Feasibility of Conducting an Online Family Dyadic/Couple Skills Training for Black Adults Enrolled in a Behavioral Weight Loss Intervention - Together, Eating and Activity, Matter+ (TEAM+)
Phase: NA
Conditions: Body Weight, Body Weight Changes, Obesity, Overweight and Obesity, Overweight, Behavior, Eating, Physical Inactivity, Chronic Disease, Weight Loss, Weight Reduction
Sponsor: University of North Carolina, Chapel Hill

PROTOCOL 
 
 
 
 Together Eating and Activity Matter Plus: Feasibility of Conducting an 
Online Family Dyadic/Couple Skills Training for Black Adults Enrolled 
in a Behavioral Weight Loss Intervention 
 
 
 
NCT number NCT05981508 
Document Date 02/23/23 
 

 
 
Together Eating and Activity Matter Plus: Feasibility of 
conducting an online family dyadic/couple skills training 
for Black adults enrolled in a behavioral weight loss 
intervention 
Protocol Number*: 1.1 
National Clinical Trial (NCT) Identified Number:   
Principal Investigator*:  Candice L. Alick, PhD 
Sponsor: University of North Carolina at Chapel Hill 
“Sponsor” indicates an institution, foundation, or individual who takes responsibility for and initiates a 
clinical investigation; often times this is the university with which the Principal Investigator is affiliated.  
Grant Title: <Grant Title> 
Grant Number*: <Grant Number> 
Funded by: National Institute for Diabetes, Digestive and Kidney Disorders 
Version Number:  v.1.1 
23 February 2023 
All versions should have a version number and a date. Use an international date format (e.g.,YYYY-MM-
DD [2017-12-21] or write  out the month (e.g., 21 December 2017).  
For the initial submission of a protocol to the IRB, indicate “Not applicable; this is the first version of the 
protocol.” in the table below.  For any subsequent amendment being submitted to the IRB, add details of 
the specific changes that are being implemented in the amendment. Please note that Section 10.4 is a 
high-level summary of all formal protocol versions/amendments. 
 
 

NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans 
CONFIDENTIALITY STATEMENT 
This document is confidential communication. Acceptance of this document constitutes agreement by the 
recipient that no unpublished information contained herein will be published or disclosed without prior 
approval of the Principal Investigator or other participating study leadership and as consistent with the 
NIH terms of award.  
 

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Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
INVESTIGATOR’S SIGNATURE .............................................................................................................................. 2 
1 
PROTOCOL SUMMARY ............................................................................................................................... 3 
1.1 
Synopsis ................................................................................................................................................ 3 
1.2 
Schema ................................................................................................................................................. 3 
1.3 
Schedule of Activities .......................................................................................................................... 5 
2 
INTRODUCTION ............................................................................................................................................ 6 
2.1 
Study Rationale .................................................................................................................................... 6 
2.2 
Background........................................................................................................................................... 6 
2.3 
Risk/Benefit Assessment .................................................................................................................... 6 
2.3.1 
Known Potential Risks ..................................................................................................... 6 
2.3.2 
Known Potential Benefits ................................................................................................ 7 
2.3.3 
Assessment of Potential Risks and Benefits ................................................................ 7 
3 
OBJECTIVES AND ENDPOINTS ................................................................................................................ 7 
4 
STUDY DESIGN ............................................................................................................................................. 7 
4.1 
Overall Design ...................................................................................................................................... 7 
4.2 
Scientific Rationale for Study Design................................................................................................ 8 
4.3 
Justification for Intervention ............................................................................................................... 8 
4.4 
End-of-Study Definition ....................................................................................................................... 8 
5 
STUDY POPULATION .................................................................................................................................. 8 
5.1 
Inclusion Criteria .................................................................................................................................. 8 
5.2 
Exclusion Criteria ................................................................................................................................. 9 
5.3 
Lifestyle Considerations ...................................................................................................................... 9 
5.4 
Screen Failures .................................................................................................................................... 9 
5.5 
Strategies for Recruitment and Retention ........................................................................................ 9 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ............................................ 10 
6.1 
Study Intervention(s) or Experimental Manipulation(s) Administration ...................................... 10 
6.1.1 
Study Intervention or Experimental Manipulation Description ................................. 10 
6.1.2 
Administration and/or Dosing ....................................................................................... 10 
6.2 
Fidelity ................................................................................................................................................. 11 
6.2.1 
Interventionist Training and Tracking .......................................................................... 11 
6.3 
Measures to Minimize Bias: Randomization and Blinding ........................................................... 11 
6.4 
Study Intervention/Experimental Manipulation Adherence.......................................................... 11 
6.5 
Concomitant Therapy ........................................................................................................................ 11 
6.5.1 
Rescue Therapy ............................................................................................................. 12 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL ......................................................................................... 12 
7.1 
Discontinuation of Study Intervention/Experimental Manipulation ............................................. 12 
7.2 
Participant Discontinuation/Withdrawal from the Study ............................................................... 12 
7.3 
Lost to Follow-Up ............................................................................................................................... 13 
8 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 13 
8.1 
Endpoint and Other Non-Safety Assessments .............................................................................. 14 
8.2 
Safety Assessments .......................................................................................................................... 18 
8.3 
Adverse Events and Serious Adverse Events ............................................................................... 18 
8.3.1 
Definition of Adverse Events ........................................................................................ 18 
8.3.2 
Definition of Serious Adverse Events .......................................................................... 18 

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8.3.3 
Classification of an Adverse Event .............................................................................. 19 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 20 
8.3.5 
Adverse Event Reporting .............................................................................................. 21 
8.3.6 
Serious Adverse Event Reporting ............................................................................... 22 
8.3.7 
Reporting Events to Participants ................................................................................. 22 
8.3.8 
Events of Special Interest ............................................................................................. 22 
8.3.9 
Reporting of Pregnancy ................................................................................................ 22 
8.4 
Unanticipated Problems .................................................................................................................... 22 
8.4.1 
Definition of Unanticipated Problems .......................................................................... 22 
8.4.2 
Unanticipated Problems Reporting .............................................................................. 22 
8.4.3 
Reporting Unanticipated Problems to Participants ................................................... 23 
9 
STATISTICAL CONSIDERATIONS .......................................................................................................... 23 
9.1 
Statistical Hypotheses ....................................................................................................................... 23 
9.2 
Sample Size Determination .............................................................................................................. 23 
9.3 
Populations for Analyses .................................................................................................................. 23 
9.4 
Statistical Analyses............................................................................................................................ 23 
9.4.1 
General Approach .......................................................................................................... 23 
9.4.2 
Analysis of the Primary Endpoint(s) ............................................................................ 23 
9.4.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 23 
9.4.4 
Safety Analyses .............................................................................................................. 23 
9.4.5 
Baseline Descriptive Statistics ..................................................................................... 24 
9.4.6 
Planned Interim Analyses ............................................................................................. 24 
9.4.7 
Sub-Group Analyses ..................................................................................................... 24 
9.4.8 
Tabulation of Individual Participant Data .................................................................... 24 
9.4.9 
Exploratory Analyses ..................................................................................................... 24 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 24 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 24 
10.1.1 
Informed Consent Process ........................................................................................... 24 
10.1.2 
Study Discontinuation and Closure ............................................................................. 30 
10.1.3 
Confidentiality and Privacy ........................................................................................... 30 
10.1.4 
Future Use of Stored Specimens and Data ............................................................... 31 
10.1.5 
Key Roles and Study Governance .............................................................................. 31 
10.1.6 
Safety Oversight ............................................................................................................. 32 
10.1.7 
Clinical Monitoring .......................................................................................................... 32 
10.1.8 
Quality Assurance and Quality Control ....................................................................... 32 
10.1.9 
Data Handling and Record Keeping ............................................................................ 33 
10.1.10 
Protocol Deviations ........................................................................................................ 33 
10.1.11 
Publication and Data Sharing Policy ........................................................................... 33 
10.1.12 
Conflict of Interest Policy .............................................................................................. 36 
10.2 
Additional Considerations ................................................................................................................. 37 
10.3 
Abbreviations and Special Terms ................................................................................................... 37 
10.4 
Protocol Amendment History ........................................................................................................... 39 
11 
REFERENCES ............................................................................................................................................. 40 
 

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STATEMENT OF COMPLIANCE 
 
[The trial will be carried out in accordance with International Council on Harmonisation Good 
Clinical Practice (ICH GCP) and the following:  
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812).  
 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have 
completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the IRB for review and approval. Approval of both the protocol and the consent 
form(s) must be obtained before any participant is consented. Any amendment to the protocol 
will require review and approval by the IRB before the changes are implemented to the study. All 
changes to the consent form(s) will be IRB approved; a determination will be made regarding 
whether a new consent needs to be obtained from participants who provided consent, using a 
previously approved consent form.] 
 
 

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INVESTIGATOR’S SIGNATURE 
The signature below constitutes the approval of this protocol and provides the necessary assurances 
that this study will be conducted according to all stipulations of the protocol, including all statements 
regarding confidentiality, and according to local legal and regulatory requirements and applicable US 
federal regulations and ICH guidelines, as described in the Statement of Compliance above. 
 
Principal Investigator or Clinical Site Investigator: 
Signed: 
Candice L Alick 
Date: 
02/23/23 
 
Name*:  Candice L. Alick, PhD 
 
Title*: Postdoctoral Fellow 
 
Investigator Contact Information 
Affiliation*: Center for Health Promotion and Disease Prevention (a CDC funded Prevention Research 
Center) at the University of North Carolina at Chapel Hill. 
Address: 1700 Martin Luther King, Jr BLVD   Chapel Hill, NC 27599 
Telephone: (919) 966-6080 
Email: alick@email.unc.edu 
 
[For multi-site studies, the protocol should be signed by the clinical site investigator who is responsible 
for the day to day study implementation at his/her specific clinical site.] 
Signed: 
 
Date: 
 
 
Name:  
 
Title: 
 
 
Affiliation: 
 
 
 
 
 

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1 
PROTOCOL SUMMARY 
No text is to be entered in this section; rather it should be included under the relevant subheadings 
below. It may be useful to complete this section after the relevant sections in the protocol have been 
completed. 
1.1 
SYNOPSIS  
 
Title: 
Feasibility of conducting an online family dyadic/couple skills training 
for Black adults enrolled in a behavioral weight loss intervention 
 
Grant Number: 
 
Study Description: 
TEAM Plus is an in-person 3-month family enhanced BWL intervention 
designed for Black adults consisting of a family dyadic skills training and 
core behavioral weight loss sessions  testing the feasibility and 
acceptability of an interactive counselor-led online training, the family 
dyadic skills training will be delivered online using a web-conferencing 
platform (e.g., Zoom). 
 
 
Objectives*: 
 
Primary Aim: To test the feasibility of implementing and acceptability 
of an online family dyadic/couple skills 
 
Secondary Aim: To explore the experience of administering a family 
dyadic/couple skills training online from a counselor perspective (i.e., 
facilitators, barriers, acceptability).  
Endpoints*: 
Described previously 
Study Population: 
Participants must be 1)≥18 years of age, 2) self-identify as Black/African 
American, 3) reside in the Raleigh/Durham/Chapel Hill area. (n=19)  
Phase* or Stage: 
Pilot 
 
Description of 
Sites/Facilities Enrolling 
Participants: 
Participants will be recruited from community organizations, local 
universities, through social media and word of mouth.  
 
 
Description of Study 
Intervention/Experimental 
Manipulation: 
The study intervention is a 3-month behavioral weight loss intervention 
adapted from the Diabetes Prevention Program (DPP). Core group 
sessions, and individual or small group family skills trainings are 
included. Family skills trainings are delivered in person or virtually.  
 
Study Duration*: 
7 months 
 
Participant Duration: 
4 months 
1.2 
SCHEMA  
 
 

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Baseline Measures 
 
Arm 2 
N = 10  
Arm 1 
N = 10  
3 month Measures 
Randomization 
(n=20) 

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1.3 
SCHEDULE OF ACTIVITIES  
 
 
 
 
 
 
 
Pre-screening 
(Pre-consent) 
Consent/ 
Baseline ( Pre- 
Visit 1)
 
Visit 1 
Day 1 ±7 
Visit 2 
Day 7 ±7 
Visit  3 
 Day 14 ±7 
Visit  4 
Day 21 ±7 
Visit  5 
Day 35 ±7 
Visit  6 
Day  49 ±7 
 
Visit  7 
Day 79 ±7 
Post 
Assessment  
Day 91 ±7 
Review Eligibility 
X 
 
 
 
 
 
 
 
 
 
Informed Consent 
 
X 
 
 
 
 
 
 
 
 
Demographics 
 
X 
 
 
 
 
 
 
 
 
Clinical history 
 
X 
 
 
 
 
 
 
 
 
Height  
 
X 
 
 
 
 
 
 
 
X 
Outcome Evaluation 
 
 
 
 
 
 
 
 
 
 
                     
Weight 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Surveys 
 
X 
 
 
 
 
 
 
 
X 
Randomization 
 
X 
 
 
 
 
 
 
 
 
Control & Experimental 
Interventions  
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Adverse Events Reporting 
 
X 
 
 
 
X 
X 
X 
X 
X 

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2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
 
See section 2.2 
2.2 
BACKGROUND  
Nearly half (49.9%) of Black adults in the United States live with obesity. Black adults are 
underrepresented in standard behavioral weight loss interventions (BWLI) and experience sub-optimal 
weight loss outcomes when included in such programs. Cultural adaptations to BWLI that recognize the 
family behavioral context and address the cultural value of family among Black populations are needed 
to improve weight loss outcomes. Prior research, including our randomized controlled pilot, Together, 
Eating and Activity, Matter (TEAM), have incorporated family skills training to enhance family 
involvement, targeting cohesion and communication, in addition to core weight loss curriculum. 
However, family inclusion in weight loss interventions can result in additional barriers to retention and 
adherence.  
   Technology has become an attractive delivery format to increase reach to at-risk populations, as a 
well-designed online program can address issues of timely access and geographical location (or distance 
from program sites), which are linked to low retention of Black participants. However, technology 
uptake among Blacks populations still lags due to mistrust, skepticism, concerns about confidentiality, 
privacy, and remote interaction with staff. Increases in acceptance and utilization of telemedicine and 
mobile-health were reported during the COVID-19 pandemic. Considering the time and location burden 
already associated with behavioral weight loss sessions, it is important to identify strategies to increase 
access that are both feasible and acceptable in the target population. Currently the feasibility and 
acceptability of an online family dyadic skills training is unknown among Black adults. 
 
2.3 
RISK/BENEFIT ASSESSMENT  
 
2.3.1 KNOWN POTENTIAL RISKS  
The possible risks and discomforts from being in this study are few and are listed below. 
• 
We do not think there is risk from the dietary advice given as part of the study 
• 
Those who increase their level of physical activity may experience minor muscle pain, but this 
type of activity rarely causes serious health problems such as chest pain or asthma.  
• 
In all studies, there is a very slight chance of loss of privacy (that is, others may see your study 
information). As stated below, we will do all we can to make sure this does not happen. 
 

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2.3.2 KNOWN POTENTIAL BENEFITS  
 
Research is designed to benefit society by gaining new knowledge. A benefit from being in this study is 
improvement in  lifestyle and losing weight.  However, some not benefit from being in this study 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
 
The potential risks are small, as noted above.  We outline our approach to minimizing risk above. We 
believe there is much to be gained from this study, especially in the context of minimal risk.  
3 
OBJECTIVES AND ENDPOINTS  
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
PUTATIVE 
MECHANISMS OF 
ACTION 
Primary 
 
 
 
  
Primary Aim: To test the 
feasibility of implementing 
and acceptability of an online 
family dyadic/couple skills 
 
Feasibility will be 
measured by the 
number of 
participants who 
consent, and the 
percent of dyads 
that attend both 
sessions.  
 
Acceptability will 
be measured by a 
satisfaction survey 
complete by both 
dyad members 
Primary Outcome   
 
 
Secondary 
 
 
 
Secondary Aim: To explore 
the experience of 
administering a family 
dyadic/couple skills training 
online from a counselor 
perspective (i.e., facilitators, 
barriers, acceptability).  
 
 
 
 
 
4 
STUDY DESIGN 
 
4.1 
OVERALL DESIGN 

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Randomized controlled pilot enrolling 20 participants in a weight loss program and followed for 3 
months.  Participants will be randomized 1:1 
• 
Arm 1:  Family Skills Training In-person;  
• 
Arm 2:  Family Skills Training On-line 
Randomized assignment will be completed by a random number generator in Excel.  
 
From the perspective of NIH, this is a single site study as the intervention is given by one investigational 
team.   
 
The acronym for the study is TEAM Plus (Together Eating & Activity, Matter).  The names of the study 
arms are given above.  
 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
Describe the rationale for the type and selection of control or comparison condition(s) and study design. 
Discuss known or potential problems associated with the control group chosen in light of the specific 
disease, health behavior, and intervention(s) being studied. 
 
<Insert text> 
 
4.3 
JUSTIFICATION FOR INTERVENTION 
 
Technology offers a promising way to reach at-risk groups, like Black communities, by reducing barriers 
such as distance and scheduling that often lead to low participation in weight loss programs. However, 
Black populations have been slower to adopt technology due to concerns about trust, privacy, and remote 
communication. During the COVID-19 pandemic, more people began using telemedicine and mobile 
health tools, showing potential for wider acceptance. Given the time and travel demands of traditional 
weight loss programs, it is important to find tech-based solutions that are both practical and trusted by 
the target population. 
4.4 
END-OF-STUDY DEFINITION 
 
The end of study is defined as completing the 3 month follow-up visit.  
 
5 
STUDY POPULATION 
 
5.1 
INCLUSION CRITERIA 
 
Participants must  
 
1) be ≥18 years of age,  

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2) self-identify as Black/African American,  
3) reside in the Raleigh/Durham/Chapel Hill area,  
4) a family member willing to participate in program sessions together, and  
5) have internet access. 
5.2 
EXCLUSION CRITERIA 
 
An individual who does not meet all of the above criteria on section 5.1 will be excluded from participation 
in this study. 
 
A participant cannot be taking any weight loss medication. 
 
5.3 
LIFESTYLE CONSIDERATIONS 
 
During this study, participants are asked to: 
 
• 
Follow the lifestyle recommendations for both dietary change and to be modestly physically 
active. 
• 
If they are unable to make the recommended changes, they will continue in the study.  
Specifically, participants will not be excluded if they fail to achieve lifestyle goals.   
 
5.4 
SCREEN FAILURES 
 
Screen failures are defined as participants who consent to participate in this study but are not 
subsequently assigned to the study intervention or entered in the study. Individuals who do not meet the 
criteria for participation in this trial (screen failure) because of meeting one or more exclusion criteria that 
are likely to change over time may be rescreened. Examples include weight loss of more than 10% of their 
baseline weight prior to the visit 1 or moving away from the Raleigh/Durham/Chapel Hill area.  
 
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
 
Recruitment: We will recruit from this sample of over 50,000 residents in the Raleigh/Durham/Chapel 
Hill, NC area who meet our race and BMI inclusion criteria through multiple recruitment channels: 1) 
advertisement on social media, 2) community partnerships, 3) university listservs, 4) medical practices, 
and 5) word of mouth. We also have community partnerships with local Black churches, local chapters 
of Historically Black Fraternities and Sororities (i.e. National Panhellenic Council), and Durham County 
Department of Public Health – our partnerships with these entities should help us achieve our 
recruitment goals.   
 
At least 20 individuals will be enrolled in the pilot study. 

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Retention:  At enrollment, we will ask for home and cell numbers, if it is OK to send text messages. We 
will also ask participants to provide contact information for an alternate contact (friend or family 
member) in case we are unable to reach them directly.  
Incentive:  Study visits were compensated with $40 per visit and Skills training sessions $20 per visit. 
This amount was to compensate for time and travel to study site. We do not think this compensation is 
coercive and think the rate is in line with what the IRB typically endorses.  
 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
 
6.1 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION 
 
6.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
Core Weight Loss Sessions: All Family dyads will be asked to attend 7 in person behavioral weight loss 
group sessions over 3 months covering content on dietary change, physical activity and behavioral 
modification to lose weight. Participants will have lessons, set goals, and receive individual feedback on 
their progress.  The theoretical underpinning of this component is the social cognitive theory. 
Family dyadic skills training: Concurrently, the brief family dyadic skills training will include two 30 
minutes sessions delivered by a counselor using a secure Zoom platform. The training provides skills that 
should optimize implementation of the recommendations, strategies, and tips provided in the behavioral 
weight loss core curriculum that has been adapted for family inclusion. To assess for differences between 
in-person and online skills training,  families will be randomized to: online and in-person  delivery modes. 
Session one will address strategies to improve cohesion, an important aspect of healthy family 
functioning. Research has shown greater cohesion has been associated with greater weight loss among 
Black adults. Session two will address communication and conflict; these are important in handling 
stressful events and have been identified as essential skills to target for family inclusion in behavioral 
weight loss interventions. The content for the sessions will be informed by the couples skills training from 
TEAM. The theoretical underpinning for this component is Interdependence and Communal Coping, Social 
Interdependence Theory, and Olson’s Circumplex of Family Model of Family Functioning. 
 
6.1.2 ADMINISTRATION AND/OR DOSING 
 
• 
The intervention will be given by trained research staff.  
• 
For participants recruited from the Raleigh/Durham/Chapel Hill area, the intervention will be 
delivered in person and/or online: 
o In person, face-to-face group sessions visits, will be given at the UNC Center for Health 
Promotion and Disease Prevention, located at 1700 Martin Luther King, Jr BLVD, Chapel 
Hill, NC 27599.  

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o The other session may be given in person or by online e.g., Zoom. 
• 
We will encourage participants to take part in all sessions.  However, a participant will not be 
dropped from the study based on session participation  
• 
If a participant takes part in 70% or more of anticipated visits, we will consider this a “full-dose.”   
• 
The intervention format for this study is group or dyad.  
 
6.2 
FIDELITY 
 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
• 
Process data:   
o 
number of sessions attended (including dates of visits),  
o 
Visit weights (if available)  
o 
A proportion (20%) of skills training will be audio-recorded to ensure that the counselor 
is correctly conducting the training as per the protocol 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
 
Randomization 
 
Participants will be randomized 1:1, to either: 
• 
Group 1: TEAM (in-person family skills training);  
• 
Group 2: TEAM Plus (on-line family skills training).  
 
Randomized assignment will be done by using the randomization number generator in excel. 
 
Blinding Plan 
 
As an open-label study, participants, providers, and many study staff will know to which group individual 
participants have been randomized. 
6.4 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
 
All session visits will be recorded.  A session checklist will be completed by counselor at the end of every 
session.  
 
The extent to which participants perform weight management behavioral skills and cognitive strategies 
will be assessed from questionnaire data addressing self-monitoring of weighing, dietary behaviors, and 
goal-setting. 
 
6.5 
CONCOMITANT THERAPY 
 
 

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For this protocol, participants may not use weight loss drugs. Medication usage will be assessed at each 
study visit and documented in the relevant Case Report Form (CRF).]  
 
 
6.5.1 RESCUE THERAPY 
No rescue therapy outside of the study protocol is planned if participants do not lose weight.  
 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
 
7.1 
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
The study intervention will not be discontinued unless the participant withdraws or is withdrawn as 
outlined in the above section. 
 
If a participant withdraws or is withdrawn, no attempts will be made to collect follow-up measures.   
 
If a participant requests to withdraw from the intervention but is willing to continue the measurement 
component of the study, he/she will be invited to continue with follow-up measures.  
 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants are free to withdraw from participation in the study at any time upon request. 
 
Participants will be withdrawn according to protocol for the following reasons: 
• 
Other medical diagnosis typically associated with significant weight loss (5% or more of body 
weight).  In addition to malignancy, examples include nonmalignant gastrointestinal disease, 
endocrinopathies, infectious disease, rheumatologic diseases, etc.  As Dr. Berkowitz (study Co-I, 
general internist) will be blinded to participants’ study group assignment, he will adjudicate in 
these situations, seeking consultation from medical colleagues as appropriate.  
• 
New diagnosis of medical condition such that participation in a behavioral weight loss 
intervention is no longer appropriate.  
• 
Permanent change in living situation (e.g. from home to nursing home) such that the participant 
has limited food options. 
 
Pregnancy:  Study participants who become pregnant may continue to participate in the study with the 
understanding that weight loss goals will be suspended during pregnancy through 3 months postpartum. 
If a pregnant participant wishes to continue with counseling session during pregnancy, the focus on 
counseling will be on dietary quality.  The participant may resume full participation 3 months 
postpartum. Any data collected while the participant is pregnant will be censured and follow-up data 
will not be collected until the participant is 6 months postpartum.  
 
 
A participant will be considered lost to follow-up if we are unable to contact him/her according to this 
algorithm.   

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• 
Attempts at telephone contact: 
o We will call up to 5 times over a 2 week period. We will attempt 2 calls during regular 
work hours (8:30 to 5:30 on weekdays) and 3 after hours, including Mon-Thurs evening 
between 5:31 and 9:00 pm and on Saturday calling between 8:30 and 5:30 pm.  
o We will leave up to 2 phone messages. 
o If no contact is made over this initial 2 week period as outlined above, we will undertake 
more limited contact attempts for an additional 2 weeks including up to 2 phone calls 
per week, 1 during business and the other  during evening hours or on the weekend.   
• 
Email:  If a participant gives us permission to contact by email, we will send up to 4 weekly 
emails. 
• 
Text:   If a participant gives us permission to contact by text, we will send up to 4 weekly texts. 
• 
Alternative contact:  During enrollment, we will collect information on an alternative contact 
that we are given permission to contact. We will attempt to contact this individual up to 3 times 
a week for 4 weeks. 
 
No replacement is planned for those who withdraw from the intervention for the study.  
 
7.3 
LOST TO FOLLOW-UP 
 
A participant will be considered lost to follow-up if we are unable to contact him/her according to this 
algorithm.   
• 
Telephone contact: 
o We will call up to 5 times over a 2 week period. We will attempt 2 calls during regular 
work hours (8:30 to 5:30 on weekdays) and 3 after hours, including Mon-Thurs evening 
between 5:31 and 9:00 pm and on Saturday calling between 8:30 and 5:30 pm.  
o We will leave up to 2 phone messages. 
o If no contact is made over this initial 2 week period as outlined above, we will undertake 
more limited contact attempts for an additional 2 weeks including up to 2 phone calls 
per week, 1 during business and the other  during evening hours or on the weekend.   
• 
Email:  If a participant gives us permission to contact by email, we will send up to 4 weekly 
emails. 
• 
Text:   If a participant gives us permission to contact by text, we will send up to 4 weekly texts. 
• 
Alternative contact:  During enrollment, we will collect information on an alternative contact 
that we are given permission to contact. We will attempt to contact this individual up to 3 times 
a week for 4 weeks. 
 
If we are unable to contact a participant as outlined above, a letter will be sent to the current mailing 
address and inviting the participant to contact us if he/she still wishes to participate in this study.   
  
Should the participant continue to be unreachable and does not respond to the mailed letter within 4 
weeks, he or she will be considered to have withdrawn from the study with a primary reason of lost to 
follow-up. 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
 

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8.1 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
Study data will be collected at baseline, and 3 months. Process data will be collected as part of the 
intervention via the web-based platform by counselors immediately after sessions.  
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Collection 
Time (min) 
Data Collection times (month) 
Primary 
 
 
 
0 
1 
2 
3 
  
Primary Aim: To 
test the feasibility of 
implementing and 
acceptability of an 
online family 
dyadic/couple skills 
 
Feasibility 
will be 
measured by 
the number 
of 
participants 
who 
consent, and 
the percent 
of dyads that 
attend both 
sessions.  
 
Acceptability 
will be 
measured by 
a satisfaction 
survey 
complete by 
both dyad 
members 
Primary Outcome   
 
1 
 
 
 
 
 
 
 
 
 
 
 
 
15 
 
X 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
Secondary 
 
 
 
 
Secondary Aim: To 
explore the 
experience of 
administering a 
family 
dyadic/couple skills 
training online from 
a counselor 
perspective (i.e., 
facilitators, barriers, 
acceptability).  
 
 
 
45 
 
 
 
X 
 
• 
Physical examination-based assessments (e.g., weight) 
• 
At study outset, weights (seven 50 pound weights) assessed and adjusted for accuracy on 
12/3/19 by North Carolina Department of Agriculture and Consumer Services Standards 
Laboratory. 

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• 
Weights to be re-assessed and adjusted for accuracy annually. 
• 
Scales tested for accuracy the first week of each month during their use in this study.  
 
Seca 874 dr Scale Tolerance Testing 
(updated 1/28/20) 
 
The scale's 6 AA batteries should be replaced at least once a year. 
It is imperative that tolerance weights be handled carefully (no slamming around or banging against one 
another) to maintain their accuracy.  
Before starting the test set the ON-OFF switch to ON.  Press the start key with no load on the scale.  If 
necessary switch the weight display from kg to lbs by pressing the 2 in 1 key for approximately 3 
seconds.  
1) Place a 50 lb wt in the center of the scale and record weight. (~50 lbs)  Remove the 50 lb wt. Press 
start key. 
2) Carefully stack two 50 lb wts on top of one another in the center of the scale.  The first weight must 
be gently vibrated until the second is in place to prevent the scale from prematurely locking in and 
giving an erroneous reading.  Record the weight reading (~ 100 lbs).  Press the 2 in 1 key. 
3) Place a third 50 lb wt on the scale and record weight. (~50 lbs  The sum of this weight and the weight 
observed in step 2, ~ 100 lbs,  is the observed reading for the expected weight of 150 lbs )  Remove 
the top 50 lb wt. only. 
 4) Place two 50 lb wts on top of the two remaining weights vibrating the stack as before.  Record the 
weight reading (~ 100 lbs The sum of this weight and the weight observed in step 2, ~ 100 lbs,  is the 
observed reading for the expected weight of 200 lbs).  Remove all four weights.  Press start key. 
5) Carefully, but quickly, stack five 50 lb wts on top of one another in the center of the scale, gently but 
firmly vibrating the stack until the fifth weight is added.  Record the weight reading (~ 250 lbs).  Press 
the 2 in 1 key.    
6) Place a sixth 50 lb wt on the scale and record weight. (~50 lbs  The sum of this weight and the weight 
observed in step 6, ~ 250 lbs,  is the observed reading for the expected weight of 300 lbs)  Remove the 
top 50 lb wt. only. 
7) Place two 50 lb wts on top of the five remaining weights vibrating the stack as before.  Record the 
weight reading (~ 100 lbs The sum of this weight and the weight observed in step 6, ~ 250 lbs,  is the 
observed reading for the expected weight of 350 lbs).  Remove all weights. 
8) Set ON-OFF switch to OFF. 
 

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During the testing if any observed reading falls outside the tolerance range repeat the testing steps to 
verify the reading.  No need to continue testing the scale if a weight is out of range and verified.   Scales 
failing the tolerance testing should no longer be used.  
 
lbs 
0.40% 
 
 
Tolerance 
 
 
Limit  
Range 
 
 
50 
0.2 
49.8 - 50.2 
100 
0.4 
99.6 - 100.4 
150 
0.6 
149.4 – 150.6 
200 
0.8 
199.2 – 200.8 
250 
1 
249.0 – 251.0 
300 
1.2 
298.8 – 301.2 
350 
1.4 
348.6 – 351.4 
 
 
Scale S/N 
  
Date 
    
Expected 
Observed  
Difference 
0.40% 
Weight (lbs.) 
Weight (lbs.) 
(lbs.) 
Tolerance 
Limit 
(lbs.) 
50 
  
  
0.2 
100 
  
  
0.4 
(50)  
 
 
 
 
 
150 
  
  
0.6 
(100)  
 
 
 
 
 
200 
  
  
0.8 
250 
  
  
1 
(50)  
 
 
 
 
 
300 
  
  
1.2 
(100)  
 
 
 
 
 
350 
  
  
1.4 
 

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WEIGHT MEASUREMENT PROTOCOL 
(last updated 10/28/19) 
 
Prior to the appointment the participant is instructed to wear light clothing and informed that the 
weight measurements will be made with shoes removed. 
 
 
Materials 
• 
Seca model 874 dr electronic personal scale 
 
Preparation  
• 
Place the scale on a hard level surface. 
• 
Turn the scale ON with the ON-OFF switch.  Press the start key with no load on the scale.  The scale 
is automatically set to zero and ready for use. 
• 
Once the digital display reads zero verify that “lbs” unit is showing.  If “kg” appears in the display 
press the 2 in 1 key for approximately 3 seconds. "lbs” should then show in the display.  
 
Procedure 
Participant 
• 
With shoes removed, scale displaying zero; step onto the middle of the scale. 
• 
Stand on both feet, knees extended (straight) with arms by sides.  
 
Research Staff 
• 
Once the reading in the digital display is stable, record the first weight on the Weight Measurement 
Form in lbs, recording the tenths of lb (i.e. 81.4 lbs). 
• 
Have the participant step off the scale. 
• 
Have the participant step back onto the scale once zero is displayed.  Note: You may need to restart 
the scale by pressing the start key to obtain the zero and lbs display before instructing the 
participant to step back onto the scale. 
• 
Once the reading in the digital display is stable, record the second weight on the form. 
• 
Record the difference between the first and second readings. 
• 
If the difference is greater than 1 lb repeat and record a third weight. 
• 
When finished weighing participants turn the scale OFF with ON-OFF switch. 
 
Note  
• 
A stabilized reading in the scale display is needed for recording.  The participant needs to stand very 
still while breathing naturally.  If moving too much the weight will not stabilize in the display.     
Scale Accuracy Testing 
• 
To insure accuracy the scales have been tested using certified tolerance weights.  (Performed by 
research center staff each month).  
• 
Staff should weigh themselves whenever the scale is set up for participant measurement  
 
Scale Care 
• 
Treat the scale as a laptop. Do not bump against other objects or expose to extreme temperatures.  
• 
Store in the horizontal position without stacking anything on top. 

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• 
Do not allow anyone to weigh without your supervision and instructions. 
• 
When not using, turn the ON-OFF switch to OFF to conserve the battery. 
• 
 
• 
Performance-based assessments (e.g., physical function – gait, balance; sensory testing – pain 
perception, proprioception; neuropsychological/cognitive assessments – dementia assessment, 
executive function, memory performance tests) 
• 
Administration of questionnaires, interviews, or other instruments for patient (or other, e.g., 
family, caregiver-) reported outcomes, such as a daily diary 
 
 
Collecting questionnaire data 
• 
See Section 5.5, Strategies for Recruitment and Retention, which outlines how eligibility and 
baseline questionnaires will be administered. 
• 
In brief, at the outset of the study, participants will complete questionnaires on-line using the 
qualtric interface.  
• 
The data collection windows are 2 weeks before baseline, and 3 month follow-up. 
 
 
8.2 
SAFETY ASSESSMENTS 
As noted, this study is considered minimal risk.  The following safety procedures are included as part of 
this protocol.  
 
• 
As part of the physical activity intervention, an information sheet on safety while being active 
will be provided. 
• 
A participant will be withdrawn from the study if they lose more than 15 lbs over the course of 
the month due to non-intervention protocol reasons. Participant will be instructed to contact 
their PCP to determine if additional evaluation is warranted for underlying medical disease that 
may be contributing to weight loss.  
 
 
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
8.3.1 DEFINITION OF ADVERSE EVENTS 
 
This protocol uses the definition of adverse event from 21 CFR 312.32 (a): any untoward medical 
occurrence associated with the use of an intervention in humans, whether or not considered intervention-
related. 
 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
For this study a serious adverse event includes, as outlined at:  https://www.hhs.gov/ohrp/regulations-
and-policy/guidance/reviewing-unanticipated-problems/index.html: 
 

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1. results in death; 
2. is life-threatening (places the subject at immediate risk of death from the event as it occurred); 
3. results in inpatient hospitalization or prolongation of existing hospitalization; 
4. results in a persistent or significant disability/incapacity; 
5. results in a congenital anomaly/birth defect; or 
6. based upon appropriate medical judgment, may jeopardize the subject’s health and may require 
medical or surgical intervention to prevent one of the other outcomes listed in this definition 
(examples of such events include allergic bronchospasm requiring intensive treatment in the 
emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient 
hospitalization, or the development of drug dependency or drug abuse) 
 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.3.3.1 SEVERITY OF EVENT 
For adverse events (AEs) not included in the protocol defined grading system, the following guidelines will 
be used to describe severity.  
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events 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.  Of note, the term “severe” does not necessarily equate to “serious”. 
 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
All adverse events (AEs) will have their relationship to study procedures, including the intervention, 
assessed by an appropriately-trained clinician based on temporal relationship and his/her clinical 
judgment. The degree of certainty about causality will be graded using the categories below.  
 
• 
Definitely Related – There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. The clinical event, including an abnormal laboratory test 
result, occurs in a plausible time relationship to study procedures administration and cannot be 
explained by concurrent disease or other drugs or chemicals. The response to withdrawal of the 
study procedures should be clinically plausible. The event must be pharmacologically or 
phenomenologically definitive. 
• 
Probably Related – There is evidence to suggest a causal relationship, and the influence of other 
factors is unlikely. The clinical event, including an abnormal laboratory test result, occurs within a 

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reasonable time after administration of the study procedures, is unlikely to be attributed to 
concurrent disease or other drugs or chemicals, and follows a clinically reasonable response on 
withdrawal.  
• 
Potentially Related – There is some evidence to suggest a causal relationship (e.g., the event 
occurred within a reasonable time after administration of study procedures). However, other 
factors may have contributed to the event (e.g., the participant’s clinical condition, other 
concomitant events). Although an AE may rate only as “possibly related” soon after discovery, it 
can be flagged as requiring more information and later be upgraded to “probably related” or 
“definitely related”, as appropriate. 
• 
Unlikely to be related – A clinical event, including an abnormal laboratory test result, whose 
temporal relationship to study procedures administration makes a causal relationship improbable 
(e.g., the event did not occur within a reasonable time after administration of the study 
procedures) and in which other drugs or chemicals or underlying disease provides plausible 
explanations (e.g., the participant’s clinical condition, other concomitant treatments). 
• 
Not Related – The AE is completely independent of study procedures administration, and/or 
evidence exists that the event is definitely related to another etiology. There must be an 
alternative, definitive etiology documented by the clinician. 
 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
Solicited potential adverse events will occur at each visit and follow-up measurement visit.  They include 
the following and we will ask if evaluation for these events included emergency room visit or overnight 
hospital stay.  
• 
Acute myocardial infarction 
• 
Angina pectoris 
• 
Stroke 
o Thrombotic 
o Hemorrhagic 
• 
TIA 
• 
Heart failure 
• 
Coronary bypass surgery 
• 
Cancer 
o Type of cancer 
• 
Broken bone 
o Type of fracture 
• 
Light headedness or dizziness 
• 
Pneumonia 
• 
Other infection 
o UTI 
o Other 
• 
Hypoglycemia 
o Other 
 
 

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Unsolicited adverse events (AE) or serious adverse events (SAE) may come to the attention of study staff 
during counseling visits, phone calls, or via other channels of communications. They will be  categorized 
as above and entered into the appropriate follow-up questionnaire at the time of occurrence.  
 
Information to be collected about AEs and SAEs includes event description, time of onset, study 
clinician’s assessment of severity, relationship to study procedures (assessed only by those with the 
training and authority to make a diagnosis), and time of resolution/stabilization of the event. All AEs 
occurring while on study will be documented appropriately regardless of relationship. All AEs will be 
followed to adequate resolution. 
 
Any medical or psychiatric 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 an assessment of the duration of the event 
at each level of severity to be performed. Documentation of onset and duration of each episode will be 
maintained for AEs characterized as intermittent. 
 
Study staff will record events with start dates occurring any time after informed consent is obtained until 
the last day of study participation.  
 
 
8.3.5 ADVERSE EVENT REPORTING  
Adverse events will be reported as follows: 
 
SAEs that include the following and are 1) definitely, 2) probably, or 3) potentially related to the study  
will be reported to the chair of the DSMC and IRB within 1 working day: 
• 
Results in death 
• 
Is life-threatening (places the subject at immediate risk of death from the event as it occurred) 
 
 
Reports of adverse events to the UNC IRB will follow their policy as outlined below: 
1. Do not wait to submit a reportable event to the IRB until you have all the information about the 
event. Report the event promptly and follow-up with additional information as it becomes 
available. 
2. A UPIRSO (Unanticipated Problem Involving Risks to Subjects or Others) that is also a Serious 
Adverse Event must be reported ASAP, but no later than one (1) week from the time you 
become aware of the event. 
3. All other UPIRSOs must be reported ASAP, but no later than two (2) weeks from the time you 
become aware of the event. 
 

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8.3.6 SERIOUS ADVERSE EVENT REPORTING  
See above. 
 
8.3.7 REPORTING EVENTS TO PARTICIPANTS  
Participants will be aware of events we consider AEs and SAEs as they will be reported to us by 
participants.  Given the low risk nature of this study, we do not anticipate reporting summary information 
on adverse events to participants. 
8.3.8 EVENTS OF SPECIAL INTEREST  
N/A 
 
8.3.9 REPORTING OF PREGNANCY  
Study participants who become pregnant may not continue to participate in the study due to the study 
duration (3 months) and the anticipated duration of a full term pregnancy 
 
8.4 
UNANTICIPATED PROBLEMS 
 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human Research 
Protections (OHRP).  OHRP considers unanticipated problems involving risks to participants or others to 
include, in general, any incident, experience, or outcome that meets all of the following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
participant population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
Suggests that the research places participants or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized 
8.4.2  UNANTICIPATED PROBLEMS REPORTING  
The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB). The UP report will include the following information: 
 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number 
• 
A detailed description of the event, incident, experience, or outcome  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP 

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• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline:   
 
• 
UPs that are serious adverse events (SAEs) will be reported to the IRB  but no later than one week 
of when the investigator becoming aware of the event.  
• 
Any other UP will be reported to the IRB but not later than within 2 weeks  of the investigator 
becoming aware of the problem  
 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
N/A 
 
9 
STATISTICAL CONSIDERATIONS  
9.1 
STATISTICAL HYPOTHESES 
 
Outcome measures: Feasibility will be measured by the number of participants who consent, and the 
percent of dyads that attend both sessions. Acceptability will be measured by a satisfaction survey 
complete by both dyad members. Fidelity of skills training by study counselor will be determined from 
recorded sessions. 
 
9.2 
SAMPLE SIZE DETERMINATION 
The study is pilot in nature. A sample of 20 is considered sufficient. 
 
9.3 
POPULATIONS FOR ANALYSES 
N/A 
9.4 
STATISTICAL ANALYSES 
 
9.4.1 GENERAL APPROACH 
This is covered in Section 9.4.2. 
9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
This is covered in Section 9.4.2. 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
This is covered in Section 9.4.2. 
 
9.4.4 SAFETY ANALYSES 

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Prior to analysis, any data-captured adverse events will be coded by the principal investigators. Each 
type of event (by seriousness, severity, relationship to study) will be descriptively summarized in 
frequency tables by group (including only a single occurrence of any distinct type of event for any 
participant). Number of CVD events, ER visits, and hospitalizations will also be descriptively summarized 
by group. No inferential statistics (p-values or confidence intervals) are planned for comparing safety 
data between groups. 
 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
We will summarize baseline data (i.e., pre-randomization data). Measures of central tendency and 
dispersion for continuous and certain discrete variables will include means, standard deviations, 
medians, minima, and maxima. Categorical data will be summarized with frequencies and percentages. 
Some continuous variables may also be grouped into categorical levels and evaluated in frequency 
tables. No inferential statistics (i.e., p-values and/or confidence intervals) for comparing data between 
groups will be presented. 
 
9.4.6 PLANNED INTERIM ANALYSES  
N/A 
9.4.7 SUB-GROUP ANALYSES 
N/A 
 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
N/A 
 
9.4.9 EXPLORATORY ANALYSES 
N/A 
 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
10.1.1 INFORMED CONSENT PROCESS 
10.1.1.1 CONSENT/ASSENT 
AND 
OTHER 
INFORMATIONAL 
DOCUMENTS 
PROVIDED 
TO 
PARTICIPANTS 
University of North Carolina at Chapel Hill 
Consent to Participate in a Research Study 
Adult Participants 
 
Consent Form Version Date: _8/17/2023_____________ 
IRB Study # 23-1598 

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Title of Study: Feasibility of conducting an online family dyadic/couple skills training for Black 
adults enrolled in a behavioral weight loss intervention - Together, Eating and Activity, Matter+ 
(TEAM+) 
Principal Investigator: Candice L. Alick 
Principal Investigator Department: Center for Health Promotion and Disease Prevention 
Principal Investigator Phone number: (919) 966-6080 
Principal Investigator Email Address: alick@email.unc.edu  
Faculty Advisor: Carmen Samuel-Hodge 
Faculty Advisor Contact Information: (919) 966-0360 
 
This is a research study to find out if components of a family-based weight loss program can be 
delivered online for Black adults.  When you enroll in this study with a family member, you will 
attend family skills training on-line or in-person together. All participants (including family 
members) will receive in-person group sessions about weight loss as well.  The two family skills 
training sessions will last approximately 30 minutes. The seven weight loss group sessions will 
last 60 minutes each. We will take measurements (e.g., weight, etc), and surveys at the beginning 
and end of the program. Half of the family pairs will be asked to complete interviews asking 
questions about their experiences in the program. There are minimal risks to this study that are 
described in this document.  If you are interested in learning more about this study, please 
continue reading below.  
What are some general things you should know about research studies? 
You are being asked to take part in a research study.  To join the study is voluntary. 
You may choose not to participate, or you may withdraw your consent to be in the study, for any 
reason, without penalty. 
 
Research studies are designed to obtain new knowledge. This new information may help people 
in the future.   You may not receive any direct benefit from being in the research study. There 
also may be risks to being in research studies.  
Details about this study are discussed below.  It is important that you understand this information 
so that you can make an informed choice about being in this research study.  
 
You will be given a copy of this consent form.  You should ask the researchers named above, or 
staff members who may assist them, any questions you have about this study at any time. 
 
What is the purpose of this study? 
The purpose of this research study is to test the feasibility and acceptability of an interactive 
counselor -led online family skills training as part of a behavioral weight loss program for Black 
Adults.  
 
You are being asked to be in the study because you: 
- self-identify as a Black or African American,  
- are between 18-75 years old 
- have a family member willing to attend study session with you 
- have Internet access 
- reside in the Raleigh/Durham/Chapel Hill area, 

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Are there any reasons you should not be in this study? 
You should not be in this study if you do not self-identify as Black or African-American, not 
interested in losing weight, do not have a family member willing to attend study sessions,  
 
How many people will take part in this study? 
Approximately 40 people (20 family dyads) at University of North Carolina at Chapel Hill will 
take part in this study. 
 
How long will your part in this study last? 
Your expected participation will last approximately 4 months. The seven group sessions will last 
approximately 60 minutes. The 2 family skills training sessions will last approximately 30 
minutes. If invented to participate for an interview, the interview will last approximately 60 
minutes.  
 
What will happen if you take part in the study? 
You will be invited to participate in a in-person 3 month behavioral weight loss program. The 
first 4 sessions will be weekly, two sessions will be biweekly and the last session will be in the 
last month. You will attend these group sessions with a family member of your choice. You will 
also be randomly assigned to attend two family skills training session either 1) in-person or 2) 
online by change, like flipping a coin.. Surveys and body measurements will be administered at 
the beginning of the program and the end of the program. Those participants invited to 
participate in the interview may chose not to answer a question for any reason.  
What are the possible benefits from being in this study? 
Research is designed to benefit society by gaining new knowledge. We think you may benefit from being in 
this study by improving your lifestyle and losing weight.  However, you may not benefit from 
being in this study. 
 
What are the possible risks or discomforts involved from being in this study? 
The possible risks and discomforts from being in this study are few and are listed below. 
• We do not think there is risk to you from the dietary advice given as part of the study 
• Those who increase their level of physical activity may experience minor muscle pain, 
but this type of activity rarely causes serious health problems such as chest pain or 
asthma.  
• In all studies, there is a very slight chance of loss of privacy (that is, others may see your 
study information). As stated below, we will do all we can to make sure this does not 
happen. 
 
Also, there may be other risks we did not list here. You should report to the research team any 
problems that may be due to this study. 
 
What if we learn about new findings or information during the study? 
You will be given any new information gained during the course of the study that might affect 
your willingness to continue your participation.  
 

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How will information about you be protected? 
Study surveys will be stored with your study ID number and your first and last initial, but NOT 
with your name (we call this de-identified data).  No one other than study staff will be able to 
connect your name and study ID as we will follow standard procedures to protect the privacy of 
research data.  
 
We may use your de-identified data, as described above, in future research without additional 
consent.  However, in some cases, the Institutional Review Board (called IRB and described 
below) may require that you be re-contacted and asked for your consent to use your data in a 
specific research study. You have the right, at that future time, not to participate in any research 
study for which your consent is sought. 
Participants will not be identified in any report or publication about this study.  We may use de-
identified data and/or specimens from this study in future research without additional consent. 
Although every effort will be made to keep research records private, there may be times when 
federal or state law requires the disclosure of such records, including personal information.  This 
is very unlikely, but if disclosure is ever required, UNC-Chapel Hill will take steps allowable by 
law to protect the privacy of personal information.  In some cases, your information in this 
research study could be reviewed by representatives of the University, research sponsors, or 
government agencies (for example, the FDA) for purposes such as quality control or safety. 
To protect other participants, we ask you as a participant, not to reveal anything you learn from 
interviews, group discussions or other activities. 
What is a Certificate of Confidentiality?  
This research is covered by a Certificate of Confidentiality. With this Certificate, the researchers may not disclose or 
use information, documents or biospecimens that may identify you in any federal, state, or local civil, criminal, 
administrative, legislative, or other proceedings in the United States, for example, if there is a court subpoena, unless 
you have consented for this use. 
 
The Certificate cannot be used to refuse a request for information from personnel of a federal or state agency that is 
sponsoring the study for auditing or evaluation purposes or for information that must be disclosed in order to meet 
the requirements of the federal Food and Drug Administration (FDA). 
 
The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, 
state, or local law, such as mandatory reporting requirements for child abuse or neglect, disabled 
adult abuse or neglect, communicable diseases, injuries caused by suspected criminal violence, 
cancer diagnosis or benign brain or central nervous system tumors or other mandatory reporting 
requirement under applicable law. The Certificate of Confidentiality will not be used if 
disclosure is for other scientific research, as allowed by federal regulations protecting research 
subjects or for any purpose you have consented to in this informed consent document. 
 
You should understand that a Certificate of Confidentiality does not prevent you from 
voluntarily releasing information about yourself or your involvement in this research. If an 
insurer, employer, or other person obtains your written consent to receive research information, 
then the researchers may not use the Certificate to withhold that information. 
Audio and/or Video Recordings 

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Family skills training sessions and in-depth interviews will be video and/or audio recorded. 
These recordings will be converted to written text (transcribed). The written text will be used to 
assess if the program components were delivered as intended and also determine the 
acceptability and feasibility of these program components. Recordings will be destroyed after all 
information is transcribed. Recording and transcriptions will be kept on an encrypted university 
server accessible only by study staff. Audio/video recordings may be requested to be turned off 
at any point during the study.  
Check the line that best matches your choice: 
_____ OK to record me during the study 
_____ Not OK to record me during the study 
 
What will happen if you are injured by this research? 
All research involves a chance that something bad might happen to you.  If you are hurt, become 
sick, or develop a reaction from something that was done as part of this study, the researcher will 
help you get medical care, but the University of North Carolina at Chapel Hill has not set aside 
funds to pay you for any such injuries, illnesses or reactions, or for the related medical care.  Any 
costs for medical expenses will be billed to you or your insurance company.  You may be 
responsible for any co-payments and your insurance may not cover the costs of study related 
injuries. 
If you think you have been injured from taking part in this study, call the Principal Investigator at 
the phone number provided on this consent form.  They will let you know what you should do.  
By signing this form, you do not give up your right to seek payment or other rights if you are 
harmed as a result of being in this study. 
If you think you have been injured from taking part in this study, call the Principal Investigator at 
the phone number provided on this consent form.  They will let you know what you should do.  
By signing this form, you do not give up your right to seek payment or other rights if you are 
harmed as a result of being in this study. 
What if you want to stop before your part in the study is complete? 
You can withdraw from this study at any time, without penalty.  The investigators also have the 
right to stop your participation at any time. This could be because you have had an unexpected 
reaction, or have failed to follow instructions, or because the entire study has been stopped. 
 
If you withdraw or are withdrawn from this study all data collected up until the point of 
withdrawal will be retained, however no additional information will be collected unless you 
provide additional written permission for further data collection at the time of your withdrawal  
Will you receive anything for being in this study? 
You will be receiving approximately $320 per family dyad ($40 per session. There are 7 group 
sessions and 2 family skills training sessions.) for taking part in this study. Those selected for 
interview, have the opportunity to receive an additional $40. Any payment provided for 
participation in this study may be subject to applicable tax withholding obligations. 
 
In order to process payments, the University may share certain identifiable information about 
you, such as name and contact information, with third parties that the University retains to 

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process payments on its behalf.  If you do not want to agree with sharing your information with 
these third parties, then you will be unable to receive payment/compensation for participating in 
the study. 
 
Will it cost you anything to be in this study? 
 
It will not cost you anything to be in this study.  
 
What if you have questions about this study? 
You have the right to ask, and have answered, any questions you may have about this research. If 
you have questions about the study (including payments), complaints, concerns, or if a research-
related injury occurs, you should contact the researchers listed on the first page of this form. 
 
A description of this clinical trial will be available on www.clinicaltrials.gov, as required by U.S. 
Law. This website will not include information that can identify you. At most, the website will 
include a summary of the results. You can search this website at any time. 
 
What if you have questions about your rights as a research participant? 
All research on human volunteers is reviewed by a committee that works to protect your rights 
and welfare.  If you have questions or concerns about your rights as a research subject, or if you 
would like to obtain information or offer input, you may contact the Institutional Review Board 
at 919-966-3113 or by email to IRB_subjects@unc.edu. 
Participant’s Agreement: 
 
I have read the information provided above.  I have asked all the questions I have at this time.  I 
voluntarily agree to participate in this research study. 
 
______________________________________________________ 
Signature of Research Participant 
____________________ 
Date 
______________________________________________________ 
Printed Name of Research Participant  
 
______________________________________________________ 
Signature of Research Team Member Obtaining Consent 
____________________ 
Date 
______________________________________________________ 
Printed Name of Research Team Member Obtaining Consent   
 
______________________________________________________ 
Signature of Witness if applicable; e.g. literacy issues, 
visually impaired, physically unable to sign, witness/interpreter for 
non-English speaking participants using the short form) 
  

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____________________ 
Date 
______________________________________________________ 
Printed Name of Witness  
  
 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
Contacting participants who expressed interest to assess eligibility 
• 
During eligibly calls, data are entered into the  eligibility questionnaire.  
• 
If a potential participant is interested and eligible, staff will email the consent forms to this 
individual and an appointment will be made for the consent phone call in about 1 week.  
Consent phone call  
• 
At this phone call, key components of the consent form are reviewed in detail to insure that the 
potential participant understands what participation entails. It the potential participant agrees 
to sign consent form via e-consent, instructions are given on how to do so. If the potential 
participant prefers to sign at the enrollment visit, then verbal consent to complete baseline 
questionnaires before the enrollment visit will be obtained, as approved by the IRB.   
• 
Instructions for completing baseline forms, on-line , are given and plans to complete these 
forms are made accordingly.  An appointment date is set for the baseline visit.  
 
Enrollment visit and randomization: At the enrollment visit, all questions will be answered about the 
study and those who did not sign the consent forms on-line will sign the consent form. Upon completion 
of baseline measures the participant will be ready for randomization. The research assistant will use a 
secure excel document to ascertain randomization assignment 
 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
Given the low risk nature of the study, we do not anticipate stopping for adverse outcomes. 
 
10.1.3 CONFIDENTIALITY AND PRIVACY  
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their 
staff, the safety and oversight monitor(s), and the sponsor(s) and funding agency. This confidentiality is 
extended to the data being collected as part of this study. Data that could be used to identify a specific 
study participant will be held in strict confidence within the research team. No personally-identifiable 
information from the study will be released to any unauthorized third party without prior written 
approval of the sponsor/funding agency.  
 
All research activities will be conducted in as private a setting as possible. 
 

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The study monitor, other authorized representatives of the sponsor or funding agency, representatives 
of the Institutional Review Board (IRB), regulatory agencies or representatives from companies or 
organizations supplying the product, may inspect all documents and records required to be maintained 
by the investigator, including but not limited to, medical records (office, clinic, or hospital) and 
pharmacy records for the participants in this study. The clinical study site will permit access to such 
records. 
 
The study participant’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the reviewing IRB, Institutional policies, or sponsor/funding agency 
requirements. 
 
Measures Taken to Ensure Confidentiality of Data Shared per the NIH Data Sharing Policies  
It is NIH policy that the results and accomplishments of the activities that it funds should be made 
available to the public (see https://grants.nih.gov/policy/sharing.htm). The PI will ensure all mechanisms 
used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, 
and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not 
be traceable to a specific study participant). Plans for archiving and long-term preservation of the data 
will be implemented, as appropriate.  
 
Certificate of Confidentiality  
To further protect the privacy of study participants, the Secretary, Health and Human Services (HHS), 
has issued a Certificate of Confidentiality (CoC) to all researchers engaged in biomedical, behavioral, 
clinical or other human subjects research funded wholly or in part by the federal 
government.  Recipients of NIH funding for human subjects research are required to protect identifiable 
research information from forced disclosure per the terms of the NIH Policy (see 
https://humansubjects.nih.gov/coc/index). As set forth in 45 CFR Part 75.303(a) and NIHGPS Chapter 
8.3, recipients conducting NIH-supported research covered by this Policy are required to establish and 
maintain effective internal controls (e.g., policies and procedures) that provide reasonable assurance 
that the award is managed in compliance with Federal statutes, regulations, and the terms and 
conditions of award. It is the NIH policy that investigators and others who have access to research 
records will not disclose identifying information except when the participant consents or in certain 
instances when federal, state, or local law or regulation requires disclosure. NIH expects investigators to 
inform research participants of the protections and the limits to protections provided by a Certificate 
issued by this Policy. 
 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
Data will be stored on secured servers administered by UNC-Chapel Hill IT. 
 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
Provide the name and contact information of the Principal Investigator and the Medical Monitor or 
Independent Safety Monitor. Update table heading to remove non-relevant role. 
Principal Investigator 
Medical Monitor or 
Independent Safety Monitor 

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Candice L. Alick, PhD 
Name, degree, title 
University of North Carolina at 
Chapel Hill  
Institution Name  
1700 M.L.K. Jr Blvd #7426, Chapel 
Hill, NC 27514 
Address 
(919) 966-6080 
Phone Number 
alick@email.unc.edu 
Email 
 
 
10.1.6 SAFETY OVERSIGHT 
Safety oversite is provided by study team self-assessments due to the time frame and minimal risk. In cases 
of safety, all incidents will be reported to the IRB and study sponsor. 
 
10.1.7 CLINICAL MONITORING 
N/A 
 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
 
As outlined below, data will be stored in identified and de-identified data sets.  The overall data 
management plan has been approved by the UNC IRB. 
 
The table below outlines sources of data, where it will be stored, and aspects of data management 
related to data quality and security.  The rows of the tables are organized by the chronological sequence 
of anticipated data acquisition. 
 
The primary data collection and management program with be UNC Qualtrics. 
 
Type/Use of Data 
Data Source 
Data Storage 
Ident. Data Review/Other Comments 
Eligibility data 
From 
participants, 
collected by 
phone by 
research 
staff 
 
Qualtrics 
yes 
Data review:  weekly, as outlined 
above.  
Consent forms 
Participants  For consent 
completed on-
line, Qualtrics 
 
yes 
Research staff ensure that consent 
documents are signed after all 
questions are answered. 
Participant study 
data collected 
using Qualtrics 
forms and 
Participants 
Qualtrics 
yes 
Surveys and forms will have PT-ID# 
and first and last initial.  Data will be 
collected via phone for those who do 

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surveys—
electronic 
questionnaires 
 
not want to complete online.  Data 
review:  weekly, as outlined above. 
Process data  
Participants 
UNC Server 
 
yes 
Data collected by counselor 
Data sets for 
analysis 
Participants 
UNC Server 
yes 
and 
no 
Analysis datasets created from excel 
datasets.  Will be stored on Study’s 
Microsoft Team’s account.  
 
 
Protocol Deviations – The study team will review protocol deviations on an ongoing basis and will 
implement corrective actions when the quantity or nature of deviations are deemed to be at a level of 
concern. 
 
Should independent monitoring become necessary, the PI will provide direct access to all trial related 
sites, source data/documents, and reports for the purpose of monitoring and auditing by the 
sponsor/funding agency, and inspection by local and regulatory authorities. 
 
10.1.9 DATA HANDLING AND RECORD KEEPING  
 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
The data issues to be described in this section are covered in Section 10.1.8. 
 
10.1.9.2 STUDY RECORDS RETENTION  
Study data will be maintained for at least 10 years after final data collection. 
 
10.1.10 
PROTOCOL DEVIATIONS   
This study will follow the protocol deviation guidelines from the UNC IRB, as outlined below: 
 
Purpose: 
To record all protocol deviations that occur at a study site for both 
observational and interventional clinical research studies. 
IMPORTANT: This log is maintained in the Study Binder (Synonyms for this 
binder include Investigator Binder, Regulatory Binder, Investigator Site File 
[ISF], and Study File.) and should be made available upon request for 
review by the IRB and the Sponsor’s monitor. Deviations should be 
reported to the IRB of record as per the IRB Standard Operating 
Procedures. See OHRE/IRB SOP 1401 for reporting requirements for 
deviations to the UNC IRB.  
Audience/User: 
Study coordinators, principal investigators (PIs), other site staff, clinical 
monitor 

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Best Practice 
Recommendations: 
• Record protocol deviations in the tracking log as they occur, to ensure 
completeness and accuracy of the data.  
• The site PI should sign each form after it has been completed or 
immediately prior to a monitoring visit. If it has been signed with fewer 
than five deviations entered into it, the next identified deviation should 
be reported on a new page to ensure that all deviations have been 
reviewed by the PI. 
• Number each page and identify the final page of the log by indicating 
FINAL in the page number field. 
• Store pages in reverse chronological order, with the newest pages of the 
log placed at the front of the section. 
• Remove this page before using the log. 
  
 
*DEVIATION CATEGORIES: 
A. Informed Consent 
B. Eligibility 
C. Protocol implementation 
D. Reporting 
E. Other, specify in log 
**DEVIATION CODES: Numbers listed by the sample protocol deviations  
Informed Consent (Category A) 
1. Failure to obtain informed consent 
2. Consent form used was not current IRB-approved version 
3. Consent form does not include updates or information required by IRB 
4. Consent form missing 

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5. Consent form not signed and dated by participant 
6. Consent form does not contain all required signatures 
7. Other, specify in log 
 
Eligibility (Category B) 
8. Participant did not meet eligibility criterion 
9. Randomization of an ineligible participant 
10. Participant randomized prior to completing Baseline Assessment, etc. 
11. Randomization and/or treatment of participant prior to IRB approval of protocol 
12. Other, specify in log 
 
Protocol implementation (Category C) 
13. Failure to keep IRB approval up to date 
14. Participant receives wrong treatment 
15. Participant seen outside visit window 
16. Use of unallowable concomitant treatments 
17. Prescribed dosing outside protocol guidelines 
18. Missed assessment  
19. Missed visit 
20. Other, specify in log 
 
Reporting (Category D) 
21. Not submitting reportable information to the IRB within 7 days 
22. Failure to respond to the NSI stipulations in the requested timeframe 
23. Other, specify in log 
 
Other (Category E) 
25. Other, specify in log 
 
IRB Study # 
   
Site 
Name/Nu
mber: 
   
Protocol Title 
(Abbreviated): 
   
Protocol 
ID/Numb
er: 
 

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Principal 
Investigator: 
   
Page 
number 
[1]: 
   
R
ef 
N
o. 
Subj
ect 
ID 
Date 
of 
Devia
tion 
Date 
Identi
fied 
Deviation Description 
Dev
. 
Typ
e 
[2] 
Res
ulte
d in 
AE? 
Did 
Subject 
Contin
ue in 
Study? 
Meets 
IRB 
Reporti
ng Req. 
(I.e. 
NSI) 
(Yes/N
o) 
IRB 
Report
ing 
Date 
1 
   
   
   
   
   
   
   
   
   
2 
   
   
   
   
   
   
   
   
   
3 
   
   
   
   
   
   
   
   
   
4 
   
   
   
   
   
   
   
   
   
5 
   
   
   
   
   
   
   
   
   
6 
   
   
   
   
   
   
   
   
   
7 
   
   
   
   
   
   
   
   
   
 
 
10.1.11 
DATA SHARING POLICY  
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 

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such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-
reviewed journals.  Data from this study may be requested from other researchers 2 years after the 
completion of the primary endpoint by contacting the principal investigators.  Considerations for 
ensuring confidentiality of these shared data are described in Section 10.1.3. 
 
10.1.12 
CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical. Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a 
way that is appropriate to their participation in the design and conduct of this trial according to the 
guidelines set forth by the Conflict of Interest Program at UNC.  
 
10.2 ADDITIONAL CONSIDERATIONS 
N/A 
 
10.3 ABBREVIATIONS AND SPECIAL TERMS 
 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 
CFR 
Code of Federal Regulations 
CLIA 
Clinical Laboratory Improvement Amendments 
CMP 
Clinical Monitoring Plan 
COC 
Certificate of Confidentiality 
CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DSMB 
Data Safety Monitoring Board 
DRE 
Disease-Related Event 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act of 2007 
FFR 
Federal Financial Report 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
GWAS 
Genome-Wide Association Studies 
HIPAA 
Health Insurance Portability and Accountability Act  
IB 
Investigator’s Brochure 
ICH 
International Council on Harmonisation  
ICMJE 
International Committee of Medical Journal Editors 

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IDE 
Investigational Device Exemption 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ITT 
Intention-To-Treat 
LSMEANS 
Least-squares Means 
MedDRA 
Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 
 
 
 

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10.4 PROTOCOL AMENDMENT HISTORY 
The table below is intended to capture changes of IRB-approved versions of the protocol, including a 
description of the change and rationale. A Summary of Changes table for the current amendment is 
located in the Protocol Title Page.  
 
Version 
Date 
Description of Change  
Brief Rationale 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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2. Stierman B, Afful J, Carroll MD, et al. National Health and Nutrition Examination Survey 2017–
March 2020 Prepandemic Data Files Development of Files and Prevalence Estimates for Selected 
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3. (CDC) CfDCaP. National Center for Health Statistics (NCHS). National Health and Nutrition 
Examination Survey Data. Hyattsville, MD: U.S. Department of Health and Human Services, 
Centers for Disease Control and Prevention; 2021.  
4. Ward ZJ, Bleich SN, Cradock AL, et al. Projected US state-level prevalence of adult obesity and 
severe obesity. New England Journal of Medicine. 2019;381(25):2440-2450.  
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6. Davis KK, Tate DF, Lang W, et al. Racial differences in weight loss among adults in a behavioral 
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7.  West DS, Elaine Prewitt T, Bursac Z, Felix HC. Weight loss of black, white, and Hispanic men and 
women in the Diabetes Prevention Program. Obesity (Silver Spring, Md). 2008;16(6):1413-1420. 
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8. Nobles WW. African American family life. Black families. 1981:77-86. 
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349. 9.  
10. Pollock ED, Kazman JB, Deuster P. Family functioning and stress in African American families: A 
strength-based approach. Journal of Black Psychology. 2015;41(2):144-169.  
11. Karenga M, Karenga T. The Nguzo Saba and the Black family. Black families. 2007:7-28.  
12. McLoyd VC, Cauce AM, Takeuchi D, Wilson L. Marital processes and parental socialization in 
families of color: A decade review of research. Journal of Marriage and Family. 2000;62(4):1070-
1093.  
13. McAdoo HP. Stress absorbing systems in Black families. Family Relations. 1982:479-488.  
14. McAdoo HP, Younge SN. Black families. Handbook of African American psychology. 2009:103-
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15. Stack CB, Burton LM. Kinscripts. Journal of Comparative Family Studies. 1993;24(2):157-170. 
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African American adults. Archives of Internal Medicine. 2009;169(19):1795-1804. 
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17. Samuel-Hodge CD, Gizlice Z, Cai J, Brantley PJ, Ard JD, Svetkey LP. Family functioning and weight 
loss in a sample of african americans and whites. Annals of Behavioral Medicine : A Publication 
of the Society of Behavioral Medicine. 2010;40(3):294-301. doi:10.1007/s12160-010-9219-z  
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