 
next scheduled DSMB meeting. Additionally, the DCC will prepare monthly reports that summarize 
adverse events and assess whether there is evidence of a between group difference in AE and SAE 
rates. 
 
All adverse events and study withdrawals, together with a detailed explanation of the event and 
withdrawal, will be forwarded to the DCC and the DSMB. In addition, at its regular meeting, the 
DSMB will summarize all adverse events of any severity, to be forwarded to the IRB via the 
designated PI. All serious adverse events will be immediately recorded by the clinical site PI and 
reported to the IRB and DCC, via the designated PI; information (i.e., event, actions, and implications 
for study) will then be distributed to the other clinical sites. Any SAEs and AEs that are judged to be 
possibly or probably related to participation in the study and/or change their assessment of risk of 
participation will be immediately reported to the DSMB. The remaining SAE/AEs will be sent to the 
DSMB with the 6 month reports (DSMB approved protocol addenda, 3.18.19). If any participant 
appears to be in crisis but the event is not classified as an SAE, appropriate action will be taken 
based on established suicide and crisis protocols, and any adverse event will be reported promptly 
to the DSMB and IRB. 
 
In addition to the existing procedures referenced above, the SMC recommends that as soon as child 
mental health SAEs are reported, to a coach or a PLAN staff designee verbally informs the 
participants’ primary care provider and/or pediatric office staff designee with the description of the 
SAE, date, and referral so that they may follow-up according to their office procedure. Specifically, if 
a child enrolled in the study reports self-injury, a suicide attempt, or harm to others, then this will be 
addressed as a SAE and reported verbally to the pediatrician. The event will be reported by the 
individual with the most amount of information within 24 business hours of learning about the 
event. If a medical, behavioral, or mental health intervention is deemed necessary to address this 
event, it is the pediatrician’s responsibility to follow up with their patient to ensure appropriate care 
is provided. Before this procedure goes into effect, the PLAN coach will communicate this plan with 
each pediatric practice to develop a practice-specific protocol with who to contact and how. In the 
event that a coach is unsure about the severity of the child mental health AE, they will collaborate 
with the local-site PI to determine the severity of the event and whether or not it should be 
reported to the pediatric office. All other mental health AEs will not be reported to the pediatrician, 
but will be reported to the IRB and DSMB as part of normal reporting procedures (DSMB approved 
protocol addenda, 11.18.19). 
 
If a parent becomes pregnant, the PLAN coach will notify the clinical site PI and all weight loss 
treatments will be stopped. The family’s continuation in the study will be limited to the child, 
siblings and non-participating parent if enrolled. The DCC, DSMB, and IRBs will be notified through 

Page 53 of 305 
 
AE reports and a standard form for excluding participants from further data collection and 
treatment. Please see Table 10 below for further details regarding AE reporting. 
 
TABLE 10. Adverse Event Reporting Guidelines 
 
What Event is Reported 
When is Event Reported 
By Whom 
To Whom 
Fatal or life-threatening 
unexpected, suspected 
serious adverse event 
Immediately upon initial receipt 
of information 
Contact PI 
• 
IRB of Record 
• 
NHLBI 
• 
SMC 
• 
DCC 
• 
All PIs and Co-Is 
Clinical Site PIs 
• 
Internal IRBs 
Non-fatal, non-life-
threatening unexpected, 
suspected serious adverse 
event 
Within 15 calendar days of initial 
receipt of information 
Contact PI 
• 
IRB of Record 
• 
NHLBI 
• 
SMC 
• 
DCC 
• 
All PIs and Co-Is 
Clinical Site PIs 
• 
Internal IRBs 
Unanticipated problem that is 
not an SAE 
Within 14 days of the 
investigator becoming aware of 
the problem 
Contact PI 
• 
IRB of Record 
• 
NHLBI 
• 
SMC 
• 
DCC 
• 
All PIs and Co-Is 
Clinical Site PIs 
• 
Internal IRBs 
All unanticipated problems 
Within 30 days of the IRB’s 
receipt of the report of the UP 
from the investigator. 
IRB 
• 
OHRP 
Contact PI 
• 
IRB of Record 
Clinical Site PIs 
• 
Internal IRBs 
All non-serious AEs that are 
not UPs 
Documented in study database 
and reported annually 
Contact PI 
• 
IRB of Record 
Clinical Site PIs 
• 
Internal IRBs 
Study Halting Rules for Participant Safety 
 
There are few risks to family-based behavioral interventions. The intervention focuses on improving 
child and parent health behaviors through behavioral strategies and improved parenting and 
parent/child relations. The main risks are development of disordered eating or psychopathology and 
risks due to a sedentary person beginning to exercise. We will be carefully monitoring participants 
for excess weight loss, psychopathology, and activity-induced injuries. Although we expect that 
there will be very few serious adverse events, we will employ the following stopping guideline based 
on the number of SAEs in the intervention group. The guideline is summarized in Table 11, which 
provides data for maximum acceptable SAE rates of 2%, 4%, 6%, 8%, and 10% and for observed 
numbers of SAEs of 2, 3, 4, and 5. Table 11 is calculated using 1-sided 95% binomial confidence 
intervals and can be interpreted as presenting the maximum total sample size N that is required in 
order to conclude that the toxicity level of the intervention may be excessive for a given number of 

Page 54 of 305 
 
observed SAEs and a given defined acceptable SAE rate. For example, suppose we define 2% as the 
maximum acceptable SAE rate. Then Table 11 indicates that if the third SAE occurs in fewer than 41 
intervention group subjects, then the guideline will have been exceeded because the SAE rate is 
greater than the acceptable 2% value with 95% certainty. 
 
TABLE 11. MAXIMUM ACCEPTABLE SAE RATES 
 
Number of 
Observed SAEs 
Maximum Acceptable SAE Rate 
2% 
4% 
6% 
8% 
10% 
2 
18 
9 
6 
4 
3 
3 
41 
21 
14 
10 
8 
4 
69 
34 
23 
17 
14 
5 
99 
50 
33 
25 
20 
 
Several points about the above discussion are worth mentioning. First, we have used the term 
“guideline” instead of “rule” because we view the decision making process as one in which the 
guideline triggers a multifaceted discussion with the DSMB of whether the study should be stopped 
or modified because of the observed SAE rate. We do not view reaching the stopping boundary as a 
rule that should automatically lead to the termination of the study. Second, the rule will be applied 
both to parents and children separately. Third, we propose setting 2% as the maximum acceptable 
SAE rate because of the low anticipated SAE rate in this study.  
 
At each DSMB meeting, recruitment and retention data will be presented to the DSMB.  If 
recruitment is less than 90% of the target or if retention is less than 80% among randomized 
subjects, study investigators will present proposals for improvements in each of these two domains.  
Note that we use an 80% figure for retention because the original power computations had 
assumed a 20% dropout rate.  Thus, an 80% retention rate is not an indication of reduced statistical 
power.  If under performance by these definitions in either of these domains is present, the DCC will 
perform conditional power computations based on various scenarios regarding the degree of 
improvement that can be anticipated in recruitment and/or retention.  As was the case in our 
original power computations, we will adopt the conservative approach of assuming that study 
dropouts provide no data.  We propose that early termination be considered if the conditional 
power under the recruitment/retention scenarios the DSMB views as most realistic is less than 50%.  
Any final decision about recommending early termination will consider factors such as the impact of 
early stopping on information about secondary endpoints and covariate effects.  It will also consider 
the adequacy of the measures that are proposed to increase recruitment and retention. 
 
II. Data Processing and Management 
 
A central focus of the DCC will be on the development and testing of a secure web based data entry and 
management system. In the sections that follow, we discuss the REDCap system that will serve our 
needs in this domain. 
 
REDCap 
Data management will be accomplished using REDCap, a secure password protected and HIPAA 
compliant web-based system developed at Vanderbilt University that has become a workhorse for 
Clinical and Translational Science Awards around the country, has served as the data entry system of 

Page 55 of 305 
 
choice for more than 1400 research projects at Washington University, and has become a standard 
data entry and management tool for the Division of Biostatistics. REDCap facilitates a variety of quality 
control procedures such as drop down menus for categorical variables, range checks, and skip logic. 
It also facilitates automated transfer to SAS where further quality control procedures will be 
implemented and through which queries will be generated when errors or inappropriately missing 
data are identified. 
 
Testing the Data Management System 
After REDCap data entry screens have been created and before data entry personnel have entered 
any test forms, the first step in testing the system will be internal to the DCC where at least three 
sets of draft forms will be completed and entered into REDCap. The data will then be transferred to 
SAS datasets and item by item comparisons between forms and SAS printouts will be performed. 
The preliminary test forms will intentionally contain outlying and missing observations to confirm 
that range checks and requirements for completing certain fields are functioning properly. A second 
level of testing which will precede the enrollment of subjects will occur when data entry personnel 
are asked, as part of their training and certification, to enter data from all data forms on at least 
three individuals. In addition to confirming the convenience and completeness of the data entry 
screens, these procedures will evaluate all components of the data management process ranging 
from edit checking, to skip logic in REDCap, to the automated transfer of REDCap data to SAS, to the 
correctness of the programs we write to create and store the SAS datasets. These procedures will be 
closely integrated with searches for ambiguous wording, the training of data entry personnel, and 
the modification of an original set of draft forms into a final version. 
 
Data Security and Confidentiality 
Standard features of REDCap and automated procedures of the Division of Biostatistics provide a 
high degree of certainty that subject confidentiality will be maintained and that data will never be 
lost. In accordance with the two key HIPAA requirements, password protection will be required for 
access to study computers and REDCap. Only authorized personnel will have access to the data 
entry system and access will be restricted to data from one’s own clinic. Data entered into REDCap 
are encrypted when transferred to SAS. Standard security and confidentiality measures at the DCC 
include requiring that employees sign confidentiality agreements, that personal identifiers are 
included in electronic databases only under strong necessity, and that encryption is used when 
identifiers are present in SAS datasets. Access to our Division computers is restricted to our faculty, 
staff, and collaborators. Access to accounts that store data from this study will be restricted to DCC 
personnel and the division’s network manager. All file transfers to outside computers use secure 
transfer methods which ensure that all such traffic is encrypted. The entire network wiring plant 
within the Division is behind a firewall and is contained within space physically controlled by us. 
Access to all computers and to REDCap is automatically logged. 
 
Forms and Datasets Manual 
All data entered into REDCap will be transferred to SAS using automated procedures for use in 
future data analyses and reports. Each dataset in the database will contain labels and formats. To 
facilitate use of this database, the DCC will prepare and maintain a detailed “Forms and Datasets 
Manual”, an easy-to-use roadmap for finding the dataset where a particular data item is stored. The 
key component of the manual will be a codebook which contains an alphabetical list of all variable 
names in the entire database, with associated labels and formats for each variable. The codebook 
will also contain the name of the dataset in which each variable is stored. In addition to the 
codebook, the Forms and Datasets Manual will include detailed contents of each dataset, a 

Page 56 of 305 
 
comprehensive set of data forms with variable names next to each entry, and a format library. We 
routinely use such manuals in large studies for a variety of reasons, the most important being that 
they greatly facilitate data management and analysis by making it very easy to find where in a large 
database an item on a particular form is stored. 
 
Archiving Data 
All data will be archived for long-term storage when the study is completed and datasets are 
cleaned and closed. Decisions regarding the timing and procedures that determine eventual public 
access to datasets will be made in accordance with institute guidelines. All publically accessible 
datasets will first be de-identified using the confidentially principles mandated by HIPAA. 
 
Quality Control 
We have a broad view of quality control in clinical research as a multifaceted process that addresses 
concerns such as the accuracy and completeness of computerized data, the common administration 
of protocols across sites, monitoring adherence to protocol requirements, and the training and 
certification of personnel. Other quality control measures we will implement include: 
 
1. 
Data Accuracy and Completeness  
REDCap has a number of built-in quality control features that help ensure accurate and 
complete data and that are accomplished at the clinics when the data are entered. Other quality 
control measures involve actions taken at the DCC, features of the data forms that help facilitate 
high quality data, and steps taken at the clinic as data forms are completed. We already noted 
that the system keeps a log of who entered or changed all data, a feature which permits us to 
discuss with the data enterer any concerns we have about a particular data item. Other quality 
control measures that will help ensure accurate and complete data include: 
 
a. Double data entry of selected forms where complete accuracy is judged to be most 
critical to the study. 
b. Range checks will flag values that are outside a predefined acceptable range. 
c. Accept only a predefined set of values for categorical measures. 
d. All data forms will contain the identification number of the person who completed the 
form, facilitating easy access to the source if there are legibility or other problems with a 
form. 
e. Forms will frequently have a “not done” option so the associated missing data will be 
understood as appropriate. 
f. Investigators and study coordinators will be expected to do visual checks of all 
completed forms to confirm legibility, completeness, and reasonableness as each form 
is filled out. 
 
Our strategy in the first item above of using double data entry for only those forms that contain 
the most critical data is based both on our own experience and a literature that supports this 
approach. Studies suggest that the number of errors that are detected by double data entry in a 
well conducted study is 4-10 per 10,000 key strokes, with range checks detecting about half of 
randomly introduced errors.57,58  Moreover, analytic results are extremely robust to small 
random error rates.59 Based on these considerations and out of concern for the resource 
expenditure that is required of double data entry, our longstanding approach has been to 
employ this approach only for those variables and data forms that are most critical to the study. 
 

Page 57 of 305 
 
2. 
Data Audits 
The DCC will conduct an annual item by item random audit of 10% of data. Logistical 
considerations will determine whether the audit will be performed during site visits or by the 
Project Manager at the DCC using requested copies of forms. Every item on the forms will be 
compared with computerized data and clinic specific error rates will be recorded. We will 
confirm that changes on forms have been initialed and documented, and all identified problems 
will be discussed with clinic personnel and, if necessary, with the Steering Committee. Following 
each audit, a detailed report will be distributed to all clinics. Audits will be timed as feasible to 
precede meetings of the DSMB so we can respond to questions about data quality. 
 
3. 
Quality Control of Forms and Data Entry System 
Section B above discussed the procedures for testing the data management system at the DCC 
itself. Closely integrated with those efforts will be approaches to field testing the data entry 
system, training data entry personnel, and ensuring that the wording of forms is unambiguous. 
To these ends, the following activities will precede enrollment of the first subject. 
a. Staff at each clinic will enter data from one set of draft forms in a formal search for 
ambiguous wording. 
b. Data collection personnel will collect data on two “practice” subjects (who may be 
friends or colleagues) with a view towards getting the outsiders view of ambiguity 
so we can subsequently modify the forms as needed. Outlying data values will be 
encouraged so they can be used in familiarizing data enterers with the quality 
control components of the data management system. 
c. Data collection personnel will test the relevant forms on two “real” subjects. These 
subjects will not become part of the study even though they may be technically 
eligible. 
d. The forms collected from the “practice” and the “real” subjects will be entered into 
REDCap to confirm the familiarity of data entry personnel with the system, as a test 
of the system itself, and as part of the certification process discussed. 
e. After these procedures yield potential modifications of the draft forms, the DCC will 
modify the REDCap screens and will perform a final set of internal tests focused on 
ensuring that any needed modifications have been correctly incorporated into the 
revised system. 
f. To facilitate the above series of sequential steps, the DCC and Steering Committee 
will develop a timeline for completing tasks, and the DCC will send reminders to 
relevant personnel as deadlines approach. 
 
4. 
Summary Reports 
The DCC will prepare summary reports of study progress in response to requests by the Steering 
Committee and the DSMB. It will also prepare regular reports which, using automated features 
to be built into our SAS database, will consider such issues as (1) recruitment rates, (2) the 
proportion of recruited subjects who are eligible, (3) missing form and data rates, (4) the time 
interval between completing a form and entering it on the computer, (5) compliance rates, and 
(6) adverse event rates. These reports will, with the exception of adverse events, be updated 
monthly and made available online through the study website. Because they will be site-specific 
as well as aggregate in their presentation, the reports will contribute significantly to our quality 
control efforts as they will help identify areas of inadequate performance at clinics. Although 
experience suggests that adverse events will be relatively uncommon in a behavioral study such 
as this, the adverse event report will differ from other reports in that severe events that may be 

Page 58 of 305 
 
study related will be reported within 72 hours to the IRB of Record and to the chair of the 
DSMB. 
 
5. 
Site Visits 
The DCC will organize annual site visits to all clinics that will focus on a detailed review of study 
procedures. Special additional site visits may occur if routine quality control measures 
determine that a clinic is having difficulty with some aspect of the protocol. Site visitors will 
prepare an agenda that will include observations of the performance of study procedures and of 
the filing system that is used to store completed data forms. They will confirm that data forms 
are correctly filed, that IRB approvals are available, and that changes on forms are appropriately 
initialed and dated by the person who made the changes. In addition, site visitors may do 
random data audits in accordance with section X.F.2. Site visits will generally be conducted by a 
DCC staff person and by an investigator from another clinic. 
 
III. Statistical Considerations 
 
A. 
Statistical Analysis Plan 
Data will be analyzed with SAS using the intention-to-treat principle.  P-values less than 0.05 will be 
considered significant and all tests are two-sided.  Details of how the intention-to-treat principle will be 
implemented are contained in a later section. 
 
B. 
Primary Analysis  
The primary goal of this study is to determine whether the change in weight status among children who 
have overweight/obesity (Primary Specific Aim 1, DSMB approved protocol addenda, 11.2.18) is superior 
among those who are randomized to family-based treatment (FBT) as compared to those who are 
randomized to usual care (UC) when treated in a primary care setting.  The primary outcome measure in 
children is the percent over the age- and sex-specific 50th BMI percentile.  The specific question of 
interest in the primary analysis is whether the change from baseline to 24 months in the intervention 
group is greater in the FBT group than in the UC group. 
 
The primary analytic strategy reflects the fact that this is an individually randomized group treatment 
(IRGT) trial.34 An IRGT trial is one in which the individual, in this case the family, is the unit of 
randomization.  It differs from a classic individually randomized trial in that the intervention is either a 
group intervention or, alternatively, is conducted by an agent who is responsible for implementing the 
intervention in a defined set of individuals.  In PLAN, participants are randomized at the family level and 
only one randomly chosen eligible child (the index child) is included in the primary analysis.  The 
intervention is conducted by a coach who assumes responsibility for a set of families that receive 
individualized interventions.  Since the study has four sites with three coaches per site, the analysis plan 
involves a nesting of the coach within the site.  Some sites have backup and floating coaches that are 
involved in delivering FBT to study participants, which will also be accounted for when outcome data is 
analyzed (This change was made on 12.4.18 prior to review and approval by the DSMB, DSMB 
approved protocol addenda on 11.18.19). While this nesting suggests a classic cluster randomized trial, 
an IRGT trial is different because the nesting applies only to the intervention group.  Since the control 
group, in this case the UC group, has no nesting factor in an IRGT trial, a proper analysis must reflect the 
fact that in an IRGT trial, the intervention group and the control group must use different covariance 
structures. 
 

Page 59 of 305 
 
With the above comments in mind and with the focus of the study being on a between-group 
comparison of the change from baseline to 24 months, the primary analysis will be an analysis of 
covariance with the 24-month value as the dependent variable and with the baseline value as a 
predictor variable.  The statistical model we employ reflects the parametrization described by Baldwin 
and Colleagues.60 It takes the initial form Y24ij = β0j + β1jXij + Y0ij + eij.  In this model, Y24ij is the 24-month 
value of the percent over the age and sex matched 50th BMI percentile (the primary outcome) for 
subject i and cluster j, with the “clusters” being defined by the coach in the intervention group and by 
individual children in the control group; β0j and β1jXij are the intercept and intervention effect for cluster 
j; Y0ij is the baseline value of the outcome measure; and eij is the normally distributed error term. In 
these models, the intercept and baseline are fixed effects while the intervention effect is random (DSMB 
approved protocol addenda, 11.2.18).  To reflect the partial clustering structure of the IRGT design, the 
above expression is modified by using the cluster-level equations β0j = λ00 and β1j = λ10 + µ1j to describe 
how the coefficients β0j and β1j vary across clusters.  The reparametrization of β1j yields two random 
effects (DSMB approved protocol addenda, 11.2.18) and the term µ1j permits between-cluster variability 
in the outcome measure only within the intervention group (coded as 1).  Substituting in the initial 
equation above yields the final model:  
Y24ij = λ00 + λ10Xij + µ1j Xij + Y0ij + eij 
 
Using PROC MIXED in SAS, separate covariance structures will be fit to the FBT group and the UC group 
to account for the fact that the coach is nested within the site in the FBT group while there is no such 
nesting in the UC group.  All analyses other than the above are secondary or exploratory analyses.  One 
of those secondary analyses will supplement the primary analysis by adjusting for the sex and race of 
the participating child, family income, the educational level of the participating parent, and whether 
there are one or two parents in the household.  These secondary analyses will provide insight regarding 
the impact the covariates may have on the primary outcome. 
 
1. 
Sample Size and Statistical Power 
Power computations for PLAN employ simulations and two-sided tests at the 0.05 level of 
significance.  The simulations reflect the planned primary analysis of covariance and the fact 
that this is an individually randomized group treatment trial with the coach (N=3 per site) nested 
within the site (N=4 sites) in the FBT group but with no such nesting in the UC group.  The 
analysis of covariance that is simulated in the power computations treats the 24-month value of 
the outcome measure as the dependent variable and the baseline value as a covariate.  The use 
of this approach reflects the primary study goal of comparing 24-month values across groups, 
with the outcome being compared being percent over normalized BMI in the participating child.  
Each result is based on 1000 simulations. 
 
Tabulated power values employ sample sizes of 528 and that are between 65% and 95% of that 
total.  Effect size estimates are generated using considerations and preliminary data discussed 
below.  Usual care data involving an intervention and subjects most similar to our UC group is 
provided by Kalarchian61 who randomized 81 8-12-year-old children with obesity to a usual care 
control condition and found an average percent overweight change of -0.17 + 10.08 at 1 year.  
We expect some deterioration in this group at 2 years but will assume conservatively for the 
purpose of power computations that the two-year change will be 0 + 10.08 in the UC group in 
the proposed research. Our estimated change in the FBT group begins with a review of seven 
studies20,62-67 authored by Dr. Epstein.  There were 314 overweight/obese children in those 
studies who received FBT interventions similar to the one we will employ. When we combined 

Page 60 of 305 
 
the data for those 314 children, we found an overall average decrease in percent over BMI of 
10.6 + 15.3 at 24 months. 
 
In translating the above decrease of 10.6 + 15.3 in percent over BMI at 24 months into the 
setting of the proposed research, we emphasize that the seven referenced studies implemented 
FBT in controlled academic settings where we anticipate better performance than is likely in the 
family practices we will employ in this study.  To estimate the degree to which the effect is likely 
to be attenuated when we switch from highly controlled to more “real life” settings, we 
considered the following.  The child weight management intervention MEND (Mind, Exercise, 
Nutrition, Do it) focused on children age 7-13 who exceeded the 91st weight percentile. MEND 
employed both (1) a community-based mass-implementation intervention68 involving many 
programs and 9563 subjects who provided complete data and (2) a rigorous randomized trial69 
(N=116) analogous to the seven Epstein studies referenced in the preceding paragraph. The 12-
month results were reductions in BMI of 0.79 kg/m2 in the community study as compared to 
1.04 kg/m2 in the intervention arm of the randomized trial.  Thus, the reduction in the 
community-based MEND intervention was 76.0% of the magnitude that was observed in the 
family-based arm of the randomized trial.   
 
Based on this 76.0%, our computations conservatively assume changes in the intervention group 
that are 50%, 60%, and 70% of the previously observed change of 10.6 + 15.3 that was observed 
in the rigorous academic environment of Dr. Epstein’s studies.20,62-67  Thus, we base our power 
on a comparison of projected reductions of 5.3 + 15.3 (50% of 10.6 + 15.3), 6.4 + 15.3 (60% of 
10.6), and 7.4 + 15.3 (70% of 10.6) in the FBT group as compared to 0 + 10.08 in the UC group.  
In addition, given projected standard deviations of 15.3 and 10.08 in the two groups, we use the 
maximum and the mean of those two values and thereby compute power assuming standard 
deviations of both 15.3 and 12.7.  In performing the calculations summarized below, we 
emphasize that we will have actual or imputed 24-month data on all subjects.  To see details of 
how we will impute the 24 month values when necessary, please see the section below titled 
“Implementation of the Intention-to-Treat Principle.” 
 
Table 1 contains the results of the power computations using the parameters discussed above, 
assuming the compound symmetry covariance structure in both study arms and assuming an 
intraclass correlation coefficient (ICC) in the UC group of 0.01 and ICCs in the FBT group of 0.04, 
0.06, 0.10, and 0.15.  We assume a small ICC in the UC group of 0.01 because there is no 
clustering within that group meaning that the ICC should be essentially zero.  While we do not 
have data with which to estimate the ICC in the FBT group, we note that many cluster trials that 
involve group interventions have reported ICCs in the 0.01 to 0.05 range.  Since the PLAN 
intervention is individualized and since we expect PLAN children to have no contact with one 
another, we do not face the impact on the ICC that is present in many cluster trials.  This argues 
for a very small ICC in the FBT group.  By contrast, the fact that the same coach will be 
responsible for multiple children will inevitably increase the ICC above where it might otherwise 
be.  Based on these considerations, we tabulate power for ICCs in the FBT group that range from 
0.04 to 0.15.  However, the many other studies that have used group interventions while 
yielding ICCs below 0.05 suggests that the ICC ultimately observed in PLAN will be substantially 
less than 0.1.  
 
Results in Table 1 indicate that if we recruit 100% of our original target of 528 families, power 
will be excellent for all tabulated scenarios with an ICC in the FBT group of 0.1 or less.  For an ICC 

Page 61 of 305 
 
no bigger than 0.1, power remains adequate for most scenarios if we recruit at least 80% of the 
target (N = 432).  If recruitment is below the 80% figure, an adequate power of at least 0.8 
requires either the smaller of the two tabulated standard deviations or a mean difference that is 
at least 60% of the value observed in Dr. Epstein’s studies (difference at least 6.4). 
 
Table 1:  Statistical power for two sided tests at the 0.05 level of significance.   
Computations are for the primary outcome which is the percent over the 50th percentile of BMI in 
children.  Results are generated using 1000 simulations of the primary analytic model:  an analysis of 
covariance with the 24-month value as the dependent variable and the baseline value as a covariate.  
The analysis reflects the fact that this is an individually randomized group treatment trial in which the 
coach is nested within the site within the FBT group but which is different from a classic cluster 
randomized trial in that there is no such nesting within the control (UC) group.  The total number of 
randomized families is assumed to range from 65% to 100% of the target of 528.  Tabulations assume an 
ICC of 0.01 in the UC group and of 0.04, 0.06, 0.10, and 0.15 in the FBT group, mean differences of 5.3, 
6.4 and 7.4 (which represent 50%, 60%, and 70% of observed results in previous studies), and standard 
deviations of 12.7 and 15.3.  
(N’s Adjusted Below, DSMB approved protocol addenda, 9.29.19). 
ICC 
SD 
Mean 
diff 
Statistical power associated with sample sizes ranging from 65% to 100% of original 
target of 528 
FBT 
grp 
UC 
grp 
N=528 
(100%) 
N=502 
(95%) 
N=476 
(90%) 
N=449 
(85%) 
N=422 
(80%) 
N=396 
(75%) 
N=370 
(70%) 
N=344 
(65%) 
 
 
0.04 
 
 
0.01 
 
12.
7 
5.3 
0.95 
0.95 
0.94 
0.92 
0.93 
0.92 
0.89 
0.89 
6.4 
0.99 
0.98 
0.99 
0.98 
0.99 
0.98 
0.98 
0.97 
7.4 
1.00 
1.00 
1.00 
1.00 
1.00 
1.00 
0.99 
1.00 
 
15.
3 
5.3 
0.84 
0.83 
0.83 
0.81 
0.80 
0.76 
0.76 
0.74 
6.4 
0.96 
0.94 
0.95 
0.92 
0.91 
0.91 
0.88 
0.87 
7.4 
0.99 
0.99 
0.99 
0.98 
0.97 
0.97 
0.97 
0.96 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
0.06 
 
 
0.01 
 
12.
7 
5.3 
0.92 
0.91 
0.90 
0.90 
0.88 
0.87 
0.85 
0.84 
6.4 
0.98 
0.98 
0.98 
0.98 
0.97 
0.96 
0.95 
0.95 
7.4 
1.00 
1.00 
1.00 
1.00 
0.99 
0.99 
0.99 
0.99 
 
15.
3 
5.3 
0.80 
0.79 
0.77 
0.78 
0.74 
0.73 
0.70 
0.68 
6.4 
0.92 
0.91 
0.92 
0.91 
0.88 
0.87 
0.85 
0.84 
7.4 
0.97 
0.97 
0.96 
0.97 
0.96 
0.95 
0.93 
0.94 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
0.10 
 
 
0.01 
 
12.
7 
5.3 
0.85 
0.83 
0.81 
0.83 
0.80 
0.80 
0.76 
0.76 
6.4 
0.95 
0.94 
0.94 
0.93 
0.91 
0.92 
0.91 
0.88 
7.4 
0.98 
0.98 
0.98 
0.98 
0.98 
0.97 
0.97 
0.97 
 
15.
3 
5.3 
0.69 
0.68 
0.69 
0.63 
0.67 
0.65 
0.62 
0.60 
6.4 
0.84 
0.82 
0.84 
0.81 
0.81 
0.77 
0.76 
0.78 
7.4 
0.94 
0.94 
0.92 
0.92 
0.91 
0.89 
0.89 
0.87 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
0.15 
 
 
0.01 
 
12.
7 
5.3 
0.73 
0.75 
0.71 
0.72 
0.69 
0.70 
0.70 
0.68 
6.4 
0.86 
0.85 
0.83 
0.85 
0.85 
0.84 
0.83 
0.81 
7.4 
0.95 
0.95 
0.95 
0.94 
0.94 
0.93 
0.93 
0.92 
 
5.3 
0.57 
0.59 
0.55 
0.56 
0.53 
0.53 
0.52 
0.52 

Page 62 of 305 
 
15.
3 
6.4 
0.73 
0.74 
0.70 
0.73 
0.71 
0.67 
0.68 
0.65 
7.4 
0.86 
0.82 
0.86 
0.83 
0.82 
0.81 
0.80 
0.79 
2. 
Rationale for Percent Over BMI as the Primary Dependent Variable for Child 
Weight Change 
We will use the percent over the 50th percentile BMI for our primary dependent measure for the 
children.61 This is commonly labeled as percent over BMI. This measure compares the child BMI 
to children who are at the average BMI for same age and sex. Twenty percent over the average 
value is approximately equivalent to the 85th BMI percentile. Using this metric, based on our 
previous research,20 we expect a reduction in percent over BMI at 2 years of at least 5.3 due to 
the impact of the intervention. One of the strengths of this measure is the large database of 
studies that have used this measure. 
 
There are other approaches to assessing child relative weight change, which include percent 
over the 95th BMI percentile and zBMI.  Percent over the 85th or 95th BMI percentile is a recently 
developed measure that has an advantage of comparing children to children with overweight or 
obesity, rather than to the average weight child.  In other words, when using the percent over 
the 85th BMI percentile, a positive number means the child is overweight, and a negative 
number means they are below the 85th BMI percentile.  We have assessed the relationship 
between values obtained using the percent over 50 versus percent over 85 or percent over 95 in 
a sample of 987 children, and to no surprise, they are correlated greater than 0.98. However, 
this does not mean they are equivalent. Using our database of children for whom we have 10-
year follow-up,62,63 we have also calculated the effect sizes for a sample of 193 children who we 
have studied for 10 years, which provides the largest and only dataset of truly long-term 
changes in the behavioral childhood obesity literature. The effect sizes for the different 
measures are similar at the end of treatment, being about 0.80, but they diverge as the length 
of the follow-up increases. As shown in Figure 1 below, the effect size gets smaller as length of 
follow-up increases, up to approximately the five-year follow-up, when the effect size increases 
for the percent over 85 and percent over 95, but not for the percent over 50. Thus, the percent 
over 50 that we have been using is the most conservative approach to assessing change in child 
relative weight among the percent overweight measures. 
 
Figure 1. Effect size for zBMI at follow-up. 
 
We have also included changes in zBMI over time for 
comparison. As can be seen in Figure 1, zBMI has the 
greatest effect sizes at all-time points. zBMI also compares 
BMI values to population values based on the child’s age 
and sex and attempts to standardize the values using z-
scores. Reductions in zBMI scores are obtained when child 
weight decreases in relationship to their growth. The z-
scores that are used to calculate zBMI are also the basis 
for calculating the 85th and 95th BMI percentiles. While 
zBMI has been used in studies, it has been criticized in part 
since baseline zBMI correlates negatively with change, 
while all other measures of child relative weight discussed 
show a positive relationship. In other words, using zBMI 
children with the lowest zBMI values show larger changes, 

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while children with higher zBMI values show smaller changes. 
  
It is also possible to use BMI values, which do not take into account the child’s age or sex. There 
are two major disadvantages of this approach. First, a child may show a reduction in relative 
weight to height for the other dependent measures, but an increase in BMI. This makes 
determination of success challenging, as you would not expect a child who is showing an 
increase in BMI to be successful. This is due to the fact that population based child BMI curves 
show an increase throughout development until about age 18, so that an increase in absolute 
BMI may be a reduction in BMI relative to normal growth for children that age and sex. 
Secondly, since boys and girls differ in their rates of maturation in terms of height and weight 
trajectories and height and weight velocity, an absolute change in BMI may have very different 
meanings for boys and girls as they develop. 
 
3. 
Longitudinal Analyses of Child Outcome Data   
Secondary analyses involving the child will look more comprehensively at the pattern of change 
over time.  While there is no specific literature on the use of mixed model repeated measures 
analyses in IRGT trials, these analyses are known to inflate the type I error in cluster trials70 and 
it is likely that this also occurs in IRGT trials.  The general recommendation is therefore that 
random coefficient models that may use different covariance structures in the two study arms 
should be employed in the longitudinal analysis of IRGT trials.70 With that in mind our secondary 
analysis of child outcome data will apply these models to all data collected at baseline and at 6, 
12, 18 and 24 months.  In light of the fact that weight changes in intervention studies sometimes 
occur more quickly at the beginning with a subsequent leveling off at later time points, these 
analyses will explore non-linear possibilities such as quadratic models.  They will also adjust for 
the same covariates that were listed in the secondary analysis of the primary outcome to 
understand the impact of the covariates on longitudinal change. 
 
4. 
Covariance Structures and Missing Data 
There are two key considerations that will guide us as we pursue these secondary random 
coefficient models: (1) the selection of appropriate covariance structures and (2) the handling of 
missing data. 
 
5. 
Selection of a Covariance Structure 
PROC MIXED in SAS contains many covariance structure options, including the ability to identify 
covariance structures that are specific to the UC group and the FBT group separately.  Our 
model-selection process for choosing the appropriate covariance structures will reflect several 
considerations including information criteria; the pattern of change in the correlation between 
observations as the time between measurements increases; and the a priori preference for 
structures that, all other things being equal, minimize the number of parameters that must be 
estimated; and whether data collection is equally spaced. While confirmation will have to await 
the availability of the final dataset, we anticipate using an unstructured covariance structure in 
the primary analysis (DSMB approved protocol addenda, 11.2.18). 
 
6. 
Missing Data 
Our handling of missing data begins with consideration of the pattern of missingness. If missing 
data in longitudinal analyses are missing completely at random or at random, they do not 
produce bias. In this setting, we will apply our random coefficient models to all data that are 
available. However, because this approach can yield a meaningful decrease in statistical power if 

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large amounts of data are missing, we will use multiple imputation71-73(using PROC MI in SAS) to 
impute missing values when missingness is excessive and will treat this imputation approach as 
a sensitivity analysis. When data are not missing at random, ignoring the pattern of missingness 
can yield biased analyses. 
  
We will begin our consideration of missing data while the trial is being implemented so we can 
minimize the amount and best understand the pattern of missingness. First, we will do 
everything we can to determine why subjects drop out of the study early and we will ask non-
dropouts the reason for missing a particular visit. If data are missing, for example, because of 
bad weather, it may be likely that they are randomly missing whereas a family that drops out 
because the child is not losing weight will suggest non-ignorable missingness. Information such 
as this will help guide our analytic strategy. Second, we will encourage subjects who wish to 
drop out early to continue to provide key follow-up data, at 24 months in particular. Our 
experience is that many dropouts appreciate the scientific value of their contributions and are 
willing to cooperate in this way. Third and most importantly, we will do all we can do avoid 
dropout and missing data in the first place. In the recently completed 24-month multicenter 
COMPASS study, we collected 24-month data on 165 of 172 children in randomized families 
(95.9%) and 18-month data on five of the 7 who were missing at 24 months. Because the 
COMPASS intervention was performed at our own facilities with us having complete control, the 
dropout rate is likely to be higher in the proposed research where we rely on family practices. 
Nevertheless, if we can come close to the low missing data rate in COMPASS, the potential 
problem posed by missingness will be very limited. 
  
The section that follows on the implementation of the intention-to-treat principle provides 
further insight into the handling of missing data (DSMB approved protocol addenda, 11.2.18). 
 
7. 
Implementation of the Intention-to-Treat Principle 
 
The primary analysis will be an intention-to-treat analysis of the child that includes all subjects.  
Recalling that the primary analysis involves an analysis of covariance with the 24-month value of 
percent over BMI (the primary outcome measure) as the dependent variable, the inclusion of all 
subjects will reflect the following three considerations. 
1. If the 24-month value of the primary outcome is available, the child will be included in the 
primary analysis without the need for further considerations. 
2. If the 24-month value of height and/or weight (the defining components of the primary 
outcome) is missing and the child had height and weight data collected by his or her 
pediatrician at a clinic visit that occurred within 30 days of the targeted 24-month PLAN 
assessment, the following considerations will be used in imputing the 24-month value to be 
used in the primary analysis.  Those considerations are designed to account for the 
anticipated imprecision of values measured at the pediatrician’s office. 
a. Within each clinic, a regression model that will allow us to impute 24-month values 
will be generated.  Using all PLAN children who attend a particular clinic and who 
have both precisely measured PLAN height and weight data and less precise height 
and weight data measured at the clinic within 30 days of the PLAN measurement, 
clinic-specific regression models will separately predict the true height and weight 
using the age and sex of the subject as well as the height and weight value 
measured at the clinic.  The goal will be to perform these calculations on a clinic-
specific basis because the causes and magnitude of measurement error may differ 

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from clinic to clinic.  However, if the number of subjects at a clinic who have the 
requisite height and weight data is less than 15 (less than 5 times the number of 
predictors), we will use all data from all clinics at the relevant study site to perform 
the desired imputation. 
b. Recalling that the children of interest in this scenario have clinic data collected 
within 30 days of the targeted 24-month PLAN assessment, the clinic-specific height 
and weight value calculated above will be used to impute the PLAN 24 month values 
from the contemporaneous value measured at the clinic.  This imputed value will be 
used in the primary analysis. 
c. If there is no clinic visit within 30 days of the 24-month target but there are visits 
both before and after the 24-month time point, we will interpolate linearly between 
predicted height and weight values at those time points to determine the predicted 
24-month value. Because we will only employ this option if height and weight data 
are available no more than three months before and three months after the target 
date for the 24-month visit, we anticipate that this interpolation approach will be 
performed infrequently in practice (DSMB approved protocol addenda, 11.2.18). 
3. If the 24-month value of height and/or weight is missing and the child did not have height 
and weight data collected by his or her pediatrician at a clinic visit that took place within 30 
days of the planned 24-month assessment and did not have height and weight data 
measured at the clinic within three months both before and after the targeted 24-month 
visit, the 24-month value will be imputed using multiple imputation (DSMB approved 
protocol addenda, 11.2.18).  Variables that will be used to facilitate the imputation process 
will be baseline height and weight, age, sex, and race.  Any height and weight data collected 
using PLAN assessments at 6, 12, or 18 months will also be included in the multiple 
imputation. 
 
Two points about the methods discussed in this section are in order.  First, the rational for 
using multiple imputation only after it has been determined that clinic visit data are not 
available as a vehicle for imputing values is as follows.  We anticipate that while values 
measured at the clinic will not employ the same rigor that will be employed in our protocol 
governed visits every six months, it is likely that the magnitude of the error will be relatively 
small and probably systematic rather than random within clinics.  We therefore anticipate 
that this use of real measured data will yield more accurate results than multiple imputation.  
This is especially so for individuals who provide no data beyond their baseline measurement. 
 
The second point concerns the definition of a missed visit.  The goal for all clinics is that PLAN 
participants should attend their six-month visits within + 30 days of the target date.  
However, we will not declare a given visit as having been missed until 3 months after the 
target date.  For example, if the six-month visit has not occurred by nine months, the six-
month visit will be declared to be missing and will therefore need to be imputed for analyses 
that include these intermediate time points.  With the six-month visit having been declared 
missing, the next visit will be defined to be the twelve-month visit and the target date for it 
to occur will be twelve months after the randomization date.  We recognize that a three-
month difference between a scheduled visit and the actual visit is substantial, especially for 
growing children.  But the use of this three-month difference before a visit will be declared 
missing will minimize the number of missed visits.  Moreover, using the methods discussed in 
the last section of this analysis plan, we will account for any between-group differences in 

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time to the final study visit when we perform the primary analysis (DSMB approved protocol 
addenda, 11.2.18). 
 
8. 
Assessing the Appropriateness of Analytic Strategies 
In addition to the above concerns about covariance structures and missing data, we will 
routinely give careful attention to the appropriateness of the analyses we perform. For example, 
t-tests comparing baseline values across groups will be performed only after assessing equal 
variance and normality assumptions, with data transformations being pursued if assumptions 
are violated and Wilcoxon’s test being a nonparametric alternative if an appropriate 
transformation cannot be found. Similar attention will be given to the appropriateness of 
random coefficient models where the distributional properties of variables will be evaluated and 
residual plots will be examined. To ensure that our conclusions are robust in the face of outlying 
values, sensitivity analyses that may exclude or attenuate outlying values will be pursued. The 
latter considerations will ensure that we are appropriately cautious about any conclusion that 
might have been altered if 1 or 2 subjects with outlying values had not been in the study or had 
had less extreme data points. 
 
C.Analysis of Secondary Aim 1 (DSMB approved protocol addenda, 11.2.18). 
The goal of secondary aim 1 is to compare the effectiveness of the FBT group with that of the UC 
group in the participating parent.  The primary outcome variable in the parent is BMI.  Since BMI is a 
continuous variable measured at the same time points as was the case with the participating child, the 
data analytic strategy for this secondary analysis is identical to what was described for the child. 
 
C. 
Analysis of Secondary Aim 2 (DSMB approved protocol addenda, 11.2.18). 
The goal of this aim is to determine if the weight loss impacts of FBT extend beyond the participating 
child by assessing the intervention in overweight/obese siblings. We hypothesize that FBT will be 
superior to UC for weight-eligible siblings. Analytic strategies will be similar to those used in the primary 
aim, the key difference being that while prior data74 support our hypothesis of FBT benefits for siblings, 
power for this aim may be limited. The most important reason for this is that we have chosen not to 
require that participating children have a weight-eligible sibling because of the recruitment challenge 
such a requirement would pose. Prior data from the NHLBI-funded COMPASS study we coordinated at 
Washington University indicate that among 377 screened families with a participating child, 163 (43.2%) 
had at least one age (age 2-18) and weight-eligible sibling. Based on these numbers, we expect that 
there will be about 228 (= 43.2% of 528) participating families with at least one eligible sibling, with the 
actual number recruited being somewhat smaller because some siblings will choose not to participate. 
 
While the above sample size may not provide the robust statistical power that would be ideal, we 
emphasize that this is a secondary aim that will study by far the largest number of overweight/obese 
siblings ever evaluated in this setting. Thus, this aim will provide a unique set of data that will yield 
valuable insights into whether FBT may benefit non-participating siblings while generating preliminary 
effect size data to guide future studies. A positive finding would provide a compelling incentive for the 
future dissemination of FBT to family practices. In cases where more than one eligible sibling is available, 
we will enroll the sibling whose age is closest to that of the study child. Data analyses will reflect the 
wide age eligibility range for siblings and current uncertainty regarding the impact of sibling age on 
outcome. We will address this uncertainty by adjusting for sibling age and whether the sibling is older or 
younger than the participating child, with particular concern for the possibility that sibling age may have 
a non-linear relationship with FBT effectiveness. The wide age eligibility range for siblings reflects our 
desire to maximize information generated about this population and the limited resource expenditure 

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that is required to study these non-participants. We will also adjust for whether the sex of the sibling is 
the same as that of the targeted child since prior data suggest that same sex siblings respond better 
than opposite sex siblings.19 
 
E.Analysis of Secondary Aim 3 (DSMB approved protocol addenda, 11.2.18). 
The goal of this aim is to assess changes in delay discounting for children and parents assigned to FBT 
versus UC and to assess the relationship between those changes and weight control. We hypothesize 
that FBT will be associated with reductions in delay discounting for children and parents compared with 
UC, and that the degree of change in delay discounting will be related to success in weight control. All 
analyses in this aim will be performed separately for the index child and the index parent (DSMB 
approved protocol addenda, 11.2.18). Delay discounting will be measured using the k-value detailed by 
Johnson and Bickel.75 These parameters will be measured at baseline, 12, and 24 months. One set of 
analyses in this aim will involve random coefficient models that compare the pattern of change in the k 
value in the UC group with corresponding changes in the FBT group. We will also use bivariate linear 
mixed models implemented by PROC MIXED in SAS76 to evaluate the association between changing k-
values and changes in weight. 
 
D.Analysis of Secondary Aim 4 (DSMB approved protocol addenda, 11.2.18). 
The goal of this aim is to examine participant level baseline predictors of outcomes, with the 
measures of interest being parental inconsistency and environmental enrichment. We hypothesize 
that FBT, as compared to UC, will benefit families with higher parental inconsistency and less enriched 
environments. Parental inconsistency will be measured using a validated parenting style inventory77 
while environmental enrichment will be evaluated using questions from the HOME78 scale developed by 
Rosenberg et al79 and the Land Use Mix-Diversity subscale from the Neighborhood Environment 
Walkability Scale (NEWS)80 that we have employed previously81 in a pediatric weight loss study involving 
FBT. The same random coefficient models with two covariance structures that we described earlier with 
the same IRGT design will be applied here with the modification that we will focus on the two baseline 
measures of current interest (parental inconsistency and environmental enrichment) as covariates. 
Because we anticipate that the efficacy of the intervention may be influenced by these measures, we 
will also evaluate interaction terms between group assignment and both our parental inconsistency and 
environmental enrichment measures. The analyses will be performed separately in both participating 
children and parents. 
 
D. 
Analysis of Exploratory Aim 1 
The goal of this exploratory aim is to examine provider attitudes towards evidence-based treatment 
at baseline and perceptions of FBT at mid study (after experience with the intervention has been 
gained) as predictors of providers’ future intention to use co-located FBT in their practices at the end 
of the study. We hypothesize that positive provider attitudes toward evidence-based treatment and 
perceptions of FBT will predict their intention to incorporate FBT into their practice settings. Appendix C 
provides details of the measures we will use in this aim. Because a provider’s intention to incorporate 
FBT into their practice settings is measured on a broad scale ranging from 0% to 100%, we will treat the 
variable as a continuous variable and expect that random coefficient models will again be appropriate. 
Specifically, we plan to implement these models using PROC MIXED in SAS, with the provider nested 
within sites in those analyses. A strength of the planned analysis is that the anticipated 185 providers at 
the four sites will provide a rich opportunity to understand predictors of future intentions regarding the 
use of FBT. An uncertainty is that we currently have little data with which to predict the distribution of 
the of the 0% to 100% response variable. It is possible, therefore, that analyses in this exploratory aim 
will require data transformations, breaking the outcome measure into categories, or the use of 

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generalized estimating equations instead of mixed models.  It should be noted that in contrast to earlier 
analyses, analyses of this aim do not involve group assignment and do not therefore reflect the overall 
IRGT trial design.  Thus, only one covariance structure will be required. 
 
 
E. 
Sensitivity Analyses 
Sensitivity analyses to be performed in PLAN are as follows.   
 
1. A modified intention-to-treat analysis of the primary outcome in which subjects who provided 
no follow-up data are excluded.  These analyses will include imputed 24-month data using 
subjects who did provide data beyond baseline but who did not provide 24-month data. 
2. To further facilitate an understanding of the impact of missing data on the primary result, the 
primary analysis will be repeated without imputation and using only subjects who provide both 
baseline and 24-month primary outcome data. 
3. A per protocol dataset will be defined as including all subjects who attend at least 80% of the 
prescribed sessions.  Sensitivity analyses will assess whether applying the primary analysis to the 
per protocol dataset yields the same result as the primary ITT analysis. All control group subjects 
who do not drop out of the study will be considered to be part of the per protocol dataset.  We 
recognize that this implies a somewhat different definition in the two study arms.  But we do not 
consider this to be a problem since this is a sensitivity analysis whose goal is to repeat the 
primary analysis in a different setting (DSMB approved protocol addenda, 11.2.18). 
4. Random coefficient models that potentially use different covariance structures in the two study 
arms will include all primary outcome data collected at baseline, 6, 12, 18, and 24 months.  Since 
weight change often occurs at a more rapid rate early in a weight loss study, these sensitivity 
analyses will include an exploration of non-linear possibilities such as quadratic models.  They 
will also assess contrasts that compare changes from baseline to 24 months across groups in 
order to use an alternative model for testing the central hypothesis of the primary analysis. 
5. Repeat the primary analysis after adjusting for baseline covariates.  The covariates to be used 
are the race and sex of the participating child, family income, the educational level of the 
participating parent, and whether there are one or two parents in the household. 
 
F. 
The Time Between Randomization and the Measurement of the Primary Outcome 
The time between randomization and the measurement of the primary outcome will vary among 
participants and will potentially differ between groups.  Our approach to addressing the potential 
impact of this reality is described below. 
Our first step in addressing this issue will involve an assessment of whether the time to the outcome 
measure differs across groups.  To address this question, we will compare Kaplan Meier survival curves 
measuring time to assessment using a generalized Wilcoxon test.  The Wilcoxon test will be used instead 
of a logrank test because dropouts in weight loss studies tend to occur early and because the Wilcoxon 
test is more sensitive to early dropout than the logrank test.  In performing these analyses, subjects who 
provide no data beyond baseline will be assumed to be on study for one month.  To ensure consistency 
across all participants, one month will also be added to the follow-up time of children who do provide 
data beyond baseline.  If the Wilcoxon test yields non-significant results, we will not modify our 
covariate-adjusted secondary analyses.  If the Wilcoxon test suggests that there is a between-group 
difference in time to the final assessment, we will adjust for the time to the final assessment in the 
covariate-adjusted analyses   Similar considerations will determine whether the time to the 24 month 
assessment will serve as a covariate in the sensitivity analyses discussed above that involve random 
coefficient models, that include data collected at all intermediate time points, and that employ 

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statistical contrasts to compare the change from baseline to the final assessment across groups.  In all of 
these analyses, the median time to the final follow-up along with 95% confidence bounds will be 
calculated. 
 
G.  
Analysis of Exploratory Aim 2 
Twelve  PLAN coaches will be asked to participate in an audio-recorded semi-structured interview; 
interested coaches will provide consent over the phone and will be asked a series of questions by a 
trained post-doctoral researcher on the study.  The questions are based on the coaches’ discussions with 
FBT families pre-COVID and amid-COVID regarding food cost, perception, and behaviors. The telephone 
interviews are voluntary and will be completed based on the coaches’ availability. All responses will be 
de-identified and aggregated with the other coaches’ responses. The data will be transcribed, and 
summary data will be compiled. The audio file will be destroyed once the data has been transcribed and 
aggregated. (DSMB approval,5.7.2020)  
 
Measures to Minimize Bias 
 
1. 
Enrollment and Randomization Procedures 
The DCC will use the REDCap randomization module to create an online password protected 
randomization system that will facilitate the random assignment of families. When the website 
is entered, the user will provide information that establishes the eligibility of the family. Group 
assignments will be revealed only if all eligibility criteria are satisfied. To avoid temporal bias, 
randomization will be blocked within clinic using random block sizes in order to preclude the 
possibility that investigators might know in advance the assignment of the last family in a 
particular block. 
 
2. 
Standardization of Height and Weight Measurements 
Verifications for collecting and entering the data for the height and weights will be followed to 
decrease bias. All stadiometers and scales used will be calibrated and consistent between all 
sites. PLAN coaches and assessors will be trained and tested on protocols for obtaining these 
measures.  All weight measurements will be taken according to a uniform protocol and written 
on hard copy measurement sheets. The handwritten weights will be manually entered into the 
REDCap database by a blinded measurement coach, which will eliminate potential measurement 
bias and minimize errors in data entry (DSMB approved change, 11.18.19). Both the written 
record and the measure in REDCap will be verified. Hard copy height and weight measurement 
forms will be uploaded to the secure REDCap database to allow the CCC, DCC and TFC to check 
for transcription and/or unit of measurement errors. Any malfunctions of equipment will be 
reported to the study staff to resolve immediately. Any measurements outside of the range of 
normal will be flagged in REDCap and staff notified to retake measurements. 
 
3. 
Masking Procedures 
Masking refers to no knowledge regarding treatment assignment. It is not the same as 
concealment, which refers to random assignment to groups. Treatment masking represents an 
extension of concealment, to minimize bias in how participants assigned to different groups are 
treated. In the current study, the research assistants and coaches who are doing the 
measurements will be blinded, or masked as to treatment assignment, and the PIs for the 
Clinical Coordinating Center and Training and Fidelity Cores (Drs. Epstein and Wilfley) and the 
DSMB will be masked as to treatment assignment. However, it is impossible to mask families, 
the family’s PLAN coach, or pediatricians to group assignment. Families and PLAN coaches will 

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know the intervention arm by the very nature of implementing a behavioral intervention. 
Pediatricians will not be told group assignment, but that is possible to discern since they may 
see FBT families coming to their clinic more than the UC families.  
 
Masking of Assessment Staff 
We recognize the importance of blinding research personnel who are collecting data to 
study arms. The primary height and weight data will be collected coaches conduct 
assessments for each other’s families at the different pediatric sites (for which they will be 
blinded to those families). Families will be explained that they are to not discuss anything 
regarding their group assignment, how often they come to the pediatric office or their 
coaches and the measurement assessor has to remain blinded to their treatment arm. 
 
Coaches will be blinded to the families’ randomization.  They will conduct assessments, 
home visits, remote assessments, and AE data collection.  
 
There are three coaches at each site, with some sites having backup and floating coaches 
that are involved in delivering FBT to study participants. A backup coach delivers treatment 
for another coach’s caseload in the event that a coach goes on vacation, leaves the position, 
or is otherwise unable to complete treatment with their families. Backup coaches are 
assigned based on coach letter assignment (i.e., coach B is the backup for coach A, coach A is 
the backup for coach C, coach C is the backup for coach B). This ensures that there is always 
a blinded measurement coach to complete assessments. A floating coach delivers treatment 
to families at multiple pediatric practices regardless of coach assignment. Floating coaches 
remain blinded to other caseloads, but see families at different practices when a practice’s 
coach does not have space in their caseload for more families (This change was made on 
12.4.18 prior to review and approval by the DSMB, DSMB approved protocol addenda on 
11.18.19). The plan is for Coach 1 to collect height and weight for families assigned to Coach 
2, Coach 2 will collect height and weight for families assigned to Coach 3, and Coach 3 will 
collect height and weight for families assigned to Coach 1. Thus, coaches will not collect 
height and weight measures from families from their caseload. We will use block scheduling 
to reduce travel time (e.g., Coach 1 can do assessments at Coach 2’s site one Friday per 
month).  
 
In order to mask assessment of outcome measures, all sites have implemented blinded 
measurement coaches that complete assessments and AE data collection, so that the PLAN 
coaches can focus on treatment. Coaches will remain blinded to group assignment outside of 
their caseload (This change was made on 2.28.18 prior to review and approval by the 
DSMB, DSMB approved protocol addenda on 11.2.18). To further ensure blinding, families 
will be notified that the assessor is unaware of their group assignment and will be asked not 
to discuss the frequency of them coming in to the practice, their group assignment, or the 
coach they normally see (DSMB approved protocol addenda, 3.18.19). 
 
Although not possible to guarantee that coaches are blind to condition for families that are 
not in their caseload due to the families not being blinded, use of a standard protocol (see 
Appendix C) ensures objective and reliable measurement of the primary outcome. Assessors 
will be blind to prior heights/weights, further protecting against assessment bias. 
 

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Reducing Bias in Unmasked Groups 
We recognize that there are numerous ways that the PLAN coaches or pediatricians can 
treat FBT UC families differently. We have several approaches to reduce bias. We are able to 
standardize interactions with PLAN coaches through extensive training, supervision and 
fidelity checks, which can help reduce bias from the PLAN coaches. Part of the training will 
include instructions not to state or imply that FBT may be better than usual care. We will not 
be directly training or assessing fidelity for usual care, as that would deviate from the reason 
for using UC as the control condition. However, we will be collecting information on usual 
care practices from participating providers at baseline and 24 months via REDCap surveys. 
Group assignment will not be in the families’ charts, and unless a family directly says 
something to the pediatrician, the pediatrician may be unaware of group assignment. 
 
II. Study Administration 
 
Study Website 
A study website will be used to: 1) provide information to families about FBT; 2) provide 
downloadable manuals for the Traffic Light Eating Plan and Activity Program; 3) manage the EFT 
component of the intervention; and 4) provide tools for cooking, getting more physical activity, and 
parenting skills. Quizzes to assess mastery of educational materials will be implemented on the 
study website, with multiple versions of quizzes on each module available with the recognition that 
some people will acquire the information more slowly than others. Families will have access to 
traditional paper and pencil self-monitoring, and consistent with current implementation of FBT, 
after self-monitoring skill is acquired, families can choose to use traditional or technology-based 
recording. Information on learning the modules, and eating, exercise, and parenting change will be 
coordinated in an online family dashboard. Families will have access to the family dashboard for 
feedback, and PLAN coaches will have access to the dashboard to assess patient progress, assist 
with problem solving, and communicate with families to structure solutions.  
 
The website will also contain password-protected sections that are for internal use by study 
personnel and will serve as a repository for study documents as well as a communications hub for 
the study. The study website will be created and maintained by the CCC. The DCC will be responsible 
for uploading to the website documents under its purview such as regular reports prepared for 
DSMB and Steering Committee meetings, the forms and datasets manual, lists of certified 
personnel, and instructions on the use of the data entry system. The website will not contain 
protected health information. 
 
Conflicts of Interest 
Dr. Schechtman has a long history of collaboration with Dr. Wilfley, the PI for the TFC and of the WU 
clinical site for the proposed research, and because both reside at WU, there is at least the 
appearance of a potential for conflict of interest. We will take two steps in addressing this issue. 
First, the reports we regularly generate regarding the progress of the study will be separated by 
clinic and shared with the SEC and/or DSMB whenever potential problems with clinical sites, 
including the WU clinical site, are identified. Second, we have asked a colleague, Dr. Mae Gordon 
(Professor of Ophthalmology and Biostatistics at WU), to address any concerns about the 
performance of the WU clinical site should Dr. Schechtman feel conflicted. Dr. Gordon has not 
worked previously with Dr. Wilfley and has years of experience as Director of the DCC for several 
NIH-funded clinical trials, including at least one where a participating clinic was at WU. 

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Disagreements regarding any of the study functions will be resolved by discussion and vote of the 
SEC. 
 
Publications and Presentations Policy 
The Steering Committee will manage the oversight and coordination of publication and presentation 
materials. The DCC director, along with members of the Steering Committee, will participate in a 
subcommittee defining publication policies, prioritizing when multiple papers and abstracts 
challenge resources, and encouraging the involvement of junior investigators in the dissemination of 
study results. The DCC director will oversee the creation of a publications and presentations 
database that will facilitate the tracking of completed publications. He will also facilitate the 
development of an automated reminder system for study investigators of abstract due dates and 
pending timelines for preparing material for publications and presentations. The publications 
database will be stored on the study website. 
 
Protocol Amendments 
All protocol amendments will be submitted to the UB IRB and DSMB for approval, and any 
consequent changes will be documented in the study database. Amendments will not be 
implemented until both the UB IRB and DSMB have given their approval. 
 
Protocol Deviations 
A protocol deviation is any noncompliance with the approved protocol, Good Clinical Practice (GCP), 
or Manual of Procedures (MOP) requirements. The noncompliance may be either on the part of the 
participant, the investigator, or the study site staff. As a result of deviations, corrective actions are 
to be developed by the site and implemented promptly. These practices are consistent with ICH E6: 
4.5 Compliance with Protocol (sections 4.5.1, 4.5.2, and 4.5.3), 5.1 Quality Assurance and Quality 
Control (section 5.1.1), and 5.20 Noncompliance (sections 5.20.1, and 5.20.2). It is the responsibility 
of the site to use continuous vigilance to identify and report deviations within working days of 
identification of the protocol deviation, or within working days of the scheduled protocol-required 
activity. All deviations must be addressed in study source documents, reported to Program Official. 
Protocol deviations must be sent to the IRB of Record per their guidelines. The site PI/study staff is 
responsible for knowing and adhering to their IRB requirements. Further details about the handling 
of protocol deviations will be included in the MOP. 
 
 

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III. References 
 
1. 
Whitaker RC, Pepe MS, Wright JA, Seidel KD, Dietz WH. Early adiposity rebound and the risk of 
adult obesity. Pediatrics. 1998;101(3):E5. 
2. 
Whitaker RC, Wright JA, Pepe MS, Seidel KD, Dietz WH. Predicting obesity in young adulthood 
from childhood and parental obesity.  N Engl J Med. 1997;337(13):869-873. 
3. 
Morrison JA, Glueck CJ, Wang P. Childhood risk factors predict cardiovascular disease, impaired 
fasting glucose plus type 2 diabetes mellitus, and high blood pressure 26 years later at a mean 
age of 38 years: the Princeton-lipid research clinics follow-up study. Metabolism. 
2012;61(4):531-541. 
4. 
Fallon EM, Tanofsky-Kraff M, Norman AC, et al. Health-related quality of life in overweight and 
nonoverweight black and white adolescents. J Pediatr. 2005;147(4):443-450. 
5. 
Schwimmer JB, Burwinkle TM, Varni JW. Health-related quality of life of severely obese children 
and adolescents. JAMA. 2003;289(14):1813-1819. 
6. 
Charney E, Goodman HC, McBride M, Lyon B, Pratt R. Childhood antecedents of adult obesity. 
do chubby infants become obese adults? N Engl J Med. 1976;295(1):6-9. 
7. 
Oliveria SA, Ellison RC, Moore LL, Gillman MW, Garrahie EJ, Singer MR. Parent-child relationships 
in nutrient intake: the Framingham Children's Study. Am J Clin Nutr. 1992;56(3):593-598. 
8. 
Contento IR, Basch C, Shea S, et al. Relationship of mothers' food choice criteria to food intake 
of preschool children: identification of family subgroups. Health Educ Q. 1993;20(2):243-259. 
9. 
Brown R, Ogden J. Children's eating attitudes and behaviour: a study of the modelling and 
control theories of parental influence. Health Educ Res. 2004;19(3):261-271. 
10. 
Wardle J. Parental influences on children's diets. The Proceedings of the Nutrition Society. 
1995;54(3):747-758. 
11. 
Epstein LH, Paluch RA, Roemmich JN, Beecher MD. Family-based obesity treatment, then and 
now: twenty-five years of pediatric obesity treatment. Health Psychol. 2007;26(4):381-391. 
12. 
Epstein LH, Paluch RA, Wrotniak BH, et al. Cost-effectiveness of family-based group treatment 
for child and parental obesity. Child Obes. 2014;10(2):114-121. 
13. 
Barton M. Screening for obesity in children and adolescents: US preventive services task force 
recommendation statement. Pediatrics. 2010;125(2):361-367. 
14. 
Bock DE, Robinson T, Seabrook JA, et al. The Health Initiative Program for Kids (HIP Kids): effects 
of a 1-year multidisciplinary lifestyle intervention on adiposity and quality of life in obese 
children and adolescents--a longitudinal pilot intervention study. BMC Pediatr. 2014;14:296. 
15. 
Steele RG, Aylward BS, Jensen CD, Cushing CC, Davis AM, Bovaird JA. Comparison of a family-
based group intervention for youths with obesity to a brief individual family intervention: a 
practical clinical trial of positively fit. J Pediatr Psychol. 2012;37(1):53-63. 
16. 
Wilfley DE, Tibbs TL, Van Buren DJ, Reach KP, Walker MS, Epstein LH. Lifestyle interventions in 
the treatment of childhood overweight: a meta-analytic review of randomized controlled trials. 
Health Psychol. 2007;26(5):521-532. 
17. 
Epstein LH, Myers MD, Raynor HA, Saelens BE. Treatment of pediatric obesity. Pediatrics. 
1998;101(3 Pt 2):554-570. 
18. 
Jelalian E, Saelens BE. Empirically supported treatments in pediatric psychology: pediatric 
obesity. J Pediatr Psychol. 1999;24(3):223-248. 
19. 
Epstein LH, Paluch RA, Raynor HA. Sex differences in obese children and siblings in family-based 
obesity treatment. Obes Res. 2001;9(12):746-753. 
20. 
Epstein LH, Valoski A, Wing RR, McCurley J. Ten-year follow-up of behavioral, family-based 
treatment for obese children. JAMA. 1990;264(19):2519-2523. 

Page 74 of 305 
 
21. 
Epstein LH, Valoski A, Wing RR, McCurley J. Ten-year outcomes of behavioral family-based 
treatment for childhood obesity. Health Psychol. 1994;13(5):373-383. 
22. 
Wrotniak BH, Epstein LH, Paluch RA, Roemmich JN. Parent weight change as a predictor of child 
weight change in family-based behavioral obesity treatment. Arch Pediatr Adolesc Med. 
2004;158(4):342-347. 
23. 
Wrotniak BH, Epstein LH, Paluch RA, Roemmich JN. The relationship between parent and child 
self-reported adherence and weight loss. Obes Res. 2005;13(6):1089-1096. 
24. 
Barlow SE. Expert committee recommendations regarding the prevention, assessment, and 
treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 
2007;120 Suppl 4:S164-192. 
25. 
van Gerwen M, Franc C, Rosman S, Le Vaillant M, Pelletier-Fleury N. Primary care physicians' 
knowledge, attitudes, beliefs and practices regarding childhood obesity: a systematic review. 
Obes Rev. 2009;10(2):227-236. 
26. 
Caprio S. Treating child obesity and associated medical conditions. Future Child. 2006;16(1):209-
224. 
27. 
Klein JD, Sesselberg TS, Johnson MS, et al. Adoption of body mass index guidelines for screening 
and counseling in pediatric practice. Pediatrics. 2010;125(2):265-272. 
28. 
Sesselberg TS, Klein JD, O'Connor KG, Johnson MS. Screening and counseling for childhood 
obesity: results from a national survey. J Am Board Fam Med. 2010;23(3):334-342. 
29. 
Harwood MD, O'Brien KA, Carter CG, Eyberg SM. Mental health services for preschool children 
in primary care: a survey of maternal attitudes and beliefs. J Pediatr Psychol. 2009;34(7):760-
768. 
30. 
Aarons GA. Mental health provider attitudes toward adoption of evidence-based practice: the 
Evidence-Based Practice Attitude Scale (EBPAS). Ment Health Serv Res. 2004;6(2):61-74. 
31. 
Scott SD, Plotnikoff RC, Karunamuni N, Bize R, Rodgers W. Factors influencing the adoption of an 
innovation: an examination of the uptake of the Canadian Heart Health Kit (HHK). Implement Sci. 
2008;3:41. 
32. 
Godin G, Kok G. The theory of planned behavior: a review of its applications to health-related 
behaviors. Am J Health Prom. 1996;11(2):87-98. 
33. 
Sheeran P. Intention—behavior relations: A conceptual and empirical review. Eur Rev Soc 
Psychol. 2002;12(1):1-36. 
34.  
Pals SL, Murray DM, Alfano CM, Shadish WR, Hannan PJ, Baker WL. Individually randomized 
group treatment trials: a critical appraisal of frequently used design and analytic approaches. 
Am J Public Health. 2008;98(8):1418-24. 
35. 
Kuczmarski RJ, Ogden CL, Guo SS, et al. 2000 CDC growth charts for the united states: methods 
and development. Vital and health statistics Series 11, Data from the national health survey. 
2002(246):1-190. 
36. 
Panel NOEIE. Clinical guidelines on the identification, evaluation, and treatment of overweight 
and obesity in adults--The evidence report. National Institutes of Health. Obes Res. 1998;6 Suppl 
2:51s-209s. 
37. 
Bickel WK, Marsch LA. Toward a behavioral economic understanding of drug dependence: delay 
discounting processes. Addiction. 2001;96(1):73-86. 
38. 
Bonato DP, Boland FJ. Delay of gratification in obese children. Addict Behav. 1983;8(1):71-74. 
39. 
Johnson WG, Parry W, Drabman RS. The performance of obese and normal size children on a 
delay of gratification task. Addict Behav. 1978;3(3-4):205-208. 
40. 
Bourget V, White DR. Performance of overweight and normal‐weight girls on delay of 
gratification tasks. Int J Eat Disord. 1984;3(3):63-71. 
41. 
Bloom BS. Human characteristics and school learning. McGraw-Hill; 1976. 

Page 75 of 305 
 
42. 
Epstein LH, McKenzie SJ, Valoski A, Klein KR, Wing RR. Effects of mastery criteria and contingent 
reinforcement for family-based child weight control. Addict Behav. 1994;19(2):135-145. 
43. 
Whitlock EP, O'Connor EA, Williams SB, Beil TL, Lutz KW. Effectiveness of weight management 
interventions in children: a targeted systematic review for the USPSTF. Pediatrics. 
2010;125(2):e396-418. 
44. 
Chen X, Beydoun MA, Wang Y. Is sleep duration associated with childhood obesity? A systematic 
review and meta-analysis. Obesity. 2008;16(2):265-274. 
45. 
Daniel TO, Stanton CM, Epstein LH. The future is now: comparing the effect of episodic future 
thinking on impulsivity in lean and obese individuals. Appetite. 2013;71:120-125. 
46. 
Daniel TO, Stanton CM, Epstein LH. The future is now: reducing impulsivity and energy intake 
using episodic future thinking. Psychol Sci. 2013;24(11):2339-2342. 
47. 
Daniel TO, Said M, Stanton CM, Epstein LH. Episodic future thinking reduces delay discounting 
and energy intake in children. Eat Behav. 2015;18:20-24. 
48. 
Lin H, Epstein LH. Living in the moment: effects of time perspective and emotional valence of 
episodic thinking on delay discounting. Behav Neurosci. 2014;128(1):12-19. 
49. 
Wilfley DE, Stein RI, Saelens BE, et al. Efficacy of maintenance treatment approaches for 
childhood overweight: a randomized controlled trial. JAMA. 2007;298(14):1661-1673. 
50. 
Wilfley DE, Van Buren DJ, Theim KR, et al. The use of biosimulation in the design of a novel 
multilevel weight loss maintenance program for overweight children. Obesity. 2010;18 Suppl 
1:S91-98. 
51. 
MacLean PS, Wing RR, Davidson T, et al. NIH working group report: Innovative research to 
improve maintenance of weight loss. Obesity. 2015;23(1):7-15. 
52. 
Wing RR, Lang W, Wadden TA, et al. Benefits of modest weight loss in improving cardiovascular 
risk factors in overweight and obese individuals with type 2 diabetes. Diabetes Care. 
2011;34(7):1481-1486. 
53. 
Van Gaal LF, Mertens IL, Ballaux D. What is the relationship between risk factor reduction and 
degree of weight loss? Eur Heart J Suppl. 2005;7(suppl L):L21-L26. 
54. 
Chesla CA, Fisher L, Skaff MM, Mullan JT, Gilliss CL, Kanter R. Family predictors of disease 
management over one year in Latino and European American patients with type 2 diabetes. Fam 
Process. 2003;42(3):375-390. 
55. 
Fisher L, Chesla CA, Chun KM, et al. Patient-appraised couple emotion management and disease 
management among Chinese American patients with type 2 diabetes. J Fam Psychol. 
2004;18(2):302-310. 
56. 
Fisher L, Skaff MM, Chesla CA, et al. Disease management advice provided to African-American 
and Chinese-American patients with type 2 diabetes. Diabetes Care. 2004;27(9):2249-2250. 
57. 
Neaton JD, Duchene AG, Svendsen KH, Wentworth D. An examination of the efficiency of some 
quality assurance methods commonly employed in clinical trials. Stat Med. 1990;9(1-2):115-123; 
discussion 124. 
58. 
Hosking JD, Newhouse MM, Bagniewska A, Hawkins BS. Data collection and transcription. 
Control Clin Trials. 1995;16(2 Suppl):66s-103s. 
59. 
Day S, Fayers P, Harvey D. Double data entry: what value, what price? Controlled clinical trials. 
1998;19(1):15-24. 
 
60. 
Baldwin, S. A., Bauer, D. J., Stice, E., & Rohde, P. Evaluating models for partially clustered 
designs. Psychol Methods. 2011; 16(2), 149. 
61. 
Kalarchian MA, Levine MD, Arslanian SA, et al. Family-based treatment of severe pediatric 
obesity: randomized, controlled trial. Pediatrics. 2009;124(4):1060-1068. 
62. 
Epstein LH, Wing RR, Koeske R, Andrasik F, Ossip DJ. Child and parent weight loss in family-based 
behavior modification programs. J Consul Clin Psychol. 1981;49(5):674-685. 

Page 76 of 305 
 
63. 
Epstein LH, Wing RR, Koeske R, Valoski A. A comparison of lifestyle exercise, aerobic exercise, 
and calisthenics on weight loss in obese children. Behav Ther. 1985;16(4):345-356. 
64. 
Epstein LH, Paluch RA, Gordy CC, Saelens BE, Ernst MM. Problem solving in the treatment of 
childhood obesity. J Consult Clin Psychol. 2000;68(4):717-721. 
65. 
Epstein LH, Paluch RA, Gordy CC, Dorn J. Decreasing sedentary behaviors in treating pediatric 
obesity. Arch Pediatr Adolesc Med. 2000;154(3):220-226. 
66. 
Epstein LH, Paluch RA, Kilanowski CK, Raynor HA. The effect of reinforcement or stimulus control 
to reduce sedentary behavior in the treatment of pediatric obesity. Health Psychol. 
2004;23(4):371-380. 
67. 
Epstein LH, Roemmich JN, Stein RI, Paluch RA, Kilanowski CK. The challenge of identifying 
behavioral alternatives to food: clinic and field studies. Ann Behav Med. 2005;30(3):201-209. 
68. 
Fagg J, Chadwick PM, Cole TJ, et al. From trial to population: a study of a family-based 
community intervention for childhood overweight implemented at scale. Int J Obes (2005). 
2014;38(10):1343-1349. 
69. 
Sacher PM, Kolotourou M, Chadwick PM, et al. Randomized controlled trial of the MEND 
program: a family-based community intervention for childhood obesity. Obesity. 2010;18 Suppl 
1:S62-68. 
70.  
Murray DM, Hannan PJ, Wolfinger RD, Baker WL, Dwyer JH. Analysis of data from group-
randomized trials with repeat observations on the same groups. Stat Med 1998;17(14):1581-
600. 
71.  
Rubin D. Multiple imputation for nonresponse in surveys. New York: John Wiley & Sons; 1987. 
72. 
Rubin D. Multiple Imputation after 18+ years. J Am Stat Assoc. 1996;91:473-489. 
73. 
Schafer J. Analysis of incomplete multivariate data. New York: Chapman & Hall; 1997. 
74. 
Epstein LH, Nudelman S, Wing RR. Long-term effects of family-based treatment for obesity on 
nontreated family members. Behav Ther. 1987;18(2):147-152. 
75. 
Johnson MW, Bickel WK. Within-subject comparison of real and hypothetical money rewards in 
delay discounting. J Exp Anal Behav. 2002;77(2):129-146. 
76. 
Thiebaut R, Jacqmin-Gadda H, Chene G, Leport C, Commenges D. Bivariate linear mixed models 
using SAS proc MIXED. Comput Methods Programs Biomed. 2002;69(3):249-256. 
77. 
Krohne H, Pulsack A. Das Erziehungsstil-Inventar (ESI): Manual. 2nd ed. Germany: Beltz Test 
Weinheim; 1995. 
78. 
Strauss RS, Knight J. Influence of the home environment on the development of obesity in 
children. Pediatrics. 1999;103(6):e85. 
79. 
Rosenberg DE, Sallis JF, Kerr J, et al. Brief scales to assess physical activity and sedentary 
equipment in the home. Int J Behav Nutr Phys Activ. 2010;7:10. 
80. 
Cerin E, Saelens BE, Sallis JF, Frank LD. Neighborhood environment walkability scale: validity and 
development of a short form. Med Sci Sports Exerc. 2006;38(9):1682-1691. 
81. 
Best JR, Theim KR, Gredysa DM, et al. Behavioral economic predictors of overweight children's 
weight loss. J Consult Clin Psychol. 2012;80(6):1086-1096. 
 
 

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IV.  Appendices 
 
A. 
Consent Form Samples: (Adjusted Primary Aim and added that there is an increased risk 
posed to participants by using third-party platforms, this change was made on 5.23.18 prior to 
review and approval by the DSMB, DSMB approved protocol addenda on 11.2.18). 
B. 
Coronavirus Addendum: Added to address the changes in assessments due to social 
distancing as a result of the serious nature of Covid-19 (UB IRB approved 5.19.20; DSMB 
approved protocol addenda on 5.7.20)
 
 
 

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University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federal wide Assurance ID#: FWA00008824 
Title of research study: THE EFFECTIVENESS OF FAMILY-BASED WEIGHT LOSS 
TREATMENT IMPLEMENTED IN PRIMARY CARE 
 
Sibling Adult Consent to Participate in a Research Study 
 
Version Date: 07-18-2018 
 
Investigators: Leonard H. Epstein, PhD 
 
Why am I being invited to take part in a research study? 
You are being invited to take part in a research study because: 
● You are an adult sibling of a child participating in a study through your doctor’s office.   
● You are able to read the English language.  
● You fall into the overweight or obese weight category (defined as at or above the 85th 
percentile for age and sex). 
This research study is supported by a grant through the National Heart Blood and Lung Institute (NHBLI). 
Research studies only include individuals who choose to take part in them. Your decision to take part in 
this study is entirely voluntary. Please read this information carefully. Ask questions about anything you 
do not understand before deciding whether or not to participate. You may also take home an unsigned 
copy of this consent form to think about participating or if you wish to discuss this matter with your 
family or your personal doctor. Please take your time to make your decision. Do not sign this form 
unless you have had the chance to ask questions and have received satisfactory answers. 
 
What should I know about a research study? 
● Someone will explain this research study to you. 
● Whether or not you take part is up to you. 
● You can choose not to take part. 
● You can agree to take part and later change your mind. 
● Your decision will not be held against you. 
● You can ask all the questions you want before you decide. 
 
 
Who can I talk to? 
If you have questions, concerns, or complaints, or think the research has hurt you, talk to the research 
team by telephone at 716-829-3400 for Dr. Leonard Epstein. You may also contact the PLAN coach at 
your child’s doctor’s office. You can also contact the research participant advocate at 716-888-4845 or 
researchadvocate@buffalo.edu.  

Page 79 of 305 
 
This research has been reviewed and approved by an Institutional Review Board (“IRB”). You may talk to 
them at (716) 888-4888 or email ub-irb@buffalo.edu  if:  
● You have questions about your rights as a participant in this research 
● Your questions, concerns, or complaints are not being answered by the research team. 
● You cannot reach the research team. 
● You want to talk to someone besides the research team. 
● You want to get information or provide input about this research. 
 
Why is this research being done? 
The goal of this study is to determine whether a specific kind of weight loss treatment called family-
based behavioral treatment (FBT) for children, delivered by a PLAN coach, can be included in the 
primary care setting. Extensive information has been gathered by our research team about the 
treatment of childhood overweight and obesity. But there is still much to learn about how the treatment 
should be incorporated into various medical settings. Such as primary care and how it effects siblings 
living with participating parents and children. 
 
How long will the research last? 
We expect that you will be in this treatment and research study for 24 months. 
 
How many people will be studied? 
We expect about 132 families will be in this research study in your geographical location. Out of 528 
families in the entire study nationally. 
 
What happens if I say yes, I want to be in this research? 
To determine if your family is eligible to participate, you and your family will be asked to complete an 
eligibility assessment at an orientation session about this study. Your height and weight will be 
measured.  
 
If your family is eligible for this research study and agrees to participate, you will attend the baseline 
assessment with your sibling. You will complete a baseline assessment and an initial appointment with 
your doctor. Your family will be randomized to one of two treatment conditions described below.  
 
 
 
 

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Groups 
At the start of the study, your family will be assigned to one of two groups. Participants in one group will 
receive the current standard of care offered by their physician for the treatment of childhood weight 
management.  Participants in the second group will receive family-based behavioral treatment for 
weight management (FBT).  
FBT is a behavioral weight-control intervention that aims to make weight changes in both a child and 
their participating parent. FBT is a well-tested treatment that targets diet, activity, behavioral 
techniques, parenting, and social facilitation in children and their parents. The treatment includes: 1) 
The Traffic Light Eating Plan uses RED, YELLOW, and GREEN labels for food to guide families toward the 
goal of eating nutritious foods. 2) The Traffic Light Activity Program also uses RED, YELLOW and GREEN 
labels for different levels of exercise to increase physical activity and reducing inactive behaviors. 3) A 
variety of behavioral techniques including changing and controlling your environment. tracking eating 
and physical activity; setting goals; problem solving; setting up a reward system; incentives for behavior 
change and weight loss; finding substitutes for unhealthy foods; and improving positive parenting. FBT 
also involves making changes in the home. So that weight loss or prevention of weight gain may extend 
to members of the family who are not regularly attending treatment sessions (e.g., siblings and spouse). 
The group that your family will be in/the treatment you get will be chosen by chance. Like flipping a 
coin. Neither you nor your sibling’s doctor will choose what treatment your family will receive. Your 
family will have an equal chance of being assigned to each group. You will be informed of the group your 
family is in following an initial physician visit. 
 
Treatment Schedule 
Every family will follow their pediatrician recommended schedule of appointments for weight 
management. Families in the group receiving FBT will additionally complete at least 26 sessions with the 
FBT PLAN Coach during the 24 months of the study. The amount of sessions completed within this range 
will be based on progress through the program. The amount will vary for each family.  You will not 
attend the sessions with the PLAN Coach. 
Assessments, Interviews, Questionnaires 
You will attend five major assessments throughout the entire 2 years of the study: 
● 1 Baseline assessment upon starting study (0 months) 
● 3 Measurement assessments during the study (6, 12, and 18 months) 
● 1 Follow-up assessment at end of study (24 months) 
Each major assessment will take approximately 30-90 minutes to complete at your child’s pediatric 
office, or a home visit can be arranged.  
 
 

Page 81 of 305 
 
What are my responsibilities if I take part in this research? 
If you take part in this research, you will be responsible to attend the baseline assessment, all 
measurement assessments, and the follow-up assessment.  Your participation in any other meetings 
with your family are voluntary. Weight measurements at these times are also voluntary and can be used 
as data. 
 
What happens if I do not want to be in this research? 
Your participation in this research study is voluntary. You may choose not to enroll in this study. There 
are no other research alternatives other than to participate in this study. 
 
What happens if I say yes, but I change my mind later? 
You can leave the research at any time. It will not be held against you, or affect your family’s 
participation in the study. You do not have to answer every question. You may refuse to answer any 
questions that you do not want to answer. 
If you decide to leave the research, you may not receive full compensation for your participation. If you 
decide to leave the research, contact the investigator at the contact information included below. If you 
stop being in the research, already collected data may not be removed from the study database. You will 
be asked whether the investigator can collect data from your routine medical care.  
 
Is there any way being in this study could be bad for me? 
There are certain risks and discomforts that may be associated with this research. They include: 
 
Likely 
● You may be inconvenienced at times by having to miss work, school activities, meetings, etc., to 
attend assessments. 
Less Likely 
● You may find having your height and weight measured uncomfortable. 
Rare 
● Although this treatment usually prevents the development of eating disorder problems, in rare 
cases it may increase them. 
● The use of online platforms is associated with risks involving breaches of confidentiality. We 
implement many layers of security to limit these risks as much as possible within our website 
and REDCap database. Outside platforms (i.e., MyFitnessPal) are subject to their own security 
measures and carry their own risks if your family chooses to use them to supplement your 
participation in this study. 
 
Will being in this study help me in any way? 
We cannot promise any benefits to you or others from your taking part in this research. This study may 
provide information that will help you to lose weight and keep it off. However, we cannot guarantee 
that you will receive any benefits from this study.  
 
What happens to the information collected for the research? 

Page 82 of 305 
 
Efforts will be made to limit the use and disclosure of your personal information, including research 
study and medical or education records, to people who have a need to review this information. We 
cannot promise complete secrecy. Organizations that may inspect and copy your information include 
the IRB and other representatives of this organization. Information related to you will be treated in strict 
confidence to the extent provided by law. Your identity will be coded and will not be associated with any 
published results. Your code number and identity will be kept in a locked file of the Principal 
Investigator. The only connection between your participation in this study and the study itself will be 
this signed consent form. If you withdraw from the study, no further data will be collected.  Any 
information that has been provided may be retained by the researchers and analyzed. In order to 
monitor this research study, representatives from the Institutional Review Board (IRB) and other federal 
agencies such as NIH (National Institutes of Health) and OHRP (Office of Human Research Protection) 
may inspect the research records which may reveal your identity. A description of this clinical trial will 
be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This web site will not include 
information that can identify you. At most, the web site will include a summary of the results. You can 
search this web site at any time. Federal law provides additional protections of your medical records and 
related health information. These are described in the HIPAA section of this document. 
 
Can I be removed from the research without my OK? 
The principal investigator of the study can remove you from the research study without your approval. 
Possible reasons for removal include need for hospitalization for physical or psychological reasons. 
 
What else do I need to know? 
This research is being funded by the National Institutes of Health, specifically the National Heart, Lung 
and Blood Institute (NHLBI).   
If you need medical care because of taking part in this research study, contact the investigator and/or 
speak with your doctor and medical care will be made available. Generally, this care will be billed to you, 
your insurance or other third party. The University at Buffalo has no program to pay for medical care for 
research-related injury.  
 
 
 
HIPAA:  Authorization for the Use and Disclosure of Identifiable Health 
Information for Research Purposes  
This section describes information about you and about your health that will be obtained by the 
researchers when you participate in the research study. Health information is considered "protected 
health information" when it may directly identify you as an individual. By signing this form you are 
agreeing to permit the researchers and/or other parties (described in detail below) to have access to 
this information. If there are any parts of this form that you do not understand, please be sure to ask us 
for further clarification. 
A. What protected health information will be collected about you as part of this research 
study? 
__√__  Information from your full medical records (height, weight, dietary restrictions and 
physical activity restrictions. 
__√__  New Health Information created from study related tests, procedures, visits, and/or                                         
questionnaires as described in this consent form. 

Page 83 of 305 
 
B.    Who is authorized to provide or collect this information? 
__√_      Principal Investigator or designee 
C.   With whom may your protected health information be shared?  
Your health information may be shared with others outside of the research group for purposes 
directly related to the conduct of this research study or as required by law, including but not 
limited to: 
__√__  
Clinical staff not involved in this research study who may become involved in your 
care if it is potentially relevant to your treatment. 
__√__  
The sponsor of this research study (National Heart, Lung and Blood Institutes 
(NHLBI) cooperative group, etc., or its agents. 
__√__  
The organization(s) responsible for administering this research (e.g., Research 
Foundation of SUNY, University at Buffalo, Washington University, Nationwide 
Children’s Hospital, University of Rochester). 
__√__  
Other medical investigators/centers/institutions participating in this research study. 
Your information may also be shared with individuals or entities responsible for general 
administration, oversight and compliance of research activities. Examples of this include the 
institution's Privacy and Security Officers or other internal oversight staff, Safety Monitoring 
Boards, an Institutional Review Board, The Research Foundation of the State University of New 
York, University at Buffalo Foundation Services, and accrediting bodies, or with certain 
government oversight agencies that have authority over the research including the Department 
of Health and Human Services (HHS), the Food and Drug Administration (FDA), the National 
Institutes of Health (NIH), and the Office of Human Research Protections (OHRP). Your 
information may also be shared with other entities as permitted or required by law. All 
reasonable efforts will be used to protect the confidentiality of your individually identifiable 
health information that may be shared with others as described above. 
All reasonable efforts will be used to protect the confidentiality of your protected health 
information. There is the potential for individually identifiable information and the associated 
health information obtained with this authorization to be re-disclosed by the recipient(s). After 
such a disclosure, the information may no longer be protected by the terms of this authorization 
against further re-disclosure. 
D.  How long will this information be kept by the Principal Investigator? 
__√__    This authorization has no expiration date. The researchers may continue to rely on this 
authorization to obtain and use protected health information about you unless you 
revoke this authorization in writing. 
__√__  Your protected health information will go into a database that will be maintained 
indefinitely. Any future study using this information that falls outside the scope of this 
current study will be required to follow guidelines designed to govern access to that 
information and to protect the privacy of that information. 
E.  What are your rights after signing this authorization? 
You have the right to revoke this authorization at any time. If you withdraw your authorization, 
no additional efforts to collect individually identifiable health information about you will be 
made. You should know, however, that protected health information acquired using this 

Page 84 of 305 
 
authorization prior to its withdrawal may continue to be used to the extent that the 
investigator(s) have already relied on your permission to conduct the research. If you chose to 
withdraw this authorization, you must do so in writing to the following individual(s): 
 
Leonard H. Epstein, Ph.D. 
University at Buffalo Department of Pediatrics 
Division of Behavioral Medicine 
3435 Main Street 
G56 Farber Hall 
Buffalo, NY 14214 
Phone: 716-829-3400 
 
If you send us a request to withdraw your authorization, we will forward that request to the 
institutions we have shared it with in order to collect your individually identifiable health 
information.  
 
F.  What will happen if you decide not to sign this authorization? 
 
Refusing to sign this authorization will not affect the present or future care you receive at this 
institution and will not cause any penalty or loss of benefits to which you are otherwise entitled. 
If you decide not to sign this authorization, you will not be able to participate in the research 
study.   
 
Signature Block for Capable Adult 
Your signature documents your permission to take part in this research. By signing this form you are not 
waiving any of your legal rights, including the right to seek compensation for injury related to negligence or 
misconduct of those involved in the research. 
 
 
 
 
Signature of subject 
 
Date 
 
 
Printed name of subject 
 
 
 
 
 
 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
Printed name of person obtaining consent 
 
 
 

Page 85 of 305 
 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
 
THE EFFECTIVENESS OF FAMILY-BASED WEIGHT LOSS TREATMENT 
IMPLEMENTED IN PRIMARY CARE 
 
Sibling Assent to be in a Research Study - (for Children 7-13 years of age) 
 
Version Date: 07-18-2018 
 
Investigators: Leonard H. Epstein, PhD 
 
Who are we? 
My name is Dr. Leonard H. Epstein and I am a researcher at the UB. I work in the Department of 
Pediatrics. 
 
Why are we meeting with you? 
We want to tell you about a study that involves children like yourself. We want to see if you would like 
to be in this study too. 
 
Why are we doing this study? 
We want to look at siblings of kids participating in a study through your doctor’s office.  
 
What will happen to you if you are in the study? 
You, your sibling, and a parent will first come to the doctor’s office. We will tell you about this study. It 
teaches kids about healthy eating and activities. We will ask you if you want to be a part of the study. If 
you want to, we will ask to you come back for more visits. 
 
You will be asked to come in 5 times over 2 years so we can measure your height and weight. This will 
be done in private. Only your parent, your sibling, and the study member will be with you. You do not 
have to answer any questions if you don’t want to. You do not have to do any activities you do not want 
to do. 
 
What are the good things and bad things that may happen to you if you are in the study? 
Most Likely:  
Good: You can learn how you are growing.  
Maybe:  
Good: You could learn what is like to be in a research study. You might lose weight.  
Bad: You might not like getting your height and weight taken. 
 
Do you have to be in the study? 
No you don’t. No one will get angry or upset with you if you don’t want to do this. If you do not want to 
be in the study at any time, it will not affect your family being in the study. Just tell us if you don’t want 

Page 86 of 305 
 
to be in the study. And remember, you can change your mind later if you decide you don’t want to be in 
the study anymore. 
 
Do you have any questions? 
You can ask questions at any time. You can ask now. You can ask later. You can talk to me or you can talk 
to someone else at any time during the study. You can call: 
 
Name of contact person on the study: Leonard H. Epstein, Ph.D.  
Phone Number: (716) 829-3400 
  
 
Signature Block for Sibling Assent of Child 
Your signature documents your permission to take part in this 
research. 
 
 
 
 
Signature of subject 
 
Date 
 
 
Printed Name of Subject 
 
 
I certify that the nature and purpose, the potential benefits and possible risks associated with 
participation in this research study have been explained to the above individual and that any questions 
about this information have been answered. A copy of this document will be given to the subject. 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
Printed name of person obtaining consent 
 
 
 
 
 

Page 87 of 305 
 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federal wide Assurance ID#: FWA00008824 
Title of research study: THE EFFECTIVENESS OF FAMILY-BASED WEIGHT LOSS 
TREATMENT IMPLEMENTED IN PRIMARY CARE 
 
Sibling Assent of a 14-17-year-old to Participate in a Research Study 
 
Version Date: 07-18-2018 
 
Investigators: Leonard H. Epstein, PhD 
 
Why am I being invited to take part in a research study? 
You are being invited to take part in a research study because: 
● You are a sibling between the ages of 14-17 able to read the English language and you fall into 
the overweight or obese weight category (defined as at or above the 85th percentile for age and 
sex) 
This research study is supported by a grant through the National Heart Blood and Lung Institutes 
(NHBLI).  Research studies only include individuals who choose to take part in them. Your decision to 
take part in this study is entirely voluntary. Please read this information carefully and ask questions 
about anything you do not understand before deciding whether or not to participate. You may also take 
home an unsigned copy of this consent form to think about participating or if you wish to discuss this 
matter with your family or your personal doctor. Please take your time to make your decision. Do not 
sign this form unless you have had the chance to ask questions and have received satisfactory answers. 
 
What should I know about a research study? 
● Someone will explain this research study to you. 
● Whether or not you take part is up to you. 
● You can choose not to take part. 
● You can agree to take part and later change your mind. 
● Your decision will not be held against you. 
● You can ask all the questions you want before you decide. 
 
Who can I talk to? 
If you have questions, concerns, or complaints, or think the research has hurt you, talk to the research 
team by telephone at 716-829-3400 for Dr. Leonard Epstein. You may also contact the PLAN coach at 
your doctor’s office, or you can contact the research participant advocate at 716-888-4845 or 
researchadvocate@buffalo.edu.  
This research has been reviewed and approved by an Institutional Review Board (“IRB”). You may talk to 
them at (716) 888-4888 or email ub-irb@buffalo.edu  if:  
● You have questions about your rights as a participant in this research 
● Your questions, concerns, or complaints are not being answered by the research team. 
● You cannot reach the research team. 

Page 88 of 305 
 
● You want to talk to someone besides the research team. 
● You want to get information or provide input about this research. 
 
Why is this research being done? 
The goal of this study is to determine whether a specific kind of weight loss treatment called family-
based behavioral treatment (FBT) for children, delivered by a PLAN coach, can be included in the 
primary care setting. Extensive information has been gathered by our research team about the 
treatment of childhood overweight and obesity, but there is still much to learn about how the treatment 
should be incorporated into various medical settings, such as primary care and how it effects siblings 
living with participating parents and children. 
 
How long will the research last? 
We expect that you will be in this treatment and research study for 24 months. 
 
How many people will be studied? 
We expect about 132 families will be in this research study in your geographical location, out of 528 
families in the entire study nationally. 
 
What happens if I say yes, I want to be in this research? 
To determine if your family is eligible to participate, you and your family will be asked to complete an 
eligibility assessment at an orientation session about this study. Your height and weight will be 
measured.  
If your family is eligible for this research study and agrees to participate, you will attend the baseline 
assessment with your sibling. After the baseline assessment and an initial appointment with your 
sibling’s doctor, your family will be randomized to one of two treatment conditions described below. 
Additionally, approximately every 6 months, you will get your height and weight measurements taken. 
Groups 
At the start of the study, your family will be assigned to one of two groups. Participants in one group will 
receive the current standard of care offered by their physician for the treatment of childhood weight 
management.  Participants in the second group will receive family-based behavioral treatment for 
weight management (FBT).  FBT is a behavioral weight-control intervention that aims to make weight 
changes in both a child and their participating parent. FBT is a well-tested treatment that targets diet, 
activity, behavioral techniques, parenting, and social facilitation in children and their parents. The 
treatment includes: 1) The Traffic Light Eating Plan, which uses RED, YELLOW, GREEN labels for food to 
guide families toward the goal of eating nutritious foods; 2) the Traffic Light Activity Program, which also 
uses RED, YELLOW and GREEN labels for different levels of exercise to increase physical activity and 
reducing inactive behaviors; and 3) a variety of behavioral techniques including changing and controlling 
your environment, tracking eating and physical activity, setting goals, problem solving, setting up a 
reward system, incentives for behavior change and weight loss, finding substitutes for unhealthy foods, 
and improving positive parenting. FBT also involves making changes in the home, so weight loss or 
prevention of weight gain may extend to members of the family who are not regularly attending 
treatment sessions (e.g., siblings and spouse). 
The group that your family will be in, will be chosen by chance, like flipping a coin. Neither you nor your 
sibling’s doctor will choose what treatment your family will receive. Your family will have an equal 
chance of being assigned to each group. You will be informed of the group your family is in following an 
initial physician visit. 

Page 89 of 305 
 
Treatment Schedule 
Every family will follow their pediatricians recommended schedule of appointments for weight 
management. Families in the group receiving FBT will additionally complete at least 26 sessions with the 
FBT interventionist during the 24 months of the study. The amount of sessions completed within this 
range will be based on progress through the program and will vary for each family. You will not attend 
the sessions with the PLAN coach. 
Assessments, Interviews, Questionnaires 
You will attend five major assessments throughout the entire 2 years of the study: 
● 1 Baseline assessment upon starting study (0 months) 
● 3 Measurement assessments during the study (6, 12, and 18 months) 
● 1 Follow-up assessment at end of study (24 months) 
Each major assessment will take approximately 30-90 minutes to complete at your sibling’s pediatric 
office, or a home visit can be arranged. Your height and weight will be taken at each major assessment.   
 
What are my responsibilities if I take part in this research? 
If you take part in this research, you will be responsible to attend the baseline assessment, all 
measurement assessments, and the follow-up assessment.  Your participation in any other meetings 
with your family are voluntary. Weight measurements at these times are also voluntary and can be used 
as data. 
 
What happens if I do not want to be in this research? 
Your participation in this research study is voluntary. You may choose not to enroll in this study, it will 
not affect your family being in the study.  There are no other research alternatives other than to 
participate in this study. 
 
What happens if I say yes, but I change my mind later? 
You can leave the research at any time, it will not be held against you. You do not have to answer every 
question and may refuse to answer any questions that you do not want to answer. 
If you decide to leave the research, you may not receive full compensation for your participation. If you 
decide to leave the research, contact the investigator at the contact information included below. If you 
stop being in the research, already collected data may not be removed from the study database. You will 
be asked whether the investigator can collect data from your routine medical care.  
 
Is there any way being in this study could be bad for me? 
There are certain risks and discomforts that may be associated with this research. They include: 
Likely 
● You may be inconvenienced at times by having to miss work, school activities, meetings, etc., to 
attend assessments. 
Less Likely 
● You may find having your height and weight measured uncomfortable. 
Rare 

Page 90 of 305 
 
● Although this treatment usually prevents the development of eating disorder problems, in rare 
cases it may increase them. 
● The use of online platforms is associated with risks involving breaches of confidentiality. We 
implement many layers of security to limit these risks as much as possible within our website 
and REDCap database. Outside platforms (i.e., MyFitnessPal) are subject to their own security 
measures and carry their own risks if your family chooses to use them to supplement your 
participation in this study. 
Will being in this study help me in any way? 
We cannot promise any benefits to you or others from your taking part in this research. This study may 
provide information that will help you to lose weight and keep it off. However, we cannot guarantee 
that you will receive any benefits from this study.  
 
What happens to the information collected for the research? 
Efforts will be made to limit the use and disclosure of your personal information, including research 
study and medical or education records, to people who have a need to review this information. We 
cannot promise complete secrecy. Organizations that may inspect and copy your information include 
the IRB and other representatives of this organization. Information related to you will be treated in strict 
confidence to the extent provided by law. Your identity will be coded and will not be associated with any 
published results. Your code number and identity will be kept in a locked file of the Principal 
Investigator. The only connection between your participation in this study and the study itself will be 
this signed consent form. If you withdraw from the study, no further data will be collected, but any 
information that has been provided may be retained by the researchers and analyzed. In order to 
monitor this research study, representatives from the Institutional Review Board (IRB) and other federal 
agencies such as NIH (National Institutes of Health) and OHRP (Office of Human Research Protection) 
may inspect the research records which may reveal your identity. A description of this clinical trial will 
be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This web site will not include 
information that can identify you. At most, the web site will include a summary of the results. You can 
search this web site at any time. 
 
Can I be removed from the research without my OK? 
The principal investigator of the study can remove you from the research study without your approval. 
Possible reasons for removal include need for hospitalization for physical or psychological reasons. 
 
What else do I need to know? 
This research is being funded by the National Institutes of Health, specifically the National Heart, Lung 
and Blood Institute (NHLBI).   
If you need medical care because of taking part in this research study, contact the investigator and/or 
speak with your doctor and medical care will be made available. Generally, this care will be billed to you, 
your insurance, or other third party. The University at Buffalo has no program to pay for medical care for 
research-related injury.  
 
Signature Block for Assent of Child 
Your signature documents your permission to take part in this research. By signing this form you are not 
waiving any of your legal rights, including the right to seek compensation for injury related to negligence or 
misconduct of those involved in the research. 
 

Page 91 of 305 
 
 
 
 
Signature of subject 
 
Date 
 
 
Printed name of subject 
I certify that the nature and purpose, the potential benefits and possible risks associated with participation 
in this research study have been explained to the above individual and that any questions about this 
information have been answered. A copy of this document will be given to the subject. 
 
 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
Printed name of person obtaining consent 
 
 
 
 
 
 

Page 92 of 305 
 
 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
 
THE EFFECTIVENESS OF FAMILY-BASED WEIGHT LOSS TREATMENT 
IMPLEMENTED IN PRIMARY CARE 
 
Participating Child Assent to be in a Research Study (for Children 7-13 yrs. of 
age) 
 
Version Date: 07-18-2018 
 
Investigators: Leonard H. Epstein, Ph.D. 
 
Who are we? 
My name is Dr. Leonard H. Epstein and I am a researcher at the University at Buffalo. I work in the 
Department of Pediatrics. 
 
Why are we meeting with you? 
We want to tell you about a study that involves children like yourself. We want to see if you would like 
to be in this study too. 
 
Why are we doing this study? 
We want to look at a certain kind of weight loss program for kids. We want to know if it will work at a 
doctor’s office. 
 
What will happen to you if you are in the study? 
You and a parent will first come to the doctor’s office. We will tell you about this study that teaches kids 
about healthy eating and activities. We will ask you if you want to be a part of the study. If you do, we 
will measure your height and weight. We will ask you to answer some questions about yourself and your 
parents. You will do a task that asks you to make choices between different amounts of money. If you 
want to, we will ask to you come back for more visits. 
 
After this, you and your parent will be put in one of two groups: 
● If you are in one group, you will follow the recommendations of your doctor. 
● If you are in the other group, you could come to your doctor’s office once a week. You would do 
this for 2 years. This would be at least 26 visits. At the visits you would meet with someone from 
the study. Your weight will be taken. You will learn about healthy food. We will teach you fun 
ways to exercise. 
 
Every 6 months we will ask you some questions about yourself. We will measure your height and weight. 
At your baseline, 12-month and Follow-up appointments, we will ask you to do a computer task that 
asks you to make choices between different amounts of money. 
 

Page 93 of 305 
 
You do not have to answer any questions that you do not want to answer. You do not have to do any 
activities that you do not want to do. 
 
What are the good things and bad things that may happen to you if you are in the study? 
Most Likely: You can have fun learning about healthy food and exercise. You could become healthy. 
 
Maybe: You could become hungry when trying to eat healthy. Your muscles could feel sore from 
exercise. That will go away once you are used to exercising.  
 
Do you have to be in the study? 
No you don’t. No one will get angry or upset with you if you don’t want to do this. Just tell us if you 
don’t want to be in the study. Also, you can change your mind later if you decide you don’t want to be in 
the study anymore. 
 
Do you have any questions? 
You can ask questions at any time. You can ask now. You can ask later. You can talk to me or you can talk 
to someone else at any time during the study. You can call: 
 
Name of contact person on the study: Leonard H. Epstein, Ph.D. Phone Number: (716) 829-3400 
  
 
Signature Block for Assent of Child 
 
Your signature documents your permission to take part in this research. 
 
 
 
Signature of subject 
 
Date 
 
 
Printed name of subject 
 
I certify that the nature and purpose, the potential benefits and possible risks associated with participation 
in this research study have been explained to the above individual and that any questions about this 
information have been answered. A copy of this document will be given to the subject. 
 
 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
Printed name of person obtaining consent 
 
 
 

Page 94 of 305 
 
 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federal wide Assurance ID#: FWA00008824 
Title of research study: THE EFFECTIVENESS OF FAMILY-BASED WEIGHT LOSS 
TREATMENT IMPLEMENTED IN PRIMARY CARE 
 
Adult Consent (Non-Participating Parent) to Participate in a Research Study 
 
Version Date: 07-18-2018 
 
Investigators: Leonard H. Epstein, Ph.D. 
 
Why am I being invited to take part in a research study? 
You are being invited to take part in a research study because: 
● You are a parent of a child participating in a study through your child’s doctor’s office.   
● You are able to read the English. 
This research study is supported by a grant through the National Heart, Lung and Blood Institutes 
(NHLBI).  Research studies only include individuals who choose to take part in them. Your decision to 
take part in this study is entirely voluntary. Please read this information carefully. Ask questions about 
anything you do not understand before deciding whether or not to participate. You may also take home 
an unsigned copy of this consent form to think about participating or if you wish to discuss this matter 
with your family or your personal doctor. Please take your time to make your decision. Do not sign this 
form unless you have had the chance to ask questions and have received satisfactory answers. 
 
What should I know about a research study? 
● Someone will explain this research study to you. 
● Whether or not you take part is up to you. 
● You can choose not to take part. 
● You can agree to take part and later change your mind. 
● Your decision will not be held against you. 
● You can ask all the questions you want before you decide. 
 
Who can I talk to? 
If you have questions, concerns, or complaints, or think the research has hurt you, talk to the research 
team by telephone at 716-829-3400 for Dr. Leonard Epstein. You may also contact the PLAN coach at 
your child’s doctor’s office, or you can contact the research participant advocate at 716-888-4845 or 
researchadvocate@buffalo.edu.  
This research has been reviewed and approved by an Institutional Review Board (“IRB”). You may talk to 
them at (716) 888-4888 or email ub-irb@buffalo.edu   if:  
● You have questions about your rights as a participant in this research 

Page 95 of 305 
 
● Your questions, concerns, or complaints are not being answered by the research team. 
● You cannot reach the research team. 
● You want to talk to someone besides the research team. 
● You want to get information or provide input about this research. 
 
Why is this research being done? 
The goal of this study is to determine whether a specific kind of weight loss treatment called family-
based behavioral treatment (FBT) for children, delivered by a PLAN coach, can be included in the 
primary care setting. Extensive information has been gathered by our research team about the 
treatment of childhood overweight and obesity. But there is still much to learn about how the treatment 
should be incorporated into various medical settings. Such as primary care and how it effects siblings 
living with participating parents and children. 
 
How long will the research last? 
We expect that you will be in this treatment and research study for 24 months. 
 
How many people will be studied? 
We expect about 132 families will be in this research study in your geographical location. Out of 528 
families in the entire study nationally. 
 
What happens if I say yes, I want to be in this research? 
To determine if you are eligible to participate, you will be asked to complete an eligibility assessment at 
an orientation session about this study. Your height and weight will be measured.  
If you are eligible for this research study and agree to participate, you will attend the baseline 
assessment with your participating child(ren), and the participating parent. After the baseline 
assessment your participating family members will attend an initial appointment with your child’s 
doctor. Your family will be randomized to one of two treatment conditions described below. 
Additionally, you will get your height and weight measurements taken at 24 months. 
Groups 
At the start of the study, your family will be assigned to one of two groups. Participants in one group will 
receive the current standard of care offered by their physician for the treatment of childhood weight 
management.  Participants in the second group will receive family-based behavioral treatment for 
weight management (FBT). 
FBT is a behavioral weight-control intervention that aims to make weight changes in both a child and 
their participating parent. FBT is a well-tested treatment that targets diet, activity, behavioral 
techniques, parenting, and social facilitation in children and their parents. The treatment includes: 1) 
The Traffic Light Eating Plan, which uses RED; YELLOW; and GREEN labels for food to guide families 
toward the goal of eating nutritious foods. 2) The Traffic Light Activity Program, which also uses RED; 
YELLOW; and GREEN labels for different levels of exercise to increase physical activity and reducing 
inactive behaviors. 3) a variety of behavioral techniques including changing and controlling your 
environment; tracking eating and physical activity; setting goals; problem solving; setting up a reward 
system; incentives for behavior change and weight loss; finding substitutes for unhealthy foods; and 
improving positive parenting. FBT also involves making changes in the home. So weight loss or 
prevention of weight gain may extend to members of the family who are not regularly attending 
treatment sessions (e.g., siblings and spouse). 

Page 96 of 305 
 
The group that your family will be in/the treatment they get will be chosen by chance, like flipping a 
coin. Neither parent nor your child’s doctor will choose what treatment they get. Your participating 
family members will have an equal chance of being assigned to each group. Your family will be informed 
of the group they are in following an initial physician visit. 
Treatment Schedule 
Every family will follow their pediatricians recommended schedule of appointments for weight 
management. Families in the group receiving FBT will additionally complete at least 26 sessions with the 
FBT interventionist during the 24 months of the study. The amount of sessions completed within this 
range will be based on progress through the program. The amount will vary for each family.  You will not 
attend the sessions with the PLAN coach. 
Assessments, Interviews, Questionnaires 
You will attend two major assessments throughout the entire 2 years of the study: 
● 1 Baseline assessment upon starting study (0 months) 
● 1 Follow-up assessment at end of study (24 months) 
Each major assessment will take approximately 15 minutes to complete at your child’s pediatric office, 
or a home visit can be arranged. Your height and weight will be taken at each major assessment. 
 
What are my responsibilities if I take part in this research? 
If you take part in this research, you will be responsible to get your height taken at baseline and weight 
taken at baseline and final assessment sessions.  Your participation in any other meetings with your 
family are voluntary. Weight measurements at these times are also voluntary and can be used as data. 
 
What happens if I do not want to be in this research? 
Your participation in this research study is voluntary. You may choose not to enroll in this study it will 
not affect your family being in the study. There are no other research alternatives other than to 
participate in this study. 
 
What happens if I say yes, but I change my mind later? 
You can leave the research at any time. It will not be held against you, or affect your family’s 
participation in the study. You do not have to answer every question. You may refuse to answer any 
questions that you do not want to answer. 
If you decide to leave the research, you may not receive full compensation for your participation. If you 
decide to leave the research, contact the investigator at the contact information included below. If you 
stop being in the research, already collected data may not be removed from the study database. You will 
be asked whether the investigator can collect data from your routine medical care.  
 
Is there any way being in this study could be bad for me? 
There are certain risks and discomforts that may be associated with this research. They include: 
Likely 
● You may be inconvenienced at times by having to miss work, school activities, meetings, etc., to 
attend assessments. 
Less Likely 
● You may find having your height and weight measured uncomfortable. 

Page 97 of 305 
 
Rare 
● Although this treatment usually prevents the development of eating disorder problems, in rare 
cases it may increase them. 
● The use of online platforms is associated with risks involving breaches of confidentiality. We 
implement many layers of security to limit these risks as much as possible within our website 
and REDCap database. Outside platforms (i.e., MyFitnessPal) are subject to their own security 
measures and carry their own risks if your family chooses to use them to supplement your 
participation in this study. 
Will being in this study help me in any way? 
We cannot promise any benefits to you or others from your family taking part in this research. This 
study may provide information that will help you to lose weight and keep it off. However, we cannot 
guarantee that you will receive any benefits from this study.  
 
What happens to the information collected for the research? 
Efforts will be made to limit the use and disclosure of your personal information, including research 
study and medical or education records, to people who have a need to review this information. We 
cannot promise complete secrecy. Organizations that may inspect and copy your information include 
the IRB and other representatives of this organization. Information related to you will be treated in strict 
confidence to the extent provided by law. Your identity will be coded and will not be associated with any 
published results. Your code number and identity will be kept in a locked file of the Principal 
Investigator. The only connection between your participation in this study and the study itself will be 
this signed consent form. If you withdraw from the study, no further data will be collected. Any 
information that has been provided may be retained by the researchers and analyzed. In order to 
monitor this research study, representatives from the Institutional Review Board (IRB) and other federal 
agencies such as NIH (National Institutes of Health) and OHRP (Office of Human Research Protection) 
may inspect the research records which may reveal your identity. A description of this clinical trial will 
be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This web site will not include 
information that can identify you. At most, the web site will include a summary of the results. You can 
search this web site at any time. Federal law provides additional protections of your medical records and 
related health information. These are described in the HIPAA section of this document. 
Can I be removed from the research without my OK? 
The principal investigator of the study can remove you from the research study without your approval. 
Possible reasons for removal include need for hospitalization for physical or psychological reasons. 
 
What else do I need to know? 
This research is being funded by the National Institutes of Health, specifically the National Heart, Lung 
and Blood Institute (NHLBI).   
If you need medical care because of taking part in this research study, contact the investigator and/or 
speak with your doctor and medical care will be made available. Generally, this care will be billed to you, 
your insurance, or other third party. The University at Buffalo has no program to pay for medical care for 
research-related injury.  
 
HIPAA:  Authorization for the Use and Disclosure of Identifiable Health 
Information for Research Purposes  

Page 98 of 305 
 
This section describes information about you and about your health that will be obtained by the 
researchers when you participate in the research study. Health information is considered "protected 
health information" when it may directly identify you as an individual. By signing this form you are 
agreeing to permit the researchers and/or other parties (described in detail below) to have access to 
this information. If there are any parts of this form that you do not understand, please be sure to ask us 
for further clarification. 
A. What protected health information will be collected about you as part of this research 
study? 
__√__   Specific information from your medical records related to height and weight. 
__√__ New Health Information created from study related tests, procedures, visits, and/or                                          
questionnaires as described in this consent form. 
 
B.    Who is authorized to provide or collect this information? 
__√_      Principal Investigator or designee 
 
C.   With whom may your protected health information be shared?  
Your health information may be shared with others outside of the research group for purposes 
directly related to the conduct of this research study or as required by law, including but not 
limited to: 
_√__  
Clinical staff not involved in this research study who may become involved in you and 
your child’s care if it is potentially relevant to your treatment. 
__√__  
The sponsor of this research study (National Heart, Lung and Blood Institutes (NHLBI) 
cooperative group, etc., or its agents. 
__√__  
The organization(s) responsible for administering this research (e.g., Research 
Foundation of SUNY, University at Buffalo, Washington University, Nationwide 
Children’s Hospital, University of Rochester). 
__√__  
Other medical investigators/centers/institutions participating in this research study. 
Your information may also be shared with individuals or entities responsible for general 
administration, oversight and compliance of research activities. Examples of this include the 
institution's Privacy and Security Officers or other internal oversight staff, Safety Monitoring 
Boards, an Institutional Review Board, The Research Foundation of the State University of New 
York, University at Buffalo Foundation Services, and accrediting bodies, or with certain 
government oversight agencies that have authority over the research including the Department 
of Health and Human Services (HHS), the Food and Drug Administration (FDA), the National 
Institutes of Health (NIH), and the Office of Human Research Protections (OHRP). Your 
information may also be shared with other entities as permitted or required by law. All 
reasonable efforts will be used to protect the confidentiality of your individually identifiable 
health information that may be shared with others as described above. 
All reasonable efforts will be used to protect the confidentiality of your protected health 
information. There is the potential for individually identifiable information and the associated 
health information obtained with this authorization to be re-disclosed by the recipient(s). After 

Page 99 of 305 
 
such a disclosure, the information may no longer be protected by the terms of this authorization 
against further re-disclosure. 
 
 
D.  How long will this information be kept by the Principal Investigator? 
__√__    This authorization has no expiration date. The researchers may continue to rely on this 
authorization to obtain and use protected health information about you unless you 
revoke this authorization in writing. 
__√__ Your protected health information will go into a database that will be maintained 
indefinitely. Any future study using this information that falls outside the scope of this 
current study will be required to follow guidelines designed to govern access to that 
information and to protect the privacy of that information. 
E.  What are your rights after signing this authorization? 
You have the right to revoke this authorization at any time. If you withdraw your authorization, 
no additional efforts to collect individually identifiable health information about you will be 
made. You should know, however, that protected health information acquired using this 
authorization prior to its withdrawal may continue to be used to the extent that the 
investigator(s) have already relied on your permission to conduct the research. If you chose to 
withdraw this authorization, you must do so in writing to the following individual(s): 
 
Leonard H. Epstein, Ph.D. 
University at Buffalo Department of Pediatrics 
Division of Behavioral Medicine 
3435 Main Street 
G56 Farber Hall 
Buffalo, NY 14214 
Phone: 716-829-3400 
 
If you send us a request to withdraw your authorization, we will forward that request to the 
institutions we have shared it with in order to collect your individually identifiable health 
information.  
 
F.  What will happen if you decide not to sign this authorization? 
 
Refusing to sign this authorization will not affect the present or future care you receive at this 
institution and will not cause any penalty or loss of benefits to which you are otherwise entitled. 
If you decide not to sign this authorization, you will not be able to participate in the research 
study.   
 
Signature Block for Capable Adult 

Page 100 of 305 
 
Your signature documents your permission to take part in this research. By signing this form you are not 
waiving any of your legal rights, including the right to seek compensation for injury related to negligence or 
misconduct of those involved in the research. 
 
 
 
 
Signature of subject 
 
Date 
 
 
Printed name of subject 
 
 
 
 
 
 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
Printed name of person obtaining consent 
 
 
 
 
 
 

Page 101 of 305 
 
 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federal wide Assurance ID#: FWA00008824 
Title of research study: THE EFFECTIVENESS OF FAMILY-BASED WEIGHT LOSS 
TREATMENT IMPLEMENTED IN PRIMARY CARE 
 
Parental Permission for Targeted Child to Participate in a Research Study 
 
Version Date: 07-18-2018 
 
Investigators: Leonard H. Epstein, Ph.D. 
 
Why is my child being invited to take part in a research study? 
Your child is being invited to take part in a research study because: 
● You are an adult able to read the English language.  You have reported no current learning 
disabilities, medical problems, or psychiatric problems.  
● Your child is between the ages of 6 and 12 years old, falls into the overweight or obese weight 
category (defined as at or above the 85th percentile for age and sex), and your child has at least 
one parent that is willing to participate in the study. 
This research study is supported by a grant through the National Heart Lung Blood Institutes (NHLBI). 
Research studies only include individuals who choose to take part in them. Your decision for your child 
to take part in this study is entirely voluntary. Please read this information carefully.  Ask questions 
about anything you do not understand before deciding whether or not to participate. You may also take 
home an unsigned copy of this consent form to think about participating or if you wish to discuss this 
matter with your family or your personal doctor. Please take your time to make your decision. Do not 
sign this form unless you have had the chance to ask questions and have received satisfactory answers. 
 
What should my child and I know about a research study? 
● Someone will explain this research study to you and your child. 
● Whether or not your child takes part is up to you and your child. 
● You and your child can choose for your child not to take part. 
● You and your child can agree to take part and later change your mind. 
● You and your child’s decision will not be held against you. 
● You and your child can ask all the questions you want before you decide. 
Who can my child and I talk to? 
If you or your child has questions, concerns, or complaints, or think the research has hurt your child, talk 
to the research team by telephone at 716-829-3400 for Dr. Leonard Epstein. You may also contact the 
PLAN coach at your child’s doctor’s office.  You can also contact the research participant advocate at 
716-888-4845 or researchadvocate@buffalo.edu.  
This research has been reviewed and approved by an Institutional Review Board (“IRB”). You may talk to 
them at (716) 888-4888 or email ub-irb@buffalo.edu  if:  

Page 102 of 305 
 
● You have questions about your child’s rights as a participant in this research 
● Your questions, concerns, or complaints are not being answered by the research team. 
● You cannot reach the research team. 
● You want to talk to someone besides the research team. 
● You want to get information or provide input about this research. 
 
Why is this research being done? 
The goal of this study is to determine whether a specific kind of weight loss treatment called family-
based behavioral treatment (FBT) for children, delivered by a PLAN coach, can be included in the 
primary care setting.  Extensive information has been gathered by our research team about the 
treatment of childhood overweight and obesity. But there is still much to learn about how the treatment 
should be incorporated into various medical settings. Such as primary care. 
 
Your child has been asked to participate because he/she is between the ages of 6 and 12 years old, falls 
into the overweight or obese weight category (defined as at or above the 85th percentile for age and 
sex), and your child has at least one parent that is willing to participate in the study. 
 
How long will the research last? 
We expect that your child will be in this treatment and research study for 24 months. 
 
How many people will be studied? 
We expect about 132 families will be in this research study in your geographical location, out of 528 
families in the entire study nationally. 
 
What happens if I say yes, my child wants to be in this research? 
To determine if your child is eligible to participate, you and your child will be asked to complete an 
eligibility assessment at an orientation session about this study. You and your child’s height and weight 
will be measured, and standard questions regarding medical and psychological history will be asked by a 
trained interviewer to determine eligibility.  
If your family is eligible for this research study and agrees to participate, you and your child will be asked 
to come to your pediatric office to complete a baseline assessment (detailed below). Additionally, we 
hope to collect information about how participation in FBT may affect others in your home. Therefore, if 
you have another child who meets eligibility criteria (between the ages of 2-18 who is at or above the 
85th percentile for age and sex), we ask that this child also attend the baseline assessment. After the 
baseline assessment and an initial appointment with your child’s doctor, your family will be randomized 
to one of two treatment conditions described below.   
 
Groups 
At the start of the study, your family will be assigned to one of two groups.  Participants in one group 
will receive the current standard of care offered by their physician for the treatment of childhood 
weight management. Participants in the second group will receive family-based behavioral treatment 
for weight management (FBT). 
FBT is a behavioral weight-control intervention that aims to make weight changes in both a child and 
their participating parent. FBT is a well-tested treatment that targets diet, activity, behavioral 
techniques, parenting, and social facilitation in children and their parents. The treatment includes: 1) 
The Traffic Light Eating Plan uses RED; YELLOW; GREEN labels for food to guide families toward the goal 

Page 103 of 305 
 
of eating nutritious foods. 2) The Traffic Light Activity Program also uses RED; YELLOW; and GREEN 
labels for different levels of exercise to increase physical activity and reducing inactive behaviors. 3) a 
variety of behavioral techniques including changing and controlling your environment; tracking eating 
and physical activity; setting goals; problem solving; setting up a reward system; incentives for behavior 
change and weight loss; finding substitutes for unhealthy foods; and improving positive parenting. FBT 
also involves making changes in the home. So that weight loss or prevention of weight gain may extend 
to members of the family who are not regularly attending treatment sessions (e.g., siblings and spouse). 
The group that your family will be in/the treatment you get will be chosen by chance. Like flipping a 
coin. Neither you nor your doctor will choose what treatment your family will receive. Your family will 
have an equal chance of being assigned to each group. You will be informed of the group your family is 
in and your treatment following an initial physician visit. 
Treatment Schedule 
Every family will follow their pediatricians recommended schedule of appointment for weight 
management. Families in the group receiving FBT will additionally complete at least 26 sessions with the 
FBT PLAN coach during the 24 months of the study. The amount of session completed within this range 
will be based on progress through the program. The amount will vary for each family. 
Assessments, Interviews, Questionnaires 
Attendance will be taken and both you and your child will be weighed at every session. In addition, there 
will be five major assessments throughout the entire 2 years of the study: 
● 1 Baseline assessment upon starting study (0 months) 
● 3 Measurement assessments during the study (6, 12, and 18 months) 
● 1 Follow-up assessment at end of study (24 months) 
Each major assessment will take approximately 30-90 minutes to complete at your child’s pediatric 
office, or a home visit can be arranged. Height and weight will be taken on you and your child as well as 
the identified other family members (if applicable). Your height will be taken at the beginning of the 
study, and your child(ren)’s height will be taken at each major assessment. You and your participating 
child will also complete short questionnaires. At your baseline, 12-month, and follow-up appointment, 
you will be asked to complete a computer task.  You both will be asked questions about parenting 
behaviors and the home food and activity environment. Throughout the study, you will have access to a 
website that contains study materials and interactive tools.   At the very end of the study, the PLAN 
coach will review your child’s chart to collect data on Usual Care. 
Audio Recording 
Your interviews and individual family and will be audiotaped or digitally recorded for research purposes, 
but you will not be identified on the recording and the recordings will not be labeled with your name. 
Recording the sessions is the best way to make sure we collect accurate information. It also helps us 
make sure that all our staff delivers the study to participants in the same way. The recordings will be 
stored on password-protected computers with restricted access within the University at Buffalo, and 
then transferred to Washington University School of Medicine. The recordings will be labeled only with 
your study ID, date, and session number. The Principal Investigator and research staff may use these 
recordings for purposes of evaluation, treatment, research, and training related to this study. 
Recordings may also be used to train staff implementing these or similar interventions at other sites. 
The recordings will be destroyed at the end of the study when all data analysis is complete. You do not 
have to agree to be audio recorded in order to participate in this study. 
Please check and initial below if you agree for you and your child to be audio recorded during your 
sessions with the PLAN coach: 

Page 104 of 305 
 
__________YES, PARENT INITIAL______________ , I give my permission to be audio recorded 
during sessions with a PLAN Coach. Date: ________________ 
 
__________NO, PARENT INITIAL______________ , I do not give my permission to be audio recorded 
during sessions with a PLAN Coach. Date: ________________ 
 
What are my child’s responsibilities if he/she takes part in this research? 
If your child takes part in this research, he/she will be responsible to: attend the baseline assessment, 
attend all measurement assessments, attend at least 26 treatment sessions if your family is in the group 
receiving FBT, and attend the follow-up assessment. 
What happens if my child does not want to be in this research? 
Your child’s participation in this research study is voluntary. You or your child may choose not to enroll 
in this study. There are no other research alternatives other than to participate in this study. 
What happens if my child and I say yes, but change our mind later? 
Your child can leave the research at any time. It will not be held against him/her. Your child does not 
have to answer every question. He/she may refuse to answer any questions that he/she does not want 
to answer. 
If your child decides to leave the research, you may not be able to find this kind of family treatment in 
your area outside of this research study. Other types of treatment may be available in your community. 
In which case we will provide a list of these and how to find them if you prefer this option. However you 
and/or your insurance company would be responsible for any costs associated with these options. You 
also may not receive full compensation for your participation. If your child decides to leave the research, 
contact the investigator at the contact information included below. If your child stops being in the 
research, already collected data may not be removed from the study database. You will be asked 
whether the investigator can collect data from your child’s routine medical care.  
 
Is there any way being in this study could be bad for my child? 
There are certain risks and discomforts that may be associated with this research. They include: 
Likely 
● Your child might feel hungry when dieting or sore after exercising. 
Less Likely 
● Your child may find some of the questions embarrassing or be uncomfortable having his/her 
height and weight measured. 
● There may be some family disagreements as issues of family functioning; communication; and 
discipline are discussed. 
● Your child may be inconvenienced at times by having to miss school activities, meetings, etc., to 
attend assessments and family sessions. 
Rare 
● There is a risk of audio recordings being lost. All recordings will be immediately stored in a 
locked drawer or saved to a password-protected computer in the research office after the 
individual family and group weight loss and maintenance sessions. Your family name will not be 
on these recordings, which will be identified only by a study ID number. 

Page 105 of 305 
 
● The use of online platforms is associated with risks involving breaches of confidentiality. We 
implement many layers of security to limit these risks as much as possible within our website 
and REDCap database. Outside platforms (i.e., MyFitnessPal) are subject to their own security 
measures and carry their own risks if your family chooses to use them to supplement your 
participation in this study. 
● In addition, although this treatment usually prevents the development of eating disorder 
problems, in rare cases it may increase them. 
Other Risks 
● In this study your child will be given a physical activity goal. Given that some people may have 
medical risks associated with increasing their physical activity, these recommendations for your 
child will be given in consultation with his/her doctor.  
● Randomization - As mentioned before, this study has two groups. Because chance decides 
which group your child will be in, the treatment your child receives as part of this study may not 
be what your own doctor would choose for your child. 
 
Will being in this study help my child in any way? 
We cannot promise any benefits to you, your child, or others from your taking part in this research. 
However, possible benefits could include your child losing weight, becoming more physically active, and 
eating more healthfully as a result of participation. In addition, maintaining weight loss may lead to 
better relationships and better mood. However, we cannot guarantee your child will receive any 
benefits from this study. This study may provide information that will help other children inside and 
outside your household to lose weight and keep it off. 
 
What happens to the information collected for the research? 
Efforts will be made to limit the use and disclosure of your child’s personal information, including 
research study and medical or education records, to people who have a need to review this information. 
We cannot promise complete secrecy. Organizations that may inspect and copy your child’s information 
include the IRB and other representatives of this organization. Information related to your child will be 
treated in strict confidence to the extent provided by law. Your child’s identity will be coded and will not 
be associated with any published results. Your child’s code number and identity will be kept in a locked 
file of the Principal Investigator. The only connection between your child’s participation in this study and 
the study itself will be this signed consent form. All recordings of the sessions will be kept in a locked file 
of the Principal Investigator until the end of the study. At which point they will be destroyed. If your 
child withdraws from the study, no further data will be collected. Any information that has been 
provided may be retained by the researchers and analyzed. In order to monitor this research study, 
representatives from the Social and Behavioral Sciences Institutional Review Board (SBSIRB) and other 
federal agencies such as NIH (National Institutes of Health) and OHRP (Office of Human Research 
Protection) may inspect the research records which may reveal your child’s identity. A description of this 
clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This web site will 
not include information that can identify your child. At most, the web site will include a summary of the 
results. You can search this web site at any time. Federal law provides additional protections of your 
child’s medical records and related health information. These are described in the HIPAA section of this 
document. 
 
 
 

Page 106 of 305 
 
Can my child be removed from the research without our OK? 
The principal investigator of the study can remove your child from the research study without your or 
your child’s approval. Possible reasons for removal include need for hospitalization for physical or 
psychological reasons. We will tell you about any new information that may affect your child’s health, 
welfare, or choice to stay in the research. 
 
What else do my child and I need to know? 
This research is being funded by the National Institutes of Health, specifically the National Heart, Lung 
and Blood Institute (NHLBI). 
If your child needs medical care because of taking part in this research study, contact the investigator 
and/or speak with your doctor and medical care will be made available. Generally, this care will be billed 
to you, your insurance or other third party. The University at Buffalo has no program to pay for medical 
care for research-related injury. If your child agrees to take part in this research study, we will pay your 
family up to $175 for your time and effort. The amount you are paid depends upon your attendance to 
visits in the study. 
 
HIPAA:  Authorization for the Use and Disclosure of Identifiable Health Information for Research 
Purposes  
This section describes information about your child and about your child’s health that will be obtained 
by the researchers when your child participates in the research study. Health information is considered 
"protected health information" when it may directly identify your child as an individual. By signing this 
form you are agreeing to permit the researchers and/or other parties (described in detail below) to have 
access to this information. If there are any parts of this form that you do not understand, please be sure 
to ask us for further clarification. 
A. What protected health information will be collected about your child as part of this 
research study? 
__√__  Information from your child’s full medical records.  
__√__  New Health Information created from study related tests, procedures, visits, and/or                                         
questionnaires as described in this consent form. 
B.    Who is authorized to provide or collect this information? 
__√_      Principal Investigator or designee 
C.   With whom may your child’s protected health information be shared?  
Your child’s health information may be shared with others outside of the research group for 
purposes directly related to the conduct of this research study or as required by law, including 
but not limited to: 
__√__  
Clinical staff not involved in this research study who may become involved in your 
child’s care if it is potentially relevant to your treatment. 
__√__  
The sponsor of this research study (National Heart, Lung and Blood Institutes 
(NHLBI) cooperative group, etc., or its agents. 
__√__  
The organization(s) responsible for administering this research (e.g., Research 
Foundation of SUNY, University at Buffalo, Washington University, Nationwide 
Children’s Hospital, University of Rochester). 

Page 107 of 305 
 
__√__  Other medical investigators/centers/institutions participating in this research study.  
Your child’s information may also be shared with individuals or entities responsible for general 
administration, oversight and compliance of research activities. Examples of this include the 
institution's Privacy and Security Officers or other internal oversight staff, Safety Monitoring 
Boards, an Institutional Review Board, The Research Foundation of the State University of New 
York, University at Buffalo Foundation Services, and accrediting bodies, or with certain 
government oversight agencies that have authority over the research including the Department of 
Health and Human Services (HHS), the Food and Drug Administration (FDA), the National Institutes 
of Health (NIH), and the Office of Human Research Protections (OHRP). Your child’s information 
may also be shared with other entities as permitted or required by law. All reasonable efforts will 
be used to protect the confidentiality of your child’s individually identifiable health information 
that may be shared with others as described above. 
All reasonable efforts will be used to protect the confidentiality of your child’s protected health 
information. There is the potential for individually identifiable information and the associated 
health information obtained with this authorization to be re-disclosed by the recipient(s). After 
such a disclosure, the information may no longer be protected by the terms of this authorization 
against further re-disclosure. 
 
D.  How long will this information be kept by the Principal Investigator? 
__√__    This authorization has no expiration date. The researchers may continue to rely on this 
authorization to obtain and use protected health information about your child unless 
you revoke this authorization in writing. 
__√__  Your child’s protected health information will go into a database that will be maintained 
indefinitely. Any future study using this information that falls outside the scope of this 
current study will be required to follow guidelines designed to govern access to that 
information and to protect the privacy of that information. 
E.  What are your rights after signing this authorization? 
You have the right to revoke this authorization at any time. If you withdraw your authorization, 
no additional efforts to collect individually identifiable health information about your child will 
be made. You should know, however, that protected health information acquired using this 
authorization prior to its withdrawal may continue to be used to the extent that the 
investigator(s) have already relied on your permission to conduct the research. If you chose to 
withdraw this authorization, you must do so in writing to the following individual(s): 
 
Leonard H. Epstein, Ph.D. 
University at Buffalo Department of Pediatrics 
Division of Behavioral Medicine 
3435 Main Street 
G56 Farber Hall 
Buffalo, NY 14214 
Phone: 716-829-3400 
 

Page 108 of 305 
 
If you send us a request to withdraw your authorization, we will forward that request to the 
institutions we have shared it with in order to collect your individually identifiable health 
information.  
 
F.  What will happen if you decide not to sign this authorization? 
 
Refusing to sign this authorization will not affect the present or future care your child receives at 
this institution and will not cause any penalty or loss of benefits to which you are otherwise 
entitled. If you decide not to sign this authorization, you and your child will not be able to 
participate in the research study.   
 
 

Page 109 of 305 
 
Signature Block for Parental Permission 
 
Your signature documents your permission for the named child to take part in this research. By signing this form you are
not waiving any of your legal rights, including the right to seek compensation for injury related to negligence or 
misconduct of those involved in the research. 
 
 
Printed name of child 
 
 
 
Signature of parent or individual legally authorized to consent to the child’s 
general medical care 
 
Date 
 
❑ Parent 
❑ Individual legally authorized to 
consent to the child’s general 
medical care (See note below) 
Printed name of parent or individual legally authorized to consent to the child’s 
general medical care 
Note: Investigators are to ensure that individuals who are not parents can demonstrate their legal authority to consent to the 
child’s general medical care. Contact legal counsel if any questions arise. 
 
 
 
Assent Process 
 
❑ Child is birth-6 yrs. old - Assent is not required 
❑ Child is 7-17 yrs. old – A separate Assent Document is to be signed by the child 
❑ Assent will be obtained Verbally 
❑ Assent has been waived by the IRB 
 
I certify that the nature and purpose, the potential benefits and possible risks associated with participation in 
this research study have been explained to the above individual and that any questions about this information 
have been answered. A copy of this document will be given to the subject. 
 
 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
Printed name of person obtaining consent 
 
 
 
 
 

Page 110 of 305 
 
 
 
 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federal wide Assurance ID#: FWA00008824 
Title of research study: THE EFFECTIVENESS OF FAMILY-BASED WEIGHT LOSS TREATMENT 
IMPLEMENTED IN PRIMARY CARE 
 
Parental Permission of Sibling to Participate in a Research Study 
 
Version Date: 07-18-2018 
 
Investigators: Leonard H. Epstein, PhD 
 
Why is my child being invited to take part in a research study? 
Your child is being invited to take part in a research study because: 
● You are an adult able to read the English language. You have reported no current learning 
disabilities, medical problems, or psychiatric problems.  
● You have a child between the ages of 2-18 years old that falls into the overweight or obese 
weight category (defined as at or above the 85th percentile for age and sex) and is willing to 
participate by getting his/her height and weight taken every 6 months over the two-year study. 
● You have another child between the ages of 6 and 12 years old that falls into the overweight or 
obese weight category (defined as at or above the 85th percentile for age and sex), and your 
child has at least one parent that is willing to participate in the study. 
This research study is supported by a grant through the National Heart Lung Blood Institutes (NHLBI). 
Research studies only include individuals who choose to take part in them. Your decision for your child 
to take part in this study is entirely voluntary. Please read this information carefully. Ask questions about 
anything you do not understand before deciding whether or not to participate. You may also take home 
an unsigned copy of this consent form to think about participating or if you wish to discuss this matter 
with your family or your personal doctor. Please take your time to make your decision. Do not sign this 
form unless you have had the chance to ask questions and have received satisfactory answers. 
 
What should my child and I know about a research study? 
● Someone will explain this research study to you and your child. 
● Whether or not your child takes part is up to you and your child. 
● You and your child can choose for your child not to take part. 
● You and your child can agree to take part and later change your mind. 
● You and your child’s decision will not be held against you. 
● You and your child can ask all the questions you want before you decide. 
 
 
 

Page 111 of 305 
 
Who can my child and I talk to? 
If you or your child has questions, concerns, or complaints, or think the research has hurt your child, talk 
to the research team by telephone at 716-829-3400 for Dr. Leonard Epstein. You may also contact the 
PLAN coach at your child’s doctor’s office. You can also contact the research participant advocate at 
716-888-4845 or researchadvocate@buffalo.edu.  
This research has been reviewed and approved by an Institutional Review Board (“IRB”). You may talk to 
them at (716) 888-4888 or email ub-irb@buffalo.edu if:  
● You have questions about your child’s rights as a participant in this research 
● Your questions, concerns, or complaints are not being answered by the research team. 
● You cannot reach the research team. 
● You want to talk to someone besides the research team. 
● You want to get information or provide input about this research. 
 
Why is this research being done? 
The goal of this study is to determine whether a specific kind of weight loss treatment called family-
based behavioral treatment (FBT) for children, delivered by a PLAN coach, can be included in the 
primary care setting.  Extensive information has been gathered by our research team about the 
treatment of childhood overweight and obesity. But there is still much to learn about how the treatment 
should be incorporated into various medical settings, such as primary care. 
 
Your child has been asked to participate because he/she is between the ages of 2 and 18 years old, falls 
into the overweight or obese weight category (defined as at or above the 85th percentile for age and 
sex), has one sibling who is also considered overweight or obese (BMI greater than 25), and has at least 
one parent that is willing to participate in the study.  
 
How long will the research last? 
We expect that your child will be in this research study for 24 months. 
 
How many people will be studied? 
We expect about 132 families will be in this research study in your geographical location, out of 528 
families in the entire study nationally. 
 
What happens if I say yes, my child wants to be in this research? 
To determine if your child is eligible to participate you, your participating (target) child, and this 
participating sibling will be asked to complete an eligibility assessment at an orientation session about 
this study. You and your children’s height and weight will be measured.  
If your family is eligible for this research study and agrees to participate, the participating sibling 
(between the ages of 2-18 who is at or above the 85th percentile for age and sex) will attend the 
baseline assessment with you and your target child. After the baseline assessment and an initial 
appointment with your child’s doctor, your family will be randomized to one of two treatment 
conditions described below.   
Groups 
At the start of the study, your family will be assigned to one of two groups. Participants in one group will 
receive the current standard of care offered by their physician for the treatment of childhood weight 
management.  FBT is a behavioral weight-control intervention that aims to make weight changes in both 
a child and their participating parent. FBT is a well-tested treatment that targets diet, activity, behavioral 

Page 112 of 305 
 
techniques, parenting, and social facilitation in children and their parents. The treatment includes: 1) 
The Traffic Light Eating Plan uses RED; YELLOW; and GREEN labels for food to guide families toward the 
goal of eating nutritious foods. 2) The Traffic Light Activity Program also uses RED; YELLOW; and GREEN 
labels for different levels of exercise to increase physical activity and reducing inactive behaviors. 3) a 
variety of behavioral techniques including changing and controlling your environment; tracking eating 
and physical activity; setting goals; problem solving; setting up a reward system; incentives for behavior 
change and weight loss; finding substitutes for unhealthy foods; and improving positive parenting. FBT 
also involves making changes in the home. So weight loss or prevention of weight gain may extend to 
members of the family who are not regularly attending treatment sessions (e.g., siblings and spouse). 
The group that your family will be in/the treatment you get will be chosen by chance. Like flipping a 
coin. Neither you nor your doctor will choose what treatment your family will receive. Your family will 
have an equal chance of being assigned to each group. You will be informed of the group your family is 
in and your treatment following an initial physician visit. 
 
Treatment Schedule 
Every family will follow their pediatrician recommended schedule of appointments for weight 
management to have at least 4 visits with their child’s doctor over the course of the 24 months of the 
study. Families in the group receiving FBT will additionally complete at least 26 sessions with the FBT 
PLAN coach during the 24 months of the study. The amount of session completed within this range will 
be based on progress through the program. The amount will vary for each family.  The participating 
sibling will not attend the sessions with the PLAN coach. 
 
Assessments, Interviews, Questionnaires 
The participating sibling will attend five major assessments throughout the entire 2 years of the study: 
● 1 Baseline assessment upon starting study (0 months) 
● 3 Measurement assessments during the study (6, 12, and 18 months) 
● 1 Follow-up assessment at end of study (24 months) 
Each major assessment will take approximately 30-90 minutes to complete at your child’s pediatric 
office, or a home visit can be arranged. Height and weight will be taken on you, your participating child, 
as well as the participating sibling and identified other family members (if applicable).   
What are my child’s responsibilities if he/she takes part in this research? 
If your child (participating sibling) takes part in this research, he/she will be responsible to attend the 
baseline assessment, the three measurement assessments, and the follow-up assessment to obtain 
height and weight information.  Your child’s (participating sibling) participation in any other meetings 
with your family are voluntary. Weight measurements at these times are also voluntary and can be used 
as data. 
 
 
 

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What happens if my child does not want to be in this research? 
Your child’s participation in this research study is voluntary. You or your child may choose not to enroll 
in this study. There are no other research alternatives other than to participate in this study. 
 
What happens if my child and I say yes, but change our mind later? 
Your child can leave the research at any time. It will not be held against him/her. Your child does not 
have to answer every question. He/she may refuse to answer any questions that he/she does not want 
to answer. If your participating sibling child leaves the research, this will not affect the status of you or 
your participating (target) child in the study. 
If you or your child decides to leave the research, you may not be able to find this kind of family 
treatment in your area outside of this research study. Other types of treatment may be available in your 
community. In which case we will provide a list of these and how to find them if you prefer this option. 
However you and/or your insurance company would be responsible for any costs associated with these 
options. You also may not receive full compensation for your participation. If your child decides to leave 
the research, contact the investigator at the contact information included below. If your child stops 
being in the research, already collected data may not be removed from the study database. You will be 
asked whether the investigator can collect data from your child’s routine medical care.  
 
Is there any way being in this study could be bad for my child? 
There are certain risks and discomforts that may be associated with this research. They include: 
Likely 
● You may be inconvenienced at times by having to miss work, school activities, meetings, etc., to 
attend assessments. 
Less Likely 
● Your child may be uncomfortable having his/her height and weight measured. 
Rare 
● In addition, although this treatment usually prevents the development of eating disorder 
problems, in rare cases it may increase them. 
● The use of online platforms is associated with risks involving breaches of confidentiality. We 
implement many layers of security to limit these risks as much as possible within our website 
and REDCap database. Outside platforms (i.e., MyFitnessPal) are subject to their own security 
measures and carry their own risks if your family chooses to use them to supplement your 
participation in this study. 
Will being in this study help my child in any way? 
We cannot promise any benefits to you, your child, or others from your taking part in this research. This 
study may provide information that will help your child to lose weight and keep it off. However, we 
cannot guarantee your child will receive any benefits from this study.  
 
What happens to the information collected for the research? 
Efforts will be made to limit the use and disclosure of your child’s personal information, including 
research study and medical or education records, to people who have a need to review this information. 
We cannot promise complete secrecy. Organizations that may inspect and copy your child’s information 
include the IRB and other representatives of this organization. Information related to your child will be 
treated in strict confidence to the extent provided by law. Your child’s identity will be coded and will not 

Page 114 of 305 
 
be associated with any published results. Your child’s code number and identity will be kept in a locked 
file of the Principal Investigator. The only connection between your child’s participation in this study and 
the study itself will be this signed consent form. All recordings of the sessions will be kept in a locked file 
of the Principal Investigator until the end of the study. At which point they will be destroyed. If your 
child withdraws from the study, no further data will be collected. Any information that has been 
provided may be retained by the researchers and analyzed. In order to monitor this research study, 
representatives from the Social and Behavioral Sciences Institutional Review Board (SBSIRB) and other 
federal agencies such as NIH (National Institutes of Health) and OHRP (Office of Human Research 
Protection) may inspect the research records which may reveal your child’s identity. A description of this 
clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This web site will 
not include information that can identify your child. At most, the web site will include a summary of the 
results. You can search this web site at any time. Federal law provides additional protections of your 
child’s medical records and related health information. These are described in the HIPAA section of this 
document. 
 
Can my child be removed from the research without our OK? 
The principal investigator of the study can remove your child from the research study without your or 
your child’s approval. Possible reasons for removal include need for hospitalization for physical or 
psychological reasons. We will tell you about any new information that may affect your child’s health, 
welfare, or choice to stay in the research. 
 
What else do my child and I need to know? 
This research is being funded by the National Institutes of Health, specifically the National Heart, Lung 
and Blood Institute (NHLBI). 
If your child needs medical care because of taking part in this research study, contact the investigator 
and/or speak with your doctor and medical care will be made available. Generally, this care will be billed 
to you, your insurance or other third party. The University at Buffalo has no program to pay for medical 
care for research-related injury. If your child agrees to take part in this research study, we will pay your 
family up to $175 for your time and effort. The amount you are paid depends upon your attendance to 
visits in the study. 
 
HIPAA:  Authorization for the Use and Disclosure of Identifiable Health 
Information for Research Purposes  
This section describes information about your child and about your child’s health that will be obtained 
by the researchers when your child participates in the research study. Health information is considered 
"protected health information" when it may directly identify your child as an individual. By signing this 
form you are agreeing to permit the researchers and/or other parties (described in detail below) to have 
access to this information. If there are any parts of this form that you do not understand, please be sure 
to ask us for further clarification. 
 
A. What protected health information will be collected about your child as part of this 
research study? 
__√__  Information from your child’s full medical records. 
__√__  New Health Information created from study related tests, procedures, visits, and/or                                         
questionnaires as described in this consent form. 

Page 115 of 305 
 
B.    Who is authorized to provide or collect this information? 
__√_      Principal Investigator or designee 
C.   With whom may your child’s protected health information be shared?  
Your child’s health information may be shared with others outside of the research group for 
purposes directly related to the conduct of this research study or as required by law, including 
but not limited to: 
__√__  
Clinical staff not involved in this research study who may become involved in your 
child’s care if it is potentially relevant to your treatment. 
__√__  
The sponsor of this research study (National Heart, Lung and Blood Institutes 
(NHLBI) cooperative group, etc., or its agents. 
__√__  
The organization(s) responsible for administering this research (e.g., Research 
Foundation of SUNY, University at Buffalo, Washington University, Nationwide 
Children’s Hospital, University of Rochester). 
__√__  Other medical investigators/centers/institutions participating in this research study.  
Your child’s information may also be shared with individuals or entities responsible for general 
administration, oversight and compliance of research activities. Examples of this include the 
institution's Privacy and Security Officers or other internal oversight staff, Safety Monitoring 
Boards, an Institutional Review Board, The Research Foundation of the State University of New 
York, University at Buffalo Foundation Services, and accrediting bodies, or with certain 
government oversight agencies that have authority over the research including the Department 
of Health and Human Services (HHS), the Food and Drug Administration (FDA), the National 
Institutes of Health (NIH), and the Office of Human Research Protections (OHRP). Your child’s 
information may also be shared with other entities as permitted or required by law. All 
reasonable efforts will be used to protect the confidentiality of your child’s individually 
identifiable health information that may be shared with others as described above. 
All reasonable efforts will be used to protect the confidentiality of your child’s protected health 
information. There is the potential for individually identifiable information and the associated 
health information obtained with this authorization to be re-disclosed by the recipient(s). After 
such a disclosure, the information may no longer be protected by the terms of this authorization 
against further re-disclosure. 
D.  How long will this information be kept by the Principal Investigator? 
__√__    This authorization has no expiration date. The researchers may continue to rely on this 
authorization to obtain and use protected health information about you unless you 
revoke this authorization in writing. 
__√__   Your child’s protected health information will go into a database that will be maintained 
indefinitely. Any future study using this information that falls outside the scope of this 
current study will be required to follow guidelines designed to govern access to that 
information and to protect the privacy of that information. 
E.  What are your rights after signing this authorization? 
You have the right to revoke this authorization at any time. If you withdraw your authorization, 
no additional efforts to collect individually identifiable health information about your child will 
be made. You should know, however, that protected health information acquired using this 

Page 116 of 305 
 
authorization prior to its withdrawal may continue to be used to the extent that the 
investigator(s) have already relied on your permission to conduct the research. If you chose to 
withdraw this authorization, you must do so in writing to the following individual(s): 
 
Leonard H. Epstein, Ph.D. 
University at Buffalo Department of Pediatrics 
Division of Behavioral Medicine 
3435 Main Street 
G56 Farber Hall 
Buffalo, NY 14214 
Phone: 716-829-3400 
 
If you send us a request to withdraw your authorization, we will forward that request to the 
institutions we have shared it with in order to collect your individually identifiable health 
information.  
 
F.  What will happen if you decide not to sign this authorization? 
 
Refusing to sign this authorization will not affect the present or future care your child receives at 
this institution and will not cause any penalty or loss of benefits to which you are otherwise 
entitled. If you decide not to sign this authorization, you and your child will not be able to  
 
 
 

Page 117 of 305 
 
Signature Block for Parental Permission 
 
Your signature documents your permission for the named child to take part in this research. By signing this form 
you are not waiving any of your legal rights, including the right to seek compensation for injury related to 
negligence or misconduct of those involved in the research. 
 
 
Printed name of child 
 
 
 
Signature of parent or individual legally authorized to consent to 
the child’s general medical care 
         Date 
 
 
❑ Parent 
❑ Individual legally authorized to consent 
to the child’s general medical care (See 
note below) 
Printed name of parent or individual legally authorized to consent 
to the child’s general medical care 
Note: Investigators are to ensure that individuals who are not parents can demonstrate their legal authority to consent to 
the child’s general medical care. Contact legal counsel if any questions arise. 
 
 
 
Assent Process    
  
❑ Child is birth-6 yrs. old - Assent is not required 
❑ Child is 7-17 yrs. old – A separate Assent Document is to be signed by 
the child  
❑ Assent will be obtained Verbally 
❑ Assent has been waived by the IRB 
 
 
I certify that the nature and purpose, the potential benefits and possible risks associated with participation in 
this research study have been explained to the above individual and that any questions about this information 
have been answered. A copy of this document will be given to the subject. 
 
 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
Printed name of person obtaining consent 
 
 
 
 
 
 
 

Page 118 of 305 
 
 
 
 
 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federal wide Assurance ID#: FWA00008824 
Title of research study: THE EFFECTIVENESS OF FAMILY-BASED WEIGHT LOSS 
TREATMENT IMPLEMENTED IN PRIMARY CARE 
 
Parental Permission of Sibling to Participate in a Research Study – Chart Review 
 
Version Date: 1.2.19 
Investigators: Leonard H. Epstein, PhD 
 
Why is my child being invited to take part in a research study? 
Your child is being invited to take part in a research study because: 
● You are an adult able to read the English language. You have reported no current learning 
disabilities, medical problems, or psychiatric problems.  
● You have a child between the ages of 6 and 12 years old that falls into the overweight or 
obese weight category (defined as at or above the 85th percentile for age and sex), and 
your child has at least one parent who also is considered overweight or obese (BMI 
greater than 25). 
● You have another child between the ages of 2-18 years old that is willing to grant access 
to his/her Medical Records for height, weight, age, and sex data and/or participate by 
getting his/her height and weight taken every 6 months over the two year study. 
This research study is supported by a grant through the National Heart Lung Blood Institute 
(NHLBI). Research studies only include individuals who choose to take part in them. Your 
decision for your child to take part in this study is entirely voluntary. Please read this information 
carefully. Ask questions about anything you do not understand before deciding whether or not to 
participate. You may also take home an unsigned copy of this consent form to think about 
participating or if you wish to discuss this matter with your family or your personal doctor. 
Please take your time to make your decision. Do not sign this form unless you have had the 
chance to ask questions and have received satisfactory answers. 
 
What should my child and I know about a research study? 
● Someone will explain this research study to you and your child. 
● Whether or not your child takes part is up to you and your child. 
● You and your child can choose for your child not to take part. 
● You and your child can agree to take part and later change your mind. 
● You and your child’s decision will not be held against you. 
● You and your child can ask all the questions you want before you decide. 
 

Page 119 of 305 
 
Who can my child and I talk to? 
If you or your child has questions, concerns, or complaints, or think the research has hurt your 
child, talk to the research team by telephone at 716-829-3400 for Dr. Leonard Epstein. You may 
also contact the PLAN coach at your child’s doctor’s office. You can also contact the research 
participant advocate at 716-888-4845 or researchadvocate@buffalo.edu.  
This research has been reviewed and approved by an Institutional Review Board (“IRB”). You 
may talk to them at (716) 888-4888 or email ub-irb@buffalo.edu if:  
● You have questions about your child’s rights as a participant in this research 
● Your questions, concerns, or complaints are not being answered by the research team. 
● You cannot reach the research team. 
● You want to talk to someone besides the research team. 
● You want to get information or provide input about this research. 
 
Why is this research being done? 
The goal of this study is to determine whether a specific kind of weight loss treatment called 
family-based behavioral treatment (FBT) for children, delivered by a PLAN coach, can be 
included in the primary care setting.  Extensive information has been gathered by our research 
team about the treatment of childhood overweight and obesity. But there is still much to learn 
about how the treatment should be incorporated into various medical settings, such as primary 
care. 
 
Your child has been asked to participate because he/she is between the ages of 2 and 18 years old 
and may fall into the overweight or obese weight category (defined as at or above the 85th 
percentile for age and sex) and has at least one parent and one sibling who are also considered 
overweight or obese (BMI greater than 25) that are participating in this study. 
 
How long will the research last? 
We expect that your child will be in this research study for 24 months. 
 
How many people will be studied? 
We expect about 132 families will be in this research study in your geographical location, out of 
528 families in the entire study nationally. 
 
What happens if I say yes, my child wants to be in this research? 
If your family is eligible for this research study and agrees to participate, the participating sibling 
(between the ages of 2-18) will grant access to his/her Medical Records at specified time points 
(i.e., 0, 6, 12, 18, & 24 months) and/or attend the baseline assessment with you and your target 
child to get his/her height and weight taken. After the baseline assessment and an initial 
appointment with your child’s doctor, your family will be randomized to one of two treatment 
conditions described below.   
Groups 
At the start of the study, your family will be assigned to one of two groups. Participants in one 
group will receive the current standard of care offered by their physician for the treatment of 
childhood weight management.  FBT is a behavioral weight-control intervention that aims to 
make weight changes in both a child and their participating parent. FBT is a well-tested 

Page 120 of 305 
 
treatment that targets diet, activity, behavioral techniques, parenting, and social facilitation in 
children and their parents. The treatment includes: 1) The Traffic Light Eating Plan uses RED; 
YELLOW; and GREEN labels for food to guide families toward the goal of eating nutritious 
foods. 2) The Traffic Light Activity Program also uses RED; YELLOW; and GREEN labels for 
different levels of exercise to increase physical activity and reducing inactive behaviors. 3) a 
variety of behavioral techniques including changing and controlling your environment; tracking 
eating and physical activity; setting goals; problem solving; setting up a reward system; 
incentives for behavior change and weight loss; finding substitutes for unhealthy foods; and 
improving positive parenting. FBT also involves making changes in the home. So weight loss or 
prevention of weight gain may extend to members of the family who are not regularly attending 
treatment sessions (e.g., siblings and spouse). 
The group that your family will be in/the treatment you get will be chosen by chance. Like 
flipping a coin. Neither you nor your doctor will choose what treatment your family will receive. 
Your family will have an equal chance of being assigned to each group. You will be informed of 
the group your family is in and your treatment following an initial physician visit. 
 
Treatment & Assessment Schedule 
Every family will follow their pediatrician recommended schedule of appointments for weight 
management to have at least 4 visits with their child’s doctor over the course of the 24 months of 
the study.  
The participating sibling will grant access to Medical Records and/or attend five major 
assessments throughout the entire 2 years of the study: 
● 1 Baseline assessment upon starting study (0 months) 
● 3 Measurement assessments during the study (6, 12, and 18 months) 
● 1 Follow-up assessment at end of study (24 months) 
Each major assessment will take approximately 30-90 minutes to complete at your child’s 
pediatric office, or a home visit can be arranged. Height and weight will be taken on you, your 
participating child, as well as the participating sibling and identified other family members (if 
applicable).   
What are my child’s responsibilities if he/she takes part in this research? 
If your child (participating sibling) takes part in this research, he/she will be responsible to attend 
the baseline assessment, the three measurement assessments, and the follow-up assessment to 
obtain height and weight information.  Your child’s (participating sibling) participation in any 
other meetings with your family are voluntary. Weight measurements at these times are also 
voluntary and can be used as data. 
What happens if my child does not want to be in this research? 
Your child’s participation in this research study is voluntary. You or your child may choose not 
to enroll in this study. There are no other research alternatives other than to participate in this 
study. 
 
What happens if my child and I say yes, but change our mind later? 
Your child can leave the research at any time. It will not be held against him/her. Your child does 
not have to answer every question. He/she may refuse to answer any questions that he/she does 

Page 121 of 305 
 
not want to answer. If your participating sibling child leaves the research, this will not affect the 
status of you or your participating (target) child in the study. 
If you or your child decides to leave the research, you may not be able to find this kind of family 
treatment in your area outside of this research study. Other types of treatment may be available 
in your community. In which case we will provide a list of these and how to find them if you 
prefer this option. However, you and/or your insurance company would be responsible for any 
costs associated with these options. You also may not receive full compensation for your 
participation. If your child decides to leave the research, contact the investigator at the contact 
information included below. If your child stops being in the research, already collected data may 
not be removed from the study database. You will be asked whether the investigator can collect 
data from your child’s routine medical care.  
 
Is there any way being in this study could be bad for my child? 
There are certain risks and discomforts that may be associated with this research. They include: 
 
 
Likely 
● You may be inconvenienced at times by having to miss work, school activities, meetings, 
etc., to attend assessments. 
● Your child might feel hungry when dieting, sore after exercising, or experience common exercise 
injuries (i.e., sprains, shin splints, tendonitis, muscle pulls, strains, etc). 
Less Likely 
● Your child may be uncomfortable having his/her height and weight measured. 
Rare 
● In addition, although this treatment usually prevents the development of eating disorder 
problems, in rare cases it may increase them. 
● The use of online platforms is associated with risks involving breaches of confidentiality. 
We implement many layers of security to limit these risks as much as possible within our 
website and REDCap database. Outside platforms (i.e., MyFitnessPal) are subject to their 
own security measures and carry their own risks if your family chooses to use them to 
supplement your participation in this study. 
Will being in this study help my child in any way? 
We cannot promise any benefits to you, your child, or others from your taking part in this 
research. This study may provide information that will help your child to lose weight and keep it 
off. However, we cannot guarantee your child will receive any benefits from this study.  
 
What happens to the information collected for the research? 
Efforts will be made to limit the use and disclosure of your child’s personal information, 
including research study and medical or education records, to people who have a need to review 
this information. We cannot promise complete secrecy. Organizations that may inspect and copy 
your child’s information include the IRB and other representatives of this organization. 

Page 122 of 305 
 
Information related to your child will be treated in strict confidence to the extent provided by 
law. Your child’s identity will be coded and will not be associated with any published results. 
Your child’s code number and identity will be kept in a locked file of the Principal Investigator. 
The only connection between your child’s participation in this study and the study itself will be 
this signed consent form. All recordings of the sessions will be kept in a locked file of the 
Principal Investigator until the end of the study. At which point they will be destroyed. If your 
child withdraws from the study, no further data will be collected. Any information that has been 
provided may be retained by the researchers and analyzed. In order to monitor this research 
study, representatives from the Social and Behavioral Sciences Institutional Review Board 
(SBSIRB) and other federal agencies such as NIH (National Institutes of Health) and OHRP 
(Office of Human Research Protection) may inspect the research records which may reveal your 
child’s identity. A description of this clinical trial will be available on 
http://www.ClinicalTrials.gov, as required by U.S. Law. This web site will not include 
information that can identify your child. At most, the web site will include a summary of the 
results. You can search this web site at any time. Federal law provides additional protections of 
your child’s medical records and related health information. These are described in the HIPAA 
section of this document. 
 
Can my child be removed from the research without our OK? 
The principal investigator of the study can remove your child from the research study without 
your or your child’s approval. Possible reasons for removal include need for hospitalization for 
physical or psychological reasons. We will tell you about any new information that may affect 
your child’s health, welfare, or choice to stay in the research. 
 
What else do my child and I need to know? 
This research is being funded by the National Institutes of Health, specifically the National 
Heart, Lung and Blood Institute (NHLBI). 
If your child needs medical care because of taking part in this research study, contact the 
investigator and/or speak with your doctor and medical care will be made available. Generally, 
this care will be billed to you, your insurance or other third party. The University at Buffalo has 
no program to pay for medical care for research-related injury. If your child agrees to take part in 
this research study, we will pay your family up to $175 for your time and effort. The amount you 
are paid depends upon your attendance to visits in the study. 
 
HIPAA:  Authorization for the Use and Disclosure of Identifiable Health 
Information for Research Purposes  
This section describes information about your child and about your child’s health that will be 
obtained by the researchers when your child participates in the research study. Health 
information is considered "protected health information" when it may directly identify your child 
as an individual. By signing this form, you are agreeing to permit the researchers and/or other 
parties (described in detail below) to have access to this information. If there are any parts of this 
form that you do not understand, please be sure to ask us for further clarification. 
A. What protected health information will be collected about your child as part of 
this research study? 
__√__  Information from your child’s full medical records. 

Page 123 of 305 
 
__√__  New Health Information created from study related tests, procedures, visits, and/or                         
questionnaires as described in this consent form. 
B.    Who is authorized to provide or collect this information? 
__√_      Principal Investigator or designee 
C.   With whom may your child’s protected health information be shared?  
Your child’s health information may be shared with others outside of the research group 
for purposes directly related to the conduct of this research study or as required by law, 
including but not limited to: 
__√__  Clinical staff not involved in this research study who may become involved in 
your child’s care if it is potentially relevant to your treatment. 
__√__  The sponsor of this research study (National Heart, Lung and Blood Institute 
(NHLBI) cooperative group, etc., or its agents. 
__√__  The organization(s) responsible for administering this research (e.g., Research 
Foundation of SUNY, University at Buffalo, Washington University, 
Nationwide Children’s Hospital, University of Rochester). 
__√__  Other medical investigators/centers/institutions participating in this research 
study.  
Your child’s information may also be shared with individuals or entities responsible for 
general administration, oversight and compliance of research activities. Examples of this 
include the institution's Privacy and Security Officers or other internal oversight staff, 
Safety Monitoring Boards, an Institutional Review Board, The Research Foundation of 
the State University of New York, University at Buffalo Foundation Services, and 
accrediting bodies, or with certain government oversight agencies that have authority 
over the research including the Department of Health and Human Services (HHS), the 
Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the 
Office of Human Research Protections (OHRP). Your child’s information may also be 
shared with other entities as permitted or required by law. All reasonable efforts will be 
used to protect the confidentiality of your child’s individually identifiable health 
information that may be shared with others as described above. 
All reasonable efforts will be used to protect the confidentiality of your child’s protected 
health information. There is the potential for individually identifiable information and the 
associated health information obtained with this authorization to be re-disclosed by the 
recipient(s). After such a disclosure, the information may no longer be protected by the 
terms of this authorization against further re-disclosure. 
D.  How long will this information be kept by the Principal Investigator? 
__√__    This authorization has no expiration date. The researchers may continue to rely 
on this authorization to obtain and use protected health information about you 
unless you revoke this authorization in writing. 
__√__   Your child’s protected health information will go into a database that will be 
maintained indefinitely. Any future study using this information that falls outside 

Page 124 of 305 
 
the scope of this current study will be required to follow guidelines designed to 
govern access to that information and to protect the privacy of that information. 
E.  What are your rights after signing this authorization? 
You have the right to revoke this authorization at any time. If you withdraw your 
authorization, no additional efforts to collect individually identifiable health information 
about your child will be made. You should know, however, that protected health 
information acquired using this authorization prior to its withdrawal may continue to be 
used to the extent that the investigator(s) have already relied on your permission to 
conduct the research. If you chose to withdraw this authorization, you must do so in 
writing to the following individual(s): 
Leonard H. Epstein, Ph.D. 
University at Buffalo Department of Pediatrics 
Division of Behavioral Medicine 
3435 Main Street 
G56 Farber Hall 
Buffalo, NY 14214 
Phone: 716-829-3400 
If you send us a request to withdraw your authorization, we will forward that request to 
the institutions we have shared it with in order to collect your individually identifiable 
health information.  
 
F.  What will happen if you decide not to sign this authorization? 
Refusing to sign this authorization will not affect the present or future care your child 
receives at this institution and will not cause any penalty or loss of benefits to which you 
are otherwise entitled. If you decide not to sign this authorization, you and your child will 
not be able to participate. 
 

Page 125 of 305 
 
          Signature Block for Parental Permission 
 
Your signature documents your permission for the named child to take part in this research. By signing this form you are not 
waiving any of your legal rights, including the right to seek compensation for injury related to negligence or misconduct of 
those involved in the research. 
 
 
Printed name of child 
 
 
 
Signature of parent or individual legally authorized to consent to the child’s 
general medical care 
         Date 
 
 
❑ Parent 
❑ Individual legally authorized to consent to 
the child’s general medical care (See note 
below) 
Printed name of parent or individual legally authorized to consent to the 
child’s general medical care 
Note: Investigators are to ensure that individuals who are not parents can demonstrate their legal authority to consent to the 
child’s general medical care. Contact legal counsel if any questions arise. 
 
 
 
Assent Process 
❑ Child is birth-6 yrs. old - Assent is not required 
❑ Child is 7-17 yrs. old – A separate Assent Document is to be signed by the child  
❑ Assent will be obtained verbally 
❑ Assent has been waived by the IRB 
 
 
I certify that the nature and purpose, the potential benefits and possible risks associated with participation in this research 
study have been explained to the above individual and that any questions about this information have been answered. A copy 
of this document will be given to the subject. 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
Printed name of person obtaining consent 
 
 
 
 
 
 
 
 
 
 
 
 

Page 126 of 305 
 
 
 
 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federal wide Assurance ID#: FWA00008824 
Title of research study: THE EFFECTIVENESS OF FAMILY-BASED WEIGHT LOSS 
TREATMENT IMPLEMENTED IN PRIMARY CARE 
 
PLAN Coach Adult Consent to Participate in a Research Study 
 
Version Date: 07-18-2018 
 
Investigators: Leonard H. Epstein, Ph.D. 
 
Why am I being invited to take part in a research study? 
You are being invited to take part in a research study because you are a PLAN coach delivering family-
based treatment (FBT) into a practice-based research network associated with University at Buffalo, 
Washington University, University of Rochester, or Nationwide Children’s Hospital. 
 
This research study is supported by a grant through the National Heart Lung and Blood Institute (NHBLI). 
Research studies only include individuals who choose to take part in them. Your decision to take part in 
this study is entirely voluntary. Please read this information carefully and ask questions about anything 
you do not understand before deciding whether or not to participate. You may also take home an 
unsigned copy of this consent form to think about the study. Please take your time to make your 
decision. Do not sign this form unless you have had the chance to ask questions and have received 
satisfactory answers. 
 
What should I know about a research study? 
● Someone will explain this research study to you. 
● Whether or not you take part is up to you. 
● You can choose not to take part. 
● You can agree to take part and later change your mind. 
● Your decision will not be held against you. 
● You can ask all the questions you want before you decide. 
 
Who can I talk to? 
If you have questions, concerns, or complaints, or think the research has hurt you, talk to the research 
team at 716-829-3400 for Dr. Leonard Epstein. You may also contact the research participant advocate 
at 716-888-4845 or researchadvocate@buffalo.edu.  
This research has been reviewed and approved by an Institutional Review Board (“IRB”). You may talk to 
them at (716) 888-4888 or email ub-irb@buffalo.edu if:  
● You have questions about your rights as a participant in this research 
● Your questions, concerns, or complaints are not being answered by the research team. 
● You cannot reach the research team. 

Page 127 of 305 
 
● You want to talk to someone besides the research team. 
● You want to get information or provide input about this research. 
 
Why is this research being done? 
There is currently a gap between the use of evidence-based treatment for children with obesity and its 
use within the community. The rationale behind this study is to understand how best to implement 
these interventions in primary care settings. We chose to test these implementation methods using FBT 
because it has been established as an effective, short- and long term treatment for weight loss 
psychotherapy that focuses on linking healthy dietary and physical activity behaviors to a child’s overall 
environment (e.g., parents, peers, school) and overcoming barriers by using problem solving techniques. 
FBT is an evidence-based treatment for overweight and obesity as well as for eating disorders. 
 
The goal of this study is to determine whether FBT for children who are overweight can be included in 
the primary care setting by using a co-located PLAN coach. Extensive information has been gathered by 
our research team about the treatment of childhood obesity, but there is still much to learn about how 
the treatment should be incorporated into various medical settings, such as primary care. Families at 
your assigned practices have been asked to participate because they have a child between the ages of 6 
and 12 years old who is overweight (defined as at or above the 85th percentile for body mass index), 
and have at least one parent who is willing to participate in the study.  
 
How long will the research last? 
We expect that you will be in this research study for 5 years. 
How many people will be studied? 
We expect about 3 PLAN coaches will be in this research study in your geographical location out of 
approximately 12 PLAN coaches in the entire study nationally at 4 different clinical sites. 
 
What happens if I say yes, I want to be in this research? 
By reading and signing this form, you agree to answer questions about yourself and your thoughts and 
opinions regarding your job, childhood obesity, and childhood obesity treatments, including FBT. 
 
Additionally, you allow audio recordings collected for the purpose of quality control of treatment to be 
used for research purposes. After reading and signing this form, the following procedures will occur: 
 
● You will complete a demographics form and take a baseline assessment to measure your 
knowledge in the area of obesity and evidence-based intervention prior to completing training. 
 
● Following training, you will complete the same assessment to assess your growth of knowledge 
and opinions of obesity and the evidence-based intervention. 
 
● At multiple time points during the study you will be asked to submit audio recordings of sessions 
you have with families to ensure the quality of care being delivered and for assessing your 
fidelity to the training protocol. These audio recordings may be transcribed and no identifying 
information will be presented to the public. 
 
● At multiple time points during the study, you will be asked to complete a short assessment on 
your thoughts regarding the study and evidence-based interventions. 
 

Page 128 of 305 
 
o The assessments taken during this study will only be reported in aggregate form to the 
public and will exclude any identifying information. 
 
What are my responsibilities if I take part in this research? 
If you take part in this research, you will be responsible to: answer several questionnaires and have your 
FBT sessions recorded.  
 
What happens if I do not want to be in this research? 
If you have agreed to treat families for the study, treatment related tasks will be considered part of your 
job responsibilities, not as part of the research. You are not required to participate in the PLAN coach 
research portion of the study. You may choose not to fill out questionnaires regarding the 
implementation of FBT into the primary care practice; however, there are certain questions we will ask 
you to answer in your role as a care provider on the study. You may also choose not to have your audio 
recordings be used for research purposes (separate section at the end); however, you will still be asked 
to record and submit treatment sessions in your role as a care provider on the study for quality control 
purposes. 
 
What happens if I say yes, but I change my mind later? 
You can leave the research at any time; it will not be held against you and will not impact your current 
job status. 
 
If you decide to leave the research, contact the investigator. You will be asked to withdraw your 
participation in writing. There will be no penalty or loss of benefits to which you are otherwise entitled. 
 
Is there any way being in this study could be bad for me? 
A risk of participating in this study is that confidential information about you may be accidentally 
disclosed. We will use our best efforts to keep the information about you secure, and we think the risk 
of accidental disclosure is very small. 
 
In addition to these risks, this research may hurt you in ways that are unknown. These may be a minor 
inconvenience. 
 
Will being in this study help me in any way? 
We cannot promise any benefits to you or others from your taking part in this research. However, 
possible benefits include: 
 
● Learning how evidence-based treatments for childhood obesity may function in primary care 
and gaining insight into how it may be effective for treatment of childhood obesity. 
 
● Other people might benefit from this study due to identification of the best way to train PLAN 
coaches in FBT best practices. This may lead to more widespread adoption of evidence-based 
childhood obesity treatments into primary care. 
 
What happens to the information collected for the research? 
Efforts will be made to limit the use and disclosure of your personal information, including research 
study and medical or education records, to people who have a need to review this information. We 
cannot promise complete secrecy. Organizations that may inspect and copy your information include 
the IRB and other representatives of this organization.  

Page 129 of 305 
 
The information you provide in this study will be strictly confidential and will not be provided to your 
employer and will not impact your current job status in the workplace. 
 
Information related to you will be treated in strict confidence to the extent provided by law. Your 
identity will be coded and will not be associated with any published results. Your code number and 
identity will be kept in a locked file of the Principal Investigator. The only connection between your 
participation in this study and the study itself will be this signed consent form. If you withdraw from the 
study, no further data will be collected, but any information that has been provided may be retained by 
the researchers and analyzed. In order to monitor this research study, representatives from the 
Institutional Review Board (IRB) and other federal agencies such as NIH (National Institutes of Health) 
and OHRP (Office of Human Research Protection) may inspect the research records which may reveal 
your identity. A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This web site will not include information that can identify you. At most, the web 
site will include a summary of the results. You can search this website at any time. 
 
Can I be removed from the research without my OK? 
The principal investigator of the study can remove you from the research study without your approval. 
Possible reasons from removal include: lack of adherence to study protocol. 
 
What else do I need to know? 
This research is being funded by the National Institutes of Health, specifically the National Heart, Lung 
and Blood Institute (NHLBI). 
You will not be paid for participating in this study. 
 
Audio Recording Permission: 
Your initial below documents your permission to use audio recorded sessions for research purposes: 
_______ Yes, I give my permission to use my audio recorded sessions for research purposes. 
_______ No, I do not give my permission to use my audio recorded sessions for research purposes. 
Signature Block for Capable Adult 
Your signature documents your permission to take part in this research. By signing this form, you are not 
waiving any of your legal rights, including the right to seek compensation for injury related to negligence or 
misconduct of those involved in the research. 
 
 
 
 
 
Signature of subject 
 
Date 
 
 
Printed name of subject 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 

Page 130 of 305 
 
Printed name of person obtaining consent 
 
 
 
 
 
 
My signature below documents that the information in the consent document and any other written information was 
accurately explained to, and apparently understood by, the subject, and that consent was freely given by the subject. 
 
 
 
Signature of witness to consent process 
 
Date 
 
 
Printed name of person witnessing consent process 
 
 
 

Page 131 of 305 
 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federal wide Assurance ID#: FWA00008824 
Title of research study: THE EFFECTIVENESS OF FAMILY-BASED WEIGHT LOSS 
TREATMENT IMPLEMENTED IN PRIMARY CARE 
 
Adult Primary Care Provider Consent to Participate in a Research Study 
 
Version Date: 07-18-2018 
 
 
Investigators: Leonard H. Epstein, Ph.D. 
 
Why am I being invited to take part in a research study? 
You are being invited to take part in a research study because you are a provider who is part of a 
practice-based research network with University at Buffalo, Washington University, University of 
Rochester, or Nationwide Children’s Hospital. 
 
You are being invited to take part in a research study supported by a grant through the National 
Heart Blood Lung Institutes(NHBLI). Research studies only include individuals who choose to take part in 
them. 
Your decision to take part in this study is entirely voluntary. Please read this information carefully and 
ask questions about anything you do not understand before deciding whether or not to participate. 
You may also take home an unsigned copy of this consent form to think about or if you wish to discuss 
this matter with your family. Please take your time to make your decision. Do not sign this form unless 
you have had the chance to ask questions and have received satisfactory answers. 
 
What should I know about a research study? 
● Someone will explain this research study to you. 
● Whether or not you take part is up to you. 
● You can choose not to take part. 
● You can agree to take part and later change your mind. 
● Your decision will not be held against you. 
● You can ask all the questions you want before you decide. 
 
Who can I talk to? 
If you have questions, concerns, or complaints, or think the research has hurt you, talk to the research 
team at 716-829-3400 for Dr. Leonard Epstein. You may also contact the research participant advocate 
at 716-888-4845 or researchadvocate@buffalo.edu.  
This research has been reviewed and approved by an Institutional Review Board (“IRB”). You may talk to 
them at (716) 888-4888 or email ub-irb@buffalo.edu if:  
● You have questions about your rights as a participant in this research 
● Your questions, concerns, or complaints are not being answered by the research team. 
● You cannot reach the research team. 
● You want to talk to someone besides the research team. 

Page 132 of 305 
 
● You want to get information or provide input about this research. 
 
Why is this research being done? 
This is a research study. We invite you to participate in this research study by the University at Buffalo 
because you are a provider at a primary care practice that has indicated interest in participating in this 
study.  
 
There is currently a gap between the use of evidence-based treatment for children with obesity and its 
use within the community. The rationale behind this study is to test the effectiveness of FBT in primary 
care settings, and to understand how best to implement these interventions in primary care settings. 
We chose to test FBT because it has been established as an effective treatment for weight loss in 
children in the short- and long term and may have a positive impact on others in the household. FBT is a 
manual-based psychotherapy that focuses on linking healthy dietary and physical activity behaviors to a 
child’s overall environment (e.g., parents, peers, school) and overcoming barriers by using problem 
solving techniques. 
 
The goal of this study is to determine whether family-based weight loss treatment (FBT) for children 
who are overweight/obese can be included in the primary care setting by using a co-located PLAN 
Coach. Extensive information has been gathered by our research team about the treatment of childhood 
obesity, but there is still much to learn about how the treatment should be incorporated into various 
medical settings, such as primary care. Families at your practice have been asked to participate because 
they have a child who is between the ages of 6 and 12 years old, is overweight/obese (defined as at or 
above the 85th percentile for body mass index), and have at least one parent who is willing to 
participate in the study.  
 
How long will the research last? 
We expect that you will be in this research study for 4 years. 
 
How many people will be studied? 
We expect about 3 primary care providers will be in this research study in your geographical location, 
and similar numbers of primary care providers at three other sites nationally. 
 

Page 133 of 305 
 
What happens if I say yes, I want to be in this research? 
Currently, the practice you work in has agreed to participate in this research study. By reading and 
signing this form, you agree to answer questions about yourself and your thoughts and opinions 
regarding your job, childhood obesity, and childhood obesity treatments, including FBT. After reading 
and signing this form, the following procedures will occur: 
 
● You will be asked about your demographics, job, attitudes, and prior knowledge of FBT and 
obesity care delivery. The assessments will take about 20 minutes to complete. You are free to 
skip any questions you don’t want to answer. 
● You will be asked to give permission for PLAN coaches to review participant charts at the end of 
the study to gather data on Usual Care. 
 
The treatment that participants will get will be chosen by chance, like flipping a coin. You will not choose 
which treatment participants will get. You will not know which treatment participants will get, however, 
some participants will inevitably inform you of their group assignment in the normal course of events.  
 
What are my responsibilities if I take part in this research? 
If you take part in this research, you will be responsible to: answer several questionnaires about the 
study.  
 
What happens if I do not want to be in this research? 
If you have agreed to treat families with Usual Care for the study, you are not required to participate in 
the provider research portion of the study. You may choose not to fill out questionnaires regarding the 
implementation of FBT into the primary care practice; however, there are certain questions we will ask 
you to answer in your role as a care provider on the study. 
 
What happens if I say yes, but I change my mind later? 
You can leave the research at any time. It will not be held against you and will not impact your current 
job status. 
 
If you decide to leave the research, contact the investigator. You will be asked to withdraw your 
participation in writing. There will be no penalty or loss of benefits to which you are otherwise entitled. 
 
Is there any way being in this study could be bad for me? 
A risk of participating in this study is that confidential information about you may be accidentally 
disclosed. We will use our best efforts to keep the information about you secure, and we think the risk 
of accidental disclosure is very small. 
 
In addition to these risks, this research may hurt you in ways that are unknown. These may be a minor 
inconvenience. 
 
 
 

Page 134 of 305 
 
Will being in this study help me in any way? 
We cannot promise any benefits to you or others from your taking part in this research. However, 
possible benefits include: 
 
● Learning how evidence-based treatments for childhood obesity may function in primary care 
and gaining insight into how it may be effective for treatment of childhood obesity. 
 
● Other people might benefit from this study due to identification of the best way to train 
providers in expert recommendations. This may lead to more widespread adoption of evidence-
based treatments into primary care. 
 
 
What happens to the information collected for the research? 
Efforts will be made to limit the use and disclosure of your personal information, including research 
study and medical or education records, to people who have a need to review this information. We 
cannot promise complete secrecy. Organizations that may inspect and copy your information include 
the IRB and other representatives of this organization.  
The information you provide in this study will be strictly confidential and will not be provided to your 
employer and will not impact your current job status in the workplace. 
 
Information related to you will be treated in strict confidence to the extent provided by law. Your 
identity will be coded and will not be associated with any published results. Your code number and 
identity will be kept in a locked file of the Principal Investigator. The only connection between your 
participation in this study and the study itself will be this signed consent form. If you withdraw from the 
study, no further data will be collected, but any information that has been provided may be retained by 
the researchers and analyzed. In order to monitor this research study, representatives from the 
Institutional Review Board (IRB) and other federal agencies such as NIH (National Institutes of Health) 
and OHRP (Office of Human Research Protection) may inspect the research records which may reveal 
your identity. A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This web site will not include information that can identify you. At most, the web 
site will include a summary of the results. You can search this website at any time. 
 
Can I be removed from the research without my OK? 
The principal investigator of the study can remove you from the research study without your approval. 
Possible reasons from removal include: lack of adherence to study protocol. 
 
What else do I need to know? 
This research is being funded by the National Institutes of Health, specifically the National Heart, Lung 
and Blood Institute (NHLBI). 
You will not be paid for participating in this study. 
 
 

Page 135 of 305 
 
Signature Block for Capable Adult 
This consent form is not a contract. It is a written explanation of what will happen during the study if you 
decide to participate. Your signature documents your permission to take part in this research. By signing this 
form, you are not waiving any of your legal rights, including the right to seek compensation for injury related 
to negligence or misconduct of those involved in the research. 
Do you agree to allow us to send your protected heath information via email?  
We will only send you PLAN related emails and we will not share your email with anyone. 
□ Yes 
□ No 
 
If yes, please provide your preferred email address below. 
_______________________________________________ 
Please verify your preferred email. 
_______________________________________________ 
If yes, please provide your preferred phone number below. 
_______________________________________________ 
Please verify your preferred phone number. 
_______________________________________________ 
 
My signature below documents that the information in the consent document and any other written 
information was accurately explained to, and apparently understood by, the subject, and that consent was 
freely given by the subject. 
 
Type your name below:  
 
 
 
 
 
 
Typed Signature of Primary Care Provider 
 
Date 
 
 
 

Page 136 of 305 
 
 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federal wide Assurance ID#: FWA00008824 
Title of research study: THE EFFECTIVENESS OF FAMILY-BASED WEIGHT LOSS 
TREATMENT IMPLEMENTED IN PRIMARY CARE 
 
Parent Adult Consent to Participate in a Research Study 
 
Version Date: 07-18-2018 
 
Investigators: Leonard H. Epstein, Ph.D. 
 
Why am I being invited to take part in a research study? 
You and your child are being invited to take part in a research study because: 
● You are an adult able to read the English language. You have reported no current learning 
disabilities, medical problems, or psychiatric problems.  
● You have a child between the ages of 6 and 12 years old. Falls into the overweight or obese 
weight category (defined as at or above the 85th percentile for age and sex). You are interested 
in weight loss and are willing to participate in the study. 
This research study is supported by a grant through the National Heart Lung and Blood Institute (NHLBI). 
Research studies only include individuals who choose to take part in them. Your decision to take part in 
this study is entirely voluntary. Please read this information carefully. Ask questions about anything you 
do not understand before deciding whether or not to participate. You may also take home an unsigned 
copy of this consent form to think about participating or if you wish to discuss this matter with your 
family or your personal doctor. Please take your time to make your decision. Do not sign this form 
unless you have had the chance to ask questions and have received satisfactory answers. 
 
What should I know about a research study? 
● Someone will explain this research study to you. 
● Whether or not you take part is up to you. 
● You can choose not to take part. 
● You can agree to take part and later change your mind.0 
● Your decision will not be held against you. 
● You can ask all the questions you want before you decide. 
 
 
 

Page 137 of 305 
 
Who can I talk to? 
If you have questions, concerns, or complaints, or think the research has hurt you, talk to the research 
team by telephone at 716-829-3400 for Dr. Leonard Epstein. You may also contact the PLAN coach at 
your child’s doctor’s office. You can also contact the research participant advocate at 716-888-4845 or 
researchadvocate@buffalo.edu.  
This research has been reviewed and approved by an Institutional Review Board (“IRB”). You may talk to 
them at (716) 888-4888 or email ub-irb@buffalo.edu   
 if:  
● You have questions about your rights as a participant in this research 
● Your questions, concerns, or complaints are not being answered by the research team. 
● You cannot reach the research team. 
● You want to talk to someone besides the research team. 
● You want to get information or provide input about this research. 
 
Why is this research being done? 
The goal of this study is to determine whether a specific kind of weight loss treatment called family-
based behavioral treatment (FBT) for children, delivered by a PLAN coach, can be included in the 
primary care setting.  Extensive information has been gathered by our research team about the 
treatment of childhood overweight and obesity. But there is still much to learn about how the treatment 
should be incorporated into various medical settings, such as primary care. 
 
How long will the research last? 
We expect that you will be in this treatment and research study for 24 months. 
 
How many people will be studied? 
We expect about 132 families will be in this research study in your geographical location. Out of 528 
families in the entire study nationally. 
 
What happens if I say yes, I want to be in this research? 
To determine if your family is eligible to participate, you and your child will be asked to complete an 
eligibility assessment at an orientation session about this study. You and your child’s height and weight 
will be measured. Standard questions regarding medical and psychological history will be asked by a 
trained interviewer to determine eligibility.  
If your family is eligible for this research study and agrees to participate, you and your child will be asked 
to come to your pediatric office to complete a baseline assessment (detailed below). Additionally, we 
hope to collect information about how participation in FBT may affect others in your home. Therefore, if 
you have another child who meets eligibility criteria (between the ages of 2-18 who is at or above the 
85th percentile for age and sex), we ask that this child also attend the baseline assessment. After the 
baseline assessment and an initial appointment with your child’s doctor, your family will be randomized 
to one of two treatment conditions described below.  
Groups 
At the start of the study, your family will be assigned to one of two groups. Participants in one group will 
receive the current standard of care offered by their physician for the treatment of childhood weight 
management.  Participants in the second group will receive family-based behavioral treatment for 
weight management (FBT). FBT is a behavioral weight-control intervention that aims to make weight 

Page 138 of 305 
 
changes in both a child and their participating parent. FBT is a well-tested treatment that targets diet, 
activity, behavioral techniques, parenting, and social facilitation in children and their parents. The 
treatment includes: 1) The Traffic Light Eating Plan uses RED; YELLOW; and GREEN labels for food to 
guide families toward the goal of eating nutritious foods. 2) The Traffic Light Activity Program, also uses 
RED; YELLOW; and GREEN labels for different levels of exercise to increase physical activity and reducing 
inactive behaviors. 3) a variety of behavioral techniques including changing and controlling your 
environment; tracking eating and physical activity; setting goals; problem solving; setting up a reward 
system; incentives for behavior change and weight loss; finding substitutes for unhealthy foods; and 
improving positive parenting. FBT also involves making changes in the home. So weight loss or 
prevention of weight gain may extend to members of the family who are not regularly attending 
treatment sessions (e.g., siblings and spouse). 
The group that your family will be in/the treatment you get will be chosen by chance. Like flipping a 
coin. Neither you nor your doctor will choose what treatment your family will receive. Your family will 
have an equal chance of being assigned to each group. You will be informed of the group your family is 
in and your treatment following an initial physician visit. 
 
Treatment Schedule 
Every family will follow their pediatrician’s recommended schedule of appointments for weight 
management to have at least 4 visits with their child’s doctor over the course of the 24 months of the 
study. Families in the group receiving FBT will additionally complete at least 26 sessions with the FBT 
PLAN Coach during the 24 months of the study. The amount of sessions completed within this range will 
be based on progress through the program and will vary for each family. 
Assessments, Interviews, Questionnaires 
Attendance will be taken and both you and your child will be weighed at every session. In addition, there 
will be five major assessments throughout the entire 2 years of the study: 
● 1 Baseline assessment upon starting study (0 months) 
● 3 Treatment assessments during the study (6, 12, and 18 months) 
● 1 Follow-up assessment at end of study (24 months) 
Each major assessment will take approximately 30-90 minutes to complete at your child’s pediatric 
office, or a home visit can be arranged. Height and weight will be taken on you and your child as well as 
the identified other family members (if applicable). Your height will be taken at the beginning of the 
study, and your child(ren)’s height will be taken at each major assessment. You and your participating 
child will also complete short questionnaires. You both will be asked questions about parenting 
behaviors and the home food and activity environment. At your baseline, 12-month, and follow-up 
appointments, you will be asked to complete a computer task. Throughout the study, you will have 
access to a website that contains study materials and interactive tools. 
 
Audio Recording 
Your interviews and individual family will be audiotaped or digitally recorded for research purposes, but 
you will not be identified on the recording and the recordings will not be labeled with your name. 
Recording the sessions is the best way to make sure we collect accurate information. It also helps us 
make sure that all our staff delivers the study to participants in the same way. The recordings will be 
stored on password-protected computers with restricted access within the University at Buffalo, and 

Page 139 of 305 
 
then transferred to Washington University School of Medicine. The recordings will be labeled only with 
your study ID, date, and session number. The Principal Investigator and research staff may use these 
recordings for purposes of evaluation, treatment, research, and training related to this study. 
Recordings may also be used to train staff implementing these or similar interventions at other sites. 
The recordings will be destroyed at the end of the study when all data analysis is complete. You do not 
have to agree to be audio recorded in order to participate in this study. 
Please check and initial below if you agree or do not agree to give permission for you and your child to 
be audio recorded during your sessions with the PLAN coach. 
 
YES __________ 
NO___________   Parent INITIAL______________ Date: ________________ 
 
What are my responsibilities if I take part in this research? 
If you take part in this research, you will be responsible to attend the baseline assessment, all treatment 
assessments, at least 26 treatment sessions if your family is in the group receiving FBT, and the follow-
up assessment. 
 
What happens if I do not want to be in this research? 
Your participation in this research study is voluntary. You may choose not to enroll in this study. There 
are no other research alternatives other than to participate in this study. 
 
What happens if I say yes, but I change my mind later? 
You can leave the research at any time. It will not be held against you. You do not have to answer every 
question and may refuse to answer any questions that you do not want to answer. 
If you decide to leave the research, you may not be able to find this kind of family treatment in your 
area outside of this research study. Other types of treatment may be available in your community. In 
which case we will provide a list of these and how to find them if you prefer this option. However, you 
and/or your insurance company would be responsible for any costs associated with these options. You 
also may not receive full compensation for your participation. If you decide to leave the research, 
contact the investigator at the contact information included below. If you stop being in the research, 
already collected data may not be removed from the study database. You will be asked whether the 
investigator can collect data from your routine medical care.  
 
Is there any way being in this study could be bad for me? 
There are certain risks and discomforts that may be associated with this research. They include: 
Likely 
● You might feel hungry when dieting or sore after exercising. 
Less Likely 
● You may find some of the questions embarrassing or be uncomfortable having your height and 
weight measured. 
● There may be some family disagreements as issues of family functioning; communication; and 
discipline are discussed. 

Page 140 of 305 
 
● You may be inconvenienced at times by having to miss work, school activities, meetings, etc., to 
attend assessments and family sessions. 
Rare 
● There is a risk of audio recordings being lost. All recordings will be immediately stored in a 
locked drawer or saved to a password-protected computer in the research office after the 
individual family and group weight loss and maintenance sessions. Your family name will not be 
on these recordings, which will be identified only by a study ID number. 
● The use of online platforms is associated with risks involving breaches of confidentiality. We 
implement many layers of security to limit these risks as much as possible within our website 
and REDCap database. Outside platforms (i.e., MyFitnessPal) are subject to their own security 
measures and carry their own risks if your family chooses to use them to supplement your 
participation in this study. 
● In addition, although this treatment usually prevents the development of eating disorder 
problems, in rare cases it may increase them. 
Other Risks 
● In this study you will be given a physical activity goal. Given that some people may have medical 
risks associated with increasing their physical activity, these recommendations for your child will 
be given in consultation with his/her doctor. As an adult, you may consider getting approval 
from your doctor for setting physical activity goals. Adult participants will be responsible for 
consulting their doctor for approval. 
● Randomization - As mentioned before, this study has two groups. Because chance decides 
which group you will be in, the treatment you receive as part of this study may not be what your 
own doctor would choose for you. 
Will being in this study help me in any way? 
We cannot promise any benefits to you or others from your taking part in this research. However, 
possible benefits could include you and your child losing weight, becoming more physically active, and 
eating more healthfully as a result of participation. In addition, maintaining weight loss may lead to 
better relationships and better mood. However, we cannot guarantee that you or your child will receive 
any benefits from this study. This study may also provide information that will help other children inside 
and outside your household to lose weight and keep it off. 
 
What happens to the information collected for the research? 
Efforts will be made to limit the use and disclosure of your personal information, including research 
study and medical or education records, to people who have a need to review this information. We 
cannot promise complete secrecy. Organizations that may inspect and copy your information include 
the IRB and other representatives of this organization. Information related to you will be treated in strict 
confidence to the extent provided by law. Your identity will be coded and will not be associated with any 
published results. Your code number and identity will be kept in a locked file of the Principal 
Investigator. The only connection between your participation in this study and the study itself will be 
this signed consent form. All recordings of the sessions will be kept in a locked file of the Principal 
Investigator until the end of the study. At which point they will be destroyed. If you withdraw from the 
study, no further data will be collected. Any information that has been provided may be retained by the 
researchers and analyzed. In order to monitor this research study, representatives from the Institutional 
Review Board (IRB) and other federal agencies such as NIH (National Institutes of Health) and OHRP 

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(Office of Human Research Protection) may inspect the research records which may reveal your identity. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law. This web site will not include information that can identify you. At most, the web site will include a 
summary of the results. You can search this web site at any time. Federal law provides additional 
protections of your medical records and related health information. These are described in the HIPAA 
section of this document. 
 
Can I be removed from the research without my OK? 
The principal investigator of the study can remove you from the research study without your approval. 
Possible reasons for removal include need for hospitalization for physical or psychological reasons. 
 
What else do I need to know? 
This research is being funded by the National Institutes of Health, specifically the National Heart, Lung 
and Blood Institutes (NHLBI). If you need medical care because of taking part in this research study, 
contact the investigator and/or speak with your doctor and medical care will be made available. 
Generally, this care will be billed to you, your insurance or other third party. The University at Buffalo 
has no program to pay for medical care for research-related injury. If you agree to take part in this 
research study, we will pay you up to $175 for your time and effort. The amount you are paid depends 
upon your attendance to visits in the study. 
 
HIPAA:  Authorization for the Use and Disclosure of Identifiable Health 
Information for Research Purposes  
This section describes information about you and about your health that will be obtained by the 
researchers when you participate in the research study. Health information is considered "protected 
health information" when it may directly identify you as an individual. By signing this form you are 
agreeing to permit the researchers and/or other parties (described in detail below) to have access to 
this information. If there are any parts of this form that you do not understand, please be sure to ask us 
for further clarification. 
A. What protected health information will be collected about you as part of this research 
study? 
__√__   Specific information from your medical records related to height, weight, dietary 
restrictions, and physical activity restrictions. 
__√__  New Health Information created from study related tests, procedures, visits, and/or                                         
questionnaires as described in this consent form. 
B.    Who is authorized to provide or collect this information? 
__√_      Principal Investigator or designee 
 
C.   With whom may your protected health information be shared?  
Your health information may be shared with others outside of the research group for purposes 
directly related to the conduct of this research study or as required by law, including but not 
limited to: 
__√__  
Clinical staff not involved in this research study who may become involved in you and 
your child’s care if it is potentially relevant to your treatment. 

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__√__  
The sponsor of this research study (National Heart, Lung and Blood Institutes 
(NHLBI) cooperative group, etc., or its agents. 
__√__  
The organization(s) responsible for administering this research (e.g., Research 
Foundation of SUNY, University at Buffalo, Washington University, Nationwide 
Children’s Hospital, University of Rochester). 
__√__  
Other medical investigators/centers/institutions participating in this research study. 
Your information may also be shared with individuals or entities responsible for general 
administration, oversight and compliance of research activities. Examples of this include the 
institution's Privacy and Security Officers or other internal oversight staff, Safety Monitoring 
Boards, an Institutional Review Board, The Research Foundation of the State University of New 
York, University at Buffalo Foundation Services, and accrediting bodies, or with certain 
government oversight agencies that have authority over the research including the Department 
of Health and Human Services (HHS), the Food and Drug Administration (FDA), the National 
Institutes of Health (NIH), and the Office of Human Research Protections (OHRP). Your 
information may also be shared with other entities as permitted or required by law. All 
reasonable efforts will be used to protect the confidentiality of your individually identifiable 
health information that may be shared with others as described above. 
All reasonable efforts will be used to protect the confidentiality of your protected health 
information. There is the potential for individually identifiable information and the associated 
health information obtained with this authorization to be re-disclosed by the recipient(s). After 
such a disclosure, the information may no longer be protected by the terms of this authorization 
against further re-disclosure. 
D.  How long will this information be kept by the Principal Investigator? 
__√__    This authorization has no expiration date. The researchers may continue to rely on this 
authorization to obtain and use protected health information about you unless you 
revoke this authorization in writing. 
__√__  Your protected health information will go into a database that will be maintained 
indefinitely. Any future study using this information that falls outside the scope of this 
current study will be required to follow guidelines designed to govern access to that 
information and to protect the privacy of that information. 
E.  What are your rights after signing this authorization? 
You have the right to revoke this authorization at any time. If you withdraw your authorization, 
no additional efforts to collect individually identifiable health information about you will be 
made. You should know, however, that protected health information acquired using this 
authorization prior to its withdrawal may continue to be used to the extent that the 
investigator(s) have already relied on your permission to conduct the research. If you chose to 
withdraw this authorization, you must do so in writing to the following individual(s): 
 
Leonard H. Epstein, Ph.D. 
University at Buffalo Department of Pediatrics 
Division of Behavioral Medicine 
3435 Main Street 
 G56 Farber Hall 

Page 143 of 305 
 
Buffalo, NY 14214 
Phone: 716-829-3400 
 
If you send us a request to withdraw your authorization, we will forward that request to the 
institutions we have shared it with in order to collect your individually identifiable health 
information.  
 
 
F.  What will happen if you decide not to sign this authorization? 
 
Refusing to sign this authorization will not affect the present or future care you receive at this 
institution and will not cause any penalty or loss of benefits to which you are otherwise entitled. 
If you decide not to sign this authorization, you will not be able to participate in the research 
study. 
Signature Block for Capable Adult 
 
Your signature documents your permission to take part in this research. By signing this form you are not 
waiving any of your legal rights, including the right to seek compensation for injury related to negligence or 
misconduct of those involved in the research. 
 
 
 
 
Signature of subject 
 
Date 
 
 
Printed name of subject 
 
 
 
 
 
 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
Printed name of person obtaining consent 
 
 
 
 
 
 
 

Page 144 of 305 
 
 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
 
THE EFFECTIVENESS OF FAMILY-BASED WEIGHT LOSS TREATMENT 
IMPLEMENTED IN PRIMARY CARE 
 
PILOT Participating Child Assent to be in a Research Study   
(for Children 7-13 years of age) 
 
Version Date: 07-18-2018 
 
Investigators: Leonard H. Epstein, PhD 
 
Who are we? 
My name is Dr. Leonard H. Epstein and I am a researcher at the University at Buffalo. I work in the 
Department of Pediatrics. 
 
Why are we meeting with you? 
We want to tell you about a study that involves children like yourself. We want to see if you would like 
to be in this study too. 
 
Why are we doing this study? 
We want to look at a certain kind of weight loss program for kids. We want to know if it will work at a 
doctor’s office. 
 
What will happen to you if you are in the study? 
You and a parent will first come to the doctor’s office. We will tell you about this study that teaches kids 
about healthy eating and activities. We will ask you if you want to be a part of the study. If you do, we 
will measure your height and weight. We will ask you to answer some questions about yourself and your 
parents. You will do a task that asks you to make choices between different amounts of money. If you 
want to, we will ask to you come back for more visits. 
 
After this, you and your parent will visit the doctor’s office once a week for 3 months. At the visits you 
would meet with someone from the study. This would be at least 12 visits. Your height and weight will 
be taken. You will learn about healthy food. We will teach you fun ways to exercise. 
 
At your first visit and at your last visit, we will ask you some questions about yourself. We will measure 
your height and weight. At your baseline and Follow-up appointment, we will ask you to do a computer 
task that asks you to make choices between different amounts of money.  
 
You do not have to answer any questions that you do not want to answer. You do not have to do any 
activities that you do not want to do. 
 

Page 145 of 305 
 
What are the good things and bad things that may happen to you if you are in the study? 
Most Likely: You can have fun learning about healthy food and exercise. You could become healthy. 
 
Maybe: You could become hungry when trying to eat healthy. Your muscles could feel sore from 
exercise. That will go away once you are used to exercising.  
 
Do you have to be in the study? 
No you do not. No one will get angry or upset with you if you don’t want to do this. Just tell us if you do 
not want to be in the study. And remember, you can change your mind later if you decide you do not 
want to be in the study anymore. 
 
Do you have any questions? 
You can ask questions at any time. You can ask now. You can ask later. You can talk to me or you can talk 
to someone else at any time during the study. You can call: 
 
Name of contact person on the study: Leonard H. Epstein, Ph.D. Phone Number: (716) 829-3400 
 
Signature Block for Assent of Child 
 
Your signature documents your permission to take part in this research. 
 
 
 
Signature of subject 
 
Date 
 
 
Printed name of subject 
 
I certify that the nature and purpose, the potential benefits and possible risks associated with participation 
in this research study have been explained to the above individual and that any questions about this 
information have been answered. A copy of this document will be given to the subject. 
 
 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
Printed name of person obtaining consent 
 
 
 
 
 

Page 146 of 305 
 
 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federal wide Assurance ID#: FWA00008824 
Title of research study: THE EFFECTIVENESS OF FAMILY-BASED WEIGHT LOSS 
TREATMENT IMPLEMENTED IN PRIMARY CARE 
 
PILOT Parental Permission for Targeted Child to Participate in a Research Study 
 
Version Date: 07-18-2018 
 
Investigators: Leonard H. Epstein, Ph.D. 
 
Why is my child being invited to take part in a research study? 
Your child is being invited to take part in a pilot research study because: 
● You are an adult able to read the English language. You have reported no current learning 
disabilities, medical problems, or psychiatric problems.  
● Your child is between the ages of 7 and 12 years old. Your child falls into the overweight or 
obese weight category (defined as at or above the 85th percentile for age and sex).  Your child 
has at least one parent who is interested in participating in the study. 
This research study is supported by a grant through the National Heart, Lung and Blood Institutes 
(NHLBI). Research studies only include individuals who choose to take part in them. Your decision for 
your child to take part in this study is entirely voluntary. Please read this information carefully.  Ask 
questions about anything you do not understand before deciding whether or not to participate. You may 
also take home an unsigned copy of this consent form to think about participating.  You may wish to 
discuss this matter with your family or your personal doctor. Please take your time to make your 
decision. Do not sign this form unless you have had the chance to ask questions and have received 
satisfactory answers. 
 
What should my child and I know about a research study? 
● Someone will explain this research study to you and your child. 
● Whether or not your child takes part is up to you and your child. 
● You and your child can choose for your child not to take part. 
● You and your child can agree to take part and later change your mind. 
● You and your child’s decision will not be held against you. 
● You and your child can ask all the questions you want before you decide. 
 
 
 

Page 147 of 305 
 
Who can my child and I talk to? 
If you or your child has questions, concerns, or complaints, or think the research has hurt your child, talk 
to the research team by telephone at 716-829-3400 for Dr. Leonard Epstein. You may also contact the 
PLAN coach at your child’s doctor’s office; or you can contact the research participant advocate at 716-
888-4845 or researchadvocate@buffalo.edu.  
This research has been reviewed and approved by an Institutional Review Board (“IRB”). You may talk to 
them at (716) 888-4888 or email ub-irb@buffalo.edu  if:  
● You have questions about your child’s rights as a participant in this research. 
● Your questions, concerns, or complaints are not being answered by the research team. 
● You cannot reach the research team. 
● You want to talk to someone besides the research team. 
● You want to get information or provide input about this research. 
 
Why is this research being done? 
The goal of this pilot study is to determine whether a specific kind of weight loss treatment called 
family-based behavioral treatment (FBT) for children, delivered by a PLAN coach, can be included in the 
primary care setting.  Extensive information has been gathered by our research team about the 
treatment of childhood overweight and obesity, but there is still much to learn about how the treatment 
should be incorporated into various medical settings, such as primary care. 
 
Your child has been asked to participate because he/she is between the ages of 7 and 12 years old, falls 
into the overweight or obese weight category (defined as at or above the 85th percentile for age and 
sex), and has at least one parent who is interested in participating in the study. 
 
How long will the research last? 
We expect that your child will be in this treatment and research study for 3 months. 
 
How many people will be studied? 
We expect about 6 families will be in pilot phase of this research study in your geographical location. 
 
What happens if I say yes, my child wants to be in this research? 
To determine if your child is eligible to participate: you and your child will be asked to complete an 
eligibility assessment at an orientation session about this study. You and your child’s height and weight 
will be measured.  Standard questions regarding medical and psychological history will be asked by a 
trained interviewer to determine eligibility.  
If your family is eligible for this research study and agrees to participate: you and your child will be asked 
to come to your pediatric office to complete a baseline assessment (detailed below). After the baseline 
assessment, your family will be enrolled. You will meet with a PLAN coach weekly. 
 
 
 

Page 148 of 305 
 
Group 
At the start of the study, your family will be assigned to receive family-based behavioral treatment for 
weight management (FBT).  FBT is a behavioral weight-control intervention that aims to make weight 
changes in both a child and their participating parent. FBT is a well-tested treatment that targets diet, 
activity, behavioral techniques, parenting, and social facilitation in children and their parents. The 
treatment includes: 1) The Traffic Light Eating Plan, which uses RED, YELLOW, GREEN labels for food to 
guide families toward the goal of eating nutritious foods; 2) the Traffic Light Activity Program, which also 
uses RED, YELLOW and GREEN labels for different levels of exercise to increase physical activity and 
reducing inactive behaviors; and 3) a variety of behavioral techniques including changing and controlling 
your environment, tracking eating and physical activity, setting goals, problem solving, setting up a 
reward system, incentives for behavior change and weight loss, finding substitutes for unhealthy foods, 
and improving positive parenting. FBT also involves making changes in the home.  Weight loss or 
prevention of weight gain may extend to members of the family who are not regularly attending 
treatment sessions (e.g., siblings and spouse). 
Treatment Schedule 
Every family will receive FBT and will complete at least 12 sessions with the FBT PLAN Coach during the 3 
months of the study.  
Assessments, Interviews, Questionnaires 
Attendance will be taken and both you and your child will be weighed at every session. In addition, there 
will be two major assessments throughout the entire 3 months of the pilot study: 
● 1 Baseline assessment upon starting study (0 months) 
● 1 Follow-up assessment at end of study (3 months) 
Each major assessment will take approximately 30-90 minutes to complete at your child’s pediatric 
office, or a home visit can be arranged. Height and weight will be taken on you and your child. Your 
height will be taken at the beginning of the study.  Your child’s height will be taken at each major 
assessment. At your baseline and Follow-up appointment, we will ask you to do a computer task that 
asks you to make choices between different amounts of money. 
Audio Recording 
Your interviews and individual family will be audiotaped or digitally recorded for research purposes.  You 
will not be identified on the recording and the recordings will not be labeled with your name. Recording 
the sessions is the best way to make sure we collect accurate information. It also helps us make sure 
that all our staff delivers the study to participants in the same way. The recordings will be stored on 
password-protected computers with restricted access within the University at Buffalo; then transferred 
to Washington University School of Medicine. The recordings will be labeled only with your study ID, 
date, and session number. The Principal Investigator and research staff may use these recordings for 
purposes of evaluation, treatment, research, and training related to this study. Recordings may also be 
used to train staff implementing these or similar interventions at other sites. The recordings will be 
destroyed at the end of the study when all data analysis is complete. You do not have to agree to be 
audio recorded in order to participate in this study. 
 
Please check and initial below if you agree for you and your child to be audio recorded during your 
sessions with the PLAN coach: 
 

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__________YES, PARENT INITIAL______________, I give my permission to be audio recorded during 
sessions with a PLAN Coach. Date: ________________ 
 
__________NO, PARENT INITIAL______________, I do not give my permission to be audio recorded 
during sessions with a PLAN Coach. Date: ________________ 
What are my child’s responsibilities if he/she takes part in this research? 
If your child takes part in this pilot research, he/she will be responsible to: attend the baseline 
assessment, follow-up assessment, and attend at least 12 treatment sessions if your family is in the 
group receiving FBT. 
 
What happens if my child does not want to be in this research? 
Your child’s participation in this pilot research study is voluntary. You or your child may choose not to 
enroll in this study. There are no other research alternatives other than to participate in this study. 
 
What happens if my child and I say yes, but change our mind later? 
Your child can leave the pilot research at any time.  It will not be held against him/her. Your child does 
not have to answer every question and may refuse to answer any questions that he/she does not want 
to answer. 
If your child decides to leave the pilot research, you may not be able to find this kind of family treatment 
in your area outside of this research study. Other types of treatment may be available in your 
community, in which case we will provide a list of these and how to find them if you prefer this option.  
You and/or your insurance company would be responsible for any costs associated with these options. 
You also may not receive full compensation for your participation if your child decides to leave the 
research.  Contact the investigator at the contact information included below if your child decides to 
leave the study. If your child stops being in the research, already collected data may not be removed 
from the study database. You will be asked whether the investigator can collect data from your child’s 
routine medical care.  
 
Is there any way being in this study could be bad for my child? 
There are certain risks and discomforts that may be associated with this research.  
They include: 
 
Likely 
● Your child might feel hungry when dieting or sore after exercising. 
Less Likely 
● Your child may find some of the questions embarrassing or be uncomfortable having his/her 
height and weight measured. 
● There may be some family disagreements as issues of family functioning, communication, and 
discipline are discussed. 
● Your child may be inconvenienced at times by having to miss school activities, meetings, etc., to 
attend assessments and family sessions. 
Rare 

Page 150 of 305 
 
● There is a risk of audio recordings being lost. All recordings will be immediately stored in a 
locked drawer or saved to a password-protected computer in the research office after the 
individual family and group weight loss and maintenance sessions. Your family name will not be 
on these recordings, which will be identified only by a study ID number. 
● The use of online platforms is associated with risks involving breaches of confidentiality. We 
implement many layers of security to limit these risks as much as possible within our website 
and REDCap database. Outside platforms (i.e., MyFitnessPal) are subject to their own security 
measures and carry their own risks if your family chooses to use them to supplement your 
participation in this study. 
● In addition, although this treatment usually prevents the development of eating disorder 
problems, in rare cases it may increase them. 
Other Risks 
● In this study your child will be given a physical activity goal. Given that some people may have 
medical risks associated with increasing their physical activity, these recommendations for your 
child will be given in consultation with his/her doctor.  
 
Will being in this study help my child in any way? 
We cannot promise any benefits to you, your child, or others from your taking part in this research. 
However, possible benefits could include your child losing weight, becoming more physically active, and 
eating more healthfully as a result of participation. In addition, maintaining weight loss may lead to 
better relationships and better mood. However, we cannot guarantee your child will receive any 
benefits from this study. This study may provide information that will help other children inside and 
outside your household to lose weight and keep it off. 
 
What happens to the information collected for the research? 
Efforts will be made to limit the use and disclosure of your child’s personal information, including 
research study and medical or education records, to people who have a need to review this information. 
We cannot promise complete secrecy. Organizations that may inspect and copy your child’s information 
include the IRB and other representatives of this organization. Information related to your child will be 
treated in strict confidence to the extent provided by law. Your child’s identity will be coded and will not 
be associated with any published results. Your child’s code number and identity will be kept in a locked 
file of the Principal Investigator. The only connection between your child’s participation in this study and 
the study itself will be this signed consent form. All recordings of the sessions will be kept in a locked file 
of the Principal Investigator until the end of the study, at which point they will be destroyed. If your 
child withdraws from the study, no further data will be collected, but any information that has been 
provided may be retained by the researchers and analyzed. In order to monitor this research study, 
representatives from the Institutional Review Board (IRB) and other federal agencies such as NIH 
(National Institutes of Health) and OHRP (Office of Human Research Protection) may inspect the 
research records which may reveal your child’s identity. A description of this clinical trial will be available 
on http://www.ClinicalTrials.gov, as required by U.S. Law. This web site will not include information that 
can identify your child. At most, the web site will include a summary of the results. You can search this 
web site at any time. Federal law provides additional protections of your child’s medical records and 
related health information. These are described in the HIPAA section of this document. 
 
Can my child be removed from the research without our OK? 

Page 151 of 305 
 
The principal investigator of the study can remove your child from the research study without you or 
your child’s approval. Possible reasons for removal include need for hospitalization for physical or 
psychological reasons. We will tell you about any new information that may affect your child’s health, 
welfare, or choice to stay in the research. 
 
What else do my child and I need to know? 
This research is being funded by the National Institutes of Health, specifically the National Heart, Lung 
and Blood Institute (NHLBI). 
If your child needs medical care because of taking part in this research study, contact the investigator 
and/or speak with your doctor and medical care will be made available. Generally, this care will be billed 
to you, your insurance or other third party. The University at Buffalo has no program to pay for medical 
care for research-related injury. If your child agrees to take part in this research study, we will pay your 
family up to $30 for your time and effort. The amount you are paid depends upon your attendance to 
visits in the study. 
 
HIPAA:  Authorization for the Use and Disclosure of Identifiable Health 
Information for Research Purposes  
This section describes information about your child and about your child’s health that will be obtained 
by the researchers when your child participates in the research study. Health information is considered 
"protected health information" when it may directly identify your child as an individual. By signing this 
form, you are agreeing to permit the researchers and/or other parties (described in detail below) to 
have access to this information. If there are any parts of this form that you do not understand, please be 
sure to ask us for further clarification. 
A. What protected health information will be collected about your child as part of this 
research study? 
__√__ Information from your child’s full medical records. 
__√__ New Health Information created from study related tests, procedures, visits, and/or                                          
questionnaires as described in this consent form. 
B.    Who is authorized to provide or collect this information? 
__√_      Principal Investigator or designee 
C.   With whom may your child’s protected health information be shared?  
Your child’s health information may be shared with others outside of the research group for 
purposes directly related to the conduct of this research study or as required by law, including 
but not limited to: 
__√__  
Clinical staff not involved in this research study who may become involved in your 
child’s care if it is potentially relevant to your treatment. 
__√__  
The sponsor of this research study (National Heart, Lung and Blood Institutes 
(NHLBI) cooperative group, etc., or its agents. 
__√__  
The organization(s) responsible for administering this research (e.g., Research 
Foundation of SUNY, University at Buffalo, Washington University, Nationwide 
Children’s Hospital, University of Rochester). 
__√__  Other medical investigators/centers/institutions participating in this research study.  

Page 152 of 305 
 
Your child’s information may also be shared with individuals or entities responsible for general 
administration, oversight and compliance of research activities. Examples of this include the 
institution's Privacy and Security Officers or other internal oversight staff, Safety Monitoring 
Boards, an Institutional Review Board, The Research Foundation of the State University of New 
York, University at Buffalo Foundation Services, and accrediting bodies, or with certain 
government oversight agencies that have authority over the research including the Department 
of Health and Human Services (HHS), the Food and Drug Administration (FDA), the National 
Institutes of Health (NIH), and the Office of Human Research Protections (OHRP). Your child’s 
information may also be shared with other entities as permitted or required by law. All 
reasonable efforts will be used to protect the confidentiality of your child’s individually 
identifiable health information that may be shared with others as described above. 
All reasonable efforts will be used to protect the confidentiality of your child’s protected health 
information. There is the potential for individually identifiable information and the associated 
health information obtained with this authorization to be re-disclosed by the recipient(s). After 
such a disclosure, the information may no longer be protected by the terms of this authorization 
against further re-disclosure. 
D.  How long will this information be kept by the Principal Investigator? 
__√__    This authorization has no expiration date. The researchers may continue to rely on this 
authorization to obtain and use protected health information about your child unless 
you revoke this authorization in writing. 
__√__ Your child’s protected health information will go into a database that will be maintained 
indefinitely. Any future study using this information that falls outside the scope of this 
current study will be required to follow guidelines designed to govern access to that 
information and to protect the privacy of that information. 
 
E.  What are your rights after signing this authorization? 
You have the right to revoke this authorization at any time. If you withdraw your authorization, 
no additional efforts to collect individually identifiable health information about your child will 
be made. You should know, however, that protected health information acquired using this 
authorization prior to its withdrawal may continue to be used to the extent that the 
investigator(s) have already relied on your permission to conduct the research. If you chose to 
withdraw this authorization, you must do so in writing to the following individual(s): 
 
Leonard H. Epstein, Ph.D. 
University at Buffalo Department of Pediatrics 
Division of Behavioral Medicine 
3435 Main Street 
G56 Farber Hall 
Buffalo, NY 14214 
Phone: 716-829-3400 
 

Page 153 of 305 
 
If you send us a request to withdraw your authorization, we will forward that request to the 
institutions we have shared it with in order to collect your individually identifiable health 
information.  
 
F.  What will happen if you decide not to sign this authorization? 
 
Refusing to sign this authorization will not affect the present or future care your child receives at 
this institution and will not cause any penalty or loss of benefits to which you are otherwise 
entitled. If you decide not to sign this authorization, you and your child will not be able to 
participate in the research study.   
 
 

Page 154 of 305 
 
Signature Block for Parental Permission 
 
Signature documents your permission for the named child to take part in this research. By signing this form, 
you are not waiving any of your legal rights, including the right to seek compensation for injury related to 
negligence or misconduct of those involved in the research. 
 
 
 
Printed name of child 
 
 
 
Signature of parent or individual legally authorized to consent to the 
child’s general medical care 
 
Date 
 
❑ Parent 
❑ Individual legally authorized 
to consent to the child’s 
general medical care (See 
note below) 
Printed name of parent or individual legally authorized to consent to the 
child’s general medical care 
Note: Investigators are to ensure that individuals who are not parents can demonstrate their legal authority to consent 
to the child’s general medical care. Contact legal counsel if any questions arise. 
 
 
 
Assent Process 
 
❑ Child is birth-6 yrs. old - Assent is not required 
❑ Child is 7-17 yrs. old – A separate Assent Document is to be signed by the 
child 
❑ Assent will be obtained Verbally 
❑ Assent has been waived by the IRB 
 
 
 
 
I certify that the nature and purpose, the potential benefits and possible risks associated with participation 
in this research study have been explained to the above individual and that any questions about this 
information have been answered. A copy of this document will be given to the subject. 
 
 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
Printed name of person obtaining consent 
 
 
 
 
 

Page 155 of 305 
 
 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federal wide Assurance ID#: FWA00008824 
Title of research study: THE EFFECTIVENESS OF FAMILY-BASED WEIGHT LOSS 
TREATMENT IMPLEMENTED IN PRIMARY CARE 
 
PILOT Parent Adult Consent to Participate in a Research Study 
 
Version Date: 07-18-2018 
 
Investigators: Leonard H. Epstein, Ph.D. 
 
Why am I being invited to take part in a research study? 
You and your child are being invited to take part in a pilot research study because: 
● You are an adult able to read the English language. You have reported no current learning 
disabilities, medical problems, or psychiatric problems.  
● You have a child between the ages of 7 and 12 years old that falls into the overweight or obese 
weight category (defined as at or above the 85th percentile for age and sex), and you are 
interested in weight loss and participating in the study. 
This research study is supported by a grant through the National Heart Lung and Blood Institute (NHBLI). 
Research studies only include individuals who choose to take part in them. Your decision to take part in 
this study is entirely voluntary. Please read this information carefully. Ask questions about anything you 
do not understand before deciding whether or not to participate. You may also take home an unsigned 
copy of this consent form to think about participating or if you wish to discuss this matter with your 
family or your personal doctor. Please take your time to make your decision. Do not sign this form 
unless you have had the chance to ask questions and have received satisfactory answers. 
 
What should I know about a research study? 
● Someone will explain this research study to you. 
● Whether or not you take part is up to you. 
● You can choose not to take part. 
● You can agree to take part and later change your mind. 
● Your decision will not be held against you. 
● You can ask all the questions you want before you decide. 
 
 
 

Page 156 of 305 
 
Who can I talk to? 
If you have questions, concerns, or complaints, or think the research has hurt you, talk to the research 
team by telephone at 716-829-3400 for Dr. Leonard Epstein. You may also contact the PLAN coach at 
your child’s doctor’s office. You can also contact the research participant advocate at 716-888-4845 or 
researchadvocate@buffalo.edu.  
This research has been reviewed and approved by an Institutional Review Board (“IRB”). You may talk to 
them at (716) 888-4888 or email ub-irb@buffalo.edu   
 If:  
● You have questions about your rights as a participant in this research 
● Your questions, concerns, or complaints are not being answered by the research team. 
● You cannot reach the research team. 
● You want to talk to someone besides the research team. 
● You want to get information or provide input about this research. 
 
Why is this research being done? 
The goal of this pilot study is to determine whether a specific kind of weight loss treatment called 
family-based behavioral treatment (FBT) for children, delivered by a PLAN coach, can be included in the 
primary care setting. Extensive information has been gathered by our research team about the 
treatment of childhood overweight and obesity. But there is still much to learn about how the treatment 
should be incorporated into various medical settings, such as primary care. 
 
How long will the research last? 
We expect that you will be in this treatment and research study for 3 months. 
 
How many people will be studied? 
We expect about 6 families will be in the pilot phase of this research study. 
 
What happens if I say yes, I want to be in this research? 
To determine if your family is eligible to participate, you and your child will be asked to complete an 
eligibility assessment at an orientation session about this study. You and your child’s height and weight 
will be measured, and standard questions regarding medical and psychological history will be asked by a 
trained interviewer to determine eligibility.  
If your family is eligible for this research study and agrees to participate, you and your child will be asked 
to come to your pediatric office to complete a baseline assessment (detailed below). After the baseline 
assessment, your family will be enrolled. You will meet with a PLAN coach weekly.  
 
Group 
At the start of the study, your family will be assigned to receive family-based behavioral treatment for 
weight management (FBT). FBT is a behavioral weight-control intervention that aims to make weight 
changes in both a child and their participating parent. FBT is a well-tested treatment that targets diet, 
activity, behavioral techniques, parenting, and social facilitation in children and their parents. The 
treatment includes: 1) The Traffic Light Eating Plan uses RED; YELLOW; and GREEN labels for food to 
guide families toward the goal of eating nutritious foods. 2) The Traffic Light Activity Program also uses 
RED; YELLOW; and GREEN labels for different levels of exercise to increase physical activity and reducing 
inactive behaviors. 3) a variety of behavioral techniques including changing and controlling your 
environment, tracking eating and physical activity, setting goals, problem solving, setting up a reward 

Page 157 of 305 
 
system, incentives for behavior change and weight loss, finding substitutes for unhealthy foods, and 
improving positive parenting. FBT also involves making changes in the home. So that weight loss or 
prevention of weight gain may extend to members of the family who are not regularly attending 
treatment sessions (e.g., siblings and spouse). 
 
Treatment Schedule 
Every family will receive FBT and will complete at least 12 sessions with the FBT PLAN coach during the 3 
months of the study.  
 
Assessments, Interviews, Questionnaires 
Attendance will be taken and both you and your child will be weighed at every session. In addition, there 
will be two major assessments throughout the entire 3 months of the pilot study: 
● 1 Baseline assessment upon starting study (0 months) 
● 1 Follow-up assessment at end of study (3 months) 
Both major assessments will take approximately 30-90 minutes to complete at your child’s pediatric 
office, or a home visit can be arranged. Height and weight will be taken on you and your child. Your 
height will be taken at the beginning of the study, and your child’s height will be taken at each major 
assessment. At your baseline and follow-up appointment, we will ask you to do a computer task that 
asks you to make choices between different amounts of money.  
 
Audio Recording 
Your interviews and individual family will be audiotaped or digitally recorded for research purposes, but 
you will not be identified on the recording and the recordings will not be labeled with your name. 
Recording the sessions is the best way to make sure we collect accurate information. It also helps us 
make sure that all our staff delivers the study to participants in the same way. The recordings will be 
stored on password-protected computers with restricted access within the University at Buffalo, and 
then transferred to Washington University School of Medicine. The recordings will be labeled only with 
your study ID, date, and session number. The Principal Investigator and research staff may use these 
recordings for purposes of evaluation, treatment, research, and training related to this study. 
Recordings may also be used to train staff implementing these or similar interventions at other sites. 
The recordings will be destroyed at the end of the study when all data analysis is complete. You do not 
have to agree to be audio recorded in order to participate in this study. 
 
 
 

Page 158 of 305 
 
Please check and initial below if you agree or do not agree to give permission for you and your child to 
be audio recorded during your sessions with the PLAN coach. 
     YES __________, Yes, I give my permission to be audio recorded during sessions with a PLAN coach 
      NO___________, No, I do not give my permission to be audio recorded during sessions with a PLAN 
coach 
Parent INITIAL______________ Date: ________________ 
What are my responsibilities if I take part in this research? 
If you take part in this pilot research, you will be responsible to attend the baseline assessment, 3 month 
follow-up assessment, and attend at least 12 treatment sessions. 
 
What happens if I do not want to be in this research? 
Your participation in this pilot research study is voluntary. You may choose not to enroll in this study. 
There are no other research alternatives other than to participate in this study. 
 
What happens if I say yes, but I change my mind later? 
You can leave the pilot research at any time. It will not be held against you. You do not have to answer 
every question. You may refuse to answer any questions that you do not want to answer. 
If you decide to leave the research, you may not be able to find this kind of family treatment in your 
area outside of this research study. Other types of treatment may be available in your community. In 
which case we will provide a list of these and how to find them if you prefer this option. However, you 
and/or your insurance company would be responsible for any costs associated with these options. You 
also may not receive full compensation for your participation. If you decide to leave the research, 
contact the investigator at the contact information included below. If you stop being in the research, 
already collected data may not be removed from the study database. You will be asked whether the 
investigator can collect data from your routine medical care.  
 
Is there any way being in this study could be bad for me? 
There are certain risks and discomforts that may be associated with this research. They include: 
Likely 
● You might feel hungry when dieting or sore after exercising. 
Less Likely 
● You may find some of the questions embarrassing or be uncomfortable having your height and 
weight measured. 
● There may be some family disagreements as issues of family functioning, communication, and 
discipline are discussed. 
● You may be inconvenienced at times by having to miss work, school activities, meetings, etc., to 
attend assessments and family sessions. 
Rare 
● There is a risk of audio recordings being lost. All recordings will be immediately stored in a 
locked drawer or saved to a password-protected computer in the research office after the 
individual family and group weight loss and maintenance sessions. Your family name will not be 
on these recordings, which will be identified only by a study ID number. 

Page 159 of 305 
 
● The use of online platforms is associated with risks involving breaches of confidentiality. We 
implement many layers of security to limit these risks as much as possible within our website 
and REDCap database. Outside platforms (i.e., MyFitnessPal) are subject to their own security 
measures and carry their own risks if your family chooses to use them to supplement your 
participation in this study. 
● In addition, although this treatment usually prevents the development of eating disorder 
problems, in rare cases it may increase them. 
Other Risks 
● In this study you will be given a physical activity goal. Given that some people may have medical 
risks associated with increasing their physical activity, these recommendations for your child will 
be given in consultation with his/her doctor. As an adult, you may consider getting approval 
from your doctor for setting physical activity goals. Adult participants will be responsible for 
consulting their doctor for approval. 
Will being in this study help me in any way? 
We cannot promise any benefits to you or others from your taking part in this research. However, 
possible benefits could include you and your child losing weight, becoming more physically active, and 
eating more healthfully as a result of participation. In addition, maintaining weight loss may lead to 
better relationships and better mood. However, we cannot guarantee that you or your child will receive 
any benefits from this study. This study may also provide information that will help other children inside 
and outside your household to lose weight and keep it off. 
 
What happens to the information collected for the research? 
Efforts will be made to limit the use and disclosure of your personal information, including research 
study and medical or education records, to people who have a need to review this information. We 
cannot promise complete secrecy. Organizations that may inspect and copy your information include 
the IRB and other representatives of this organization. Information related to you will be treated in strict 
confidence to the extent provided by law. Your identity will be coded and will not be associated with any 
published results. Your code number and identity will be kept in a locked file of the Principal 
Investigator. The only connection between your participation in this study and the study itself will be 
this signed consent form. All recordings of the sessions will be kept in a locked file of the Principal 
Investigator until the end of the study. At which point they will be destroyed. If you withdraw from the 
study, no further data will be collected. Any information that has been provided may be retained by the 
researchers and analyzed. In order to monitor this research study, representatives from the Institutional 
Review Board (IRB) and other federal agencies such as NIH (National Institutes of Health) and OHRP 
(Office of Human Research Protection) may inspect the research records which may reveal your identity. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law. This web site will not include information that can identify you. At most, the web site will include a 
summary of the results. You can search this web site at any time. Federal law provides additional 
protections of your medical records and related health information. These are described in the HIPAA 
section of this document. 
 
Can I be removed from the research without my OK? 
The principal investigator of the study can remove you from the research study without your approval. 
Possible reasons for removal include need for hospitalization for physical or psychological reasons. 
 
What else do I need to know? 

Page 160 of 305 
 
This research is being funded by the National Institutes of Health, specifically the National Heart, Lung 
and Blood Institutes (NHLBI). If you need medical care because of taking part in this research study, 
contact the investigator and/or speak with your doctor and medical care will be made available. 
Generally, this care will be billed to you, your insurance or other third party. The University at Buffalo 
has no program to pay for medical care for research-related injury. If you agree to take part in this 
research study, we will pay you up to $30 for your time and effort. The amount you are paid depends 
upon your attendance to visits in the study. 
 
HIPAA:  Authorization for the Use and Disclosure of Identifiable Health Information for Research 
Purposes  
This section describes information about you and about your health that will be obtained by the 
researchers when you participate in the research study. Health information is considered "protected 
health information" when it may directly identify you as an individual. By signing this form, you are 
agreeing to permit the researchers and/or other parties (described in detail below) to have access to 
this information. If there are any parts of this form that you do not understand, please be sure to ask us 
for further clarification. 
A. What protected health information will be collected about you as part of this research 
study? 
 __√__ Specific information from your full medical records related to your height, weight, dietary 
restrictions, and physical activity restrictions. 
 
__√__ New Health Information created from study related tests, procedures, visits, and/or                                          
questionnaires as described in this consent form. 
B.    Who is authorized to provide or collect this information? 
__√_      Principal Investigator or designee 
 
C.   With whom may your protected health information be shared?  
Your health information may be shared with others outside of the research group for purposes 
directly related to the conduct of this research study or as required by law, including but not 
limited to: 
__√__  
Clinical staff not involved in this research study who may become involved in you and 
your child’s care if it is potentially relevant to your treatment. 
__√__  
The sponsor of this research study (National Heart, Lung and Blood Institutes 
(NHLBI) cooperative group, etc., or its agents. 
__√__  
The organization(s) responsible for administering this research (e.g., Research 
Foundation of SUNY, University at Buffalo, Washington University, Nationwide 
Children’s Hospital, University of Rochester). 
___√_  
Other medical investigators/centers/institutions participating in this research study. 
Your information may also be shared with individuals or entities responsible for general 
administration, oversight and compliance of research activities. Examples of this include the 
institution's Privacy and Security Officers or other internal oversight staff, Safety Monitoring 

Page 161 of 305 
 
Boards, an Institutional Review Board, The Research Foundation of the State University of New 
York, University at Buffalo Foundation Services, and accrediting bodies, or with certain 
government oversight agencies that have authority over the research including the Department 
of Health and Human Services (HHS), the Food and Drug Administration (FDA), the National 
Institutes of Health (NIH), and the Office of Human Research Protections (OHRP). Your 
information may also be shared with other entities as permitted or required by law. All 
reasonable efforts will be used to protect the confidentiality of your individually identifiable 
health information that may be shared with others as described above. 
All reasonable efforts will be used to protect the confidentiality of your protected health 
information. There is the potential for individually identifiable information and the associated 
health information obtained with this authorization to be re-disclosed by the recipient(s). After 
such a disclosure, the information may no longer be protected by the terms of this authorization 
against further re-disclosure. 
D.  How long will this information be kept by the Principal Investigator? 
__√__    This authorization has no expiration date. The researchers may continue to rely on this 
authorization to obtain and use protected health information about you unless you 
revoke this authorization in writing. 
__√__ Your protected health information will go into a database that will be maintained 
indefinitely. Any future study using this information that falls outside the scope of this 
current study will be required to follow guidelines designed to govern access to that 
information and to protect the privacy of that information. 
E.  What are your rights after signing this authorization? 
You have the right to revoke this authorization at any time. If you withdraw your authorization, 
no additional efforts to collect individually identifiable health information about you will be 
made. You should know, however, that protected health information acquired using this 
authorization prior to its withdrawal may continue to be used to the extent that the 
investigator(s) have already relied on your permission to conduct the research. If you chose to 
withdraw this authorization, you must do so in writing to the following individual(s): 
Leonard H. Epstein, Ph.D. 
University at Buffalo Department of Pediatrics 
Division of Behavioral Medicine 
3435 Main Street 
 G56 Farber Hall 
Buffalo, NY 14214 
Phone: 716-829-3400 
 
If you send us a request to withdraw your authorization, we will forward that request to the 
institutions we have shared it with in order to collect your individually identifiable health 
information.  
 
F.  What will happen if you decide not to sign this authorization? 
 

Page 162 of 305 
 
Refusing to sign this authorization will not affect the present or future care you receive at this institution 
and will not cause any penalty or loss of benefits to which you are otherwise entitled. If you decide not 
to sign this authorization, you will not be able to participate in the research study.   
 

Page 163 of 305 
 
Signature Block for Capable Adult 
 
Your signature documents your permission to take part in this research. By signing this form, you are not 
waiving any of your legal rights, including the right to seek compensation for injury related to negligence or 
misconduct of those involved in the research. 
 
 
 
 
Signature of subject 
 
Date 
 
 
Printed name of subject 
 
 
 
 
 
 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
Printed name of person obtaining consent 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Page 164 of 305 
 
 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
 
THE EFFECTIVENESS OF FAMILY-BASED WEIGHT LOSS TREATMENT 
IMPLEMENTED IN PRIMARY CARE 
 
Participating Child Assent to be in a Research Study (for Children 7-13 yrs. of 
age) 
 
Version Date: 6.25.19 
 
Investigators: Leonard H. Epstein, PhD. 
 
Who are we? 
My name is Dr. Leonard H. Epstein and I am a researcher at the University at Buffalo. I work in the 
Department of Pediatrics. 
 
Why are we meeting with you? 
You have aged into a different age group of 7-13 year olds. We need you to assent to continue 
participating in this weight loss program for kids.  
 
Why are we doing this study? 
We want to look at a certain kind of weight loss program for kids. We want to know if it will work at a 
doctor’s office. 
 
What will happen to you if you continue to participate in the study? 
You will continue to come to the doctor’s office like before, nothing has changed. You will keep coming 
in to get your height and weight measured and fill out surveys.   
You and your parent will continue to be a part of one of two groups: 
● If you are in one group, you follow the recommendations of your doctor. 
● If you are in the other group, you come to your doctor’s office once a week for 2 years. This 
happens for at least 26 visits. At the visits you meet with someone from the study. Your weight 
is taken and you learn about healthy food. We teach you fun ways to exercise. 
 
Every 6 months we ask you some questions about yourself. We continue to measure your height and 
weight. At your 12-month and follow-up appointments, we ask you to do a computer task that asks you 
to make choices between different amounts of money. 
 
You do not have to answer any questions that you do not want to answer. You do not have to do any 
activities that you do not want to do. 
 
What are the good things and bad things that may happen to you if you continue to be a part of the 
study? 

Page 165 of 305 
 
Most Likely: You can have fun learning about healthy food and exercise. You could become healthy. 
 
Maybe: You could become hungry when trying to eat healthy. Your muscles could feel sore from 
exercise. That will go away once you are used to exercising. You might experience common exercise 
injuries (i.e., sprains, shin splints, tendonitis, muscle pulls, strains, etc). 
 
Do you have to continue to be in the study? 
No you don’t. No one will get angry or upset with you if you don’t want to do this. Just tell us if you 
don’t want to continue to be in the study. Also, you can change your mind later if you decide you don’t 
want to be in the study anymore. 
 
Do you have any questions? 
You can ask questions at any time. You can ask now. You can ask later. You can talk to me or you can talk 
to someone else at any time during the study. You can call: 
 
Name of contact person on the study: Leonard H. Epstein, Ph.D. Phone Number: (716) 829-3400 
  
 
Signature Block for Assent of Child 
 
Your signature documents your permission to continue to take part in this research. 
 
 
 
Signature of subject 
 
Date 
 
 
Printed name of subject 
 
I certify that the nature and purpose, the potential benefits and possible risks associated with continued 
participation in this research study have been explained to the above individual and that any questions 
about this information have been answered. A copy of this document will be given to the subject. 
 
 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
Printed name of person obtaining consent 
 
 
 
(This change was made on 7.25.19 prior to review and approval by the DSMB, DSMB approved protocol 
addenda, 10.25.19). 
 
 
 

Page 166 of 305 
 
 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federal wide Assurance ID#: FWA00008824 
Title of research study: THE EFFECTIVENESS OF FAMILY-BASED WEIGHT LOSS 
TREATMENT IMPLEMENTED IN PRIMARY CARE 
 
Targeted Child Ages 14-17 Assent to Participate in a Research Study 
 
Version Date: 7.8.19 
 
Investigators: Leonard H. Epstein, PhD. 
 
Why am I being asked to continue in this research study? 
You are being asked to assent to continue in this research study because: 
● You have aged into a different age group of 14-17 years. 
This research study is supported by a grant through the National Heart Lung and Blood Institute (NHLBI). 
Research studies only include individuals who choose to take part in them. Your decision to continue in 
this study is entirely voluntary. Please read this information carefully. Ask questions about anything you 
do not understand before deciding whether or not to continue to participate. You may also take home 
an unsigned copy of this consent form to think about continuing to participate or if you wish to discuss 
this matter with your family or your personal doctor. Please take your time to make your decision. Do 
not sign this form unless you have had the chance to ask questions and have received satisfactory 
answers. 
 
What should I know about a research study? 
● Someone will explain this research study to you. 
● Whether or not you continue is up to you. 
● You can choose not to continue. 
● You can agree to continue and later change your mind. 
● Your decision will not be held against you. 
● You can ask all the questions you want before you decide. 
 
 
 

Page 167 of 305 
 
Who can I talk to? 
If you have questions, concerns, or complaints, or think the research has hurt you, talk to the research 
team by telephone at 716-829-3400 for Dr. Leonard Epstein. You may also contact the PLAN coach at 
your child’s doctor’s office. You can also contact the research participant advocate at 716-888-4845 or 
researchadvocate@buffalo.edu.  
This research has been reviewed and approved by an Institutional Review Board (“IRB”). You may talk to 
them at (716) 888-4888 or email ub-irb@buffalo.edu if:  
● You have questions about your rights as a participant in this research 
● Your questions, concerns, or complaints are not being answered by the research team. 
● You cannot reach the research team. 
● You want to talk to someone besides the research team. 
● You want to get information or provide input about this research. 
 
Why is this research being done? 
The goal of this study is to determine whether a specific kind of weight loss treatment called family-
based behavioral treatment (FBT) for children, delivered by a PLAN coach, can be included in the 
primary care setting.  Extensive information has been gathered by our research team about the 
treatment of childhood overweight and obesity. But there is still much to learn about how the treatment 
should be incorporated into various medical settings, such as primary care. 
 
How long will the research last? 
We expect that you will be in this treatment and research study for 24 months from your original start 
of the study. 
 
How many people will be studied? 
We expect about 132 families will be in this research study in your geographical location. Out of 528 
families in the entire study nationally. 
What happens if I say yes, I want to continue to be in this research? 
You will continue your participation as before and no components of the research study have changed. 
As a reminder, you will continue to be asked to come to your pediatric office to complete assessment 
appointments (detailed below).  
Groups 
Your family has been assigned to one of two groups. Participants in one group receive the current 
standard of care offered by their physician for the treatment of childhood weight management.  
Participants in the second group receive family-based behavioral treatment for weight management 
(FBT). FBT is a behavioral weight-control intervention that aims to make weight changes in both a child 
and their participating parent. FBT is a well-tested treatment that targets diet, activity, behavioral 
techniques, parenting, and social facilitation in children and their parents. The treatment includes: 1) 
The Traffic Light Eating Plan uses RED; YELLOW; and GREEN labels for food to guide families toward the 
goal of eating nutritious foods. 2) The Traffic Light Activity Program, also uses RED; YELLOW; and GREEN 
labels for different levels of exercise to increase physical activity and reducing inactive behaviors. 3) a 
variety of behavioral techniques including changing and controlling your environment; tracking eating 
and physical activity; setting goals; problem solving; setting up a reward system; incentives for behavior 
change and weight loss; finding substitutes for unhealthy foods; and improving positive parenting. FBT 
also involves making changes in the home. So weight loss or prevention of weight gain may extend to 
members of the family who are not regularly attending treatment sessions (e.g., siblings and spouse). 

Page 168 of 305 
 
The group that your family is in/the treatment you receive was chosen by chance. Like flipping a coin. 
Neither you nor your doctor chose what treatment your family is receiving.  
Treatment Schedule 
Every family will follow their pediatrician’s recommended schedule of appointments for weight 
management to have at least 4 visits with their child’s doctor over the course of the 24 months of the 
study. Families in the group receiving FBT will additionally complete at least 26 sessions with the FBT 
PLAN Coach during the 24 months of the study. The amount of sessions completed within this range will 
be based on progress through the program and will vary for each family. 
Assessments, Interviews, Questionnaires 
Attendance will be taken and you will continue to be weighed at every session. In addition, there are 
five major assessments throughout the entire 2 years of the study: 
● 1 Baseline assessment upon starting study (0 months) 
● 3 Treatment assessments during the study (6, 12, and 18 months) 
● 1 Follow-up assessment at end of the study (24 months) 
Each major assessment takes approximately 30-90 minutes to complete at your pediatric office, or a 
home visit can be arranged. Height and weight is taken on you as well as the identified other family 
members (if applicable). Your height was taken at the beginning of the study and will be taken at each 
major assessment. You will also complete short questionnaires. You as well as the identified other family 
members will be asked questions about parenting behaviors and the home food and activity 
environment. At your baseline, 12-month, and follow-up appointments, you will be asked to complete a 
computer task. Throughout the study, you will have access to a website that contains study materials 
and interactive tools. 
Audio Recording 
Your interviews and individual family will be audiotaped or digitally recorded for research purposes, but 
you will not be identified on the recording and the recordings will not be labeled with your name. 
Recording the sessions is the best way to make sure we collect accurate information. It also helps us 
make sure that all our staff delivers the study to participants in the same way. The recordings will be 
stored on password-protected computers with restricted access within the University at Buffalo, and 
then transferred to Washington University School of Medicine. The recordings will be labeled only with 
your study ID, date, and session number. The Principal Investigator and research staff may use these 
recordings for purposes of evaluation, treatment, research, and training related to this study. 
Recordings may also be used to train staff implementing these or similar interventions at other sites. 
The recordings will be destroyed at the end of the study when all data analysis is complete.  
What are my responsibilities if I continue to take part in this research? 
If you continue to take part in this research, you will be responsible to attend all treatment assessments, 
at least 26 treatment sessions if your family is in the group receiving FBT, and the follow-up assessment. 
 
What happens if I do not want to continue to be in this research? 
Your participation in this research study is voluntary. You may choose not to continue in this study. 
There are no other research alternatives other than to participate in this study. 
 
What happens if I say yes, but I change my mind later? 
You can leave the research at any time. It will not be held against you. You do not have to answer every 
question and may refuse to answer any questions that you do not want to answer. 

Page 169 of 305 
 
If you decide to leave the research, you may not be able to find this kind of family treatment in your 
area outside of this research study. Other types of treatment may be available in your community. In 
which case we will provide a list of these and how to find them if you prefer this option. However, you 
and/or your insurance company would be responsible for any costs associated with these options. You 
also may not receive full compensation for your participation. If you decide to leave the research, 
contact the investigator at the contact information included above. If you stop being in the research, 
already collected data may not be removed from the study database. You will be asked whether the 
investigator can collect data from your routine medical care.  
 
Is there any way continuing to be in this study could be bad for me? 
There are certain risks and discomforts that may be associated with this research. They include: 
Likely 
● You might feel hungry when dieting, sore after exercising, or experience common exercise 
injuries (i.e., sprains, shin splints, tendonitis, muscle pulls, strains, etc). 
Less Likely 
● You may find some of the questions embarrassing or be uncomfortable having your height and 
weight measured. 
● There may be some family disagreements as issues of family functioning; communication; and 
discipline are discussed. 
● You may be inconvenienced at times by having to miss work, school activities, meetings, etc., to 
attend assessments and family sessions. 
 
 
Rare 
● There is a risk of audio recordings being lost. All recordings will be immediately stored in a 
locked drawer or saved to a password-protected computer in the research office after the 
individual family and group weight loss and maintenance sessions. Your family name will not be 
on these recordings, which will be identified only by a study ID number. 
● The use of online platforms is associated with risks involving breaches of confidentiality. We 
implement many layers of security to limit these risks as much as possible within our website 
and REDCap database. Outside platforms (i.e., MyFitnessPal) are subject to their own security 
measures and carry their own risks if your family chooses to use them to supplement your 
participation in this study. 
● In addition, although this treatment usually prevents the development of eating disorder 
problems, in rare cases it may increase them. 
Other Risks 
● In this study you will be given a physical activity goal. Given that some people may have medical 
risks associated with increasing their physical activity, these recommendations will be given in 
consultation with your doctor. Participants will be responsible for consulting their doctor for 
approval. 
Will continuing to be in this study help me in any way? 

Page 170 of 305 
 
We cannot promise any benefits to you or others from your continuing to take part in this research. 
However, possible benefits could include you losing weight, becoming more physically active, and eating 
more healthfully as a result of participation. In addition, maintaining weight loss may lead to better 
relationships and better mood. However, we cannot guarantee that you will receive any benefits from 
this study. This study may also provide information that will help other children inside and outside your 
household to lose weight and keep it off. 
 
What happens to the information collected for the research? 
Efforts will be made to limit the use and disclosure of your personal information, including research 
study and medical or education records, to people who have a need to review this information. We 
cannot promise complete secrecy. Organizations that may inspect and copy your information include 
the IRB and other representatives of this organization. Information related to you will be treated in strict 
confidence to the extent provided by law. Your identity will be coded and will not be associated with any 
published results. Your code number and identity will be kept in a locked file of the Principal 
Investigator. The only connection between your participation in this study and the study itself will be 
this signed consent form. All recordings of the sessions will be kept in a locked file of the Principal 
Investigator until the end of the study. At which point they will be destroyed. If you withdraw from the 
study, no further data will be collected. Any information that has been provided may be retained by the 
researchers and analyzed. In order to monitor this research study, representatives from the Institutional 
Review Board (IRB) and other federal agencies such as NIH (National Institutes of Health) and OHRP 
(Office of Human Research Protection) may inspect the research records which may reveal your identity. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law. This web site will not include information that can identify you. At most, the web site will include a 
summary of the results. You can search this web site at any time. Federal law provides additional 
protections of your medical records and related health information.  
 
Can I be removed from the research without my OK? 
The principal investigator of the study can remove you from the research study without your 
approval. Possible reasons for removal include need for hospitalization for physical or 
psychological reasons. 
 
What else do I need to know? 
This research is being funded by the National Institutes of Health, specifically the National Heart, Lung 
and Blood Institutes (NHLBI). If you need medical care because of taking part in this research study, 
contact the investigator and/or speak with your doctor and medical care will be made available. 
Generally, this care will be billed to you, your insurance or other third party. The University at Buffalo 
has no program to pay for medical care for research-related injury. If you agree to continue to take part 
in this research study, we will pay your parents up to $175 for your family’s time and effort. The amount 
your parents are paid depends upon your attendance to visits in the study. 
 
Signature Block for 14-17 year-old 
 
Your signature documents your permission to continue to take part in this research. By signing this form, 
you are not waiving any of your legal rights, including the right to seek compensation for injury related to 
negligence or misconduct of those involved in the research. 
 

Page 171 of 305 
 
 
 
 
Signature of subject 
 
Date 
 
 
Printed name of subject 
 
 
 
 
 
 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
Printed name of person obtaining consent 
 
 
 
 
(This change was made on 7.25.19 prior to review and approval by the DSMB, DSMB approved protocol 
addenda, 10.25.19). 
 
 

Page 172 of 305 
 
 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
 
THE EFFECTIVENESS OF FAMILY-BASED WEIGHT LOSS TREATMENT 
IMPLEMENTED IN PRIMARY CARE 
 
Sibling Assent to be in a Research Study - (for Children 7-13 years of age) 
 
Version Date: 6.25.19 
 
Investigators: Leonard H. Epstein, PhD. 
 
Who are we? 
My name is Dr. Leonard H. Epstein and I am a researcher at the UB. I work in the Department of 
Pediatrics. 
 
Why are we meeting with you? 
You have aged into a different age group of 7-13 year olds. We need you to assent to continue 
participating in this weight loss program for kids.  
 
Why are we doing this study? 
We want to look at siblings of kids participating in a study through your doctor’s office.  
 
What will happen to you if you continue to participate in the study? 
You will continue to come to the doctor’s office like before, nothing has changed. You will keep coming 
in for a total of 5 times over 2 years so we can measure your height and weight. This will be done in 
private. Only your parent, your sibling, and the study member will be with you. You do not have to 
answer any questions if you don’t want to. You do not have to do any activities you do not want to do. 
 
What are the good things and bad things that may happen to you if you continue to be a part of the 
study? 
Most Likely:  
Good: You can learn how you are growing.  
Maybe:  
Good: You could learn what is like to be in a research study. You might lose weight. 
Bad: You might not like getting your height and weight taken. You might feel hungry when 
dieting, sore after exercising, or experience common exercise injuries (i.e., sprains, shin splints, 
tendonitis, muscle pulls, strains, etc). 
 
Do you have to continue to be in the study? 
No you don’t. No one will get angry or upset with you if you don’t want to do this. If you do not want to 
be in the study at any time, it will not affect your family being in the study. Just tell us if you don’t want 

Page 173 of 305 
 
to be in the study. And remember, you can change your mind later if you decide you don’t want to be in 
the study anymore. 
 
Do you have any questions? 
You can ask questions at any time. You can ask now. You can ask later. You can talk to me or you can talk 
to someone else at any time during the study. You can call: 
 
Name of contact person on the study: Leonard H. Epstein, Ph.D.  
Phone Number: (716) 829-3400 
  
 
Signature Block for Sibling Assent of Child 
Your signature documents your permission to continue to take part 
in this research. 
 
 
 
 
Signature of subject 
 
Date 
 
 
Printed Name of Subject 
 
 
I certify that the nature and purpose, the potential benefits and possible risks associated with continued 
participation in this research study have been explained to the above individual and that any questions 
about this information have been answered. A copy of this document will be given to the subject. 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
Printed name of person obtaining consent 
 
 
 
 
(This change was made on 7.25.19 prior to review and approval by the DSMB, DSMB approved protocol 
addenda, 10.25.19). 
 
 

Page 174 of 305 
 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federal wide Assurance ID#: FWA00008824 
Title of research study: THE EFFECTIVENESS OF FAMILY-BASED WEIGHT LOSS 
TREATMENT IMPLEMENTED IN PRIMARY CARE 
 
Sibling Assent of a 14-17-year-old to Participate in a Research Study 
 
Version Date: 7.8.19 
 
Investigators: Leonard H. Epstein, PhD. 
 
Why am I being invited to take part in a research study? 
You are being asked to assent to continue in this research study because: 
● You have aged into a different age group of 14-17 years. 
This research study is supported by a grant through the National Heart Blood and Lung Institutes 
(NHBLI).  Research studies only include individuals who choose to take part in them. Your decision to 
take part in this study is entirely voluntary. Please read this information carefully and ask questions 
about anything you do not understand before deciding whether or not to participate. You may also take 
home an unsigned copy of this consent form to think about participating or if you wish to discuss this 
matter with your family or your personal doctor. Please take your time to make your decision. Do not 
sign this form unless you have had the chance to ask questions and have received satisfactory answers. 
 
What should I know about a research study? 
● Someone will explain this research study to you. 
● Whether or not you continue is up to you. 
● You can choose not to continue. 
● You can agree to continue and later change your mind. 
● Your decision will not be held against you. 
● You can ask all the questions you want before you decide. 
 
Who can I talk to? 
If you have questions, concerns, or complaints, or think the research has hurt you, talk to the research 
team by telephone at 716-829-3400 for Dr. Leonard Epstein. You may also contact the PLAN coach at 
your child’s doctor’s office. You can also contact the research participant advocate at 716-888-4845 or 
researchadvocate@buffalo.edu.  
This research has been reviewed and approved by an Institutional Review Board (“IRB”). You may talk to 
them at (716) 888-4888 or email ub-irb@buffalo.edu if:  
● You have questions about your rights as a participant in this research 
● Your questions, concerns, or complaints are not being answered by the research team. 
● You cannot reach the research team. 
● You want to talk to someone besides the research team. 
● You want to get information or provide input about this research. 

Page 175 of 305 
 
 
Why is this research being done? 
The goal of this study is to determine whether a specific kind of weight loss treatment called family-
based behavioral treatment (FBT) for children, delivered by a PLAN coach, can be included in the 
primary care setting. Extensive information has been gathered by our research team about the 
treatment of childhood overweight and obesity, but there is still much to learn about how the treatment 
should be incorporated into various medical settings, such as primary care and how it effects siblings 
living with participating parents and children. 
 
How long will the research last? 
We expect that you will be in this treatment and research study for 24 months from your original start 
of the study. 
 
How many people will be studied? 
We expect about 132 families will be in this research study in your geographical location, out of 528 
families in the entire study nationally. 
 
What happens if I say yes, I want to continue to be in this research? 
You will continue your participation as before and no components of the research study have changed. 
As a reminder, you will continue to be asked to come to your pediatric office to complete assessment 
appointments (detailed below).  
Groups 
Your family has been assigned to one of two groups. Participants in one group receive the current 
standard of care offered by their physician for the treatment of childhood weight management.  
Participants in the second group receive family-based behavioral treatment for weight management 
(FBT). FBT is a behavioral weight-control intervention that aims to make weight changes in both a child 
and their participating parent. FBT is a well-tested treatment that targets diet, activity, behavioral 
techniques, parenting, and social facilitation in children and their parents. The treatment includes: 1) 
The Traffic Light Eating Plan uses RED; YELLOW; and GREEN labels for food to guide families toward the 
goal of eating nutritious foods. 2) The Traffic Light Activity Program, also uses RED; YELLOW; and GREEN 
labels for different levels of exercise to increase physical activity and reducing inactive behaviors. 3) a 
variety of behavioral techniques including changing and controlling your environment; tracking eating 
and physical activity; setting goals; problem solving; setting up a reward system; incentives for behavior 
change and weight loss; finding substitutes for unhealthy foods; and improving positive parenting. FBT 
also involves making changes in the home. So weight loss or prevention of weight gain may extend to 
members of the family who are not regularly attending treatment sessions (e.g., siblings and spouse). 
The group that your family is in/the treatment you receive was chosen by chance. Like flipping a coin. 
Neither you nor your doctor chose what treatment your family is receiving.  
Treatment Schedule 
Every family will follow their pediatricians recommended schedule of appointments for weight 
management. Families in the group receiving FBT will additionally complete at least 26 sessions with the 
FBT interventionist during the 24 months of the study. The amount of session completed within this 
range will be based on progress through the program and will vary for each family. You will not attend 
the sessions with the PLAN coach. 
Assessments, Interviews, Questionnaires 
You will continue to attend five major assessments throughout the entire 2 years of the study: 

Page 176 of 305 
 
● 1 Baseline assessment upon starting study (0 months) 
● 3 Measurement assessments during the study (6, 12, and 18 months) 
● 1 Follow-up assessment at end of study (24 months) 
Each major assessment takes approximately 30-90 minutes to complete at your sibling’s pediatric office, 
or a home visit can be arranged. Your height and weight will continue to be taken at each major 
assessment.   
 
What are my responsibilities if I continue to take part in this research? 
If you continue to take part in this research, you will be responsible to attend all measurement 
assessments and the follow-up assessment. Your continued participation in any other meetings with 
your family are voluntary. Weight measurements at these times are also voluntary and can be used as 
data. 
 
What happens if I do not want to continue to be in this research? 
Your continued participation in this research study is voluntary. You may choose not to continue in this 
study, it will not affect your family being in the study. There are no other research alternatives 
other than to participate in this study. 
 
What happens if I say yes, but I change my mind later? 
You can leave the research at any time, it will not be held against you. You do not have to answer every 
question and may refuse to answer any questions that you do not want to answer. 
If you decide to leave the research, you may not receive full compensation for your participation. If you 
decide to leave the research, contact the investigator at the contact information included below. If you 
stop being in the research, already collected data may not be removed from the study database. You will 
be asked whether the investigator can collect data from your routine medical care.  
 
Is there any way continuing to be in this study could be bad for me? 
There are certain risks and discomforts that may be associated with this research. They include: 
 
Likely 
● You may be inconvenienced at times by having to miss work, school activities, meetings, etc., to 
attend assessments. 
● You might feel hungry when dieting, sore after exercising, or experience common exercise 
injuries (i.e., sprains, shin splints, tendonitis, muscle pulls, strains, etc). 
Less Likely 
● You may find having your height and weight measured uncomfortable. 
Rare 
● Although this treatment usually prevents the development of eating disorder problems, in rare 
cases it may increase them. 
● The use of online platforms is associated with risks involving breaches of confidentiality. We 
implement many layers of security to limit these risks as much as possible within our website 
and REDCap database. Outside platforms (i.e., MyFitnessPal) are subject to their own security 

Page 177 of 305 
 
measures and carry their own risks if your family chooses to use them to supplement your 
participation in this study. 
Will continuing to participate in this study help me in any way? 
We cannot promise any benefits to you or others from your continuing to take part in this research. This 
study may provide information that will help you to lose weight and keep it off. However, we cannot 
guarantee that you will receive any benefits from this study.  
 
What happens to the information collected for the research? 
Efforts will be made to limit the use and disclosure of your personal information, including research 
study and medical or education records, to people who have a need to review this information. We 
cannot promise complete secrecy. Organizations that may inspect and copy your information include 
the IRB and other representatives of this organization. Information related to you will be treated in strict 
confidence to the extent provided by law. Your identity will be coded and will not be associated with any 
published results. Your code number and identity will be kept in a locked file of the Principal 
Investigator. The only connection between your participation in this study and the study itself will be 
this signed consent form. If you withdraw from the study, no further data will be collected, but any 
information that has been provided may be retained by the researchers and analyzed. In order to 
monitor this research study, representatives from the Institutional Review Board (IRB) and other federal 
agencies such as NIH (National Institutes of Health) and OHRP (Office of Human Research Protection) 
may inspect the research records which may reveal your identity. A description of this clinical trial will 
be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This web site will not include 
information that can identify you. At most, the web site will include a summary of the results. You can 
search this web site at any time. 
 
 
 
Can I be removed from the research without my OK? 
The principal investigator of the study can remove you from the research study without your approval. 
Possible reasons for removal include need for hospitalization for physical or psychological reasons. 
 
What else do I need to know? 
This research is being funded by the National Institutes of Health, specifically the National Heart, Lung 
and Blood Institute (NHLBI).   
If you need medical care because of taking part in this research study, contact the investigator and/or 
speak with your doctor and medical care will be made available. Generally, this care will be billed to you, 
your insurance, or other third party. The University at Buffalo has no program to pay for medical care for 
research-related injury.  
 
Signature Block for Assent of Child 
Your signature documents your permission to continue to take part in this research. By signing this form, 
you are not waiving any of your legal rights, including the right to seek compensation for injury related to 
negligence or misconduct of those involved in the research. 
 
 
 
 
Signature of subject 
 
Date 

Page 178 of 305 
 
 
 
Printed name of subject 
 
I certify that the nature and purpose, the potential benefits and possible risks associated with continued 
participation in this research study have been explained to the above individual and that any questions 
about this information have been answered. A copy of this document will be given to the subject. 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
Printed name of person obtaining consent 
 
 
 
(This change was made on 7.25.19 prior to review and approval by the DSMB, DSMB approved protocol 
addenda, 10.25.19). 
 
 

Page 179 of 305 
 
 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federal wide Assurance ID#: FWA00008824 
Title of research study: THE EFFECTIVENESS OF FAMILY-BASED WEIGHT LOSS 
TREATMENT IMPLEMENTED IN PRIMARY CARE 
 
Sibling Adult Consent to Participate in a Research Study 
 
Version Date: 6.25.19 
 
Investigators: Leonard H. Epstein, PhD. 
 
Why am I being invited to continue in this research study? 
You are being asked to assent to continue in this research study because: 
● You have aged into a different age group of 14-17 years. 
This research study is supported by a grant through the National Heart Blood and Lung Institute (NHBLI). 
Research studies only include individuals who choose to take part in them. Your decision to take part in 
this study is entirely voluntary. Please read this information carefully. Ask questions about anything you 
do not understand before deciding whether or not to participate. You may also take home an unsigned 
copy of this consent form to think about participating or if you wish to discuss this matter with your 
family or your personal doctor. Please take your time to make your decision. Do not sign this form 
unless you have had the chance to ask questions and have received satisfactory answers. 
 
What should I know about a research study? 
● Someone will explain this research study to you. 
● Whether or not you continue is up to you. 
● You can choose not to continue. 
● You can agree to continue and later change your mind. 
● Your decision will not be held against you. 
● You can ask all the questions you want before you decide. 
 
Who can I talk to? 
If you have questions, concerns, or complaints, or think the research has hurt you, talk to the research 
team by telephone at 716-829-3400 for Dr. Leonard Epstein. You may also contact the PLAN coach at 
your child’s doctor’s office. You can also contact the research participant advocate at 716-888-4845 or 
researchadvocate@buffalo.edu.  
This research has been reviewed and approved by an Institutional Review Board (“IRB”). You may talk to 
them at (716) 888-4888 or email ub-irb@buffalo.edu if:  
● You have questions about your rights as a participant in this research 
● Your questions, concerns, or complaints are not being answered by the research team. 
● You cannot reach the research team. 

Page 180 of 305 
 
● You want to talk to someone besides the research team. 
● You want to get information or provide input about this research. 
 
Why is this research being done? 
The goal of this study is to determine whether a specific kind of weight loss treatment called family-
based behavioral treatment (FBT) for children, delivered by a PLAN coach, can be included in the 
primary care setting. Extensive information has been gathered by our research team about the 
treatment of childhood overweight and obesity. But there is still much to learn about how the treatment 
should be incorporated into various medical settings. Such as primary care and how it effects siblings 
living with participating parents and children. 
 
How long will the research last? 
We expect that you will be in this treatment and research study for 24 months from your original start 
of the study. 
 
How many people will be studied? 
We expect about 132 families will be in this research study in your geographical location. Out of 528 
families in the entire study nationally. 
 
What happens if I say yes, I want to continue to be in this research? 
You will continue your participation as before and no components of the research study have changed. 
As a reminder, you will continue to be asked to come to your pediatric office to complete assessment 
appointments (detailed below).  
Groups 
Your family has been assigned to one of two groups. Participants in one group receive the current 
standard of care offered by their physician for the treatment of childhood weight management.  
Participants in the second group receive family-based behavioral treatment for weight management 
(FBT).  
FBT is a behavioral weight-control intervention that aims to make weight changes in both a child and 
their participating parent. FBT is a well-tested treatment that targets diet, activity, behavioral 
techniques, parenting, and social facilitation in children and their parents. The treatment includes: 1) 
The Traffic Light Eating Plan uses RED; YELLOW; and GREEN labels for food to guide families toward the 
goal of eating nutritious foods. 2) The Traffic Light Activity Program, also uses RED; YELLOW; and GREEN 
labels for different levels of exercise to increase physical activity and reducing inactive behaviors. 3) a 
variety of behavioral techniques including changing and controlling your environment; tracking eating 
and physical activity; setting goals; problem solving; setting up a reward system; incentives for behavior 
change and weight loss; finding substitutes for unhealthy foods; and improving positive parenting. FBT 
also involves making changes in the home. So weight loss or prevention of weight gain may extend to 
members of the family who are not regularly attending treatment sessions (e.g., siblings and spouse). 
The group that your family is in/the treatment you receive was chosen by chance. Like flipping a coin. 
Neither you nor your doctor chose what treatment your family is receiving.  
Treatment Schedule 
Every family will follow their pediatrician recommended schedule of appointments for weight 
management. Families in the group receiving FBT will additionally complete at least 26 sessions with the 
FBT PLAN Coach during the 24 months of the study. The amount of sessions completed within this range 

Page 181 of 305 
 
will be based on progress through the program. The amount will vary for each family.  You will not 
attend the sessions with the PLAN Coach. 
Assessments, Interviews, Questionnaires 
You will attend five major assessments throughout the entire 2 years of the study: 
● 1 Baseline assessment upon starting study (0 months) 
● 3 Measurement assessments during the study (6, 12, and 18 months) 
● 1 Follow-up assessment at end of study (24 months) 
Each major assessment will take approximately 30-90 minutes to complete at your pediatric office, or a 
home visit can be arranged. Height and weight measurements will be taken at each major assessment.  
What are my responsibilities if I continue to take part in this research? 
If you take part in this research, you will be responsible to attend all measurement assessments and the 
follow-up assessment.  Your participation in any other meetings with your family are voluntary. Weight 
measurements at these times are also voluntary and can be used as data. 
 
What happens if I do not want to continue to be in this research? 
Your participation in this research study is voluntary. You may choose not to continue in this study. 
There are no other research alternatives other than to participate in this study. 
 
What happens if I say yes, but I change my mind later? 
You can leave the research at any time. It will not be held against you, or affect your family’s 
participation in the study. You do not have to answer every question. You may refuse to answer any 
questions that you do not want to answer. 
If you decide to leave the research, you may not receive full compensation for your participation. If you 
decide to leave the research, contact the investigator at the contact information included below. If you 
stop being in the research, already collected data may not be removed from the study database. You will 
be asked whether the investigator can collect data from your routine medical care.  
 
Is there any way continuing to be in this study could be bad for me? 
There are certain risks and discomforts that may be associated with this research. They include: 
Likely 
● You may be inconvenienced at times by having to miss work, school activities, meetings, etc., to 
attend assessments. 
Less Likely 
● You may find having your height and weight measured uncomfortable. 
 
Will continuing to be in this study help me in any way? 
We cannot promise any benefits to you or others from your continued participation in this research. This 
study may provide information that will help you to lose weight and keep it off. However, we cannot 
guarantee that you will receive any benefits from this study.  
 
What happens to the information collected for the research? 
Efforts will be made to limit the use and disclosure of your personal information, including research 
study and medical or education records, to people who have a need to review this information. We 

Page 182 of 305 
 
cannot promise complete secrecy. Organizations that may inspect and copy your information include 
the IRB and other representatives of this organization. Information related to you will be treated in strict 
confidence to the extent provided by law. Your identity will be coded and will not be associated with any 
published results. Your code number and identity will be kept in a locked file of the Principal 
Investigator. The only connection between your participation in this study and the study itself will be 
this signed consent form. If you withdraw from the study, no further data will be collected.  Any 
information that has been provided may be retained by the researchers and analyzed. In order to 
monitor this research study, representatives from the Institutional Review Board (IRB) and other federal 
agencies such as NIH (National Institutes of Health) and OHRP (Office of Human Research Protection) 
may inspect the research records which may reveal your identity. A description of this clinical trial will 
be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This web site will not include 
information that can identify you. At most, the web site will include a summary of the results. You can 
search this web site at any time. Federal law provides additional protections of your medical records and 
related health information. These are described in the HIPAA section of this document. 
 
Can I be removed from the research without my OK? 
The principal investigator of the study can remove you from the research study without your approval. 
Possible reasons for removal include need for hospitalization for physical or psychological reasons. 
What else do I need to know? 
This research is being funded by the National Institutes of Health, specifically the National Heart, Lung 
and Blood Institute (NHLBI).   
If you need medical care because of taking part in this research study, contact the investigator and/or 
speak with your doctor and medical care will be made available. Generally, this care will be billed to you, 
your insurance or other third party. The University at Buffalo has no program to pay for medical care for 
research-related injury.  
 
HIPAA:  Authorization for the Use and Disclosure of Identifiable Health 
Information for Research Purposes  
This section describes information about you and about your health that will be obtained by the 
researchers when you participate in the research study. Health information is considered "protected 
health information" when it may directly identify you as an individual. By signing this form you are 
agreeing to permit the researchers and/or other parties (described in detail below) to have access to 
this information. If there are any parts of this form that you do not understand, please be sure to ask us 
for further clarification. 
A. What protected health information will be collected about you as part of this research 
study? 
__√__  Information from your full medical records (height, weight, dietary restrictions and 
physical activity restrictions. 
__√__  New Health Information created from study related tests, procedures, visits, and/or                                         
questionnaires as described in this consent form. 
B.    Who is authorized to provide or collect this information? 
__√_      Principal Investigator or designee 
C.   With whom may your protected health information be shared?  

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Your health information may be shared with others outside of the research group for purposes 
directly related to the conduct of this research study or as required by law, including but not 
limited to: 
__√__  
Clinical staff not involved in this research study who may become involved in your 
care if it is potentially relevant to your treatment. 
__√__  
The sponsor of this research study (National Heart, Lung and Blood Institutes 
(NHLBI) cooperative group, etc., or its agents. 
__√__  
The organization(s) responsible for administering this research (e.g., Research 
Foundation of SUNY, University at Buffalo, Washington University, Nationwide 
Children’s Hospital, University of Rochester). 
__√__  
Other medical investigators/centers/institutions participating in this research study. 
Your information may also be shared with individuals or entities responsible for general 
administration, oversight and compliance of research activities. Examples of this include the 
institution's Privacy and Security Officers or other internal oversight staff, Safety Monitoring 
Boards, an Institutional Review Board, The Research Foundation of the State University of New 
York, University at Buffalo Foundation Services, and accrediting bodies, or with certain 
government oversight agencies that have authority over the research including the Department 
of Health and Human Services (HHS), the Food and Drug Administration (FDA), the National 
Institutes of Health (NIH), and the Office of Human Research Protections (OHRP). Your 
information may also be shared with other entities as permitted or required by law. All 
reasonable efforts will be used to protect the confidentiality of your individually identifiable 
health information that may be shared with others as described above. 
All reasonable efforts will be used to protect the confidentiality of your protected health 
information. There is the potential for individually identifiable information and the associated 
health information obtained with this authorization to be re-disclosed by the recipient(s). After 
such a disclosure, the information may no longer be protected by the terms of this authorization 
against further re-disclosure. 
D.  How long will this information be kept by the Principal Investigator? 
__√__    This authorization has no expiration date. The researchers may continue to rely on this 
authorization to obtain and use protected health information about you unless you 
revoke this authorization in writing. 
__√__  Your protected health information will go into a database that will be maintained 
indefinitely. Any future study using this information that falls outside the scope of this 
current study will be required to follow guidelines designed to govern access to that 
information and to protect the privacy of that information. 
E.  What are your rights after signing this authorization? 
You have the right to revoke this authorization at any time. If you withdraw your authorization, 
no additional efforts to collect individually identifiable health information about you will be 
made. You should know, however, that protected health information acquired using this 
authorization prior to its withdrawal may continue to be used to the extent that the 
investigator(s) have already relied on your permission to conduct the research. If you chose to 
withdraw this authorization, you must do so in writing to the following individual(s): 

Page 184 of 305 
 
 
Leonard H. Epstein, Ph.D. 
University at Buffalo Department of Pediatrics 
Division of Behavioral Medicine 
3435 Main Street 
G56 Farber Hall 
Buffalo, NY 14214 
Phone: 716-829-3400 
 
If you send us a request to withdraw your authorization, we will forward that request to the 
institutions we have shared it with in order to collect your individually identifiable health 
information.  
 
F.  What will happen if you decide not to sign this authorization? 
 
Refusing to sign this authorization will not affect the present or future care you receive at this 
institution and will not cause any penalty or loss of benefits to which you are otherwise entitled. 
If you decide not to sign this authorization, you will not be able to continue to participate in the 
research study.   
 
 
 

Page 185 of 305 
 
Signature Block for Capable Adult 
Your signature documents your permission to continue to take part in this research. By signing this form you 
are not waiving any of your legal rights, including the right to seek compensation for injury related to 
negligence or misconduct of those involved in the research. 
 
 
 
 
Signature of subject 
 
Date 
 
 
Printed name of subject 
 
 
 
 
 
 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
Printed name of person obtaining consent 
 
 
 
 
(This change was made on 7.25.19 prior to review and approval by the DSMB, DSMB approved protocol 
addenda, 10.25.19). 
 
 

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University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federalwide Assurance ID#: FWA00008824 
Title of research study: THE EFFECTIVENESS OF FAMILY-BASED WEIGHT LOSS TREATMENT 
IMPLEMENTED IN PRIMARY CARE 
 
Addendum: Parental Permission for Targeted Child to Participate in a Research Study 
 
Version Date: 9.6.19 
 
Investigators: Leonard H. Epstein, PhD, Denise Wilfley, PhD, Stephen Cook, MD, MPH, Ihuoma 
Eneli, MD, MS, FAAP 
 
Change of Assessment Compensation: 
In the initial consent form that you signed, we indicated that ‘If your child agrees to take part in this 
research study, we will pay your family up to $175 for your time and effort. The amount you are paid 
depends upon your attendance to visits in the study’. However, the compensation for the 24-month 
assessment has increased from $50 to $100. This brings total potential compensation to $225. The 
amount you are paid depends upon your attendance to visits in the study.  
In addition, each participating site will give participants tickets when they attend an assessment. Each 
participant will have a chance of accumulating up to 4 tickets depending on the number of assessments 
they attend (i.e., 6, 12, 18, & 24 month appointments). The number of winning tickets will be 
proportional to the number of families randomized at each site. Each winning ticket is worth $50.00. 
Please let the PLAN staff member know if you have any questions.  
To ensure that each family is aware of this change to the consent form, please sign where indicated 
below:  
 
 

Page 187 of 305 
 
 
Signature Block for Capable Adult 
 
Your signature documents your permission to continue to take part in this research. By signing this form you 
are not waiving any of your legal rights, including the right to seek compensation for injury related to 
negligence or misconduct of those involved in the research. 
 
 
 
 
Signature of subject 
 
Date 
 
 
Printed name of subject 
 
 
 
 
 
 
 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
Printed name of person obtaining consent 
 
 
 
(DSMB approved protocol addenda, 10.25.19). 
 
 
 

Page 188 of 305 
 
 
Title of research study: THE EFFECTIVENESS OF FAMILY-BASED WEIGHT LOSS 
TREATMENT IMPLEMENTED IN PRIMARY CARE  
 
Addendum: Assessment Protocol in Response to Coronavirus Pandemic (COVID-19) 
 
Date: 4.14.2020  
 
Investigators: Leonard H. Epstein, PhD, Denise Wilfley, PhD, Stephen Cook, MD, MPH, 
Ihuoma Eneli, MD, MS, FAAP 
 
Change of Assessment Protocol: 
Due to the recent Coronavirus Disease (COVID-19) pandemic, we have modified our assessment 
protocols to adhere to public health guidelines as recommended by the Center for Disease 
Control and Prevention. In the initial consent form that you signed, we indicated “Each major 
assessment takes approximately 30-90 minutes to complete at your pediatric office, or a home 
visit can be arranged.”  Assessments will now take place at your home using scales, measuring 
tapes, and household objects to gather height and weight measurements that you will complete. 
Any materials that you may need as described in our protocol, but you do not currently possess, 
will be sent to your home by a PLAN With Families vendor (ie. Amazon) via postal mail at no 
cost to you. A subset of 10 families from each site, will be asked to complete a second height 
measurement one to two weeks after completing a remote assessment for quality control for an 
additional payment of $10.00.   
 
During the assessment, a PLAN staff member will call or video conference with you to guide 
you through the measurement protocol to assist you through the process, and record your height 
and weight data. Additionally, you will be sent online questionnaires to complete using your 
personal computer, tablet, or smartphone, including a new questionnaire to assess your family’s 
well-being during the current pandemic. 
 
Upon the lifting of social distancing recommendations, we will meet with your family at your 
pediatric practice to gather your height and weight measurements based on our usual 
standardized lab protocol. You will be compensated 50% of the normal assessment payment for 
your self-conducted home measurement, and paid the remaining 50% at the in-person portion of 
the assessment. 
 
 

Page 189 of 305 
 
 
 
Signature Block for Capable Adult 
Your signature documents your permission to continue to take part in this research. By 
signing this form you are not waiving any of your legal rights, including the right to seek 
compensation for injury related to negligence or misconduct of those involved in the 
research. 
  
  
  
Signature of subject 
  
Date 
 
  
Printed name of subject 
 
 
 
  
  
  
Signature of person obtaining consent 
  
Date 
 
  
  
  
Printed name of person obtaining consent 
  
  
(DSMB approved protocol addenda, 5.7.20). 
 
 
 

Page 190 of 305 
 
 
 
C. 
Screening Measures 
 
INITIAL ELIGIBILITY SURVEY SCRIPT 
Introduce yourself and the PLAN program: 
 
“Hello, my name is (name), this research is being conducted by the National Institutes of 
Health to encourage healthy eating habits and promote healthy lifestyles changes for families. 
Our study is for families with a 6-12-year-old child and a parent, both of whom are overweight 
or obese. Additionally, overweight siblings and non-participating parents that are interested in 
the program will have the opportunity to participate as well.   
Would you be interested in learning more about the study?  
IF NO → Thank you for your time and consideration. END SCREEN. 
IF YES → Do you have a few minutes right now for me to tell you more about the program and 
ask you a few questions to see if this program would be a good fit for your family?” 
 
If NO: 
Schedule a follow-up call, verify phone number. Document contact in the tracking database:  
 
“Would there be a day/time that works better for you to talk more about the program? I can 
give you a call at a time that works best for you. What is your phone number? Or I could send 
you an email with a link to more information about the program. What is your email 
address?” 
 
If YES: 
Describe the study: 
 
“Great! I want to let you know that specific personal questions will be asked during this phone 
screen and recorded into a private database maintained by Washington University in St. Louis, 
MO.  This database will include your contact information and your answers to any specific 
eligibility criteria discussed during this phone screen.” 
 
“Just to review, our program is called PLAN with Families. That stands for Primary care 
pediatrics, Learning, Activity, and Nutrition. The goal of the program is for you and your 
child to learn ways to become healthier and stay healthy.” 
 
“In this study, we require that one child and one parent participate. The study will last about 2 
years. To help us and you see what progress you make during your participation, you will 
complete some questionnaires, a short computer task, and have your height and weight taken 
5 times over the 2 years. Since we think learning to be healthier is important for the whole 
family, you can include any other children you may have and your child’s other parent in the 
study, too, but you don’t have to. If one of your child’s siblings is involved in the study, he or 

Page 191 of 305 
 
she will only be asked to attend appointments every 6 months for height and weight 
measurements.” 
 
“All of the program meetings will be held here at your child’s doctor’s office. Your family will 
have an opportunity to participate in one of two groups.  The first group is a Family Based 
Treatment (FBT) group where your family would meet regularly with a trained PLAN coach 
to learn new information and skills related to health topics, such as calorie intake and 
physical activity. The second group is called a Usual Care (UC) group where your family 
would continue to receive the most up to date health information from working closely with 
your child’s pediatrician.” 
 
“If your family is interested and you decide this study would be a good fit for you, you and 
your child will be asked to come here to [practice name] to complete an orientation session. 
After the orientation meeting, if you join the program, you will learn which group you and 
your child will participate in.  
 
“Does this sound like a study you might be interested in for you and your family?” 
 
If NO: 
Thank them for their time, share your contact information: 
 
“Thank you for your time. Here’s my contact information in case you change your mind or 
have any questions.” 
 
“Here is a postcard from the program. On this card is our website,   
http://planwithfamilies.com , where you can learn more about our program” 
 
If MAYBE: 
If the family would rather think about if the study is the right fit for them or if they seem 
hesitant: 
 
“If you would like to take some time to think about if the PLAN program is the right fit for 
you and your family, that’s okay. I can follow-up with you in a few days. Would that be ok?” 
 
“Here is a postcard from the program. Please provide a contact number and a preferred time 
to be reached. You can also check out the website http://planwithfamilies.com  that is listed on 
the card.” 
 
If YES: 
Begin Initial Eligibility Survey 
 
“Great! In order to get started I need to ask you some questions first. Do you have a few 
minutes to answer some questions?” 
 
INITIAL ELIGIBILITY SURVEY INTRODUCTION 
 

Page 192 of 305 
 
This survey is the first step in determining if the PLAN program is right for your family.  This 
survey is brief and should only take approximately 10 minutes. 
 
Your participation in this survey is voluntary and you may stop the survey at any time.  Any 
information related to you and your household will be kept confidential and will be stored in a 
secure database that is only accessible to the PLAN team.   
If you have questions at any time, please stop me and I will answer them for you.  If you have 
questions in the future, feel free to contact me at (PLAN coach’s cell phone number). I will be 
happy to answer any questions or concerns that you or your family may have about our 
program! Do you have any questions at this time?”  
PARENT INFORMATION 
The following questions must be answered by the parent or adult interested in enrolling in the 
PLAN program.  If there are any questions that you do not wish to answer, please let me know 
and will move onto the next question. 
Q: What is your first name? (*Ask for spelling if necessary*) __________________ 
 
Q: What is your last name? (*Ask for spelling if necessary*) __________________ 
 
Q: What is your address? 
 
Street Address: ______________________ 
 
Street Address, continued: _________________ 
 
City: _________________ 
 
State: ______________ 
 
Zip Code: ______________ 
 
Q: What is the best number at which to contact you?  ____________________ 
 
Q:  What is the best email address to use to contact you?  ___________________ 
 
Q: Is your family planning to move from the area in the next two years? 
● No 
● Yes 
● Refuse to answer 
Q: What is your date of birth?  (select from Calendar MM/DD/YYYY) 
Q: What is your sex? Choose from dropdown menu: 
● Male  
● Female 
● Other 
● Refuse 
 
Q: What is your race? 
● American Indian or Alaskan Native 
● Asian 
● Native Hawaiian or Other Pacific Islander 
● Black or African American, not of Hispanic Origin 
● White or Caucasian, not of Hispanic Origin 

Page 193 of 305 
 
● Hispanic or Latina/o 
● Other, please specify: 
○ Other, please describe: _________ 
Q: What is your height, in inches? ____________ 
 
Q: What is your weight? ___________ 
 
BMI Parent: ______________ 
 
Q: When was your weight last taken? (Estimated if necessary MM/YYYY or YYYY)  
_________________ 
 
Q: Are you able to complete, at minimum, a brisk 5-10-minute walk? 
● Yes 
● No 
● Refuse to answer 
 
Q: Have you had a concussion in the last 3 months? 
● No  
● Yes,  
○ Date of concussion: ________________ 
○ Please describe: (description, effects) _____________________ 
 
Q: How many children do you have? ____________ 
 
Q: Do you have a child between the ages of 6-12 that you would like to enroll in this study? 
● Yes 
● No 
 
If family is ineligible: 
“Thank you for your interest and answering these questions.  A requirement of this program 
is that the adult is joined by one of their children between the ages of 6-12 years old.  Because 
you do not have a child between these ages that you would like to enroll, the PLAN program is 
not a good fit for your family.  However, may we keep your information and contact you with 
future projects for which you or your family may be a good match?” 
● No 
● Yes  
 
If family is eligible: 
“Thank you for answering the survey questions about yourself.  Next we will ask you to 
answer some general information questions about your child.”   
 
CHILD INFORMATION 
 
“The following questions pertain to the child between the ages of 6-12 who you would like to 
enroll in the PLAN program.” 

Page 194 of 305 
 
 
If family has two or more children between the ages of 6-12 years old: 
“It is great that your children are interested in participating!  Unfortunately, we can only 
enroll once child as the participating child.  We typically encourage the enrollment of the 
oldest sibling because s/he will serve as a role model for the younger sibling.  However, we 
leave it up to our parents to decide which child would best fit our program.” 
 
“If there are any questions that you do not wish to answer, please let me know.” 
 
Q: What is the first name of the child you wish to enroll in the study? (*Ask for spelling if 
necessary*) ________________ 
 
Q: What is the last name of the child you wish to enroll in the study? (*Ask for spelling if 
necessary*) ________________ 
 
Q: Is this child: 
● Biological child 
● Adopted child 
● Step child 
● Foster child 
● Other relative 
○ If other relative, please describe: ______________________ 
 
Q: What is the name of your child’s primary care physician?  _______________________ 
 
Q: What is this __________’s date of birth? (select from Calendar MM/DD/YYYY) 
 
Q: Child’s age: (will automatically populate) __________ 
 
Q: What is ____________’s sex?  Choose from dropdown menu: 
● Male  
● Female 
● Other 
● Refuse 
 
Q: What is your child’s race? 
● American Indian or Alaskan Native 
● Asian 
● Native Hawaiian or Other Pacific Islander 
● Black or African American, not of Hispanic Origin 
● White or Caucasian, not of Hispanic Origin 
● Hispanic or Latina/o 
● Other, please specify: 
○ Other, please describe: _________ 
 
Q: How much does this child weigh?  ____________ 

Page 195 of 305 
 
 
Q: When was his/her weight last measured? (Estimated if necessary MM/YYYY or YYYY) 
___________ 
 
Q: What is _________’s height in inches? _______________ 
 
Participating child’s BMI: ___________________ 
 
Q: Has this child had a concussion in the last 3 months? 
● Yes 
○ If yes, date of concussion: (M-D-Y) ___________ 
○ Please explain (description, effects): ________________________ 
● No 
● Refused 
Q: Is ___________ able to complete, at minimum, a brisk 5-10-minute walk? 
● Yes 
● No 
● Refused 
 
If family is ineligible because there are no children between the ages of 6-12 in the household: 
Thank you for your interest and your willingness to answer these questions.  A requirement of 
this program is that the adult is joined by one of their children between the ages of 6-12 years’ 
old who meets certain criteria.  Because you do not have a child between these ages that meets 
our criteria, the PLAN program is not a good fit for your family.  However, may we keep your 
information and contact you with future projects for which you or your family may be a good 
match?   
● No 
● Yes 
 
If child has had a concussion in the last three months: 
“One of our requirements is that the participating child has not had a concussion in the last 
three months.  This is because your child’s performance on one of our program tasks may be 
affected by concussion symptoms.  Therefore, I would like to wait until ____ more months have 
passed before continuing the screening process.  Would that be okay with you?” 
 
If YES: Coach will schedule a call back date/time. 
 
If NO: Thank them for their time. 
 
If family is eligible: The coach will proceed to asking questions regarding additional siblings. 
 
ADDITIONAL SIBLING INFORMATION 
“We want the entire family to benefit from the program.  Therefore, we offer an opportunity for 
your child’s siblings to participate, as well. The sibling(s) would have their height and weight 
taken with you and your child at the 5 time points, as well as have access to the information on 
healthy lifestyle that we provide.” 
 

Page 196 of 305 
 
Do you have another child, who also meets the criteria for overweight/obesity, in your family 
between the ages of 2-18 that you would like to enroll in this program as well? 
 
If YES: “How many additional children would you like to enroll?  You may  
enroll up to four additional children in the program.” 
 
If YES: Move on INCLUDING all parts about participating sibling and collect the  
following information. 
 
If NO: Move onto the “Wrapping Up” section below. 
 
The coach will ask the following questions for all non-participating siblings. 
Q: What is the first name of the second/third/fourth child you would like to enroll in the 
study? (*Ask for spelling if necessary*) ________________ 
 
Q: What is the last name of the second/third/fourth child you wish to enroll in the study? 
(*Ask for spelling if necessary*) ________________ 
 
Q: Is ________ your: 
● Biological child 
● Adopted child 
● Step child 
● Foster child 
● Other relative 
○ If other relative, please describe: _____________________ 
 
Q: What is the name of _________’s primary care physician?  _______________________ 
 
Q: What is this __________’s date of birth? (select from Calendar MM/DD/YYYY) 
 
Q: Age: (will automatically populate) __________ 
 
Q: What is this child’s sex?  Choose from dropdown menu: 
● Male  
● Female 
● Other 
● Refuse 
 
Q: How much does ________ weigh?  ____________ 
 
Q: When was his/her weight last measured? (Estimated if necessary MM/YYYY or YYYY) 
___________ 
 
Q: What is _________’s height in inches? _______________ 
 
Q: Non Participating Child’s BMI: (Automatically calculated) _____________ 

Page 197 of 305 
 
 
Q: Has _________ had a concussion in the last 3 months? 
● Yes 
○ If yes, date of concussion: (M-D-Y) ___________ 
○ Please explain (description, effects): ________________________ 
● No 
● Refused 
Q: Is ___________ able to complete, at minimum, a brisk 5-10-minute walk? 
● Yes 
● No 
● Refused 
 
READING LEVEL INFORMATION 
The coach will ask this question about the participating child and any non-participating 
siblings: 
Q: Can ___________ read and comprehend at a first grade level? 
● Yes 
● No 
WRAPPING UP 
 
The coach will then wrap up the Initial Eligibility Survey: 
“Thank you for answering the questions on the Initial Eligibility Survey.  Next we will ask you 
to answer additional questions about you and your child’s medical and psychiatric histories on 
the Eligibility Survey.  This survey usually takes between 15-20 minutes to complete.  Do you 
have time for us to complete this survey right now?” 
 
If NO: 
Schedule a follow-up call, verify phone number. Document contact in the tracking database: 
 “Would there be a day/time that works better for you to talk more about the program?  
I can give you a call at a time that works best for you, or we could schedule another  
time to meet here at the office.” 
If YES:  Schedule a call (verify phone number) or in person meeting at the practice.  
 
   Document contact in the database. 
If NO:  Thank them for their time. 
  
If YES: 
Begin Eligibility Phone Screen. 
 
ELIGIBILITY PHONE SCREEN SCRIPT 
 
“Just to review, our program is called Primary care pediatrics, Learning, Activity, and Nutrition, 
or PLAN for short. The goal of our program is for you and your child to learn ways to become 
healthier and stay healthy.  In this program, we require that one child and one parent 
participate. The study will last about 2 years. During your participation in the program, we will 
look at your progress by asking you to complete some questionnaires, a short computer task, 
and have your height and weight taken 5 times over the 2 years.   

Page 198 of 305 
 
All of the meetings will be held here at your child’s doctor’s office. If interested, you and your 
family, including the participating child and parent, non-participating parent, and participating 
sibling/s will be asked to come to your child’s physician’s office to meet with the PLAN coach 
to complete an orientation, height and weight measurements, and an assessment, 
 
Your family will have an opportunity to participate in one of two groups: A Family Based 
Treatment group (FBT) where your family meets regularly with a trained health coach at the 
practice, or the usual care group where your child will continue to receive standard care from 
their doctor.   
 
Families are randomly selected into each group.  Those in the group receiving Family Based 
Treatment, or FBT, will additionally complete at least 26 sessions with the health coach 
during the 24 months of the study. The amount of sessions completed within this range will be 
based on progress through the program and will vary for each family.  Participating siblings, 
as well as the non-participating parent, will be asked to attend appointments every 6 months 
for height and weight measurements. 
  
“Does this sound like a program you might be interested in for your family?” 
  
If NO: Thank them for their time  
If YES: Continue to Eligibility Phone Screen. 
 
ELIGIBILITY PHONE SCREEN 
 
“Next, there are a few more questions to answer in order to determine your full eligibility for 
this study.  Some of these questions are a little repetitive from the questions that I asked you 
during the Initial Eligibility Survey because I want to make sure all of the information that I 
gather about your family is correct.  Do you have any questions?”    
 
Q: We ask that one overweight parent attends and participates with the child in the program.  
What is the first name of the parent interested in participating?  ___________________ 
 
Q: What is the participating parent’s last name?  _____________ 
 
Q: Is [parent’s first name] willing to attend all treatment sessions and assessments with the child 
over the next two years? 
● Yes 
● No 
 
Q: Parent BMI is _________ (answer is automatically generated) 
 
Q: Is the parent able to continue with the screen based on BMI? 
● Yes 
○ If yes, continue with screening. 

Page 199 of 305 
 
● No 
○ If no, follow the procedure listed below. 
 
If the preferred participating parent is not overweight based on the reported height and weight from 
the Initial Eligibility Survey: 
We require that the participating parent meets specific weight criteria.  Unfortunately, your 
answers indicate that you do not meet these criteria.  Is there another parent who meets the 
overweight criteria that would be interested in participating? 
 
 
If NO: Thank them for their time 
If YES: Continue on with Eligibility Phone Screen by gathering information about the  
 
parent who is eligible. 
 
Q: What is the name of your/_______’s current physician?  _______________ 
 
Q: What is the physician’s practice name?  _________________ 
 
Q: What is the practice address?   
Practice address: __________________________ 
Practice address continued, if necessary: _____________________ 
City, State, Zip: ____________________ 
 
Q: Practice phone number:  ____________________ 
 
Q: We want the entire family to benefit from the program.  Therefore, we offer an opportunity 
for your child’s siblings to participate as well.  The sibling would have his/her height and weight 
taken with you and your child at the 5 time points, as well as have access to the information on 
healthy lifestyles that we provide.   
Do you have another child (a sibling of the child participating) that would be interested in 
participating? 
● Yes 
● No 
 
Q: What are the ages of the children who would like to participate? 
● 2 
● 3 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 
● 10 
● 11 
● 12 
● 13 

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● 14 
● 15 
● 16 
● 17 
● 18 
● Over 18 
 
If age is < 2 or > 18: 
“Unfortunately your child (participating sibling) does not meet the age criteria to participate in 
this study; however, this does not affect you and your other child’s ability to participate.” 
● Move on with script EXCLUDING all parts about participating sibling. 
● This is not an exclusionary criterion for the primary participating child and parent. 
 
If age is 2-18: 
“Would he/she be interested in participating in this study?” 
● If yes, move on to INCLUDING all parts about participating sibling. 
o If family has two children ages 6-12 years old, we will be encouraging that the 
older sibling be the primary participant, as it is more likely the older sibling will 
serve as a role-model for the younger sibling. 
o In families where more than one eligible sibling is available, we will enroll the 
sibling whose age is closest to that of the study child. 
● If no, move on EXCLUDING all parts about participating sibling. 
 
“Next, there are a few more questions related to your family’s medical and psychiatric histories.  
I will ask you specific personal questions. Your participation in this survey is voluntary and you 
may stop the survey at any time.  Any information related to you and your household will be 
kept confidential and will be stored in a secure database that is only accessible to the PLAN 
team.  Do you have any questions?” 
 
“I will start by asking you questions about the child that would like to participate in the 
program.” 
 
Q: What is your child’s first name?  ________________ 
 
Q: Does ___________ have any medical conditions or is s/he undergoing any medical 
treatment?” 
● Yes 
○ If yes, can you describe the treatment? _______________________ 
● No 
 
Q: Does ______________ take any medications? 
● Yes 
● No 
 
Q: How many medications? 
● 1 

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● 2 
● 3 
● 4 
● 5 
 
Q: Name of first medication: _____________________ 
 
Q: Dose: ________________________ 
 
Q: How often does your child take [medication]? 
● Once per day 
● Twice per day 
● Three times per day 
● Four times per day 
● As needed 
● Every other day 
● Weekly 
● Bi-weekly 
● Monthly 
● Only during the school week 
 
Q: Years taking [medication]? 
● 0 
● 1 
● 2 
● 3 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 
● 10 
● 11 
● 12 
● 13 
● 14 
● 15 
● 16 
● 17 
● 18 
 
Q: Number of months [medication]? 
● 0 
● 1 
● 2 

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● 3 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 
● 10 
● 11 
 
Q: Name of second medication: _____________________ 
 
Q: Dose: ________________________ 
 
Q: How often does your child take [medication]? 
● Once per day 
● Twice per day 
● Three times per day 
● Four times per day 
● As needed 
● Every other day 
● Weekly 
● Bi-weekly 
● Monthly 
● Only during the school week 
 
Q: Years taking [medication]? 
● 0 
● 1 
● 2 
● 3 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 
● 10 
● 11 
● 12 
● 13 
● 14 
● 15 
● 16 
● 17 
● 18 

Page 203 of 305 
 
 
Q: Number of months [medication]? 
● 0 
● 1 
● 2 
● 3 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 
● 10 
● 11 
 
Q: Name of third medication: _____________________ 
 
Q: Dose: ________________________ 
 
Q: How often does your child take [medication]? 
● Once per day 
● Twice per day 
● Three times per day 
● Four times per day 
● As needed 
● Every other day 
● Weekly 
● Bi-weekly 
● Monthly 
● Only during the school week 
 
Q: Years taking [medication]? 
● 0 
● 1 
● 2 
● 3 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 
● 10 
● 11 
● 12 
● 13 

Page 204 of 305 
 
● 14 
● 15 
● 16 
● 17 
● 18 
 
Q: Number of months [medication]? 
● 0 
● 1 
● 2 
● 3 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 
● 10 
● 11 
 
Q: Name of fourth medication: _____________________ 
 
Q: Dose: ________________________ 
 
Q: How often does your child take [medication]? 
● Once per day 
● Twice per day 
● Three times per day 
● Four times per day 
● As needed 
● Every other day 
● Weekly 
● Bi-weekly 
● Monthly 
● Only during the school week 
 
Q: Years taking [medication]? 
● 0 
● 1 
● 2 
● 3 
● 4 
● 5 
● 6 
● 7 
● 8 

Page 205 of 305 
 
● 9 
● 10 
● 11 
● 12 
● 13 
● 14 
● 15 
● 16 
● 17 
● 18 
 
Q: Number of months [medication]? 
● 0 
● 1 
● 2 
● 3 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 
● 10 
● 11 
 
Q: Name of fifth medication: _____________________ 
 
Q: Dose: ________________________ 
 
Q: How often does your child take [medication]? 
● Once per day 
● Twice per day 
● Three times per day 
● Four times per day 
● As needed 
● Every other day 
● Weekly 
● Bi-weekly 
● Monthly 
● Only during the school week 
 
Q: Years taking [medication]? 
● 0 
● 1 
● 2 
● 3 

Page 206 of 305 
 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 
● 10 
● 11 
● 12 
● 13 
● 14 
● 15 
● 16 
● 17 
● 18 
 
Q: Number of months [medication]? 
● 0 
● 1 
● 2 
● 3 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 
● 10 
● 11 
 
 
Q: Does your child have any condition that would make him/her unable to exercise or limit the 
amount of exercise?”  
● Yes 
 
● No 
 
Q: Has ______________ever had weight-related surgery such as gastric bypass? 
● Yes 
● No 
 
Q: Is your child currently participating in a weight loss or weight management program? 
● Yes 
● No 
 
Q: Does ______________ have any food allergies or dietary restrictions? 

Page 207 of 305 
 
● Yes 
○ If yes, please list restrictions and/or allergies: _______________________ 
● No 
 
Q: Has this child undergone any psychological treatment and/or counseling?”   
● Yes 
○ If yes, please describe condition: ____________________ 
● No 
 
Q: Has ____________ ever been diagnosed with a psychiatric condition like depression or 
anxiety? 
● Yes 
● No 
 
Q: Has your child ever been diagnosed with a developmental delay, intellectual disability, or 
Autism Spectrum Disorder? 
● Yes 
● No 
 
Q: Is ____________ able to speak and comprehend English at the first grade level? 
● Yes 
● No 
 
PARENT QUESTIONS 
 
“Now I am going to ask you some questions about yourself.” 
 
Q: Are you ___________’s biological, adoptive parent, or legal guardian? 
● Yes 
● No 
 
Q: Do you and your child live together full time? 
● Yes 
● No 
○ If no, how often does ____________ live with you? (closest percentage) 
■ 0 
■ 10 
■ 20 
■ 30 
■ 40 
■ 50 
■ 60 

Page 208 of 305 
 
■ 70 
■ 80 
■ 90 
■ 100 
 
Q: Please obtain detailed notes on family situation: _______________________________ 
 
Q: Who does ___________ live with?  List all in home, and their relationship to the participating 
child:  ____________________________________________ 
 
Q: Do you have another child or children [sibling(s) of the child participating] that would be 
interested in participating? 
● Yes 
● No 
 
Q: If yes, how many children who are between the ages of 2-18 would like to participate? 
● 1 
● 2 
● 3 
● 4 
 
PARTICIPATING PARENT HEALTH 
 
Q: Do you have any medical conditions or are you undergoing any medical treatment? 
● Yes 
○ Notes: _____________________________________ 
● No 
 
Q: Do you take any medications? 
● Yes 
○ Q: How many medications do you currently take? (Select answer from dropdown) 
■ 1 
■ 2 
■ 3 
■ 4 
■ 5 
■ 6 
■ 7 
● No 
 

Page 209 of 305 
 
Q: Name of first medication: _____________________ 
 
Q: What is your dose of [medication]? ________________________ 
 
Q: How often do you take [medication]? 
● Once per day 
● Twice per day 
● Three times per day 
● Four times per day 
● As needed 
● Every other day 
● Weekly 
● Bi-weekly 
● Monthly 
● Only during the school week 
 
Q: How many years have you been taking [medication]? 
● 0 
● 1 
● 2 
● 3 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 
● 10 
● 11 
● 12 
● 13 
● 14 
● 15 
● 16 
● 17 
● 18 
● 19 
● 20 
● 21 
● 22 
● 23 
● 24 
● 25 
● 26 
● 27 
● 28 
● 29 
● 30 
● 31 
● 32 
● 33 
● 34 
● 35 
● 36 
● 37 
● 38 
● 39 
● 40 
● 41 
● 42 
● 43 
● 44 
● 45 
● 46 
● 47 
● 48 
● 49 
● 50 
 
Q: How many months have you been taking [medication]? 
● 0 
● 1 
● 2 
● 3 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 

Page 210 of 305 
 
● 10 
● 11 
 
Q: Name of second medication: _____________________ 
 
Q: What is your dose of [medication]? ________________________ 
 
Q: How often do you take [medication]? 
● Once per day 
● Twice per day 
● Three times per day 
● Four times per day 
● As needed 
● Every other day 
● Weekly 
● Bi-weekly 
● Monthly 
● Only during the school week 
 
Q: How many years have you been taking [medication]? 
● 0 
● 1 
● 2 
● 3 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 
● 10 
● 11 
● 12 
● 13 
● 14 
● 15 
● 16 
● 17 
● 18 
● 19 
● 20 
● 21 
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● 23 
● 24 
● 25 
● 26 
● 27 
● 28 
● 29 
● 30 
● 31 
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● 35 
● 36 
● 37 
● 38 
● 39 
● 40 
● 41 
● 42 
● 43 
● 44 
● 45 
● 46 
● 47 
● 48 
● 49 
● 50 
 
Q: How many months have you been taking [medication]? 
● 0 
● 1 
● 2 
● 3 
● 4 
● 5 
● 6 

Page 211 of 305 
 
● 7 
● 8 
● 9 
● 10 
● 11 
 
Q: Name of third medication: _____________________ 
 
Q: What is your dose of [medication]? ________________________ 
 
Q: How often do you take [medication]? 
● Once per day 
● Twice per day 
● Three times per day 
● Four times per day 
● As needed 
● Every other day 
● Weekly 
● Bi-weekly 
● Monthly 
● Only during the school week 
 
Q: How many years have you been taking [medication]? 
● 0 
● 1 
● 2 
● 3 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 
● 10 
● 11 
● 12 
● 13 
● 14 
● 15 
● 16 
● 17 
● 18 
● 19 
● 20 
● 21 
● 22 
● 23 
● 24 
● 25 
● 26 
● 27 
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● 36 
● 37 
● 38 
● 39 
● 40 
● 41 
● 42 
● 43 
● 44 
● 45 
● 46 
● 47 
● 48 
● 49 
● 50 
 
Q: How many months have you been taking [medication]? 
● 0 
● 1 
● 2 
● 3 

Page 212 of 305 
 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 
● 10 
● 11 
 
Q: Name of fourth medication: _____________________ 
 
Q: What is your dose of [medication]? ________________________ 
 
Q: How often do you take [medication]? 
● Once per day 
● Twice per day 
● Three times per day 
● Four times per day 
● As needed 
● Every other day 
● Weekly 
● Bi-weekly 
● Monthly 
● Only during the school week 
 
Q: How many years have you been taking [medication]? 
● 0 
● 1 
● 2 
● 3 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 
● 10 
● 11 
● 12 
● 13 
● 14 
● 15 
● 16 
● 17 
● 18 
● 19 
● 20 
● 21 
● 22 
● 23 
● 24 
● 25 
● 26 
● 27 
● 28 
● 29 
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● 31 
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● 33 
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● 35 
● 36 
● 37 
● 38 
● 39 
● 40 
● 41 
● 42 
● 43 
● 44 
● 45 
● 46 
● 47 
● 48 
● 49 
● 50 
 
Q: How many months have you been taking [medication]? 
● 0 

Page 213 of 305 
 
● 1 
● 2 
● 3 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 
● 10 
● 11 
 
Q: Name of fifth medication: _____________________ 
 
Q: What is your dose of [medication]? ________________________ 
 
Q: How often do you take [medication]? 
● Once per day 
● Twice per day 
● Three times per day 
● Four times per day 
● As needed 
● Every other day 
● Weekly 
● Bi-weekly 
● Monthly 
● Only during the school week 
 
Q: How many years have you been taking [medication]? 
● 0 
● 1 
● 2 
● 3 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 
● 10 
● 11 
● 12 
● 13 
● 14 
● 15 
● 16 
● 17 
● 18 
● 19 
● 20 
● 21 
● 22 
● 23 
● 24 
● 25 
● 26 
● 27 
● 28 
● 29 
● 30 
● 31 
● 32 
● 33 
● 34 
● 35 
● 36 
● 37 
● 38 
● 39 
● 40 
● 41 
● 42 
● 43 
● 44 
● 45 
● 46 
● 47 
● 48 
● 49 
● 50 

Page 214 of 305 
 
 
Q: How many months have you been taking [medication]? 
● 0 
● 1 
● 2 
● 3 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 
● 10 
● 11 
 
Q: Name of sixth medication: _____________________ 
 
Q: What is your dose of [medication]? ________________________ 
 
Q: How often do you take [medication]? 
● Once per day 
● Twice per day 
● Three times per day 
● Four times per day 
● As needed 
● Every other day 
● Weekly 
● Bi-weekly 
● Monthly 
● Only during the school week 
 
Q: How many years have you been taking [medication]? 
● 0 
● 1 
● 2 
● 3 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 
● 10 
● 11 
● 12 
● 13 
● 14 
● 15 
● 16 
● 17 
● 18 
● 19 
● 20 
● 21 
● 22 
● 23 
● 24 
● 25 
● 26 
● 27 
● 28 
● 29 
● 30 
● 31 
● 32 
● 33 
● 34 
● 35 
● 36 
● 37 
● 38 
● 39 
● 40 
● 41 

Page 215 of 305 
 
● 42 
● 43 
● 44 
● 45 
● 46 
● 47 
● 48 
● 49 
● 50 
 
Q: How many months have you been taking [medication]? 
● 0 
● 1 
● 2 
● 3 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 
● 10 
● 11 
 
Q: Name of seventh medication: _____________________ 
 
Q: What is your dose of [medication]? ________________________ 
 
Q: How often do you take [medication]? 
● Once per day 
● Twice per day 
● Three times per day 
● Four times per day 
● As needed 
● Every other day 
● Weekly 
● Bi-weekly 
● Monthly 
● Only during the school week 
 
Q: How many years have you been taking [medication]? 
● 0 
● 1 
● 2 
● 3 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 
● 10 
● 11 
● 12 
● 13 
● 14 
● 15 
● 16 
● 17 
● 18 
● 19 
● 20 
● 21 
● 22 
● 23 
● 24 
● 25 
● 26 
● 27 
● 28 
● 29 
● 30 
● 31 
● 32 

Page 216 of 305 
 
● 33 
● 34 
● 35 
● 36 
● 37 
● 38 
● 39 
● 40 
● 41 
● 42 
● 43 
● 44 
● 45 
● 46 
● 47 
● 48 
● 49 
● 50 
 
Q: How many months have you been taking [medication]? 
● 0 
● 1 
● 2 
● 3 
● 4 
● 5 
● 6 
● 7 
● 8 
● 9 
● 10 
● 11 
 
Q: Do you have a condition that would make you unable to exercise or limit the amount of 
exercise? 
● Yes 
● No 
 
Q: Have you ever had weight-related surgery such as gastric bypass? 
● Yes 
● No 
 
Q: Are you or any other immediate family members currently participating in a weight loss or 
weight management program? 
● Yes 
o Please describe: ________________________ 
● No 
 
Q: Would you or your family member be willing to stop their program if accepted into our 
program? (This is necessary to participate in the study.) 
● Yes 
● No 
 
Q: Do you have any food allergies or food restrictions? 
● Yes 
o Please list food allergies and/or restrictions: ____________________________ 
● No 
 

Page 217 of 305 
 
Q: Have you ever participated in any psychological treatment and/or counseling? 
● Yes 
● No 
 
Q: Have you ever been diagnosed with a psychiatric condition such as depression or anxiety? 
● Yes 
● No 
 
Q: Are you currently pregnant or plan to become pregnant in the next 2 years? 
● Yes 
● No 
 
 
“Thank you for your willingness to answer all of these questions.  We want to make sure your 
family has a great experience in our program.  Let’s look at your eligibility status.” 
  
PLAN EXCLUSIONARY CRITERIA 
● The participating parent is pregnant or planning on becoming pregnant during the 2-year 
study period. 
● Participation to any degree in a weight management or weight loss program. 
● Weight-related surgeries (e.g., gastric bypass) if within the last 2 years. 
○ Please note that the patient must be weight stable or gaining weight (cannot be 
losing weight) (DSMB approved protocol addenda, 11.2.18). 
● Medical condition altering the nutritional status or intestinal absorption (e.g., 
inflammatory bowel disease, diabetes). 
● Medical condition that affects growth (e.g., genetic or metabolic disease/syndrome that is 
associated with obesity). 
● Chronic medical condition, including: Type 1 diabetes, heart disease/failure, HIV/AIDS, 
muscular dystrophy, renal diseases, hypothyroidism (if untreated or treated with 
medication for less than 6 months). 
● Severe restriction of that would inhibit family from reasonably following the Traffic 
Light Eating Plan. 
● Significant developmental delays, intellectual disabilities, or Autism Spectrum Disorder. 
● Unmanaged/active psychiatric conditions (e.g., binge eating disorder, schizophrenia) with 
impairing clinical symptoms (e.g., suicidality). 
○ Further assessed in Pre-Orientation Surveys and follow-up clinical interviews 
● Disability that prevents performance of physical activity at the level of a brisk walk. 
○ Further assessed via PCP Medical Clearance Form 
● Exclusionary medications: 
○ Orlistat (Xenical), Phentermine, Sibutramine (Meridia), and Topirimate (Topama) 
are exclusionary at all doses and durations 
○ All other weight/growth-affecting medications should be noted (name, dose, 

Page 218 of 305 
 
frequency, and duration) and brought to the attention of onsite physician 
 
 
Q: Does exclusionary criteria exist? 
● Yes 
○ The following script can be used for these exclusionary issues: Unfortunately, it 
does not look like your family is eligible to participate in the study at this time. 
Because we are a research-based program, we must adhere to certain criteria and 
are not able to accept families where the parent or child (insert exclusionary 
criteria). However, I would like to continue to gather information from you so 
that we can keep your family in our database. This way, when we run another 
study that you or your child does qualify for, we can contact you to see if you are 
interested in participating. Would you like to proceed with the screening so that 
you will be in our database to contact for other studies your child may be eligible 
for?”  
■ Yes 
● Continue to collect household information according to site 
specific rules. 
■ No 
● Thank them for their time. END CALL. 
● No 
 
Q: Is the family eligible to participate? 
● Yes 
○ Family creates website profile and coach collects household information. 
● No 
○ Thank them for their time. 
● Unsure (see below): If coach is unsure about whether or not the family is 
eligible/eligible, s/he should follow-up with their project coordinator for clarification and 
use the following script: Thank you for taking the time to answer all of these questions.  
At the moment, I have all of the information that I need.  The next step is for me to 
review your responses in order to determine your eligibility status.  I will follow-up with 
you within the next few days. 
 
If YES/ELIGIBLE: 
“It appears your family is initially eligible for our study so the next step is for you and your 
child to complete a few online questionnaires.  I will send you an e-mail link to these 
questionnaires after our phone call.  The first three questionnaires will be for you to complete 
about you and your child.  The final questionnaire should be completed by your child.  Please 
be sure to complete these questionnaires at your earliest convenience.  Also, there is the 

Page 219 of 305 
 
possibility that you may need to complete a brief interview following these questionnaires.  If 
so, I will call you to schedule that interview, which can be done over the phone.” 
 
Q: Is your email address [automatically generated]? 
● Yes 
● No 
o What is your email? _____________________ 
 
“In the meantime, I would like to schedule you and your family for an orientation 
appointment here at the office, which will last for approximately two hours.  During the 
orientation, you will be given a presentation on the study goals and procedures.  You will have 
an opportunity to ask questions and then decide if the study is right for you and your child.  If 
you decide you are not interested, your appointment will end.  If you decide that you are 
interested in participating after the orientation, you will complete several assessments and 
schedule upcoming study appointments. 
 
Both the participating parent and participating child need to attend in order to enroll in the 
program.  We will also need to collect measurements from any non-participating siblings and 
non-participating parents. We do offer the option to have them attend the orientation session 
as well.  However, we recommend that they schedule an appointment separate from the 
orientation session due to the length of the session.  If these individuals do attend the session, 
we recommend that they have a mode of transportation that is separate from the participating 
child’s and participating parent’s.” 
 
Q: Is the participant able to schedule at this time? 
● Yes 
o If yes, when is the orientation appointment? ________________ 
● No 
 
“We will call you and send you an e-mail reminder two days prior to the orientation session, 
scheduled on (MM/DD/YYY) at (HH:MM) at (pediatric office name).  Do you have any 
questions?” 
 
If non-participating parent cannot come in with family: 
If the non-participating parent is not able to come in at the same time as the rest of the family, 
they are able to come in at any time (based on health coach hours) to have their height and 
weight taken and ask questions/get information from the health coach about the program. 
 
Q: Would the non-participating parent like to be contacted about the program and times when 
they can come in? 

Page 220 of 305 
 
● Yes 
● No 
 
Q: What is the best phone number to reach them? ______________________ 
 
Q: What is the best email address to reach them? _______________________ 
 
“Thank you for your time, and we look forward to seeing you soon!” END CALL. 
 
 

Page 221 of 305 
 
Table 1. Exclusionary Medications 
Criteria 
Medication 
Exclusionary at all doses and 
durations 
Orlistat (Xenical) 
Phentermine 
Sibutramine (Meridia) 
Topirimate (Topamax) 
Exclusionary if at current dose 
for <6 months 
Adderall (ADHD) 
 
Amourthyroid (hypothyroid) 
Carbamazepine (Tegretol) 
Celexa 
Clonidine (ADHD) 
Clozapine (Clozaril) 
Cyproheptadine (Periactin) 
Diethylproprion (Tenuate) 
Elavil 
Gabapentin 
Haloperidol 
Insulin 
Lithium 
Metformin 
Mirtazapine 
Neurotin 
Nortriptyline  
Olanzapine (Zyprexa) 
Paroxetine 
Perphenazine 
Prozac 
Quetiapine (Seroquel) 
Risperidone (Risperdal) 
Sertraline 
Steroids (non-inhalant) 
Trazadone 
Tofranil 
Tricyclics 
Trileptal 
Valproate 
Valproic acid 
(Depakote/Depakene/Depacon) 
Ziprasidone (Geodon) 
Zyprexa 
Exclusionary if started within 
past 6 months 
Synthroid (hypothyroid) 
 
 

Page 222 of 305 
 
Patient Health Questionnaire (PHQ)  
 
This questionnaire is an important part of providing you with the best health care possible. Your answers 
will help in understanding problems that you may have. Please answer every question to the best of 
your ability unless you are requested to skip over a question. 
 
 
1. During the last 4 weeks, how much have you been 
bothered by any of the following problems? 
Not bothered 
hered a little 
thered a lot 
a. Stomach pain 
 
 
 
b. Back pain 
 
 
 
c. Pain in your arms, legs, or joins (knees, hips, 
etc.) 
 
 
 
d. Menstrual cramps or other problems with 
your periods 
 
 
 
e. Pain or problems during sexual intercourse 
 
 
 
f. Headaches 
 
 
 
g. Chest pain 
 
 
 
h. Dizziness 
 
 
 
i. 
Fainting spells 
 
 
 
j. 
Feeling your heart pound or race 
 
 
 
k. Shortness of breath 
 
 
 
l. 
Constipation, loose bowels, or diarrhea 
 
 
 
m. Nausea, gas, or indigestion 
 
 
 
2. Over the last 2 weeks, how often have you been 
bothered by any of the following problems? 
Not at all 
eral days 
e than half 
the days y every day 
a. Little interest or pleasure in doing things 
 
 
 
 
b. Feeling down, depressed, or hopeless 
 
 
 
 
c. Trouble falling or staying asleep, or sleeping 
too much 
 
 
 
 
d. Feeling tired or having little energy 
 
 
 
 
e. Poor appetite or overeating 
 
 
 
 
f. Feeling bad about yourself – or that you are 
a failure or have let yourself or your family 
down 
 
 
 
 
g. Trouble concentration on things, such as 
reading the newspaper or watching 
television 
 
 
 
 
h. Moving or speaking so slowly that other 
people could have noticed? Or the opposite 
– being so fidgety or restless that you have 
been moving around a lot more than usual 
 
 
 
 
i. 
Thoughts that you would be better off dead 
or of hurting yourself in some way 
 
 
 
 
3. Questions about anxiety. 
No 
Yes 

Page 223 of 305 
 
a. In the last 4 weeks, have you had an anxiety 
attack – suddenly feeling fear or panic? 
 
 
If “No”, go to question 5. 
b. Has this ever happened before? 
 
 
c. Do some of these attacks come suddenly 
out of the blue- that is, in situations where 
you don’t expect to be nervous or 
uncomfortable? 
 
 
d. Do these attacks bother you a lot or are you 
worried about having another attack? 
 
 
4. Think about your last bad anxiety attack. 
a. Were you short of breath? 
 
 
b. Did your heart race, pound, or skip? 
 
 
c. Did you have chest pain or pressure? 
 
 
d. Did you sweat? 
 
 
e. Did you feel as if you were choking? 
 
 
f. Did you have hot flashes or chills? 
 
 
g. Did you have nausea or an upset stomach, 
or the feeling that you were going to have 
diarrhea? 
 
 
h. Did you feel dizzy, unsteady, or faint? 
 
 
i. 
Did you have tingling or numbness in parts 
of your body? 
 
 
j. 
Did you tremble or shake? 
 
 
k. Were you afraid you were dying? 
 
 
5. Over the last 4 weeks, how often have you been 
bothered by any of the following problems? 
Not at all 
everal days 
e than half the 
days 
a. Feeling nervous, anxious, on edge, or 
worrying about a lot of different things. 
 
 
 
If “Not at all”, go to questions 6. 
b. Feeling restless so that it is hard to sit still. 
 
 
 
c. Getting very tired easily. 
 
 
 
d. Muscle tension, aches, or soreness. 
 
 
 
e. Trouble falling asleep or staying asleep. 
 
 
 
f. Trouble concentrating on things, such as 
reading a book or watching TV. 
 
 
 
g. Becoming easily annoyed or irritable. 
 
 
 
6. Questions about eating. 
No 
Yes 
a. Do you often feel that you can’t control 
what or how much you eat? 
 
 
b. Do you often eat, within any 2-hour period, 
what most people would regard as an 
unusually large amount of food? 
 
 

Page 224 of 305 
 
If “No” to either a. or b., go to questions 9. 
c. Has this been as often, on average, as twice 
a week for the last 3 months? 
 
 
7. In the last 3 months, have you often done any of the following in order to avoid gaining weight? 
a. Made yourself vomit? 
 
 
b. Took more than twice the recommended 
dose of laxatives? 
 
 
c. Fasted – not eaten anything at all for at least 
24 hours? 
 
 
d. Exercised for more than an hour specifically 
to avoid gaining weight after binge eating? 
 
 
8. If you checked “Yes” to any of these ways to avoid 
gaining weight, were any as often, on average, as 
twice a week? 
 
 
9. Do you ever drink alcohol (including beer or 
wine)? 
 
 
If “No”, go to question 11. 
10. Have any of the following happened to you more than once in the last 6 months? 
a. You drank alcohol even though a doctor 
suggested that you stop drinking because of 
a problem with your health. 
 
 
b. You drank alcohol, were high from alcohol, 
or hung over while you were working, going 
to school, or taking care of children or other 
responsibilities. 
 
 
c. You missed or were late for work, school, or 
other activities because you were drinking 
or hung over. 
 
 
d. You had a problem getting along with other 
people while you were drinking. 
 
 
e. You drove a car after having several drinks 
or after drinking too much? 
 
 
11. If you checked off any problems on this 
questionnaire, how difficult have these problems 
made it for you to do your work, take care of 
things at home, or get along with other people? 
difficult at all 
mewhat 
difficult y difficult 
tremely 
difficult 
 
 
 
 
 
 
 

Page 225 of 305 
 
Pediatric Symptom Checklist 
 
©1988, M.S. Jellinek and J.M. Murphy, Massachusetts General Hospital 
 
Emotional and physical health go together in children. Because parents are often the first to notice a 
problem with their child’s behavior, emotions or learning, you may help your child get the best care 
possible by answering these questions. Please mark under the heading that best fits your child. 
 
Never (0) 
Sometimes (1) 
Often (2) 
1. Complains of aches/pains 
  
 
 
2. Spends more time alone 
 
 
 
3. Tires easily, has little energy 
 
 
 
4. Fidgety, unable to sit still 
 
 
 
5. Has trouble with a teacher 
 
 
 
6. Less interested in school 
 
 
 
7. Acts as if driven by a motor 
 
 
 
8. Daydreams too much 
 
 
 
9. Distracted easily 
 
 
 
10. Is afraid of new situations 
 
 
 
11. Feels sad, unhappy 
 
 
 
12. Is irritable, angry 
 
 
 
13. Feels hopeless 
 
 
 
14. Has trouble concentrating 
 
 
 
15. Less interest in friends 
 
 
 
16. Fights with others 
 
 
 
17. Absent from school 
 
 
 
18. School grades dropping 
 
 
 
19. Is down on him or herself 
 
 
 
20. Visits doctor with doctor finding nothing wrong 
 
 
 
21. Has trouble sleeping 
 
 
 
22. Worries a lot 
 
 
 
23. Wants to be with you more than before 
 
 
 
24. Feels he or she is bad 
 
 
 
25. Takes unnecessary risks 
 
 
 
26. Gets hurt frequently 
 
 
 
27. Seems to be having less fun 
 
 
 
28. Acts younger than children his or her age 
 
 
 
29. Does not listen to rules 
 
 
 
30. Does not show feelings 
 
 
 
31. Does not understand other people’s feelings 
 
 
 
32. Teases others 
 
 
 
33. Blames others for his or her troubles 
 
 
 
34. Takes things that do not belong to him or her 
 
 
 
35. Refuses to share 
 
 
 
Total Score 
 
 
No 
Yes 

Page 226 of 305 
 
Does your child have any emotional or behavioral problems 
for which she/he needs help?     
 
 
Are there any services that you would like your child to 
receive for these problems?        
 
 
If yes, what services? 
 
 
 

Page 227 of 305 
 
QUESTIONNAIRE ON EATING AND WEIGHT PATTERNS-5 - Parent 
(QEWP-5-Parent) 
Marian Tanofsky-Kraff, Susan Z. Yanovski, and Jack A. Yanovski 
 
1. During the past three months, did your child ever eat what most people, like their friends, would 
think was a REALLY BIG amount of food? 
YES                         NO                              IF NO, SKIP TO QUESTION 18 
 
2. When your child ate a REALLY BIG amount of food, was it ever within a short time (2 hours or less)? 
YES                         NO                              IF NO, SKIP TO QUESTION 18 
 
3. When your child ate a REALLY BIG amount of food, did you ever feel your child could not stop 
eating or control what or how much they were eating? 
YES                         NO                              IF NO, SKIP TO QUESTION 18 
 
4. During the past three months, how often did your child eat like this--ate a REALLY BIG amount of 
food along with the feeling that their eating was out of control? There may have been some weeks 
where this did not happen—just give your best guess. 
____ Less than 1 time a week 
____ 1 time a week 
____ 2 or 3 times a week 
____ 4 to 7 times a week 
____ 8 to 13 times a week 
____ 14 or more times a week 
 
5. When your child ate a REALLY BIG amount of food and felt like they could not control their eating, 
did they usually: 
YES 
NO 
 Eat very fast? 
YES 
NO 
 Eat until their stomach hurt or they felt sick to their stomach? 
YES 
NO 
 Eat REALLY BIG amounts of food even when they were not hungry? 
YES 
NO 
 Eat by themselves because they did not want anyone to see how 
much they ate? 
YES 
NO 
 Feel REALLY BAD about themselves because of what or how much 
they were eating? 
 
6. Think about a usual time when your child ate a REALLY BIG amount of food and felt they could not 
control their eating: 
 
a. During that time, when did they start eating? 
____ (8 AM to 12 Noon) 
____ (12 Noon to 4 PM) 
____ (4 PM to 8 PM) 
____ (8 PM to 12 Midnight) 
____ (12 Midnight to 8 AM) 
 
b. For how long did they eat during this time? 
         hours 
         minutes 

Page 228 of 305 
 
 
c. As best as you can remember, please list everything your child ate or drank during 
this time. Be specific - include brand names where possible, and amounts as best 
you can guess. 
__________________________________________________________________________
___________________________________________________________________
___________________________________________________________________
___________________________________________________________________
___________________________________________________________________
__________________________________________________________ 
 
d. At the time they started eating, how long had it been since your child had last eaten a 
meal or snack? 
         hours 
         minutes 
 
7. During the past three months, how bad did your child feel when they ate a REALLY BIG amount of 
food and felt their eating was out of control? 
____ Not bad at all 
____ Just a little bad 
____ Pretty bad 
____ Very bad 
____ Very, very bad 
 
8. During the past three months, did your child ever make themselves vomit, throw up, or get sick in 
order to keep     from gaining weight after eating like you described (when your child ate a REALLY 
BIG amount of food and felt their eating was out of control)? 
YES                         NO 
 
IF YES: How often, in general, did your child do that? 
____ Less than 1 time a week 
____ 1 time a week 
____ 2 to 3 times a week 
____ 4 to 7 times a week 
____ 8 to 13 times a week 
____ 14 or more times a week 
 
9. During the past three months, did your child ever take medicine to make them poop or have a 
bowel movement (laxatives) in order to keep from gaining weight after eating like you described 
(when your child ate a REALLY BIG amount of food and felt their eating was out of control)? 
YES                         NO 
IF NO, SKIP TO QUESTION 11 
 
10. Did your child take more medicine than the directions on the box or bottle say to take? 
YES                         NO 
 
IF YES: How often, in general, was that? 
____ Less than 1 time a week 
____ 1 time a week 

Page 229 of 305 
 
____ 2 to 3 times a week 
____ 4 to 5 times a week 
____ 6 to 7 times a week 
____ 8 or more times a week 
 
11. During the past three months, has your child ever taken medicine to make them pee or urinate 
(diuretics or water pills) in order to keep from gaining weight after eating like you described (when 
your child ate a REALLY BIG amount of food and felt their eating was out of control)? 
YES                         NO 
IF NO, SKIP TO QUESTION 13 
 
12. Did your child take more medicine than the directions on the box or bottle say to take? 
YES                         NO 
 
IF YES: How often, in general, was that? 
____ Less than 1 time a week 
____ 1 time a week 
____ 2 to 3 times a week 
____ 4 to 5 times a week 
____ 6 to 7 times a week 
____ 8 or more times a week 
 
13. During the past three months, did your child ever eat nothing at all for at least 24 hours (a full day) 
in order to keep from gaining weight after eating like you described (when your child ate a REALLY 
BIG amount of food and felt their eating was out of control)? 
YES                         NO 
 
IF YES: How often, in general, was that? 
____ Less than 1 day a week 
____ 1 day a week 
____ 2 days a week 
____ 3 days a week 
____ 4 to 5 days a week 
____ More than 5 days a week 
 
14. During the past three months, did your child ever exercise too much (for example, even though they 
were hurt or sick or it kept them from doing important things) MAINLY in order to keep from gaining 
weight after eating like you described (when your child ate a REALLY BIG amount of food and felt 
their eating was out of control)? 
YES                         NO 
 
IF YES: How often in general, was that? 
____ Less than 1 time a week 
____ 1 time a week 
____ 2 to 3 times a week 
____ 4 to 7 times a week 
____ 8 to 13 times a week 
____ 14 or more times a week 
 

Page 230 of 305 
 
15. During the past three months, did your child ever take diet pills in order to keep from gaining 
weight after eating like you described (when your child ate a REALLY BIG amount of food and felt 
their eating was out of control)? 
YES                         NO 
IF NO, SKIP TO QUESTION 17 
 
16. Did your child take more medicine than the directions on the box or bottle say to take? 
YES                         NO 
 
IF YES: How often, in general, was that? 
____ Less than 1 time a week 
____ 1 time a week 
____ 2 to 3 times a week 
____ 4 to 5 times a week 
____ 6 to 7 times a week 
____ 8 or more times a week 
 
17. During the past three months, how important has your child’s weight or shape been in how they 
feel about themselves as a person – as compared to other things in their life, such as their 
schoolwork, friends, sports, or getting along with their family? 
 
____ Weight and shape were not very important 
____ Weight and shape were played a part in how they felt about themselves 
____ Weight and shape were among the main things that affected how they felt about 
themselves 
____ Weight and shape were the most important things that affected how 
they felt about themselves 
 
Continue here after completing question 17 OR if you skipped to question 18 from Question 1, 2, or 3 
 
18. During the past three months, did your child ever have times when they felt that they could not stop 
eating or control what or how much they were eating, but when they did not eat a REALLY BIG 
amount of food? 
YES                         NO                              IF NO, SKIP TO QUESTION 32 
 
19. During the past three months, how often did your child eat like this—felt that their eating was out 
of control, but they did not eat a REALLY BIG amount of food. There may have been some weeks 
where this did not happen—just give your best guess. 
____ Less than 1 time a week 
____ 1 time a week 
____ 2 to 3 times a week 
____ 4 to 7 times a week 
____ 8 to 13 times a week 
____ 14 or more times a week 
 
20. When your child felt their eating was out of control but they did not eat a REALLY BIG amount of 
food, did they usually: 
YES 
NO  
Eat very fast? 
YES 
NO  
Eat until their stomach hurt or they felt sick to their stomach? 

Page 231 of 305 
 
YES 
NO  
Eat REALLY BIG amounts of food even when they were not hungry? 
YES 
NO  
Eat by themselves because they did not want anyone to see how much they 
ate? 
YES 
NO  
Feel REALLY BAD about themselves because of what or how much they were 
eating? 
 
21. Think about a usual time when your child felt they could not stop eating or control what or 
how much they were eating, but they did not eat a REALLY BIG amount of food: 
 
a. During that time, when did they start eating? 
____ (8 AM to 12 Noon) 
____ (12 Noon to 4 PM) 
____ (4 PM to 8 PM) 
____ (8 PM to 12 Midnight) 
____ (12 Midnight to 8 AM) 
 
b. For how long did they eat during this time? 
         hours 
         minutes 
 
c. As best as you can remember, please list everything your child ate or drank during 
this time. Be specific - include brand names where possible, and amounts as best 
you can guess. 
___________________________________________________________________
___________________________________________________________________
___________________________________________________________________
___________________________________________________________________
___________________________________________________________________
_________________________________________________________________ 
 
d. At the time they started eating, how long had it been since your child had last eaten a 
meal or snack? 
         hours 
         minutes 
 
22. During the past three months, how bad did your child feel that they could not stop eating or control 
what or how much they were eating even when they did not eat a REALLY BIG amount of food? 
____ Not bad at all 
____ Just a little bad 
____ Pretty bad 
____ Very bad 
____ Very, very bad 
 
23. During the past three months, did your child ever make themselves vomit, throw up, or get sick in 
order to keep from gaining weight after eating like you described (when your child felt their eating 
was out of control but they did not eat a REALLY BIG amount of food)? 
YES                  
NO 

Page 232 of 305 
 
 
IF YES: How often, in general, did your child do that? 
____ Less than 1 time a week 
____ 1 time a week 
____ 2 to 3 times a week 
____ 4 to 7 times a week 
____ 8 to 13 times a week 
____ 14 or more times a week 
 
24. During the past three months, did your child ever take medicine to make them poop or have a 
bowel movement (laxatives) in order to keep from gaining weight after eating like you described 
(when your child felt their eating was out of control, but they did not eat a REALLY BIG amount of 
food)? 
YES                         NO 
IF NO, SKIP TO QUESTION 26 
 
25. Did your child take more medicine than the directions on the box or bottle say to take? 
YES                         NO 
 
IF YES: How often, in general, was that? 
____ Less than 1 time a week 
____ 1 time a week 
____ 2 to 3 times a week 
____ 4 to 5 times a week 
____ 6 to 7 times a week 
____ 8 or more times a week 
 
26. During the past three months, has your child ever taken medicine to make them pee or urinate 
(diuretics or water pills) in order to keep from gaining weight after eating like you described (when 
your child felt their eating was out of control, but they did not eat a REALLY BIG amount of food)? 
YES                         NO 
IF NO, SKIP TO QUESTION 28 
 
27. Did your child take more medicine than the directions on the box or bottle say to take? 
YES                         NO 
 
IF YES: How often, in general, was that? 
____ Less than 1 time a week 
____ 1 time a week 
____ 2 to 3 times a week 
____ 4 to 5 times a week 
____ 6 to 7 times a week 
____ 8 or more times a week 
 
28. During the past three months, did your child ever eat nothing at all for at least 24 hours (a full day) 
in order to keep from gaining weight after eating like you described (when your child felt their 
eating was out of control, but they did not eat a REALLY BIG amount of food)? 
YES                         NO 
 
IF YES: How often, in general, was that? 

Page 233 of 305 
 
____ Less than 1 day a week 
____ 1 day a week 
____ 2 days a week 
____ 3 days a week 
____ 4 to 5 days a week 
____ More than 5 days a week 
 
29. During the past three months, did your child ever exercise too much (for example, even though 
they were hurt or sick or it kept them from doing important things) MAINLY in order to keep from 
gaining weight after eating like you described (when your child felt their eating was out of control, 
but they did not eat a REALLY BIG amount of food)? 
YES                   NO 
 
IF YES: How often in general, was that? 
____ Less than 1 time a week 
____ 1 time a week 
____ 2 to 3 times a week 
____ 4 to 7 times a week 
____ 8 to 13 times a week 
____ 14 or more times a week 
 
30. During the past 3 months, did your child ever take diet pills in order to keep from gaining weight 
after eating like you described (when your child felt their eating was out of control, but they did 
not eat a REALLY BIG amount of food)? 
YES                         NO 
IF NO, SKIP TO QUESTION 32 
 
31. Did your child take more medicine than the directions on the box or bottle say to take? 
YES                   NO 
 
IF YES: How often, in general, was that? 
____ Less than 1 time a week 
____ 1 time a week 
____ 2 to 3 times a week 
____ 4 to 5 times a week 
____ 6 to 7 times a week 
____ 8 or more times a week 
 
Continue here after completing question 31 OR if you skipped to question 32 from Question 18 
 
32. Please look at these drawings of people. Pick the person that matches your child’s biological (birth) 
father’s and mother’s sizes. If you don’t know their biological (birth) father or mother, don’t pick 
anything for that parent. 

Page 234 of 305 
 
 
 
The QEWP-5-P is an adaptation of the QEWP-5.  Yanovski SZ, Marcus MD, Wadden TA, Walsh BT.  The 
Questionnaire on Eating and Weight Patterns-5: an updated screening instrument for binge eating 
disorder. Int J Eat Disord. 2015 Apr;48(3):259-61. doi: 10.1002/eat.22372. Epub 2014 Dec 26. Adapted 
with permission. 
 
 

Page 235 of 305 
 
 
 
PLAN ELIGIBILITY TRACKING FORM 
 
Initial Eligibility Survey  
 
 
 
 
 
 
 
 
Date 
___/___/___ 
YES 
NO 
Child is between 6 and 12 years of age.   
 
 
YES 
NO  
Child’s BMI is above the 85th percentile for sex and age. 
YES 
NO  
Parent’s BMI is above 25kg/m2. 
YES 
NO  
Child and parent have not had a concussion in past 3 months. 
YES 
NO  
Child and parent are able to complete a brisk 5-10 minute walk. 
YES 
NO  
Family is not planning to move away within next 2 years. 
Notes: 
_____________________________________________________________________________________
_______ 
_____________________________________________________________________________________
_____________ 
_____________________________________________________________________________________
_____________ 
_____________________________________________________________________________________
_____________ 
 
Eligibility Phone Screen  
 
 
 
 
 
 
 
 
Date 
___/___/___ 
YES 
NO 
Parent agrees to attend all treatment meetings. 
YES 
NO  
Child resides with targeted parent at least 50% of the time. 
YES 
NO 
Parent is child’s biological or adoptive parent or legal guardian. 
YES 
NO  
Child and parent do not have any exclusionary medical conditions. 
YES 
NO  
Child and parent are not taking any exclusionary medications. 
YES 
NO  
Child and parent have not had any weight-related surgeries. 
YES 
NO  
Child and parent are not in a weight management/weight-loss program. 
YES 
NO  
Child and parent do not have severe restriction of diet. 
YES 
NO  
Child and parent do not have any significant intellectual delays, disabilities, or ASD. 
YES 
NO  
Child and parent do not have any unmanaged or active psychiatric conditions/symptoms 
(self-report). 
YES 
NO  
Child and parent have no history of an eating disorder (self-report). 
YES 
NO  
Child and parent are able to speak/comprehend English at a 1st grade level (self-report). 

Page 236 of 305 
 
YES 
NO  
Parent is not pregnant or planning on becoming pregnant during study period. 
Notes: 
_____________________________________________________________________________________
_______ 
_____________________________________________________________________________________
_____________ 
_____________________________________________________________________________________
_____________ 
_____________________________________________________________________________________
_____________ 
 
Pre-Orientation Surveys (PHQ, PSC, QEWP-5 Parent and Child Report)  
 
 
Date 
___/___/___ 
YES 
NO  
Child and parent do not have any unmanaged or active psychiatric 
conditions/symptoms. 
YES 
NO  
Child and parent have no history of an eating disorder. 
Notes: 
_____________________________________________________________________________________
_______ 
_____________________________________________________________________________________
_____________ 
_____________________________________________________________________________________
_____________ 
_____________________________________________________________________________________
_____________ 
 
Follow-Up Interview (KSADS, SCID) 
 
 
 
 
 
 
 
Date 
___/___/___ 
YES 
NO 
Did a PLAN Coach administer the KSADS for the child? 
 
 
Modules: 
_____________________________________________________________________________ 
________________________________________________________________________
_____________ 
YES 
NO 
Did a PLAN coach administer the SCID for the parent? 
Modules: 
________________________________________________________________________
_____ 
________________________________________________________________________
_____________ 

Page 237 of 305 
 
YES 
NO  
Child and parent do not have any unmanaged or active psychiatric 
conditions/symptoms. 
YES 
NO  
Child and parent have no history of an eating disorder. 
Notes: 
_____________________________________________________________________________________
_______ 
_____________________________________________________________________________________
_____________ 
_____________________________________________________________________________________
_____________ 
_____________________________________________________________________________________
_____________ 
 
Orientation 
YES 
NO 
Child’s BMI is above the 85th percentile for sex and age. 
YES 
NO 
Parent’s BMI is above 25kg/m2. 
YES 
NO 
Child and parent are able to speak/comprehend English at a 1st grade level (per the 
WRAT). 
Notes: 
_____________________________________________________________________________________
_______ 
_____________________________________________________________________________________
_____________ 
_____________________________________________________________________________________
_____________ 
_____________________________________________________________________________________
_____________ 
 
Pre-Randomization 
YES 
NO 
Child and parent received medical clearance from their PCPs. 
YES 
NO 
Family is eligible for randomization. 
Notes: 
_____________________________________________________________________________________
_______ 
_____________________________________________________________________________________
_____________ 
_____________________________________________________________________________________
_____________ 
_____________________________________________________________________________________ 
 

Page 238 of 305 
 
Assessment Measures 
Height and Weight Measurement Checklist. (Primary Aim 1a & b and Secondary Aim 1) 
 
General Information for Measurements: 
HEIGHT RELIABILITY CRITERIA 
Height measurements are to be within 0.3cm (3mm) of a reliable staff member. The above requirements 
are to be met for 10 different height measurements (i.e., 10 participants measured by a reliable staff 
member and the staff in training).  If the reliable staff member and new staff member do not meet 
acceptable reliability criteria, additional participants should be measured by both staff members until 
adequate reliability is established. 
● Reliability should be checked periodically throughout the study to assure that there is no 
measurement drift between height assessors. 
● Height and weight will be monitored and rechecked randomly to ensure accuracy of the data. 
● Calibration of the stadiometer and scale will occur every so often to ensure the accuracy of the 
equipment. 
 
HEIGHT PROCEDURES FOR CHILDREN AGES ≥ 4 YEARS AND ADULTS  
1. The participant should be barefoot or in thin socks. 
2. The PLAN coach will instruct the participant to stand up straight with his/her back against 
stadiometer board.  The coach should make sure that the participant is not standing on his/her 
pants if long. 
3. Ask the participant to stand with his/her heels together and toes pointing out to form a “V”. 
4. The participant should be looking straight ahead with his/her arms at his/her sides. 
5. The PLAN coach should lightly rest headboard on top of the participant’s head to be sure that it 
sits at the highest point of the head and then lift the head board out of the way. 
6. The coach should instruct the participant to take a deep breath in and stretch upwards while 
s/he places both hands under the mastoid process of skull. The coach should then gently lift the 
participant’s head, which will elongate the spine to ensure an accurate height reading. 
a. The mastoid process of the skull is the bony projection of the temporal bone and is 
located behind the ears. 
7. The coach should make sure there is an imaginary line between the participant’s eyes and ears 
that runs parallel with the floor while the participant's eyes gaze forward.  
8. The coach should ensure that the participant's feet are firmly planted on the ground and that 
s/he is not standing on his/her toes. 
9. The coach should take the height measurement. 
a. The headboard should rest on highest point of the participant’s head and, if applicable, 
should compress the participant’s hair. 
10. The coach should then ask the participant to step away from the height board. 
11. The coach will record the height on a hard copy of the “Height and Weight” REDCap form that 
s/he will print off prior to the appointment.   
12. The coach will measure the height in millimeters.  Then, the coach will read what this 
measurement is in centimeters to the nearest decimal place (i.e., 65.7).  If the height falls in 
between two decimal places, the coach will record to the lower decimal place. 
13. The coach should repeat the process two times to check validity. 
a. If the two height measurements are not within 0.3 centimeters of each other, the coach 
will take two additional measurements. 
b. The coach will repeat this process until s/he has two measurements that are within 0.3 
centimeters of each other. 

Page 239 of 305 
 
c. REDCap will take the mean of the last pair of measurements to determine the 
participant’s BMI. 
i. 
All measurements will remain in REDCap so that the total measurements taken 
and the values of the measurements can be reviewed. 
14. The coach will enter the two height measurements into the participant’s file in REDCap on the 
“Height Tracking Form”. 
15. Coaches will use their REDCap username and password to log on to the PLAN study in REDCap 
via https://redcap.wustl.edu/redcap/srvrs/.  They will then complete the following steps: 
a. Open the “Add/Edit Records” tab that is located on the left side of the screen. 
b. Select the appropriate Screening ID from the “Choose an existing Screening ID” 
dropdown menu, which will take the coach to the “Record Home Page” for the family. 
c. Double click on the appropriate “Height and Weight Tracking Form”. 
d. Complete the height portion of the Height and Weight Tracking Form. 
e. The coach will select the appropriate form status based on whether or not s/he has to 
input more measurement data. 
f. The coach will click “Save & Exit Form”. 
16. The coach should wipe down the scale pre and post measurement with a Lysol wipe if the 
participant is bare footed. 
 
MANUAL CALIBRATION OF THE HEAD SLIDE  
1. All PLAN coaches will use 72 centimeter PVC pipes to calibrate their stadiometers. 
a. SR scales will cut 72 (+/- 0.3) centimeter PVC pipe sections with a laser cutter.  
b. The exact length of each pipe will be written on the pipe. 
c. A staff member from the University at Buffalo will retrieve the pipes and mail out them 
out to each site. 
2. All PLAN coaches will take height measurements with their PVC pipes each time their 
stadiometer is used. 
a. The stadiometer should always measure the known height of the PVC pipe that was 
documented on the pipe. 
b. If the stadiometer measures the height of the PVC pipe as something different than the 
known height, the coach will document the discrepancy.  The coach will then make 
arrangements to procure a new stadiometer 
 
HEIGHT MEASUREMENT REPORT 
1. The height measurements will be manually entered into REDCap for analysis of outcome 
measures as well as written on hard copy of height and weight form (pdf form from REDCap).  
2. The reported height measurements will be exactly the same as the reading on the stadiometer, 
which will provide an unbiased report of the height measurements (This change was made on 
9.18.17 prior to review and approval by the DSMB, DSMB approved protocol addenda on 
11.2.18). 
 
WEIGHT PROCEDURES  
1. To begin, the PLAN coach should plug the SR Scale into a wall outlet.  The coach should then 
press the “Zero/Weigh” button that is located on the right side of the scale.  The scale will be 
operational when the display reads 0.00.  The coach should ensure that the scale is recording 
weight in pounds.  If the scale is set to measure weight in kilograms, the coach will press the 
toggle button next to the “Zero/Weigh” button to switch the unit measurement from kilograms 
to pounds. 

Page 240 of 305 
 
2. In order to ensure accurate measurement, the coach should instruct the participant to do the 
following: 
a. The participant should empty out his/her pockets, and remove shoes and any heavy 
clothing or accessories. 
b. The participant should always be weighed around the same time of the day. 
c. The participant should always use the bathroom prior to being weighed.  
d. The participant should follow similar eating and activity schedules. 
3. The coach will ask the participant to stand in the middle of the scale and instruct the participant 
to do the following: 
a. The coach will ask the participant to remain still, have relaxed shoulders, and to have 
his/her hands at his/her sides. 
b. The coach will ask the participant to look straight ahead. 
c. The coach will tell the participant to stand with the same posture as on a balance beam 
scale. 
4. The coach will wait for weight measurement to stabilize. 
a. While standing to the left of the scale, the coach will monitor the digital readout. 
5. Once the measurement has stopped fluctuating, the coach will record the weight on a hard copy 
of the “Height and Weight” REDCap form that s/he will print off prior to the appointment.   
6. The coach will repeat this procedure a second time. 
7. The coach will instruct the participant to step off the scale.   
8. The coach should wipe down the scale pre and post measurement with a Lysol wipe if the 
participant is bare footed. 
 
MANUAL CALIBRATION OF THE SCALE  
1. All PLAN coaches will use Pro-Form 15-pound kettle bells to calibrate their scales. 
a. A staff member from the University at Buffalo will perform weight measurements with 
all Pro-Form kettle bells on a calibrated scale.  
b. The staff member will document the exact weight of each kettle bell. 
c. The staff member will write the exact weight on a piece of painter’s tape and tape it to 
the kettle bell.   
d. The staff member will mail out the kettle bells each site. 
2. All PLAN coaches will take weight measurements with their kettle bells each time their scale is 
used. 
a. The scale should always measure the known weight of the kettle bell that was 
documented by the University at Buffalo on the painter’s tape. 
b. If the scale measures the weight of the kettle bell as something different than the known 
weight, the coach will document the discrepancy.  The coach will then make 
arrangements to send the scale to SR Scales for re-calibration.  
 
WEIGHT MEASUREMENT REPORT 
1.  For analysis of outcome measures (see 11 in Weight Procedures above; (This change was made 
on 9.18.17 prior to review and approval by the DSMB, DSMB approved protocol addenda on 
11.2.18). 
Use of Weight App was discontinued (DSMB approved change, 11.18.19).Hard copy height and weight 
measurement forms will be uploaded to the secure REDCap database to allow the CCC, DCC and TFC to 
check for transcription and/or unit of measurement errors. 
 
 

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Remote assessments Protocol   
Step 1: Coach Instructions for CONTACTING FAMILY 
1. Schedule phone call with family to introduce the remote assessment, check for materials, 
review instructions, describe changes in payment, complete the AE survey, and to schedule an 
assessment date with a blinded measurement coach. A random subset of families from each site 
will be asked to complete the height protocol for a second quality control measure of this remote 
height measurement.  
a. See email script if they do not answer the phone: 
“Hello [Parent], 
Thank you for participating in the PLAN with Families Program! It is time for your 
family's [X] month assessment. 
Because of the current unexpected circumstances, we will be conducting your 
assessment virtually. This means we will supply you with measurement equipment 
and call you to walk you through measuring yourself and your children. 
You will receive payment for this assessment. Please call, text, or email me so we 
discuss the details and schedule a date. 
Thank you, 
[Name] 
[phone number] 
b. Introduction of remote assessment: 
i. 
“Due to unforeseen circumstances, our assessments for the measurement 
procedures have changed for the time being. At this time, we are asking families 
to complete height and weight measurements at home using equipment that 
you have or can be sent to you. With your permission, we will call you during the 
assessment to walk you through the procedures.” 
c. Describe payment procedure: 
i. 
“You will get the usual payment for this remote measurement.” 
1. Remote payment will be sent by each site’s PC 
a. Within 2-3 days of completing the remote measurement 
b. UB checks, UR gift cards 
i. 
Certified mail serves as receipt of payment 
c. WU e-gift cards and NCH ClinCard will be instantaneous 
2. In-person payment will be directly given to the family as normal 
protocol procedures. 

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d. Discuss consenting procedures: Electronic signature procedure through downloads or 
directly in REDCap) 
i. 
“I will email you an addendum document for the remote assessment and 
instructions for opening and signing the document. Can you please confirm your 
correct and working email address where I can send this form? [Confirm email 
address in REDCap]” 
ii. 
“To complete the consent form, you will need to open the email, download the 
document and open the form in your “downloads folder” on your computer. 
Open this file using the Adobe application, there will be blue squares and 
rectangles which are interactive. You can select a box to either consent, or do 
not consent. You will input the date, and then click the blue box below signature 
to sign the document. A window will appear asking about a digital ID, if you 
have a preset one with your correct name you may use it. If not, you can 
configure a new one according to the instructions that will be included in my 
email to you. Please contact me should you have any troubles or questions with 
any step of this consenting process.” 
iii. 
“Please send me a confirmation email when you receive the instructions and 
consent form to your email.” 
1. Follow-up with family 1 day after sending the email if you do not receive 
confirmation. 
iv. 
REDCap consent procedure: 
1. “You will receive an email from me in a few minutes. In it, there will be a 
link to the electronic consent form. Let me know when you have it open 
so I can go over it with you. [wait]” 
2. “This consent form is telling you about some updates to the study and is 
asking you to sign to agree to these changes.” 
a. Addendum: “First, as you know we will be doing your 
assessment remotely, meaning you will take heights and 
weights for all the PLAN participants in the study. Second, we 
will be paying your regular payment for the remote assessment 
Third, we have changed the total payment for the 24 month 
assessment from $50 to $100. Last, we have started a lottery 
where you earn 1 chance to win an extra $50 for every in 
person assessment you attend.” 
b. Reconsent: “I have sent a second email with another consent 
form for [child] to sign. Now that [child] has turned [age], they 
are old enough to sign a consent form for an older age group. 
This consent is just asking [child] to sign so we can keep doing 
the study just as we have in the past. There is nothing new in 
this consent form.” 
3. “Please take your time and read over the form(s). If you have any 
questions, I can answer them. Whenever you are ready, you may scroll 

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to the bottom and “sign” your name with today’s date. (For reconsent: 
Please make sure your child is the one to sign and not you.) I will stay on 
the line with you until you are ready.” 
e. Ask if they have: 
i. 
“In order to complete the measurement you will need the following pieces of 
equipment. Please let me know if any of the following are not available to you: 
1. PLAN Provided Weight Scale 
a. Is their mailing address correct?  
2. Carpenter’s Square  
3. Metal Measuring Tape 
4. Computer or phone access to internet and web camera 
a. If they don’t have these, ask if they have some form of camera 
to take a picture of the measurements. Pictures can be emailed 
to the measurement coach. 
ii. 
If these items are available: 
a. “Great. Please have these items ready at the time of your 
measurement, we will provide you with a PLAN weight scale 
through the mail. Please confirm your mailing address and any 
special delivery instructions for your residence.” 
iii. 
If an item(s) is not available: 
a. “We will mail a standardized scale and [item(s)] to your address 
for the assessment. Please confirm your mailing address and 
any special delivery instructions for your residence.” 
2. Contact PC to coordinate delivery of materials 
f. Schedule the family’s remote measurement 
i. 
“To allow time for materials to arrive for the measurement, we will schedule 2 
weeks out from this call.”  
ii. 
Give 2-3 possible days/times to schedule appointment. 
g. Complete AE survey according to protocol 
i. 
“At this time I have a 5-10 minute survey to go through with you. Is now a good 
time to complete this?” 
1. If yes, complete AE survey.  
2. If no, “is there a convenient day/time where I can contact you to 
complete this survey?” or email it to the family 
h. Notify family that necessary questionnaires will be emailed and should be completed 
before the measurement appointment through REDCap.  
i. 
If family does not have computer/phone access with internet: 
1. Surveys can be done over the phone BEFORE the appointment 
a. AEQ, DDs, FNPA, 24M Parent/Child 
2. Measurement instructions will be mailed to their address  
ii. 
Send reminder email 1 day before assessment if questionnaires are not 
complete 

Page 244 of 305 
 
i. 
Check when family’s next well child visit is to coordinate in person follow-up 
measurement at a convenient date and time 
i. 
“In addition to the remote measurement, we will also schedule a follow-up 
measurement at the pediatric office. Does your child have an existing well-visit 
appointment that would be convenient for you to schedule this follow-up?” 
ii. 
If not, schedule a follow-up appointment that will take place in the summer 
j. 
Ending the phone call 
i. 
“Thank you so much for your time today, I will send you a 1 week and 1 day 
reminder prior to your assessment. Please contact me with any changes or 
questions in the meantime.” 
2. Record all assessment information into your site’s specific tracking spreadsheet.  
a. Add date and time, and all other necessary information, (UB Assessments - Tracking, 
WU, NCH, UR)  
b. Include family’s consent for audio/video recording 
3. Contact a blinded measurement coach to run the assessment via video conference or phone. 
a. For 24 month assessments, both the blinded assessor and the PLAN Coach should be 
present 
4. Send video conference email link to family and assessor using https://zoom.us/home?zcid=2478 
or Webex 
a. Set the duration as 30 min, or 60 min for a 24 month assessment.  
b. Set a password.  
c. Attach Family Instructions for measurements 
5. Email all the surveys to the family through REDCap (see next section) 
6. Confirm assessment dates with family one week before and the day of the assessment 
a. Include the call-in information and instruction sheet again. 
 
Step 2: PLAN Coach Instructions for FORMS AND PAPERWORK COMPLETION 
NOTE: For 6, 12, and 18 month assessments, all surveys should be completed by families BEFORE the 
assessment. 
For 24 month assessments, surveys should be completed by families BEFORE the assessment, AND the 
PLAN Coach should attend the assessment to give FBT materials and finish payment AFTER the blinded 
assessor leaves the call. 
1. For families doing 12- and 24-month assessments, have them complete the online 
questionnaires. 
a. At 12 month assessments: Child DD Validation, Child DD, Parent DD.  
b. At 24 month assessments: Child DD Validation, Child DD, Parent DD, FN & PA, and 24 
Month for both Child and Parent. 
c. For families with internet access, use REDCap to send the online surveys. 

Page 245 of 305 
 
i. 
In the family’s REDCap record, click the circle that corresponds to the 
questionnaire that needs to be sent 
ii. 
Under the “Survey Options” drop down menu, select “Compose Survey 
Invitation” 
iii. 
Fill out the invitation form 
1. Send out immediately 
2. Check the box to enable reminders and choose to resend every 3 days 
with recurrence up to 5 times 
3. Make sure it is your email address the email will be from, and choose 
the participant’s email address to where it will be sent 
4. Type in subject line: “PLAN with Families 12/24 month survey” 
5. Compose a message in the text box. 
a.  For example, “Hi [Name], Please click the link and complete the 
questionnaire, following the directions provided. If you have 
any questions, contact your PLAN coach at [phone number 
here].” 
b. Be sure to clarify if that specific questionnaire needs to be filled 
out by the parent or the child 
iv. 
Repeat for each questionnaire that needs to be completed 
d. For families who don’t have access to internet 
i. 
DD tasks, FNPA, and 24 Month Surveys can be done over the phone BEFORE the 
assessment 
ii. 
Contact PC about mailing paper forms if necessary 
2. If the family needs a re-assent, re-consent, or an addendum: 
a. These will become forms in REDCap 
b. You will send them just like you send the surveys BEFORE the assessment 
c. In the subject line, use: “PLAN with Families Consent form for [Name of participant]” 
d. If they do not complete, the blinded assessor will have to go over them with the family 
during the assessment 
i. 
They will have to send the REDCap form at beginning of assessment and check 
to see if it is finished before they end the call. 
3. Payment 
a. Site specific payment procedures 
i. 
UB: PC will send a check via certified mail within 2-3 days of the assessment. 
1. There will be a receipt mailed with the check, please have the family 
sign this receipt and text the PLAN or measurement coach a picture of 
their signature. 
2. Follow-up with the family 1 week from the mailing date if a receipt 
picture has not been submitted. 
ii. 
WU: PC will mail a VISA gift card or email an Amazon e-gift card within 2-3 days 
of the assessment 
iii. 
UR: PC will mail gift cards or other site determined method.  

Page 246 of 305 
 
iv. 
NCH: PP will be credited the money to the ClinCard within 2-3 days of the 
assessment. 
b. 6 month measurements: 
i. 
At the end of the measurement, assure the participating parent that they 
earned $     25 
ii. 
Inform family that they have earned the chance to be entered for a $50 raffle at 
the end of the study. 
c.      12 and 18 month measurements: 
i. 
At the end of the measurement assure the participating parent that they earned      
$50 
ii. 
Inform family that they have earned the chance to be entered for a $50 raffle at 
the end of the study. 
d.      24 month measurements: 
i. 
At the end of the measurement assure the participating parent that they earned      
$100 
ii. 
There will be a receipt mailed with the check, please have the family sign this 
receipt and text the PLAN or measurement coach a picture of their signature. 
1. Follow-up with the family 1 week from the mailing date if a receipt 
picture has not been submitted. 
iii. 
Measurement coach will need to contact site PC immediately following session 
to notify them if family has won lottery or not so that check can be prepared if 
needed 
e.      Height quality control measurement: 
i. 
Families that participate in the second measurement     will receive $10.00 
payment as specified above. 
4. 24 Month-specific procedures 
a. Inform family that they have earned the chance to be entered for a $50 raffle. 
i. 
The blinded assessor will pull from the ticket bag via video conference for the 
family. 
ii. 
If the family wins the raffle, notify the Coach and the PC so they can adjust the 
payment. 
b. PLAN Coach sends the family the link to 24-month video to describe PLAN website and 
handouts. 
i. 
Sent during the assessment, but after the blinded assessor leaves the call 
ii. 
Sent via email 
iii. 
Include the PC’s contact information 
Thank the family for their participation.      
Step 3: Measurement Coach Instructions for HEIGHT MEASUREMENTS 
1. Confirm with family and/or coach that measurement is set for the scheduled date 

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2. Contact family at the day and time of assessment 
a. If the family has a Webcam and Internet Access: use WebEx and/or Zoom 
b. If they do not have a WebCam and Internet access: use phone to call the family and 
ensure they have a camera 
3. Guide family through height and weight procedure, giving them feedback, answering any 
questions, making notes, and voicing corrections if they are needed 
a. Assume the family has NOT read the instruction sheet and will need to be walked 
through the steps 
b. Have them e-sign consent forms if they need to (see previous section) 
c. Remind the family about which members need to be measured 
d. Reference “Measurement Coach Checklist” with all the necessary information 
4. Have family report their measurements aloud, and write them on a blank paper 
5. Measurement coach will confirm accurate values and write them down on “Height and Weight 
form” 
6. After the assessment, enter these values into REDCap as per normal protocol 
Family Instructions for HEIGHT MEASUREMENTS 
NOTE: Only children who enrolled in PLAN as participants need to have their heights measured. Parents 
or legal guardians enrolled in PLAN should measure the children’s heights. 
Location: On a level, non-carpeted, flat surface (e.g. wood, concrete floor, tile) against a door 
Materials Needed: 
1. Carpenter’s square  https://www.homedepot.com/p/Empire-7-in-Polycast-Rafter-Square-
296/100154430 
2.       Metal measuring tape 
3. Tape 
4. Object of known height (ie participating parent, adult, yardstick) 
5. Pencil or Pen  
6. Piece of paper 
7. Stool (especially if your child is taller than you) 
8. Computer or phone with a web cam and internet access 
1. If you do not have a web cam and/or internet access, have a camera present 
Procedure: 
1. First, you will practice taking a height measurement with the carpenter’s square and foldable 
yardstick. 
a. Tape the foldable yardstick against a door with the bottom on  a level, flat floor and it 
standing straight.   
b. Place an object of known height against the foldable yardstick 
c. Place the carpenter’s square on top of the person’s head or object,  
i. 
Make sure one of the square’s flat edges is directly touching the doorl 

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ii. Make sure the object is standing straight up and not leaning, compare to edge 
of door. 
d. Check the height of the object with the bottom edge of the carpenter square 
e. Remove the person or object 
f. Tell your measurement coach the height of the object  
g. Did your measurement match the known height of the object? if it did not to make 
some adjustments and recheck. 
2. Now, you will measure your child. Make sure: 
a. Your child’s hair is let down (if possible) 
b. Your child is not wearing shoes 
3. Have your child stand with their back against the door. 
4. Tape a piece of paper on the door behind the foldable yardstick,  around the center of the top of 
their head. 
5. Have them put their heels as close to the door as possible 
6. Have them touch their heels together so they are standing 
in a V-shape 
7. Have your child look straight ahead at you 
8. Find your child’s mastoid process (a bony knob behind 
their ears – see picture) 
9. Place your pointer and middle fingers of both hands on 
your child’s mastoid processes 
10. Tell them, “On the count of three, take a deep breath, and 
I will lift your head up” 
11. Count to three, and as they breath in, gently lift their head 
slightly upwards. 
12. While they are holding their breath: 
a. Make sure they are NOT on their tiptoes 
b. Make sure their head is NOT tilted up or down 
c. Place the carpenter’s speed square on top of your child’s head with the right angle 
facing the wall and one flat side directly touching the wall 
d. Make a mark of their height on the paper 
13. Tell your child they can let go of their breath and step away from the wall 
14. Write the number “1” and your child’s initials next to the mark 
15. Report the height to the measurement coach 
16. Repeat steps 2-15 to complete a second measurement 
a. Mark the line on the piece of paper with a “2” and the child’s initials to differentiate 
from the first mark 
b. If measurements 1 and 2 differ by more than 0.3 centimeters, the measurement coach 
will ask you to take two more measurements. 
17. Repeat steps 2-16 for additional siblings enrolled using a new piece of paper. 
Family Instructions for WEIGHT MEASUREMENTS  

Page 249 of 305 
 
NOTE: All participants who are enrolled in PLAN—parents and children—should measure their weight. 
Location: On a level, non-carpeted, flat surface (e.g. wood, concrete floor) 
Materials Needed: 
1.      PLAN weight scale 
                              Procedure: 
1.                          Before stepping on the scale, make sure: 
a. You remove shoes, any items in your pockets, and 
any heavy pieces of clothing or jewelry, such as 
belts, hoodies, etc. 
b. You use the restroom beforehand 
2. Step on the scale 
a. Stand straight, in the middle of the scale, with feet shoulder-width apart, looking 
straight ahead 
b. Make sure your child does not move on the scale, as that can affect the accuracy of the 
measurement 
3. Once the weight has stabilized, step off the scale and write down the weight. 
4. Report the measurement to the measurement coach . 
5. Repeat steps 2-5 to get a second weight 
6. If measurements 1 and 2 differ by more than 0.25 pounds, your measurement coach will tell you 
to take two more weights. 
7. Repeat steps 2-7 for every PLAN participant 
  
Step 4: Wrapping up Assessment 
1. PLAN Coach: 
a. Thank the family and praise their efforts. 
b. Identify families that will participate in the quality measurement of height to take a 
second measurement at a later date, confirm date and time. Follow protocol for remote 
height. 
c. Instruct family to make confirm they received payment 
d. Contact PC with payment amount and family address 
e. Update site-specific tracking forms 
2. Measurement Coach: 
a. Enter data into REDCap 
i. 
Check email to see if you received the pictures of the measurements 
b. Contact PLAN Coach to notify that assessment was completed (or not completed) 

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Participant Instructions on Opening and Signing Consent Form 
Steps: 
1. Coach and participant will discuss how the consent form will be sent. 
a. I.e. Email 
i. 
Confirm email is correct and working 
2. Coach will send the consent form to the participant and confirm that the participant has indeed 
received it. 
3. Participant will open the email and download the document. 
a. Once the form is downloaded, participant will open the form 
b. The document will open up as a tab 
c. This tab CANNOT be used to sign the form 
i. 
Steps on how to sign the form will be below 
4. Participant will close the tab and instead open the consent form manually from the ‘Downloads’ 
folder on the computer 
5. To access the ‘Downloads’ folder: 
a. Open up ‘Start’ menu option 
b. Search for ‘File Explorer’ 
i. 
This icon looks like a vanilla folder 
c. Open the ‘File Explorer’ 
d. On the left hand side should be a tab labeled as ‘Quick access’ 
i. 
A drop down menu should be below ‘Quick access’ 
e. Select the ‘Downloads’ option 
f. You are now in the ‘Downloads’ folder 
6. Once in the ‘Downloads’ folder 
a. Find the name of the consent form, labeled as ‘(INSERT CONSENT FORM NAME HERE)’ 
b. Open the consent form, it should automatically open up with ‘Adobe’ 

Page 251 of 305 
 
7. To complete the consent form: 
a. There will be blue squares and rectangles which are interactive 
b. Participant will click on the blue rectangle below ‘Participant Name’ and type their name 
c. Participant will then select a box on whether they consent or do not consent 
i. 
These boxes will pop-up a check mark when clicked on 
d. Participant will then ‘Date’ the form before signing it 
i. 
Just like the ‘Name’ section of the form, click the box and write the date in 
ii. 
Format the date in as MM/DD/YYYY 
1. Click the ‘Enter’ key on your keyboard 
2. The program will then change the format of the date, this is fine 
e. Participant will then sign the document by clicking on the blue box below ‘Signature’ 
8. To sign the document is a little complicated to be sure to follow the steps below: 
a. Click on the blue box below ‘Signature’ 
b. Another window will appear on the form asking about a Digital ID 
i. 
If you already have one preset with your correct name, you may use it and and 
click the ‘Continue’ button 
1. Then click ‘Sign’ and move on to step 9 
ii. 
If you need to create a Digital ID, the steps are: 
1. There may be a button which says ‘Configure New Digital ID’ at the 
bottom of the window Click this button to go to a screen which asks you 
to ‘Select the type of Digital ID’ 
a. If there is no ‘Configure New Digital ID’ button, but instead asks 
you to ‘Select the type of Digital ID’ then this is the screen which 
you need to be on 
2. ‘Select the type of Digital ID’ window is what you want to see 
a. There should be a list of options 
b. Select the option which says ‘Create a new Digital ID’ 
c. Then click ‘Continue’ 
3. A new window will appear labeled ‘Select the Destination of the New 
Digital ID’ 
a. Two options will be there 
i. 
First option will be to save your Digital ID to your 
computer 
ii. 
Second option will be to save your Digital ID to the 
Windows Certificate Store 
b. Either option is fine, which ever the participant prefers 
i. 
PLAN Recommends to save the Digital ID to a file on 
your computer 
ii. 
However, it is up to the participant to decide which 
option is best for them 
c. Once the destination is selected, click ‘Continue’ 
d. ‘Create a self-signed Digital ID’ window will appear 

Page 252 of 305 
 
i. 
This window will ask for your name 
1. First and Last is preferred 
ii. 
The window will also ask for your email address 
1. Preferably the email address you have 
registered with PLAN 
iii. 
These two pieces of information are the only ones that 
you need to provide, all else can be ignored 
iv. 
Click ‘Continue’ once you have filled this window out 
e. ‘Save the self-signed Digital ID to a file’ window will appear 
 
i. 
Here is where you would select a file on your computer 
where the Digital ID should be stored 
ii. 
Select the ‘Browse Button’ 
iii. 
And select a file 
iv. 
PLAN Recommends that you should select the 
‘Documents’ file as for convenience purposes 
1. However, it is up to the participant to decide 
where the Digital ID should be stored 
v. 
Once you have selected the location of the file, you will 
have to give a password for security purposes of your 
Digital ID 
1. The participant is responsible for choosing the 
password and remembering this password 
2. PLAN recommends you choose a password that 
only the participant knows and keeps the 
password a secret 
vi. 
Once the password is written and rewritten on the 
second box, click ‘Save’ 
4. You have now created your Digital ID and should see your Name on the 
window that pops up 
c. Select the option which has your name on it 
d. Then click ‘Continue’ 
e. A new window will appear asking you for your password that you have previously made 
i. 
First review that all the information is correct on this screen 
ii. 
Then type the password in 
iii. 
Click ‘Sign’ 
f. Once you have clicked the ‘Sign’ button a new window will appear asking you where the 
Consent Form should be saved to 
i. 
PLAN Recommends for the document to be saved in the ‘Documents’ tab which 
can be located on the left hand side of the window that pops up, for easy access 
ii. 
However, the participant is responsible to decide where the best location to 
save this document is 
g. Once you have decide the location, click the ‘Enter’ key on your keyboard 

Page 253 of 305 
 
h. Once you have done this, your signature should appear on the document and the 
document is complete 
9. The participant will now review the consent form to make sure everything is correct 
10. The participant will then save the entire file once more by: 
a. Click the ‘File’ tab in the top left of the window 
b. A drop menu will appear 
c. Select the ‘Save’ option 
d. Your document is not saved once again 
11. The participant will now email the consent form to their coach  
If any problems arise during this process that the participant cannot solve, please contact your coach, 
who will then proceed to help and fix the issue. The coach can also reach out to the tech specialist if 
more assistance is needed. This process can be done through email or a phone call. 
 
NEED TO ASSESS COSTS AND BUDGET 
EQUIPMENT 
Equipment Cost 
Shipping Cost 
Scale 
25.00 
TBD 
Carpenters 90 degree Angle 
8.00 
TBD 
Tape measure 
5.00 
TBD 
Yard stick 
10.00 
TBD 
Total 
48.00 
TBD 
 
 
 
 
 
 
 
 

Page 254 of 305 
 
Delay of Gratification. (Delay Discounting: Secondary Aim 2) 
 
The following items are representative of the type of questions a participant may be asked to 
answer in the delay of gratification computer task. The task is adaptive and adjusts the questions 
based on participant responses, thus each participant will receive different questions. 
 
Instructions: For each of the following choices, please choose which reward you would prefer: the 
smaller reward at the time point listed, or the larger reward in the specified number of days. Please 
carefully consider each of the choices. 
 
 
1. Would you 
prefer 
$49 today 
o
r 
$60 in 89 
days? 
 
2. Would you 
prefer 
 
$47 today 
 
o
r 
 
$50 in 160 
days? 
 
3. Would you 
prefer 
 
$54 today 
 
o
r 
 
$80 in 30 
days? 
 
4. Would you 
prefer 
 
$27 today 
 
o
r 
 
$50 in 21 
days? 
 
5. Would you 
prefer 
 
$41 today 
 
o
r 
 
$75 in 20 
days? 
 
 
 
 
 

Page 255 of 305 
 
Parental Survey – Child Report. (Secondary Aim 3)  
 
Instructions: Please circle the best answer for the questions below.  
 
1. It happens that my parent/caregiver promises me a reward and then forgets about it. 
 
Never or Very Rarely 
 
Sometimes 
 
Often  
Always or Almost Always 
 
 
2. My parent/caregiver promises to get something for me, but then [s]he doesn’t do it. 
 
Never or Very Rarely 
 
Sometimes 
 
Often  
Always or Almost Always 
 
 
3. It happens that my parent/caregiver announces something (e.g., a family excursion, a visit at the 
zoo), and then it falls through. 
 
Never or Very Rarely 
 
Sometimes 
 
Often  
Always or Almost Always 
 
 
 
 
Scoring: Items are scored from 1 (never or very rarely) to 4 (always or almost always) and summed to 
create a total score. 
 
 

Page 256 of 305 
 
 
 
 
 
 
FAMILY NUTRITION & PHYSICAL ACTIVITY (FNPA) 
 
Administered at Baseline, 12 month, and 24 month assessments (DSMB approved protocol addenda, 
9.29.19). 
 
For Each Question, please select the answer that best represents your child/family 
Question 
Almost 
Never 
Sometimes 
Usually 
Almost 
Always 
1.      My child eats breakfast….   
  
  
  
  
2.      Our family eats meals together….. 
  
  
  
  
3.      Our family eats while watching 
TV… 
  
  
  
  
4.      Our family eats fast food… 
  
  
  
  
5.      Our family uses microwave or ready 
to eat foods… 
  
  
  
  
6.      My child eats fruits and vegetables at 
meals or snacks… 
  
  
  
  
7.      My child drinks soda pop or sugary 
drinks… 
  
  
  
  
8.      My child drinks low fat milk at meals 
or snacks… 
  
  
  
  
9.      Our family limits eating of chips, 
cookies, and candy… 
  
  
  
  
10.  Our family uses candy as reward for 
good behavior… 
  
  
  
  
11.  My child spends 2 hours on 
TV/games/computer per day or less… 
  
  
  
  

Page 257 of 305 
 
12.  Our family limits the amount of TV 
our child watches… 
  
  
  
  
13.  Our family allows our child to watch 
TV in their bedroom… 
  
  
  
  
14.  Our family provides opportunities for 
physical activity… 
  
  
  
  
15.  Our family encourages our child to be 
active every day… 
  
  
  
  
16.  Our family finds ways to be physically 
active together… 
  
  
  
  
17.  My child does physical activity during 
his/her free time… 
  
  
  
  
18.  My child is enrolled in sports or 
activities with a coach or leader… 
  
  
  
  
19.  Our family has a daily routine for our 
child’s bedtime… 
  
  
  
  
20.  My child gets 9 hours of sleep a 
night… 
  
  
  
  
 
             
Scoring: Add up scores for each scale (items should be scored 1, 2, 3, 4 from left to right except 
for items that are reverse coded (3, 4, 5, 7, 10, and 13), These should be scored 4, 3, 2, 1 from 
left to right. See back for Feedback. 
Family Meal Patterns                    Item 1 _________   +  Item 2    _________  =  __________ 
Family Eating Habits                    Item 3 _________   +  Item 4    _________  =  __________ 
Food Choices                                Item 5 _________   +  Item 6    _________  =  __________ 
Beverage Choices                         Item 7 _________   +  Item 8    _________  =  __________ 
Restriction / Reward                      Item 9 _________   +  Item 10  _________  =  __________ 
Screen time behavior and monitoring Item 11 _________ +  Item 12  _________  =  __________ 
Healthy Environment                         Item 13 _________ +  Item 14  _________  =  __________ 
Family Activity Involvement          
Item 15 _________ +  Item 16  _________  =  __________ 
Child Activity Involvement           
Item 17 _________ +  Item 18  _________  =  __________ 
Family Routine                                   Item 19 _________ +  Item 20  _________  =  __________ 

Page 258 of 305 
 
Total Score: ________________ 
  
 The FNPA Tool was developed at Iowa State University by Michelle Ihmels 
(mihmels@iastate.edu) and Greg Welk (gwelk@iastate.edu) in partnership with the American 
Dietetic Association. 
 
 
 

Page 259 of 305 
 
Environmental Enrichment – Parent Report. (Secondary Aim 3) 
 
Instructions: The following questions ask you about your home environment and the surrounding areas. 
Please read the instructions for each section and answer the corresponding questions. 
 
About how long would it take to get from your home to the nearest businesses or facilities listed below if 
you walked to them? Please put only one check mark (√) for each business or facility. 
 
 
1–5 min 
6-10 min 
11-20 min 
20-30 min 
30+ min 
Don’t Know 
Example:  gas station          
 
 
√ 
 
 
 
Environment 
 
 
 
 
 
 
1.  convenience/small grocery store 
 
 
 
 
 
 
2.  supermarket 
 
 
 
 
 
 
3.  hardware store 
 
 
 
 
 
 
4.  fruit/vegetable market 
 
 
 
 
 
 
5.  laundry/dry cleaners 
 
 
 
 
 
 
6.  clothing store 
 
 
 
 
 
 
7.  post office 
 
 
 
 
 
 
8.  library 
 
 
 
 
 
 
9.  elementary school 
 
 
 
 
 
 
10.  other schools 
 
 
 
 
 
 
11.  book store 
 
 
 
 
 
 
12.  fast food restaurant 
 
 
 
 
 
 
13.  coffee place 
 
 
 
 
 
 
14.  bank/credit union 
 
 
 
 
 
 
15.  non-fast food restaurant 
 
 
 
 
 
 
16.  video store 
 
 
 
 
 
 
17.  pharmacy/drug store 
 
 
 
 
 
 
18.  salon/barber shop 
 
 
 
 
 
 
19.  your job or school 
               [check here  _____   if not applicable] 
 
 
 
 
 
 
20. bus or train stop 
 
 
 
 
 
 
21. park 
 
 
 
 
 
 
22. recreation center 
 
 
 
 
 
 
23. gym or fitness facility 
 
 
 
 
 
 
 
 
For each of the following food types, please tell us whether they are RIGHT NOW in your home, 
immediately eatable, and about how much is there. (Answer yes if any of the items listed for each 
question is in your home.)  
 
● In home = the food can be in the kitchen, pantry, bedrooms, basement, garage, or other rooms 

Page 260 of 305 
 
● Child can immediately eat = Is the food in a package/container that the child is able to open, 
and/or does it require preparation that the child can do on her/his own? (Regardless of whether 
or what rules may be about your child accessing food by himself/herself) 
● How much = A little (enough for up to 2 people to eat at a snack/meal), Some (enough for 3-8 
people to eat at a snack/meal), A lot (more than a little or some) 
 
FOOD 
In home? 
Child can immed
24. fresh bananas, oranges, pineapple, melons 
Yes   No 
Yes   N
25. fresh apples, grapes, celery, lettuce 
Yes   No 
Yes  N
26. potatoes, corn on the cob, whole tomato, frozen vegetables 
Yes   No 
Yes   N
27. "100% fruit juice" 
Yes   No 
Yes   N
 
For the following electronic devices, please write down the total number in each room that work, regardles
If an electronic device has multiple functions, please list each function in the appropriate spot UNLESS it is a DVD/CD 
under DVD. However, if you have a stereo that plays CDs, tapes, and the radio, count all three o
 
General room categories are listed at the end for you to add rooms that are specific to your home that may have th
additional bedrooms, dining room, etc.).  BR stands for Bedroom. 
 
Electronics 
Kitchen 
Living 
Room 
Parent's 
BR 
Child's 
BR 
 BR #3: 
 BR 
#4: 
Other 
Room: 
_______ 
28. TVs 
  
  
  
  
  
  
  
29. VCR (not portable) 
  
  
  
  
  
  
  
30. DVD player (not portable) 
  
  
  
  
  
  
  
31. Digital TV recorders (e.g., TiVo, ReplayTV) 
  
  
  
  
  
  
  
32. Radio (not portable) can include alarm clock 
  
  
  
  
  
  
  
33. CD player (not portable) 
  
  
  
  
  
  
  
34. Tape Player (not portable) 
  
  
  
  
  
  
  
35. Desktop computer with internet access 
  
  
  
  
  
  
  
36. Desktop computer without internet access 
  
  
  
  
  
  
  
37. Video game player (e.g., Playstation, xbox) 
  
  
  
  
  
  
  
38. Telephone (non-cell phone) 
  
  
  
  
  
  
  
39. Portable CD player  
  
  
  
  
  
  
  
40. Portable Tape Player 
  
  
  
  
  
  
  
41. Portable Radio Player 
  
  
  
  
  
  
  
42. Portable MP3 player (ex: iPod) 
  
  
  
  
  
  
  
43. Portable DVD player 
  
  
  
  
  
  
  
44. Hand held videogame player (e.g., Game 
boy, Sony PSP etc.) 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
45. Laptop or portable computer 
 
 
 
 
 
 
 
Total number of electronics in each room: 
  
  
  
  
  
  
  

Page 261 of 305 
 
 
 
 
 
 
 
 
 
Which of the following things are available and in useable condition in your 
home or yard/common area? Do not include things that are buried in boxes 
(except toy boxes), buried in a closet, or in storage. Please circle either “Not 
Available” or “Available,” and then indicate whether your child commonly 
uses the item(s) If any of the items listed for each question is available, circle 
available. 
 
Activities 
Not 
Availabl
e 
Availabl
e 
If 
available, 
does your 
child 
commonl
y use this 
item? 
46. bike 
0 
1 
Yes        
No        
N/A 
47. basketball hoop (includes child size or adult 
size) 
0 
1 
Yes        
No        
N/A 
48. jump rope 
0 
1 
Yes        
No        
N/A 
49. sports equipment (e.g., balls, racquets, bats, 
sticks) 
0 
1 
Yes        
No        
N/A 
50. swimming pool (including kiddie pool) 
0 
1 
Yes        
No        
N/A 
51. roller skates, skateboard, scooter 
0 
1 
Yes        
No        
N/A 
52. fixed play equipment (e.g., swing set, play 
house, jungle gym) 
0 
1 
Yes        
No        
N/A 
53. home aerobic equipment (e.g., treadmill, 
cycle, cross trainer, stepper, rower, 
workout video or audiotapes) 
0 
1 
Yes        
No        
N/A 
54. weight lifting equipment, toning devices 
(e.g., free weights, pull up bars, exercise 
balls, ankle weights, etc.) 
0 
1 
Yes        
No        
N/A 
55. water or snow equipment (e.g., skis, skates, 
canoe, row boat, surf board, boogie board, 
windsurf board, slip-n-slide, etc.) 
0 
1 
Yes        
No        
N/A 
56. yoga/exercise mats 
0 
1 
Yes        
No        
N/A 
57. exercise, play, or recreation room 
0 
1 
Yes        
No        
N/A 

Page 262 of 305 
 
58. trampoline 
0 
1 
Yes        
No        
N/A 
 
 

Page 263 of 305 
 
59. How many books are in the home that are approximately at your child's reading level and that he/she has access to? (please che
                                ___ 0 books        ___ 1 - 10 books          ___  11 - 20 books         ___ 21 - 30 books          ___ 31 - 40 books           ___ 4
Books 
Never 
Rarely 
Sometime
60. How often does a parent or caregiver in the home read to your child? 
 
 
 
61. How often does your child read for pleasure? 
 
 
 
62. How often does your family receive magazines and/or newspapers? 
 
 
 
63. How often does a parent or caregiver take your child to a museum? 
 
 
 
64. How often does a parent or caregiver take your child to a show or   
performance? 
 
 
 
65. Are there any musical instruments in the home that your child has access to? 
Yes 
No 
66. Does your child receive lessons for singing or playing a musical instrument? 
Yes 
No 
67. Does your child engage in any other regular hobbies or activities? 
       If YES, please specify: _____________________________________________ 
Yes 
No 
 
 
 
Scoring for Environmental Enrichment: 
 
1-23: Land-Use Mix Diversity 
Responses (item scoring):  
1-5 min (5) 
6-10 min (4) 
11-20 min (3) 
20-30 min (2) 
30+ min (1) 
don’t know (1) 
Additional scoring: Tally the number of items ≤20-minute walk (either a ‘3’, ‘4’ or ‘5’ response) and call this ‘tally of 
close facilities’) 
 
24-27: Fruit and Vegetable 
Each food item can be given a total of up to 5 points (range: 0-5). Points are given – then summed to get the total 
points for that food item – based on (a) presence in the home, (b) the child being able to immediately eat the food, 
and (c) amount present: 
 
“In home?” – Yes=1, No=0 
“Child can immediately eat?” – Yes=1, No=0 
“How much is there?” – A little=1, Some=2, A lot=3 
 
28-45: Electronic Equipment 
OVERALL TOTAL = The total number of electronics in the household:  Sum the “total” row for all rooms (i.e., 
kitchen, living room, etc.), including the total for “in house (not always in 1 room).” If “total” for a given room is 
blank, code that room as 0. 
 
46-58: Physical Activity 

Page 264 of 305 
 
Each physical activity item can be given a total of 0, 1, or 2 points. Points are given – then summed to get the total 
points for that physical activity equipment item – based on availability and whether the child uses the item: 
 
“Which of the following things are available and in usable condition in your home or yard/common area?” 
 
Not available = 0, Available = 1 
 
“If available, does your child commonly use this item?” 
Yes = 1 
No = 0 
N/A = 0 
Total score = sum of physical activity item points (items 41-53)  
 
59-67: Cognitive Stimulation 
A total of 0-28 points may be awarded based on the presence of cognitively-stimulating items in the child’s home. 
These questions are scored on different scales, as follows: 
 
Item 59 (“How many books…”) 
0 books = 0 
1-10 books = 1 
11-20 books = 2 
21-30 books = 3 
31-40 books = 4 
41 or more books = 5 
 
Items 60 – 64 (“How often does a parent…”) 
Never = 0 
Rarely = 1 
Sometimes = 2 
Often = 3 
Very Often = 4 
 
Items 65 – 67 
Yes = 1 
No = 0 
Total score = sum of points awarded for items 59-67 
 
Summary Score for Environmental Enrichment Questionnaire: Sum all subscales to create a global score of non-
snack food reinforcers available to the child.  
 
 

Page 265 of 305 
 
Attitudes toward Evidence-Based Treatment. (Exploratory Aim) 
 
The following questions ask about your feelings about using new types of therapy, interventions, or 
treatments. Manualized therapy, treatment, or intervention refers to any intervention that has specific 
guidelines and/or components that are outlined in a manual and/or that are to be followed in a 
structured or predetermined way. Indicate the extent to which you agree with each item using the 
scale shown below. 
 
 
0 
Not at all 
1 
To a slight 
extent 
3 
To a moderate 
extent 
4 
To a great 
extent 
5 
To a very 
great extent 
1. I like to use new types of therapy/interventions 
to help my clients. 
 
 
 
 
 
2. I am willing to try new types of 
therapy/interventions, even if I have to follow a 
treatment manual. 
 
 
 
 
 
3. I know better than academic researchers how 
to care for my clients. 
 
 
 
 
 
4. I am willing to use new and different types of 
therapy/interventions developed by researchers. 
 
 
 
 
 
5. Research-based treatments/interventions are 
not clinically useful. 
 
 
 
 
 
6. Clinical experience is more important than 
using manualized therapy/interventions. 
 
 
 
 
 
7. I would not use manualized 
therapy/interventions. 
 
 
 
 
 
8. I would try a new therapy/intervention, even if 
it were very different from what I am used to 
doing. 
 
 
 
 
 
 
 
For the following questions if you received training in a new therapy or intervention how likely would you be to adopt 
it if: 
 
0 
Not at all 
1 
To a slight 
extent 
3 
To a moderate 
extent 
4 
To a great 
extent 
5 
To a very 
great extent 
9. It was intuitively appealing? 
 
 
 
 
 
10. It made sense to you? 
 
 
 
 
 
11. It was required by your supervisor? 
 
 
 
 
 
12. It was required by the counseling center 
director? 
 
 
 
 
 
13. It was a state requirement? 
 
 
 
 
 
14. It was being used by colleagues who were 
happy with it? 
 
 
 
 
 
15. You felt you had enough training to use it 
correctly? 
 
 
 
 
 
 
 
 

Page 266 of 305 
 
 
 
 
 
 
 
 
Scoring guide for Attitudes Towards Evidence-Based Treatment 
 
Scoring the Subscales 
The score for each subscale is created by computing a total or mean score for the items that load on a 
given subscale. For example, Items 11, 12, and 13 constitute subscale 1. 
 
Subscales  
Requirements 
Items: 11, 12, 13 
 
Appeal 
Items: 9, 10, 14, 15 
 
Openness 
Items: 1, 2, 4, 7 
 
Divergence 
Items: 3, 5, 6, 7 
 
Computing the Total Scale Score 
For the total score, all items from the Divergence subscale (Sub-scale 4) must be reverse scored before 
being used in computing the EBPAS total score. 
 
 
 

Page 267 of 305 
 
Attributes of FBT. (Exploratory Aim) 
 
Given your knowledge and understanding of FBT, please respond to the following questions. 
 
1. Using FBT in the clinic was more effective than the clinic’s existing treatment method. 
1 
 
2 
 
3 
 
4 
 
5 
Strongly Agree  
 
 
 
 
 
Strongly Disagree 
 
 
2. The content of FBT is compatible with my personal beliefs and values. 
1 
 
2 
 
3 
 
4 
 
5 
Strongly Agree  
 
 
 
 
 
Strongly Disagree 
 
 
3. FBT is useful. 
1 
 
2 
 
3 
 
4 
 
5 
Strongly Agree  
 
 
 
 
 
Strongly Disagree 
 
 
4. FBT is credible. 
1 
 
2 
 
3 
 
4 
 
5 
Strongly Agree  
 
 
 
 
 
Strongly Disagree 
 
 
5. FBT is easy to administer in the practice setting. 
1 
 
2 
 
3 
 
4 
 
5 
Strongly Agree  
 
 
 
 
 
Strongly Disagree 
 
 
6. The content of FBT is clear. 
1 
 
2 
 
3 
 
4 
 
5 
Strongly Agree  
 
 
 
 
 
Strongly Disagree 
 
 
7. The content of FBT is relevant to my work as a medical treatment provider. 
1 
 
2 
 
3 
 
4 
 
5 
Strongly Agree  
 
 
 
 
 
Strongly Disagree 
 
 
8. FBT can be experimented without requiring an extensive involvement. 
1 
 
2 
 
3 
 
4 
 
5 
Strongly Agree  
 
 
 
 
 
Strongly Disagree 
 
 
9. FBT can be adapted or modified to suit the needs of the interventionist. 
1 
 
2 
 
3 
 
4 
 
5 
Strongly Agree  
 
 
 
 
 
Strongly Disagree 

Page 268 of 305 
 
 
 
10. The benefits of using FBT with my patients are obvious/visible. 
1 
 
2 
 
3 
 
4 
 
5 
Strongly Agree  
 
 
 
 
 
Strongly Disagree 
 
11. The evidence regarding the impact of FBT is available. 
1 
 
2 
 
3 
 
4 
 
5 
Strongly Agree  
 
 
 
 
 
Strongly Disagree 
 
 
 
Scoring for Attributes of FBT: 
The scale is composed of five subscales: Relative advantage (1), compatibility (2-4), complexity (5-7), 
trialability (e.g., the potential to experiment with an innovation before implementing; 8-9), and 
observability (10-11). If the subscale has more than one item, the subscale score is created by 
computing a total or mean score for the items that load on a given subscale. 
 
 
 

Page 269 of 305 
 
Intended Adoption. (Exploratory Aim) 
 
How likely is it that you will use this model of having a co-located interventionist to treat children who 
are overweight/obese as a result of your experiences with an FBT interventionist within your practice? 
 
0%_____________________________________________________________100% 
 
 
Scoring: Physicians will place an X on the electronic line to signal their percentage likelihood.  
 
 
 

Page 270 of 305 
 
Family Demographics. (Descriptor) 
 
Please put an X in the appropriate box for your mother’s, your father’s, your spouse / partner’s, and 
your level of school completed and occupation. If the exact occupation is not listed, please put an X by 
the category that most closely matches the individual’s occupation, and if a parent is retired, please 
indicate their most recent occupation. If you grew up in a single parent home, mark only your one 
parent, and mark “N/A” for the other parent. If you are neither married nor partnered, mark “N/A” for 
Spouse/Partner. 
 
A. Level of School completed 
Mother 
Father 
Spouse/Partner 
You 
(N/A) 
 
 
 
 
Less than 7th grade 
 
 
 
 
Junior high / Middle school (up to 9th grade) 
 
 
 
 
Partial high school (10th or 11th grade) 
 
 
 
 
High school graduate 
 
 
 
 
Partial college (at least one year) 
 
 
 
 
College education 
 
 
 
 
Graduate degree 
 
 
 
 
 
B. Occupation 
Mother 
Father 
Spouse/Partner 
You 
(N/A or stay-at-home parent) 
 
 
 
 
Day laborer, janitor, house cleaner, farm worker, food counter 
sales, food preparation worker, busboy. 
 
 
 
 
Garbage collector, short-order cook, cab driver, shoe sales, 
assembly line workers, masons, baggage porter. 
 
 
 
 
Painter, skilled construction trade, sales clerk, truck driver, cook, 
sales counter, or general office clerk. 
 
 
 
 
Automobile mechanic, typist, locksmith, farmer, carpenter, 
receptionist, construction laborer, hairdresser. 
 
 
 
 
Machinist, musician, bookkeeper, secretary, insurance sales, 
cabinet maker, personnel specialist, welder. 
 
 
 
 
Supervisor, librarian, aircraft mechanic, artist or artisan, 
electrician, administrator, military enlisted personnel, buyer. 
 
 
 
 
Nurse, skilled technician, medical technician, counselor, 
manager, police or fire personnel, financial manager, 
physical/occupational/speech therapist. 
 
 
 
 
Mechanical/nuclear/electrical engineer, educational 
administrator, veterinarian, military officer, elementary/high 
school/special education teacher. 
 
 
 
 
Physician, attorney, professor, chemical/aerospace engineer, 
judge, CEO, senior manager, public official, psychologist, 
pharmacist, accountant. 
 
 
 
 
 
C. Please indicate whether your current household income is derived from: (circle all that apply) 
 
1. One income 
2. Two incomes 
3. Unemployment 
4. Public assistance 
5. Child support / alimony 
6. Other: _______________________  

Page 271 of 305 
 
 
D. Please circle your current annual household income: 
1. Under $9,999                      
9. $80,000 - $89,999 
 
 
17. $170,000 - $179,999 
2. $10,000 - $19,999              
10. $90,000 - $99,999 
 
 
18. $180,000 - $189,999 
3. $20,000 - $29,999               
11. $100,000 - $119,999  
19. $190,000 - $199,000 
4. $30,000 - $39,999              
12. $120,000 - $129,999  
20. Over $200,000 
5. $40,000 - $49,999              
13. $130,000 - $139,999  
 
6. $50,000 - $59,999 
 
14. $140,000 - $149,999 
7. $60,000 - $69,999 
 
15. $150,000 - $159,999 
8. $70,000 - $79,999 
 
16. $160,000 - $169,999 
 
 
E. Please circle the ethnic group(s) that YOU identify with (please circle all that apply): 
 
1. American Indian or Alaskan Native 
2. Asian 
3. Native Hawaiian or Other Pacific Islander 
4. Black or African American, not of Hispanic origin 
5. White or Caucasian, not of Hispanic origin 
6. Hispanic or Latino 
7. Other (please specify): ___________________________  
 
F. Please circle the ethnic group(s) that your CHILD most identifies with (please circle all that apply): 
 
1. American Indian or Alaskan Native 
2. Asian 
3. Native Hawaiian or Other Pacific Islander 
4. Black or African American, not of Hispanic origin 
5. White or Caucasian, not of Hispanic origin 
6. Hispanic or Latino 
7. Other (please specify): ___________________________  
 
G. Think of this ladder as representing where people stand in the United States. 
 
At the top of the ladder are the people who are the best off—those who have the most money, the most 
education, and the most respected jobs. At the bottom are the people who are the worst off—who have the least 
money, least education, and the least respected jobs or no job. The higher up you are on this ladder, the closer you 
are to the people at the very top; the lower you are, the closer you are to the people at the very bottom. 
 
Where would you place yourself on this ladder? 

Page 272 of 305 
 
Please place a large “X” on the rung where you think you stand at this time in your life, relative to other people in 
the United States.  
 
 

Page 273 of 305 
 
Scoring guide for Participant Demographics: 
 
Parts A and B: 
The parent indicates level of school completed by their Mother, their Father, their Spouse / Partner, and 
themselves. If the parent grew up in a single-parent home, they only provide information for their one parent. If 
the parent is not married and does not have a partner, they do not provide information on a spouse. If they are a 
full-time student, they only circle scores for their parents. Point values are assigned depending on the level of 
school completed for each person:  
 
Level of School Completed  
Mother 
Father 
Spouse 
You 
Less than 7th grade  
3  
3  
3  
3  
Junior high / Middle school (9th grade)  
6  
6  
6  
6  
Partial high school (10th or 11th grade)  
9  
9  
9  
9  
High school graduate  
12  
12  
12  
12  
Partial college (at least one year)  
15  
15  
15  
15  
College education  
18  
18  
18  
18  
Graduate degree  
21  
21  
21  
21  
 
The parent indicates the occupation for their Mother, their Father, their Spouse / Partner, and themselves. If the 
parent grew up in a single-parent home, they only provide information for their one parent. If the parent is not 
married and does not have a partner, they do not provide information on a spouse. If they were a full-time 
student, they only circle scores for their parents. If a parent is retired, they use their most recent occupation. Point 
values are assigned depending on the occupation for each person: 
 
Occupation 
Mother 
Father 
Spouse 
You 
Day laborer, janitor, house cleaner, farm worker, food counter 
sales, food preparation worker, busboy.  
5  
5  
5  
5  
Garbage collector, short-order cook, cab driver, shoe sales, 
assembly line workers, masons, baggage porter.  
10  
10  
10  
10  
Painter, skilled construction trade, sales clerk, truck driver, cook, 
sales counter or general office clerk.  
15  
15  
15  
15  
Automobile mechanic, typist, locksmith, farmer, carpenter, 
receptionist, construction laborer, hairdresser.  
20  
20  
20  
20  
Machinist, musician, bookkeeper, secretary, insurance sales, 
cabinet maker, personnel specialist, welder.   
25  
25  
25  
25  
Supervisor, librarian, aircraft mechanic, artist and artisan, 
electrician, administrator, military enlisted personnel, buyer.  
30  
30  
30  
30  
Nurse, skilled technician, medical technician, counselor, manager, 
police and fire personnel, financial manager, physical, 
occupational, speech therapist.  
35  
35  
35  
35  
Mechanical, nuclear, and electrical engineer, educational 
administrator, veterinarian, military officer, elementary, high 
school and special education teacher.  
40  
40  
40  
40  
Physician, attorney, professor, chemical and aerospace engineer, 
judge, CEO, senior manager, public official, psychologist, 
pharmacist, accountant.  
45  
45  
45  
45  

Page 274 of 305 
 
 
Level of School Completed 
1  
Parents’ score: If they grew up with both parents, add “Mother” + “Father” and divide by 2. If 
they grew up with one parent, enter that score to the right.  
 
2  
If they are married or partnered, add “Spouse” + “You” and divide by 2. If they live alone/are not 
married/do not have a partner, enter the “You” score to the right. If they are a full-time student, 
leave this blank.  
 
3  
Double the score from line 2. If they are a full-time student, leave this blank.  
 
4  
If they are a full-time student, enter only their parents’ score. Otherwise, add line 1 and line 3, 
then divide by 3 (three) for a TOTAL EDUCATION.  
Note: Score should be between 3 and 21  
 
 
Occupation Scoring 
1  
If they grew up with both parents, add “Mother” + “Father” and divide by 2. If they grew up with 
one parent, enter that score to the right.  
 
2  
If they are married or partnered, add “Spouse” + “You” and divide by 2. If they live alone/are not 
married/do not have a partner, enter the “You” score to the right. If they are a full-time student, 
leave this blank.  
 
3  
Double the score from line 2. If they are a full-time student, leave this blank.  
 
4  
If they are a full-time student, enter only their parents’ score. Otherwise, add line 1 and line 3, 
then divide by 3 (three) for TOTAL OCCUPATION.  
Note: Score should be between 5 and 45  
 
 
TOTAL SES Score (A & B) 
Add TOTAL EDUCATION + TOTAL OCCUPATION.  Note: Score should be between 8 and 66  
 
Parts C-F: 
Individual stand-alone items 
 
Part G: 
The ladder contains 10 rungs and responses will be scored based on location of the “X.” The bottom rung is given 
the score of 1 and each subsequent rung progresses in numerical order until the top rung, which is given the score 
of 10.  
 
 
 

Page 275 of 305 
 
Participant Acceptability: Parent. (Descriptor) 
 
We are interested in your honest opinions regarding the services you have received through the study, 
whether they are positive or negative. Please answer all questions. 
 
 
1. How would you rate the quality of service you received? 
4 
 
 
3 
 
 
2 
 
 
1 
                      Excellent 
                      Good 
 
             Fair 
                         Poor 
 
 
2. Did you get the kind of service you wanted? 
1 
 
 
2 
 
 
3 
 
 
4 
No, definitely not 
    No, not really       
Yes, generally  
Yes, definitely 
 
 
3. To what extent has our program met your needs? 
4 
 
 
3 
 
 
2 
 
 
1 
 
Almost all of my  
Most of my needs 
Only a few of my 
     None of my needs 
   needs have been met 
   have been met           needs have been me                have been met 
 
 
4. If a friend were in need of similar help, would you recommend the treatment to him/her? 
1 
 
 
2 
 
 
3 
 
 
4 
No, definitely not 
    No, not really             Yes, generally  
Yes, definitely 
 
 
5. How satisfied are you with the amount of help you received? 
1 
 
 
2 
 
 
3 
 
 
4 
 
Quite dissatisfied                Indifferent or                    Mostly satisfied             Very satisfied              
Mildly dissatisfied 
 
 
6. Have the services you received helped you deal more effectively with your problems? 
4 
 
 
3 
 
 
2 
 
 
1 
    Yes, they helped 
     Yes, they helped 
   No, they really 
No, they seemed to  
                    a great deal          somewhat                      didn’t help                 make things worse 
 
 
7. In an overall, general sense, how satisfied are you with the service you received? 
1 
 
 
2 
 
 
3 
 
 
4 
Very satisfied 
 
Mostly satisfied                   Indifferent or              Quite dissatisfied 
 
 
 
 
 
 
Mildly dissatisfied 
 
8. If you were to seek help again, would you use the treatment you received again? 
1 
 
 
2 
 
 
3 
 
 
4 
No, definitely not 
    No, not really                 Yes, generally                  Yes, definitely 
 

Page 276 of 305 
 
 
9. I would follow through if my child was referred outside this clinic for childhood obesity 
treatment. 
1 
 
2 
 
3 
 
4 
 
5 
Strongly Agree  
 
 
 
 
 
Strongly Disagree 
 
 
10. I am comfortable having my child receive obesity treatment at the clinic. 
1 
 
2 
 
3 
 
4 
 
5 
Strongly Agree  
 
 
 
 
 
Strongly Disagree 
 
 
11. My child was treated the same as other people who get care at the clinic. 
1 
 
2 
 
3 
 
4 
 
5 
Strongly Agree  
 
 
 
 
 
Strongly Disagree 
 
 
12. I prefer my child to receive obesity treatment services at the location where he/she receives 
medical care. 
1 
 
2 
 
3 
 
4 
 
5 
Strongly Agree  
 
 
 
 
 
Strongly Disagree 
 
 

Page 277 of 305 
 
Participant Acceptability: Child. (Descriptor) 
 
What do you think about the care we gave you? Was it good or bad? Tell us by answering all of the 
questions below. Please be honest! 
 
1. Did you like the care we gave you? 
 
4 
 
 
3 
 
 
2 
 
 
1 
                      Very Good           
           Good 
 
            Bad 
                      Very Bad 
 
2. Did you get the kind of care you wanted? 
 
1 
 
 
2 
 
 
3 
 
 
4 
   No, not at all   
   No, not really      
     Yes, sort of  
 Yes, I really did 
 
3. Did we help with all the things you wanted? 
 
4 
 
 
3 
 
 
2 
 
 
1 
All of the things  
Most of the things  
Some of the things  
None of the things  
     I wanted 
 
     I wanted 
 
     I wanted 
 
     I wanted 
 
4. If a friend needed care like you did, would you tell them to see us? 
 
1 
 
 
2 
 
 
3 
 
 
4 
No, not at all 
 No, not really  
   Yes, sort of 
 
   Yes, I would 
 
5. Were you happy with all of the kinds of help we gave you? 
 
1 
 
 
2 
 
 
3 
 
 
4 
 
     Very Happy        
          Happy 
      
 Kind of happy                Kind of unhappy 
 
6. Has the care we gave you helped with your problems? 
 
4 
 
 
3 
 
 
2 
 
 
1 
Yes, it helped a lot  
Yes, it helped a little 
   No, it didn’t help 
No, it made it worse 
 
7. How happy are you with the care we gave you? 
 
1 
 
 
2 
 
 
3 
 
 
4 
Very Happy  
 
       Happy  
 
Kind of happy   
Kind of unhappy 
 
8. Would you want us to help you again if you needed it? 
 
1 
 
 
2 
 
 
3 
 
 
4 
No, not at all  
 
No, not really   
Yes, sort of  
 
Yes, I would 
 

Page 278 of 305 
 
Provider Demographics. (Descriptor) 
 
Please respond to the following questions. For the questions with space to mark your answer (e.g., place 
an “X”), please mark all that apply. For any responses that you mark as “Other,” please write in your 
response. 
 
1. What is your age? _____ years 
 
2. What is your race? (Check all that apply.) 
__ American Indian or Alaskan 
__ Asian or Asian American 
 
__ African American or Black 
 
__ Caucasian or White  
 
__ Native Hawaiian or Pacific Islander 
__ Other: ________________________ 
 
3. What is your ethnicity? 
__ Hispanic 
__ Non-Hispanic 
 
4. What is your gender? 
__ Male 
__ Female 
__ Other: ________________________ 
 
5. What is your highest degree? 
__ MD 
__ NP 
__ PA 
__ DO 
__ Other: ________________________ 
 
6. What is your job title? ___________________________________________ 
 
7. How many years have you worked at the clinic? ______________________ 
 
8. How many years have you been in practice? _________________________ 
 
9. What is your specialty? __________________________________________ 
 
10. Before your enrollment in this study: 
 
a) Were you aware of the American Academy of Pediatrics Guidelines for Assessing Obesity? 
Yes 
 
No 
 
If yes, how did you learn about these guidelines? 
 
b) Were you aware of Family-based Behavioral Weight Loss Treatment for Children with Obesity? 

Page 279 of 305 
 
Yes 
 
No 
 
If yes, how did you learn about this treatment? 
 
11. Have you had experience(s) with weight-related counseling for obesity or behavioral intervention 
for obesity (including weight control/weight management)? If yes, what type of experience(s)? 
(Check all that apply.) 
 
__ I have not had any experience with weight-related counseling or behavioral interventions for      
obesity  
 
__Yes, I have observed weight-related counseling or behavioral interventions for obesity 
 
__Yes, I have delivered weight-related counseling or behavioral interventions for obesity 
 
__Yes, I have received weight-related counseling or behavioral interventions for obesity 
 
__Yes, other: _____________________________________________________________ 
 
________________________________________________________________________ 
 
12. Have you had experience(s) with other counseling or behavioral interventions (i.e., not related to 
weight or obesity)? If yes, what type of experience(s)? (Check all that apply.) 
 
 
 
__ I have not had any experience with counseling interventions or behavioral interventions  
 
__Yes, I have observed counseling interventions or behavioral interventions for: ________ 
 
               _________________________________________________________________________ 
 
__Yes, I have delivered counseling interventions or behavioral interventions for: ________ 
 
               _________________________________________________________________________ 
 
__Yes, I have received counseling interventions or behavioral interventions for: _________ 
 
               _________________________________________________________________________ 
 
__Yes, other: ______________________________________________________________ 
 
               _________________________________________________________________________ 
 
 
 

 
 
 
 
Page 280 of 305 
 
Provider Usual Care Survey. (Descriptor) 
 
 
At well child visits, I (check all that apply): 
 
Accurately measure height and weight of child 
 
o Calculate BMI 
o Plot BMI on BMI growth chart 
o Make a weight category diagnosis using BMI percentile 
 
 
 
Define BMI and explain consequences of high BMI to families 
 
Perform a thorough physical examination 
 
o Measure blood pressure 
o Order lab tests 
 
 
Take a family history, including: 
 
o Obesity 
o Type 2 diabetes 
o Cardiovascular disease 
o Early deaths from heart disease or stroke 
 
 
 
 
Assess diet and physical activity behaviors 
 
o Sugar-sweetened beverages 
o Servings of fruits and vegetables per day 
o Daily eating patterns (e.g., consumption of breakfast, portion sizes, family meals) 
o Frequency of fast food or restaurant eating 
o Amount of moderate to vigorous physical activity per day 
o Screen time 
 
 
 
 
 
 
Provide positive feedback for behavior(s) in optimal range 
 
o Elicit response to feedback 
o Reflect/probe  
 
 
Provide neutral feedback for behavior(s) not in optimal range 
 
o Elicit response to feedback 
o Reflect/probe 
 
 
Query which, if any, of the behaviors the family may be interested in changing or which might be 
easiest to change 
 
Agree on a target behavior 
 
Assess readiness to change 
 
Assess self-efficacy to change 
 
Collaborate possible next steps to change 
 
Develop and write a plan for change 
 
Summarize change plan and provide positive feedback 

 
 
 
 
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Offer referral to a more intensive behavioral weight management intervention if necessary 
 
Agree to follow up within a certain amount of time (e.g., 6 months from today) 
 
 

 
 
 
 
Page 282 of 305 
 
24 Month Survey – Parent (DSMB approved protocol addenda, 9.29.19).  
 
 
 
 
Date:______________ 
 
1. Which site are you at? *this is required for branching logic for the next question* 
a. Buffalo 
b. Rochester 
c. Columbus 
d. St. Louis 
2. Who was your most recent Coach? * list of each site’s Coaches will appear with a “Don’t Know” option * 
3. Were you ever assigned another Coach? 
a. Yes 
b. No 
4. Who else was your Coach? * list of each site’s Coaches will appear with a “Don’t Know” option * 
 
For the following questions, please CIRCLE the number that matches how much you agree with each statement. 
 
Strongly 
Disagree 
Disagree 
Neither 
Agree Nor 
Disagree 
Agree 
Strongly 
Agree 
5. This program changed the healthy 
habits of my family members who 
were not enrolled. 
1 
2 
3 
4 
5 
6. If a friend were in need of similar 
help, I would recommend this 
program to him/her. 
1 
2 
3 
4 
5 
7. This program has met my needs. 
1 
2 
3 
4 
5 
 
Some people have made the following statements about their food situation. Please answer whether the statements 
were OFTEN, SOMETIMES, or NEVER true for you and your household in the last 12 months. 
 
8. Within the past 12 months, you worried that your food would run out before you got money to buy more.  
• 
Often true 
• 
Sometimes true 
• 
Never true 
• 
Don’t know, Refuse 
 
9. Within the past 12 months, the food you bought just didn't last and you didn't have money to get more. 
• 
Often true 
• 
Sometimes true 
• 
Never true 
• 
Don’t know, Refuse 
 
The following are behaviors that people may or may not use to support their healthy lifestyle. For each of the following behaviors: 
 
Please choose how often YOU use them on a scale from Never to Daily: 
 
Never 
 
Yearly  
Monthly 
Weekly  
Daily 
0 
 
1 
 
2 
 
3 
 
4 
Please choose how helpful YOU find them on a scale from Slightly Helpful to Very Helpful: 

 
 
 
 
Page 283 of 305 
 
 
N/A 
 
Slightly Helpful 
 
Somewhat Helpful 
 
Moderately Helpful 
 
Very Helpful 
0 
 
1 
 
 
 
2 
 
 
 
3 
 
 
4 
 
If you do not use the behavior, you may write “0” for N/A in the helpfulness column. 
 
How Often? 
How
10. Using a food journal or food diary (Habit Book) 
 
 
11. Tracking the number of Calories you eat 
 
 
12. Increasing the number of low-calorie, green, leafy foods you eat, like spinach or kale (GREEN 
foods) 
 
 
13. Decreasing the number of high-calorie, low-nutrient foods you eat, like candy or pizza (RED 
foods) 
 
 
14. Decreasing the number of high-calorie, low-nutrient drinks you drink, like soda (RED drinks) 
 
 
15. Increasing your moderate to intense physical activity, like walking or biking (GREEN physical 
activity) 
 
 
16. Weighing yourself 
 
 
17. Praising your child 
 
 
18. Planning meals ahead of time 
 
 
19. Having a Daily Check-In with your child about what they are eating 
 
 
20. Decreasing recreational screen time 
 
 
21. Sleeping for 7-9 hours a night 
 
 
22. Using a rewards or points system to encourage healthy behaviors (Reinforcement System) 
 
 
23. Engaging in physical activity with your family 
 
 
24. Engaging in healthy eating with your friends 
 
 
25. Engaging in physical activity with your friends 
 
 
26. Accessing community healthy eating resources, like a farmer’s market 
 
 
27. Accessing community physical activity resources, like a fun run or walk 
 
 
28. How helpful were the PLAN sessions for you? 
 
 
29. How helpful was the entire PLAN program for you? 
 
 
 
For each of the following questions, please circle the best answer.  
 
30. Avocados, marshmallows, and black olives are a part of which food group? 
a. Proteins 
b. Fats, Oils, Sweets & Others  
a. Condiments, Dressings, & Other Ingredients   
31. Which of the following are examples of the lowest calorie foods with the most nutrition (GREEN foods)? 
a. Green (non-starchy) vegetables 
b. Fruit 
c. Dairy 
d. Beans/legumes 
32. Why is a food journal (Habit Book) important for weight loss and making healthy food choices? 
a. It helps you to be more aware about what you are eating 
b. It helps you to be more accountable about what you are eating 
c. It is not really that important for weight loss or healthy food choices 
d. A and B 

 
 
 
 
Page 284 of 305 
 
33. The benefits of planning meals ahead of time include: 
a. Allowing time for food preparation and cooking 
b. Budgeting for groceries 
c. Knowing the number of calories in meals 
d. All of the above 
34. Aerobic exercises (moderate to intense physical activity) does not burn a lot of calories and is not good for weight 
loss. 
a. True 
b. False 
35. Once your child has learned a new behavior, you can slowly decrease the amount of praise for that behavior. 
a. True 
b. False 
36. Which of the following methods can be used to remove distractions when eating? 
a. Eat when sitting down 
b. Eat in the same place 
c. Turn the television and laptop off 
d. All of the above 
37. When you give children a choice about an activity, they are more likely to enjoy that activity. 
a. True 
b. False 
38. Which of the following is a way to shop healthy on a budget? 
a. Meal planning 
b. Making a grocery list 
c. Using leftovers 
d. All of the above 
39. Which of the following are examples of activities that only burn limited calories (RED activities)?  
a. Sending text messages 
b. Watching a movie on your tablet 
c. Sitting and playing a video game 
d. All of the above 
40. A good sleeping area includes all of the following EXCEPT: 
a. Comfort 
b. Low noise level 
c. Bright room lights 
d. No distractions 
41. The portion sizes in many restaurants will make up two or more meals. 
a. True 
b. False 
42. How can you decrease the chance of relatives giving your child high-calorie, low-nutrient foods like candy (RED 
foods)? 
a. Give your child high-calorie, low-nutrient foods before they go over to a relative’s house 
b. Threaten to ground your child if they accept any high-calorie, low-nutrient foods 
c. Give your relatives examples of non-food items that they can give your child  
d. Tell your child it’s okay for them to eat high-calorie, low-nutrient foods because it is like they’re on 
vacation 
43. Which of the following will increase the chance of a person staying committed to a physical activity? 
a. Paying for an exercise class 
b. Buying new exercise clothes  

 
 
 
 
Page 285 of 305 
 
c. Buying new workout music 
d. Doing it with a buddy 
44. Parents can increase their child’s concern about body shape by doing which of the following? 
a. Talking about their own concerns about their body shape in front of their children. 
b. Ignoring any concerns about their body shape they might have in front of their children. 
c. Downplaying their own concerns about their body shape in front of their children. 
d. All of the above. 
 
Is there anything about the program that you really liked or you thought worked really well for your family? 
__________________________________________________________________________________________________
__________________________________________________________________________________________________
__________________________________________________________________________________________________
__________________________________________________________________________________________________
_ 
__________________________________________________________________________________________________
_________________________________ 
Is there anything about the program that you would change or would recommend for future programs that would make 
it work better for your family? 
__________________________________________________________________________________________________
__________________________________________________________________________________________________
__________________________________________________________________________________________________

 
 
 
 
Page 286 of 305 
 
__________________________________________________________________________________________________
_ 
__________________________________________________________________________________________________
_________________________________ 
 
 

 
 
 
 
Page 287 of 305 
 
24 Month Survey – Child (DSMB approved protocol addenda, 9.29.19).  
 
 
 
 
Date:______________ 
 
For these questions, please CIRCLE how much you agree with the sentence: 
 
 
Strongly 
Disagree 
Disagree 
Neither 
Agree Nor 
Disagree 
Agree 
Stron
Agre
45. This program helped my family members (like 
your other parent or your brother or sister) 
who were not a part of the program. 
1 
2 
3 
4 
5 
46. If a friend needed the same help as me, I 
would tell them to try the PLAN program. 
1 
2 
3 
4 
5 
47. This program helped me. 
1 
2 
3 
4 
5 
  
For each of the following questions, please circle the best answer. 
 
48. Avocados, marshmallows, and black olives are a 
part of which food group? 
a. Proteins. 
b. Fats, Oils, and Sweets. 
c. Condiments and Dressings.   
49. Which of the following are examples of the lowest 
calorie foods with the most nutrition (GREEN 
foods)? 
a. Green (non-starchy) vegetables. 
b. Fruit. 
c. Dairy. 
d. Beans/legumes. 
50. Why is a food journal (Habit Book) important for 
weight loss and making healthy food choices? 
a. It helps you really think about what you 
are eating. 
b. It helps you to track the foods you are 
having throughout the day. 
c. It is not really that important for weight 
loss or healthy food choices. 
d. A and B. 
51. A good thing about planning ahead for meals is: 
a. Allowing time for you and your parent 
to prepare food. 
b. Having healthy meals already chosen. 
c. Knowing the calorie content of meals. 
d. All of the above. 
52. Aerobic exercises (medium to intense activity) do 
not burn a lot of calories and are not good for 
weight loss. 
a. True 
b. False 
53. The best rewards or reinforcers are: 
a. Something you want. 
b. Not food, money, or sitting activities. 
c. Special.  
54. All of the above. When you are eating, you should: 
a. Watch television. 
b. Play on your tablet. 
c. Just eat. 
d. None of the above. 
e. All of the above. 
55. You want to eat foods that are low in: 
a. Fat. 
b. Fiber. 
c. Protein. 
d. Color. 
56. Instead of drinking soda, a healthier option is: 
a. Diet soda. 
b. Water with fruit. 
c. Juice. 
d. Iced tea. 

 
 
 
 
Page 288 of 305 
 
57. Which of the following are examples of activities 
that only burn limited calories (RED activities)?  
a. Watching television. 
b. Watching a movie on your tablet. 
c. Playing a video game while sitting. 
d. All of the above 
58. Why might fast food restaurants be unhealthy? 
a. Fast food is high in calories. 
b. Fast food is high in fat. 
c. Fast food restaurants usually do not 
offer a lot of healthy options. 
d. All of the above. 
 
 
59. A bedtime routine could include which of the 
following? 
a. A bath. 
b. Reading a book. 
c. Brushing teeth. 
d. All of the above. 
60. How could you tell your friends about your healthy 
habits? 
a. Give your friends examples of medium 
to intense activity (GREEN physical 
activity) that they can do with you. 
b. Give your friends examples of low-
calorie foods (GREEN foods) that they 
can eat every day. 
c. Tell them that you can only eat high-
calorie foods (RED foods) when you are 
playing at their houses. 
d. Both A and B. 
61. Which of the following is a benefit of planning 
physical activities to do with your friends during 
get-togethers? 
a. You can strengthen friendships with 
your healthy friends. 
b. It helps you and your friend to feel 
good. 
c. It makes it easier to make healthy 
activity choices. 
d. All of the above. 
62. If you have a positive body image, you think which 
of the following? 
a. That your body is good. 
b. That your body is valuable. 
c. That you feel proud of what your body 
can do. 
d. All of the above. 
 
 
 
 
 
 
The following are behaviors that people may or may not use to support their healthy lifestyle. For each of the following 
behaviors: 
 
Please choose how often YOU use them on a scale from Never to Daily: 
 
Never  
Yearly  
Monthly 
Weekly  
Daily 
0 
 
1 
 
2 
 
3 
 
4 
 
Please choose how helpful YOU find them on a scale from Slightly Helpful to Very Helpful: 
 
N/A  
 
Slightly Helpful  
Somewhat Helpful 
 
Moderately Helpful 
 
Very Helpful 
0 
 
1 
 
 
 
2 
 
 
 
3 
 
 
4 
 
If you do not use the behavior, you may write “0” for N/A in the helpfulness column. 

 
 
 
 
Page 289 of 305 
 
 
 
How Often? 
How
63. Using a food journal where you write down what you ate every day (Habit Book) 
 
 
64. Writing down the number of Calories you eat 
 
 
65. Increasing the number of low-calorie, green, leafy foods you eat like spinach or kale (GREEN 
foods) 
 
 
66. Decreasing the number of high-calorie, low-nutrient foods you eat like candy or pizza (RED 
foods) 
 
 
67. Decreasing the number of high-calorie, low-nutrient drinks you drink like soda (RED drinks) 
 
 
68. Increasing your medium to intense physical activity like walking or biking (GREEN physical 
activite) 
 
 
69. Weighing yourself 
 
 
70. Getting praise from your parent 
 
 
71. Having a Daily Check-In with your parent about what you are eating 
 
 
72. Decreasing screen time 
 
 
73. Sleeping for 9-11 hours a night 
 
 
74. Getting rewards or points (reinforcers) for doing healthy behaviors 
 
 
75. Doing physical activity with your family 
 
 
76. Eating healthy with your friends 
 
 
77. Doing physical activity with your friends 
 
 
78. How helpful were the PLAN sessions for you? 
 
 
79. How helpful was the PLAN program for you? 
 
 
 
Is there anything about the program that you really liked or you thought worked really well for your 
family? 
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________ 

 
 
 
 
Page 290 of 305 
 
_____________________________________________________________________________________
______________________________________________ 
 
Is there anything about the program that you would change, or would recommend for future programs 
that would make it work better for your family? 
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________ 
 
 

 
 
 
 
Page 291 of 305 
 
Coach Demographics Survey (This change was made on 7.25.19 prior to review and approval by the 
DSMB, DSMB approved protocol addenda on 9.29.19). 
 
Please complete the survey below. Thank you! 
 
Which Site are you from?  
● Buffalo 
● Columbus 
● Rochester 
● St Louis 
 
Which Coach are you, A,B,C?  
● A 
● B 
● C 
 
What is your age? __________________________________ 
 
How would you describe your race?  
● Native American Indian or Alaskan 
● Asian or Asian American 
● African American or Black 
● Caucasian or White 
● Native Hawaiian or Pacific Islander 
● Other or Multi-racial: 
● Refused 
Please describe: __________________________________ 
 
What is your ethnicity?  
● Hispanic or Latina/o 
● Non-Hispanic or Latina/o 
 
What is your sex:  
● Female 
● Male 
● Other 
● Refused 
 
What is your job title? __________________________________ 
 
 

 
 
 
 
Page 292 of 305 
 
BEFORE YOUR ENROLLMENT AND PARTICIPATION IN THIS STUDY: 
 
Were you aware of the American Academy of Pediatrics Guidelines for Assessing Obesity?  
A. Yes 
B. No 
 
If yes, how did you learn about these guidelines? __________________________________ 
 
Were you aware of Family-Based Behavioral Weight Loss Treatment for Children with Obesity?  
• Yes 
• No 
 
If yes, how did you learn about this treatment? __________________________________ 
 
Have you had experience(s) with weight-related counseling or behavioral intervention for 
obesity (including weight control or weight management)? 
• Yes  
• No 
 
If yes, what type of experience(s)? Check all that apply.  
• Yes, I have observed weight-related counseling or behavioral interventions for obesity. 
• Yes, I have delivered weight-related counseling or behavioral interventions for obesity. 
• Yes, I have received weight-related counseling or behavioral interventions for obesity. 
• Yes, other, please describe: 
Other, please describe: 
__________________________________________ 
Have you had experience(s)with other counseling or behavioral interventions (i.e., not related 
to weight gain or obesity)? 
• Yes  
• No 
 
What type of experience(s) have you had with other counseling or behavioral interventions 
(i.e., not related to weight gain or obesity)? Check all that apply: 
• Yes, I have observed counseling interventions or behavioral interventions. 
• Yes, I have delivered counseling interventions or behavioral interventions. 
• Yes, I have received counseling interventions or behavioral interventions. 
• Yes, Other, please describe. 
 
Please describe the type of experience you have: 
_________________________________________ 
 
 
 

 
 
 
 
Page 293 of 305 
 
Coach Treatment Knowledge (This change was made on 7.25.19 prior to review and approval by the 
DSMB, DSMB approved protocol addenda on 9.29.19). 
 
Please complete the survey below. Thank you! 
 
For a child, overweight is defined as ____ for age and sex. 
A. Weight-for-height ratio >85th percentile 
B. Weight-for-height ratio >99th percentile 
C. Body mass index (BMI) percentile of 85th to 94th 
D. BMI > 90th percentile 
 
For a child, obesity is defined as _______ for age and sex.  
A. Weight-for-height ratio >95th percentile 
B. Weight-for-height ratio >99th percentile 
C. BMI >99th percentile 
D. BMI> 95th percentile 
 
At what age should BMI begin being calculated, and how often should BMI be calculated?  
A. At age 2, every year 
B. At age 2, every well-child visit 
C. Overweight or obese children, every other year 
D. All children every other year 
 
What are the maximum recommended weight loss targets for obese children and adolescents?  
A. Weight loss should not exceed 1 lb. per month in children 2-11 years or 3 lbs. per 
week in older children and adolescents. 
B. Weight loss not to exceed .5 lb. per month in children 2-11 years or 1 lb. per week in 
older children and adolescents 
C. Weight loss not to exceed 1 lb. per month in children 2-11 years or 2 lbs. per week in 
older children and adolescents. 
D. Weight loss not to exceed .5 lb. per month in children 2-11 or 2 lbs. per month in 
older children and adolescents. 
 
23) There are several recommendations for assessing obesity. Calculating and plotting BMI is 
one of them. Which of the following are the other recommendations for assessing obesity?  
I. Assess medical risk, including patient history, parental obesity, family history, and 
physical exam and review of systems. 
II. Assess psychological risk, including depression, anxiety, and eating disorders 
III. Assess behavior risk, including sedentary time, eating, physical activity, and home 
environment 
IV. Assess attitudes, including family and patient concern, and motivation. 
A. I, III, and IV 
B. All four 

 
 
 
 
Page 294 of 305 
 
C. I and III 
D. I, II, and III 
 
24) For children 2 and older, which of the following are appropriate recommendations for what 
children should be eating, drinking, and doing each day?  
A. 5 or more fruits and vegetables, 1 hour or less or recreational screen time, 30 
minutes or more of physical activity 
B. 6 or more fruits and vegetables, 2 hours or less of recreational screen time, 90 
minutes or more of physical activity, 0 sugary drinks 
C. 5 or more fruits and vegetables, 2 hours or less of recreational screen time, 60 
minutes or more of physical activity, 1 sugary drink or less 
D. 6 or more fruits and vegetables, 1 hour or less of recreational screen time, 60 
minutes or more of physical activity, 1 sugary drink or less. 
 
25) Imagine you that you are working with a family of an overweight child and have 
recommended that the child lose a small amount of weight in the next few months (e.g., 4 
pounds). If you only have time to set one goal, which of the following is the most likely to help 
the child to lose weight and establish healthy habits? 
A. Identify healthy options the child can choose for lunch at school by discussing the 
menu (i.e., reviewing what is posted online by the child's school). 
B. Determine which healthy foods the parents(s) will have available at home so that the 
home is a "healthy zone" and increase the amount of foods consumed from home. 
C. Discuss physical activity options and increase walking to and from school or the bus 
stop. 
D. Reduce the child's time spent watching movies or playing video games by 
determining an appropriate amount of time and having the parent(s) set a timer. 
 
26) If you are setting a goal with the parent(s) and child about increasing exercise to 3 times in 
the next week, but they seem resistant to the goal (i.e., they are not "getting it"), what would 
you do? 
A. Patiently describe the exercise goal and its importance in their larger goals for health, 
focusing on the goal you have defined (3 times in the next week). 
B. Ask them what they are interested in setting as a goal for exercise, then encourage 
them to follow through with their identified goal. 
C. Discuss their perceived barriers and collaboratively identify an appropriate goal that 
will address their exercise behaviors. 
D. If they seem more willing to focus on a goal related to the child's eating patterns 
instead, identify a goal for the family that will address eating behaviors rather than 
activity behaviors. 
 
 
 
 

 
 
 
 
Page 295 of 305 
 
 
Coach Attributes of Evidence Based Treatment (This change was made on 7.25.19 prior to review 
and approval by the DSMB, DSMB approved protocol addenda on 9.29.19). 
 
Please complete the survey below. Thank you! 
The following questions ask about your feelings about using new types of therapy, 
interventions or treatments. Manualized therapy, treatment, or intervention refers to any 
intervention that has specific guidelines and/or components that are outlined in a manual 
and/or that are to be followed in a structured or predetermined way. 
 
Indicate to the extent to which you agree with each item using the scale shown below. 
1. Not at all  
2. To a slight extent  
3. To a moderate extent  
4. To a great extent  
5. To a very great extent 
 
I like to use new types of therapy or interventions to help my clients. 
1. Not at all  
2. To a slight extent  
3. To a moderate extent  
4. To a great extent  
5. To a very great extent 
 
I am willing to try new types of therapy or interventions, even if I have to follow a treatment 
manual. 
1. Not at all  
2. To a slight extent  
3. To a moderate extent  
4. To a great extent  
5. To a very great extent 
 
I know better than academic researchers how to care for my clients. 
1. Not at all  
2. To a slight extent  
3. To a moderate extent  
4. To a great extent  
5. To a very great extent 
 
I am willing to use new and different types of therapy or interventions developed by 
researchers. 
1. Not at all  
2. To a slight extent  

 
 
 
 
Page 296 of 305 
 
3. To a moderate extent  
4. To a great extent  
5. To a very great extent 
 
Research-based treatments/interventions are not clinically useful. 
1. Not at all  
2. To a slight extent  
3. To a moderate extent  
4. To a great extent  
5. To a very great extent 
 
Clinical experience is more important than using manualized interventions. 
1. Not at all  
2. To a slight extent  
3. To a moderate extent  
4. To a great extent  
5. To a very great extent 
 
I would not use manualized therapy/interventions. 
1. Not at all  
2. To a slight extent  
3. To a moderate extent  
4. To a great extent  
5. To a very great extent 
 
I would try a new therapy or intervention, even if it were very different from what I am used to 
doing. 
1. Not at all  
2. To a slight extent  
3. To a moderate extent  
4. To a great extent  
5. To a very great extent 
 
For the following questions if you received training in a new therapy or intervention how 
likely would you be to adopt it if: 
 
It was intuitively appealing? 
1. Not at all  
2. To a slight extent  
3. To a moderate extent  
4. To a great extent  
5. To a very great extent 
 

 
 
 
 
Page 297 of 305 
 
It made sense to you? 
1. Not at all  
2. To a slight extent  
3. To a moderate extent  
4. To a great extent  
5. To a very great extent 
 
It was required by your supervisor? 
1. Not at all  
2. To a slight extent  
3. To a moderate extent  
4. To a great extent  
5. To a very great extent 
 
It was a state requirement? 
1. Not at all  
2. To a slight extent  
3. To a moderate extent  
4. To a great extent  
5. To a very great extent 
 
It was being used by colleagues who were happy with it? 
1. Not at all  
2. To a slight extent  
3. To a moderate extent  
4. To a great extent  
5. To a very great extent 
 
You felt you had enough training to use it correctly? 
1. Not at all  
2. To a slight extent  
3. To a moderate extent  
4. To a great extent  
5. To a very great extent 
 
 
 

 
 
 
 
Page 298 of 305 
 
Coach Attributes Family Based Treatment (FBT) (This change was made on 7.25.19 prior to review 
and approval by the DSMB, DSMB approved protocol addenda on 9.29.19). 
 
Please complete the survey below. Thank you! 
 
1. Strongly Agree 
2. Agree  
3. Neither Agree or Disagree 
4. Disagree  
5. Strongly Disagree 
 
The content of FBT is compatible with my personal beliefs and values. 
1. Strongly Agree 
2. Agree  
3. Neither Agree or Disagree 
4. Disagree  
5. Strongly Disagree 
 
FBT is useful. 
1. Strongly Agree 
2. Agree  
3. Neither Agree or Disagree 
4. Disagree  
5. Strongly Disagree 
 
FBT is credible. 
1. Strongly Agree 
2. Agree  
3. Neither Agree or Disagree 
4. Disagree  
5. Strongly Disagree 
 
FBT is easy to administer in the practice setting. 
1. Strongly Agree 
2. Agree  
3. Neither Agree or Disagree 
4. Disagree  
5. Strongly Disagree 
 
The content of FBT is clear. 
1. Strongly Agree 
2. Agree  
3. Neither Agree or Disagree 

 
 
 
 
Page 299 of 305 
 
4. Disagree  
5. Strongly Disagree 
 
FBT can be implemented without requiring an extensive training. 
1. Strongly Agree 
2. Agree  
3. Neither Agree or Disagree 
4. Disagree  
5. Strongly Disagree 
 
FBT can be adapted or modified to suit the needs of the interventionist. 
1. Strongly Agree 
2. Agree  
3. Neither Agree or Disagree 
4. Disagree  
5. Strongly Disagree 
 
The benefits of using FBT with my clients are obvious/visible. 
1. Strongly Agree 
2. Agree  
3. Neither Agree or Disagree 
4. Disagree  
5. Strongly Disagree 
 
The evidence regarding the impact of FBT is available. 
1. Strongly Agree 
2. Agree  
3. Neither Agree or Disagree 
4. Disagree  
5. Strongly Disagree 
 
The content of FBT is relevant to my work as a clinical treatment provider. 
1. Strongly Agree 
2. Agree  
3. Neither Agree or Disagree 
4. Disagree  
5. Strongly Disagree 
 
Coach consent 
Please upload the .pdf file of the signed Coach consent. 
 
Indicate yes or no that Coach consent is uploaded.  
• No 

 
 
 
 
Page 300 of 305 
 
• Yes 
 
Why is the coach consent not uploaded? __________________________________ 
  
 

 
 
 
 
Page 301 of 305 
 
D.     Additional Forms 
 
Figure 1. Study Flow Chart 
 
 
 
UC: Families attend follow-up visits at their 
provider’s discretion across 2 years. UC consists of 
the care typically delivered by the pediatrician. 
FBT: Families attend 26 or more sessions across 2 
years with FBT interventionist for support in diet, 
physical activity, and behavioral changes. 
Participants complete an eligibility phone screen with a 
PLAN coach over the phone. 
Participants recruited via research match, study 
advertisements, website, or well-child visit. 
 
Participants attend an orientation session with a PLAN 
coach, during which study overview is provided, consent is 
obtained, and baseline assessments are administered. 
Participants Randomized 
FBT Group 
Participants complete an initial eligibility survey in person, 
via REDCap, or over the phone. 
 
Participants complete pre-orientation surveys via REDCap 
and, if necessary, follow-up clinical interviews with a PLAN 
coach. 
UC Group 

 
 
 
 
Page 302 of 305 
 
PLAN Adverse Event Questionnaire 
 
During the time since your last visit on (insert date of last major assessment), have you or your child: 
 
1. Been hospitalized overnight?  
YES  
 
NO 
 
2. Been to the emergency room or an urgent care clinic? 
YES  
 
NO 
 
3. Been treated by a medical provider for illness or injury? 
YES  
 
NO 
 
4. Had any injuries (e.g., sprained ankle or broken bone)? 
YES  
 
NO 
 
5. Started any new medications or receive a change in dosage of a current medication? 
YES  
 
NO 
 
6. Experience increased symptoms of a current illness or injury (If applicable)?  
YES  
 
NO 
 
7. Seen a new counselor, psychologist, or psychiatrist? 
YES  
 
NO 
 
8. Gone long periods (8 waking hours or more) without eating to control your weight? 
YES  
 
NO 
 
9. Felt like you have lost control over your eating? 
YES  
 
NO 
 
10. Thrown up after eating? 
YES  
 
NO 
 
11. Taken laxatives or diet pills? 
YES  
 
NO 
 
12. Felt particularly nervous, worried, or anxious? 
YES  
 
NO 
 
13. Felt very sad or down? Or lost interest in things that you normally enjoy doing? 
YES  
 
NO 
 
 (This change was made on 5.23.18 prior to review and approval by the DSMB, DSMB approved 
protocol addenda on 11.2.18) 
 

 
 
 
 
Page 303 of 305 
 
ADVERSE EVENT FORM 
 
 
The Effectiveness of Family-based Weight Loss Treatment Implemented in Primary
 
 
Site: __________________________________________________ 
 
Participant ID: __________________________________________ 
 
 
Has the participant had any adverse ev
□ Yes (Please list all AEs below
□ No 
 
Severity 
Relationship to Study 
Intervention 
Action Taken Regarding 
Study Intervention 
Outcome of AE 
1. Mild 
2. Moderate 
3. Severe 
1. Definitely related 
2. Possibly related 
3. Not related 
1. None 
2. Discontinued 
1. Resolved 
2. AE still present – no treatment 
3. AE still present – being treated 
4. Residual effects present – not treated 
5. Residual effects present – treated  
6. Death (complete SAE form) 
7. Unknown 
Adverse Event 
Start Date 
 
Stop Date 
Severity 
Relationship to 
Study Intervention 
Action 
Taken 
Outcom
of AE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Clinical Site PI: 
 
 
 
 
 
Date: 
SERIOUS ADVERSE EVENT FORM 
 
 
The Effectiveness of Family-based Weight Loss Treatment Implemented in Primary Care 
 
 
Site: __________________________________________________ 
 
Participant ID: __________________________________________ 
 
 

 
 
 
 
Page 304 of 305 
 
1. SAE Onset Date: ____/____/________ 
 
2. SAE Stop Date: ____/____/________ 
 
3. Location of SAE: 
 
4. Was this an unexpected adverse event?  
□ Yes   
□ No 
 
5. Brief description of participant with no personal identifiers: 
□ Male □ Female 
 
Age________ 
 
6. Brief description of SAE (attach description if more space needed): 
_____________________________________ 
_____________________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
________________________________ 
 
□Death  
 
 
 
 
□ Congenital anomaly/birth defect 
□ Life-threatening 
 
 
 
□ Required intervention to prevent permanent 
impairment 
□ Hospitalization – initial or prolonged   
□ Other: 
____________________________________________ 
□ Disability/incapacity   
 
 
 
 
7. Intervention type: 
□ Medication or nutritional supplement 
□ Behavioral/lifestyle 
□ Device 
□ Surgery 
 
8. Relationship of SAE to intervention: 
□ Unrelated (clearly not related to intervention) 
□ Possible (may be related to intervention) 
□ Definite (clearly related to intervention) 
 
9. Was study intervention discontinued due to event? 
□ Yes   
□ No 
 
10. What other steps were taken to treat SAE? 
________________________________________________________ 
_____________________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
________________________________ 
 
Signature of Clinical Site PI:  
 
 
 
 
Date: