Enhancing Effectiveness Of Existing Weight Management Programs For Teens With Severe Obesity: A 6-Month Feasibility Pilot
Phase: NA
Conditions: Obesity
Sponsor: Children's Hospital Medical Center, Cincinnati

 
 
 
 
 
 
Enhancing Effectiveness of Existing Weight Management 
Programs for Teens with Severe Obesity: a 6 Month 
Feasibility Pilot 
 
NCT#: 03939494 
 
7/22/19 

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TITLE OF STUDY: ENHANCING EFFECTIVENESS OF EXISTING WEIGHT 
MANAGEMENT PROGRAMS FOR TEENS WITH SEVERE OBESITY: A 6-MONTH 
FEASIBILITY PILOT 
SHORT TITLE: HEALTHY WEIGHT FOR TEENS STUDY
Sponsor:
NIH/NIDDK – R34DK118510
Study Sites: Cincinnati Children’s Hospital Medical Center (CCHMC), Cincinnati, OH’
Helen DeVos Children’s Hospital (HDVCH), Grand Rapids, MI.
Principal Investigator: Shelley Kirk, PhD, RD, LD (CCHMC)
Sub-Investigators: 
William Stratbucker, MD (HDVCH)
Robert Siegel, MD (CCHMC)
Eileen King, PhD (CCHMC)
Aaron Kelly, PhD (Regents of the University of Minnesota, 
   Medical School, Minneapolis, MN)
1.
ABSTRACT
The prevalence of obesity among adolescents (ages 12-19) continues to be a serious 
public health problem as the most recent national survey (NHANES: 2015-2016) 
reported 20.5% of adolescents have a BMI > 95th percentile. Especially concerning is 
the steady increase of severe obesity (≥ 120% of the 95th percentile for BMI) within this 
age group. Also the concurrent rise in obesity-related health complications, such as 
insulin resistance, dyslipidemia, and fatty liver disease, underscores this major health 
burden from severe obesity. The recommended treatment for adolescents with obesity 
is a pediatric weight management (PWM) program offered in a tertiary-care setting that 
combines dietary, physical activity and behavioral strategies, using a patient-centered 
model with frequent contact. However this approach often has poor adherence to 
treatment and high attrition rates. Providing at least 26 hours of contact over a 6-month 
treatment period was found to be most effective, but a recent survey of 29 PWM 
programs in POWER (Pediatric Obesity Weight Evaluation Registry) found most sites 
offer low-intensity interventions (<26 hours) due to limited resources and patient 
circumstances. To improve the effectiveness of PWM programs, this proposed study 
has identified a “bundle of program enhancements” (BPE) informed by a literature 
review, preliminary POWER outcomes, and evaluation of program characteristics of 
POWER’s “top-performing” sites. The BPE components are: 1) Increasing provider 
contact hours in existing PWM programs to reach 26 hours during a 6-month treatment 
period by using remote interactive technologies to supplement standard-of-care clinic 
visits;  2) Identification of mental health problems during an individual program 
orientation prior to starting a PWM program, in order to initiate needed treatment as part 

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of a PWM program; and 3) Evaluation of “readiness to change” and “barriers to making 
lifestyle changes” with motivational interviewing during the orientation session, allowing 
for interventions tailored to the patient’s needs. The proposed study is a pilot pragmatic 
trial designed to test the feasibility, acceptance, and preliminary effectiveness of the 
BPE (Intervention group: N=40) vs. standard-of-care (Control group: N=20) for 
adolescents with severe obesity in PWM programs at two POWER sites. The primary 
aims are: 1) Test whether existing PWM programs can successfully implement the BPE 
for 80% of participants randomly assigned to the Intervention group and 2) Test whether 
70% of participants in the Intervention group will complete 26 contact hours during 6 
months of treatment. The secondary aims test whether the Intervention group has 
greater rates of participation and retention, plus better health outcomes compared to the 
Control group.  If the results of this pilot study are promising, then a fully-powered multi-
site clinical trial can be designed to evaluate the BPE’s efficacy in existing PWM 
programs. By developing more successful evidence-based interventions for PWM 
programs, this research can help reverse the adolescent obesity epidemic and prevent 
the onset or worsening of comorbidities.
2.
INTRODUCTION
2.1.
Background
The prevalence of obesity among adolescents (ages 12-19) continues to be a serious 
public health problem nationwide with 20.5% of adolescents having a body mass index 
(BMI) greater than the 95th percentile. 1 Though the rate of increase over the past 
decade has slowed, 2 there is a growing concern about the steady increase in severe 
obesity (BMI ≥ 120 percent of the 95th percentile for age and sex) within this age group. 
Based on NHANES survey from 1999-2014, the prevalence of adolescents with severe 
obesity doubled for girls (5.2% to 10.2%) and increased by one-third for boys (6.7% to 
8.9%).3 In addition the concurrent rise in obesity-related health complications, such as 
insulin resistance, dyslipidemia, fatty liver disease, hypertension, obstructive sleep 
apnea and low self-esteem 4 emphasizes the extensive health burden resulting from 
severe obesity. Since obesity during adolescence is likely to persist into adulthood 5 
developing effective intervention strategies is critically important. For adolescents with 
obesity who are unsuccessful with primary care management, the American Academy 
of Pediatrics recommends a structured multi-component pediatric weight management 
(PWM) program offered in a tertiary-care setting that combines dietary, physical activity 
and behavioral strategies, using a patient-centered model with more frequent contact.6 
However this approach has had limited success, often characterized by poor adherence 
to treatment and high attrition rates.7-15 A systematic literature review of clinical trials of 
behavioral multi-component PWM interventions for youth with obesity reported that 
those offering a medium-intensity (26-75 provider contact hours) to high-intensity (>75 
contact hours) intervention over a 6-month period were the most effective, consistently 
resulting in small to moderate improvements in weight status. 5 However a recent 
survey of 29 multi-component PWM programs participating in POWER (Pediatric 
Obesity Weight Evaluation Registry) from across the country reported the majority of 
sites only offered low-intensity (<26 contact hours) interventions. 16 Therefore 

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innovative strategies are needed to increase provider contact time and improve 
retention rates of multi-component PWM programs in order to improve their 
effectiveness in treatment of adolescents with severe obesity. By developing a more 
intensive, yet practical evidence-based intervention strategy for multi-component PWM 
programs, we can help reverse the adolescent obesity epidemic and prevent the onset 
or worsening of obesity-related comorbidities. 
Preliminary Studies
POWER was established in 2013 to identify and promote effective intervention 
strategies for pediatric obesity within the tertiary care, specialty weight management 
program environment. Participating sites in POWER are multi-component PWM 
programs that collect a defined set of demographic, anthropometric, and laboratory data 
that are regularly sent to the POWER Data Coordinating Center.16 POWER now has 
data on 7200 patients with obesity aged 2-18 from 33 pediatric weight management 
programs). Patient enrollment began in May 2014 and is ongoing. Sites began enrolling 
patients into POWER after receiving approval from their local IRB. Sixty-three percent of 
patients have at least one on-site follow-up visit in addition to their baseline medical visit 
and 57% of patients have at least one follow-up lab. Nearly 50% of the patients enrolled 
in POWER are adolescents, 54% female, 54% white, 18% black, 31% Hispanic, and 
59% publically insured. Seventy-four percent of patients present to the clinic with severe 
obesity. 
The proposed study will enroll adolescents (12-18 years) that present with severe 
obesity. The demographics for adolescents in POWER are similar to the entire POWER 
population: 54% female, 56% Caucasian, 21% Black, 26% Hispanic, 62% publically 
insured and 61% with at least 1 follow-up visit. At the baseline medical visit, the median 
[IQR] weight status (measured by percent of the 95th percentile) is 141% [130%, 158%] 
and a high percentage present with abnormal (elevated) lab values: triglycerides (38%), 
non-HDL (20%), HbA1c (27%), fasting glucose (13%) and ALT (24%), underscoring the 
prevalence and severity of the comorbidities associated with severe obesity. This BMI 
metric is recommended for evaluating youth with higher levels of obesity.17, 18 Modest 
changes in weight status have been observed in these adolescents during participation 
in the various pediatric weight management program in POWER; median [IQR] change 
in BMI: percent of the 95th percentile is -2.4 [-7.1, 1.0] at 6 months and -3.75 [-11.6, 1.4] 
at 12 months with 14.5 and 29 having at least a 10 percentage point improvement in 
percent of the 95th percentile at 6 and 12 months respectively. 
For many PWM programs, provider contact with patients occurs only during on-site 
visits. The aims of this study are to determine if increasing contact hours by 
supplementing on-site visits and remote follow-up interactive contacts will lead to 
improved outcomes and a higher retention rate.  Outcomes data from on-site visits that 
measure height and weight are captured in the POWER data base.  The median [IQR] 
number of on-site visits for adolescent patients with severe obesity enrolled in POWER 
is 3 [3,5] at 6 months and 5.5 [4,7] at 12 months.  The power data set shows a modest, 
yet statistically significant, correlation between an increased number of visits and a 
larger improvement in weight status at 9 and 12 months (9 months: r=0.20, p<0.0001; 

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12 months: r=0.22, p=0.0006).  As the number of visits increases, the percentage of 
patients with improvement in weight status increases. Also, the longer patients stay in 
the PWM program with an increasing number of visits, the percentage of patients with 
improvements in weight status increases (Figure 1).
The POWER data set also shows significant correlations between improvement in 
weight status and improvement in laboratory values (ALT: r=0.46, p<0.0001; non-HDL: 
r=0.27, p=0.0022; HgA1c: r=0.27, p=0.0009; triglycerides: r=0.22, p=0.02) (Figures 2 
and 3). A large percentage of patients with abnormal labs at baseline that achieved at 
least a 10 point improvement in weight status (i.e. percent of 95th percentile) at 
approximately 6 months also achieved normalized labs (alt: 57%; triglycerides: 46%; 
HgA1c: 62%; non-HDL: 43%). 
Cincinnati Children’s Hospital Medical Center (CCHMC) and Helen DeVos Children’s 
Hospital (HDVCH) will be the two PWM programs participating in this trial and these 
sites see approximately 929 and 564 new patients each year, respectively. CCHMC 
began enrolling patients into POWER in May, 2014 with HDVCH following in June, 
2014. The demographics for adolescents with severe obesity for these two sites are 
very similar to the POWER population with the exception of a lower percentage of 

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Hispanic ethnicity (7%) and a higher percentage of Black race (31%). For these two 
sites, the median [IQR] number of visits by 6 months is 3 [3, 7] and the median [IQR] 
change in percent of the 95th percentile for BMI at 6 months is -1.7 [-4, 3] with only 6% 
achieving an improvement of 10 percentage points in the weight status measurement at 
6 months. Significant correlations between improvement in weight status and 
improvement in laboratory values were also seen for patients from these two sites (ALT: 
r=0.36, p=0.02; HbA1c: r=0.31, p=0.048; triglycerides: r=0.34, p=0.03). Testing the 
feasibility and acceptability of the BPE in these two sites that are representative of the 
entire POWER population will provide the needed data, including estimates of treatment 
effects, to design a fully powered multi-site clinical trial to evaluate the efficacy of the 
BPE as an enhancement for existing multi-component PWM programs. 
Rationale for the Study
POWER is uniquely positioned to evaluate characteristics of multi-component PWM 
programs that are associated with “favorable” health outcomes for treatment-seeking 
youth with obesity. The POWER Data Coordinating Center developed ranking reports of 
the 33 participating sites based on weight status change at 6 months. An in-depth 
review of program design of 4 “top-performing” sites was conducted. A unique feature 
identified was offering an individual program orientation session to patient-families prior 
to the start of the multi-component PWM program. This orientation helped patient-
families better understand the program’s expectations, and offered an opportunity to 
evaluate readiness to change, barriers for making lifestyle changes, and mental health 
problems. This information was used to tailor the intervention to better meet the needs 
of participating patient-families. When a survey of program characteristics was 
conducted of the 33 participating sites, this “top-performing site” was the only one to 
offer such a program orientation session prior to patient-families starting the PWM 
program. Therefore this program feature was included as part of the “bundle of program 
enhancements” (BPE) for this proposed pragmatic pilot study.

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Figure 2

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Figure 3.
Analysis of POWER data has also shown most participating sites have low provider 
contact hours compared to the recommendation of at least 26 provider contact hours 
over a 6-month treatment period, X particularly when resources, staffing, clinic space 
are limited, and circumstances of patient-families often prevent more frequent 
attendance at clinic visits. To address this gap in provider contact hours, an innovation 
in the proposed pilot study is the use of technology, such as telehealth19 to provide 
remote follow-up interactive encounters (FIEs). The sites in the proposed study have 
the capability to offer patient-families FIEs through a telehealth platform (Jabber®), 
email exchange, and/or phone calls. Furthermore the Twilio® text messaging platform 
will be used to send reminders to patient-families about scheduled FIEs. Twilio® will 
also be used to record FIEs scheduled and completed via the linked REDCap database. 
This feature of the BEP will be tailored to each participating site in order to achieve the 
goal of 26 provider contact hours over a 6-month treatment period from the combination 
of FIEs plus the standard-of-care clinic visits and group sessions (if offered).
3.
PURPOSE OF THE STUDY
This pilot pragmatic trial is designed to test the feasibility, acceptance, and preliminary 
effectiveness of a “bundle of program enhancements” (BPE) vs. a standard-of-care 
control group for treatment-seeking adolescents with severe obesity. The BPE was 

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informed by a literature review of the effectiveness of pediatric weight management 
(PWM) interventions and evaluation of program characteristics of top-performing sites in 
POWER (Pediatric Obesity Weight Evaluation Registry). BPE components offer: 1) 
Increased contact hours with existing clinical staff of a multi-component PWM program 
to achieve a medium-intensity intervention (26 contact hours during a 6-month 
treatment period) using remote interactive technologies to supplement standard-of-care 
clinic visits;  2) Identification of mental health problems during a program orientation 
offered prior to starting a PWM program, in order to initiate needed treatment while 
participating in a PWM program; and 3) Evaluation of “readiness to change” and 
“barriers to making lifestyle changes” using motivational interviewing as part of the 
orientation session, allowing for tailored interventions to better meet patient needs.  This 
proposed pilot study will involve 2 multi-component PWM programs, which both are 
participating in POWER. 
Primary Aim 1 (Feasibility): Test whether existing multi-component PWM programs 
can successfully implement the BPE for adolescents with severe obesity using 
existing clinical staff. Successful implementation of the BPE will be defined as ≥80% 
of the Intervention group participants randomly assigned to the Intervention group and 
their parent/guardian attending the individual program orientation prior to the initial 
medical assessment visit of the PWM program. The program orientation will include: 1) 
Validated mental health questionnaires to assess cognitive, emotional and behavioral 
problems, anxiety, and binge eating disorder; 2) Clinical evaluation of “readiness to 
change” and barriers to lifestyle changes, using motivational interviewing; and 3) 
Scheduling of follow-up interactive encounters (FIEs: telehealth visits, phone calls, 
and/or email exchange) for the 1st month of the 6-month treatment period.  For the 
remaining 5 months of treatment, participants in the Intervention group will be 
scheduled monthly for FIEs between clinic visits to achieve a total of 26 contact hours 
when combined with standard-of-care clinic visits and group sessions, if offered. 
Hypothesis 1.1:  80% of participants in the Intervention group (N=40) will successfully 
complete all components of the BPE in the program orientation session (as described 
above), with existing clinical staff in their respective multi-component PWM program. 
   
Hypothesis 1.2: 80% of participants in the Intervention group will successfully schedule 
FIEs between clinic visits for the remaining 5 months of the 6-month treatment period to 
achieve a total of 26 contact hours.
 
 Primary Aim 2 (Acceptability): Evaluate rates of retention and attrition among  
 participants in the Intervention group 
   Hypothesis 2.1: 70% of participants in the Intervention group will complete 26 contact 
hours (including standard-of-care clinic visits, group sessions, and FIEs between clinic 
visits) during the 6-month treatment period.

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   Hypothesis 2.2: 70% of the scheduled FIEs will be completed by participants in the 
Intervention group.
  
 Secondary Aim 3 Test whether the Intervention group has greater rates of 
participation and retention in standard-of-care clinic visits and group sessions (if 
offered) compared to the Control group.  
   Hypothesis 3.1. Participants  in the Intervention group will have a greater rate of 
participation in the standard-of-care PWM program as measured by percent of 
scheduled clinic visits and group sessions (if offered) attended over the 6-month 
treatment period, compared to those assigned to the Control group (N=20) 
   
Hypothesis 3.2. Participants in the Intervention group will have a greater retention rate 
(percent of participants that complete the 6-month treatment period) than those in the 
Control group.  
Secondary Aim 4 Test whether the Intervention group has better health outcomes 
when compared to the Control group after the 6-month treatment period. Health 
outcomes to be measured at baseline, 3-month, and 6-month assessment visits will 
include: 1) Weight status (BMI metric: percent of the 95th percentile); 2) Body 
composition (% body fat, skeletal muscle mass; fat-free mass); and 3) Blood pressure. 
Laboratory measures (HbA1c, ALT, non-HDL, TG, fasting glucose) will be obtained at 
baseline and 6-months.  
Hypothesis 4. The Intervention group will have better health outcomes than the Control 
group.  
Expected outcomes and impact: If the results of this pilot pragmatic study show that 
the BPE is feasible, acceptable and potentially effective, then we will have the 
information needed to design a fully-powered multi-site clinical trial to evaluate the 
efficacy of the BPE as an enhancement for existing multi-component PWM programs. If 
it is found that the BPE is efficacious, this evidence-based approach can then be widely 
implemented in order to improve the treatment of adolescents with severe obesity. 
4.
STUDY DESIGN
4.1.
Study Description
A pilot pragmatic trial involving 2 multi-component PWM programs participating in 
POWER (Pediatric Obesity Weight Evaluation Registry) will be conducted to determine 
the feasibility of implementing a “bundle of program enhancements” (BPE) and its 
acceptability to 40 adolescents (ages 12-18) with severe obesity. 

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4.2 
Study Duration
Each patient will participate in the study for approximately 6 months. Study is expected 
to last approximately 2 years.
5.
SELECTION AND RECRUITMENT OF PARTICIPANTS
Participants will be drawn from the patient population of the multi-component PWM 
program selected to participate in the proposed study. Potentially eligible participants 
will be identified from clinic schedules for new patients who meet age criteria (12 to 18 
years) and are scheduled at least 4 weeks in advance of the initial medical assessment 
visit. Name of patient and parent/guardian, current home address and contact phone 
numbers will be obtained for the identified patients, who will then be mailed the study’s 
Introductory Letter. This letter will provide an overview of the study and inform them that 
a study staff member will be contacting them by phone with more details. The 
Introductory Letter will include a phone number and email address that will allow 
patient-families to opt out of the follow-up phone call. A standardized script will be used 
for the follow-up telephone interview. Details of the study will be explained and a 
screening questionnaire will be completed to further ascertain inclusion/exclusion 
criteria, and interest of the adolescent and parent/guardian to commit to the study. If the 
adolescent and parent/guardian meet the study’s eligibility criteria based on information 
obtained during the telephone interview, they will be invited to schedule a screening visit 
with study staff to confirm eligibility criteria are met. The screening visit will be 
scheduled before they are seen for their scheduled initial medical assessment visit with 
the PWM program. Informed consent will be obtained in person at the screening visit.
5.1.
Inclusion Criteria
Subjects who meet all of the following criteria will be eligible for the study:

≥ 12 years of age and < 18

Scheduled for a new patient clinic visit at the multi-component PWM program at 
CCHMC or HDVCH

Severe obesity (≥ 120% of the 95th percentile for BMI based on age and gender 
at time of screening visit)

Able to understand and complete the consent process

Have access to a smart phone, device, or computer with a web camera

Have access to the internet

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5.2.
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from the study:

Lacking capacity to provide informed consent

Non-English speaking

Participating in any other weight management program or research study related 
to weight management

Have a sibling participating in any other weight management program or 
research study related to weight management

Currently taking anti-obesity medication (Phentermine, Orlistat, Qsymia, 
Naltrxone-Bupropion, Lorcaserin, or other medications that promote weight loss 
such as Victoza (liraglutide), Trulicity (dulaglutide), Byetta (exenatide), others at 
the discretion of the PI).  Also, patients should not start these medications while 
enrolled in the study.
6.
STUDY PROCEDURES
Screening Visit– Adolescents and their parents/guardians who appear to qualify for the 
study based on the telephone interview will be scheduled to attend a screening visit. At 
the screening visit, height and weight measurements for the adolescent will be obtained 
by a qualified member of the study staff, using a standardized protocol and 
demographic information (date of birth, sex, race, ethnicity, and type of health insurance 
coverage) will be obtained and recorded. Adolescents and their parents/guardians who 
meet all inclusion/exclusion criteria, and express interest in participating in the study, 
will engage with a qualified member of the study staff who will review the 
consent/assent with the participant and their parent/guardian to ensure information 
presented is understood prior to obtaining the appropriate signatures for the IRB-
approved informed consent/assent form. At the screening visit, participants and their 
parents/guardians who have met all criteria and informed consent/assent was obtained, 
will be enrolled in the study. Enrolled subjects at the screening visit will then be 
randomly assigned to either the Intervention or Control group, using a 2 Intervention:1 
Control randomization ratio. At the end of the screening visit, all participants will be 
given a reminder card about their scheduled initial medical assessment visit with the 
PWM program. The week prior to this clinic visit, they will also receive a reminder call. 
This initial medical visit with the PWM program will serve as the baseline assessment 
visit for the study. 
Group Assignment – Subjects will be randomized to either the Intervention or Control 
group using a 2 Intervention:1 Control randomization ratio.  The randomization plan will 
be stratified by study site such that the 2:1 randomization ratio will be obtained within 
each study site.    In addition, randomization will be stratified by baseline obesity status 
(Class 2, Class 3) to ensure the appropriate balance of obesity classes within each 
treatment group.  A statistician independent from the study team will provide the 

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randomization plan so that the study team is blinded to the group assignment for each 
newly enrolled patient until that patient is randomized.  
Program Orientation – Immediately after the screening visit, participants assigned to 
the Intervention group will attend an individual Program Orientation session. This will 
include the following: 1) Detailed site-specific description of the PWM program; 2) 
Assessment of “readiness to change” and barriers to lifestyle changes using 
motivational interviewing strategies, including “confidence rulers”; 3) Completion of 
selected validated mental health assessment questionnaires; and 4) Scheduling of FIEs 
between clinic visits. The frequency, time spent, and type of FIE will take into 
consideration the needs of each patient-family enrolled in the study. The adolescent and 
parent/guardian will determine whether they will participate together during a FIE, do 
them separately or have a combination of the two. The frequency of contact between 
clinic visits will be determined by the number of contact hours provided by clinic visits as 
part of the “standard-of-care” over a 6-month treatment. The goal for the Intervention 
group is to have a total of 26 provider contact hours over the 6-month treatment period. 
After accounting for the contact hours from clinic visits as part of the “standard of care”, 
the balance of the 26 contact hours will consist of FIEs scheduled between clinic visits. 
At the end of the Program Orientation, the subject and parent/guardian will schedule 
FIEs and use tracking calendar booklet provided to keep record of their scheduled clinic 
visits and FIEs for the first month of treatment. A summary of the findings from the 
mental health assessment measures, assessment of “readiness to change” and barriers 
to lifestyle change for each subject in the Intervention group will be reviewed with the 
clinical team at each site prior to the initial medical visit with PWM program (Table 1). 
Baseline Assessment - Each participant (Intervention and Control groups) will complete 
at their initial medical visit with the PWM program a baseline assessment that includes 
the following measures: 1) Anthropometric measurements (height and weight); 2) Body 
composition assessment (% body fat, skeletal muscle mass, fat-free mass); and 3) 
Blood pressure (systolic and diastolic). Fasting blood work (plasma lipids, glucose, liver 
enzymes, and hemoglobinA1c) will be obtained up to 3 months prior to the initial 
medical visit or up to 6 weeks after the initial medical assessment visit. Fasting blood 
samples will be drawn for the laboratory analyses by qualified staff at a certified medical 
laboratory affiliated with CCHMC and HDVCH. Standardized methods and analytic 
procedures will be done for each blood parameter. The results of all clinical 
measurements and laboratory values, and referrals and/or additional clinic visits made 
to address mental health concerns will be recorded on the study’s source document, 
specific for each subject. In addition contact time and provider types involved in the 
initial medical visit will also be recorded (Table 1). 
Height will be measured with a calibrated wall-mounted stadiometer by qualified clinical 
staff following a standardized protocol. 
Body Weight will be determined using the same calibrated, electronic digital scale for 
all subjects at each site to eliminate mechanical variation between and within subjects. 

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Body Composition will be measured using the InBody 270® that is based on 
bioelectrical impedance analyses. When scheduling female patients for their study 
assessment visits, consideration will be given to avoiding the time period of their 
menstrual cycle. In the event a subject has her period when attending a study 
assessment visit, the subject will return to obtain a body composition measurement 
when their menstrual period is done. 
Blood Pressure will be measured using a standardized protocol33 by qualified clinical 
staff at each site. Blood pressure (BP) will be measured in the right arm unless specific 
subject conditions prohibit the use of the right arm. Upper arm circumference may be 
measured to ensure proper cuff size. Three consecutive blood pressure readings are 
obtained, using the same arm. 

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Six-month Treatment Period: Intervention group – Subjects will be scheduled for clinic 
visits and program group sessions (if offered) in accordance with the “standard of care” 
for the PWM program at each clinic location. Scheduling of remote FIEs (telehealth, 
phone call and/or email exchange) between clinic visits will be done on a monthly basis 
for the duration of the 6-month treatment period. The projected contact hours 
accumulated for the scheduled interactive encounters between clinic visits, when 
combined with the planned clinic visits and group sessions (if offered) is targeted to 
achieve 26 contact hours for the 6-month treatment period. These scheduled FIEs will 
be entered in the Twilio text messaging platform, which will automatically provide text 
message reminders of the scheduled FIEs. Twilio is also integrated with REDCap, 
which can provide reports on the FIEs scheduled, completed FIEs and time spent, 
provider type at encounter, and who participated (adolescent alone, parent/guardian 
alone and/or adolescent and parent/guardian together. Control group - Subjects will only 
receive the “standard of care” for weight management at their clinic location. Treatment 
data collection - Each clinic visit and group session attended, type of interactive 
encounter completed between clinic visits, and time spent by provider type, will be 
recorded on the study’s source document, specific to each subject. In addition referrals 
made and additional clinic visits completed to address mental health concerns, as 
indicated, will be recorded as well (Table 1). 

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Three-month and Six-month Assessments: Participants will be assessed following 
the same procedures as for the baseline assessment, with measurement of height, 
weight, body composition, and blood pressure.  If the participant is at Tanner stage I, II, 
or III at the baseline visit, Tanner staging will be assessed again at the six-month visit.  
Fasting blood work will be obtained at the 6-month assessment visits. The results of all 
clinical measurements and laboratory values will be recorded on the study’s source 
document, specific for each subject (Table 1). Completion of the 3-month and 6-month 
reassessment clinic visits can occur 2-weeks prior or 4 weeks after the 3-month and 6-
month time points.

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Table 1
Schedule of Procedures
Elapsed Time
Screening 
Visit
Baseline 
Medical 
Visit
#Month 3 
Medical 
Assessment
#Month 6 
Medical 
Assessment 
Telehealth/Phone/Email 
remote encounters 
between visits
Other clinical 
in-person 
encounters
Randomization
X
Height and Weight
X
X
X
X
X
Body Composition (%body fat, 
skeletal muscle mass, fat-free mass)
 
X
X
X
X
Blood Pressure
X
X
X
X
Demographics
X
Program orientation session detailing 
site-specific description of pediatric 
weight management program
X*
Mental Health Assessments
X*
Readiness to change assessment
X*
Schedule Follow-up Interactive 
Encounters
X*
X*
X*
X*
Review Medical History
X
X
X
X
Physical Exam
X
X
X
X
Blood for serum chemistry 
X
 
X
Assess for adverse events
X
X
X
X
X
Medication Review
X
X
X
X
*Intervention Group Only
# -2 weeks/+4 weeks

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6.1.
Process of Obtaining Informed Consent
A waiver of documentation of consent will be in place to collect patient height and 
weight to determine subject eligibility prior to the patient being consented. Consent, 
parental permission and/or assent will be obtained from all patients before any other 
study related procedures are performed. Written assent will be obtained from 
participants 12 years of age and older. The investigator will be available to answer any 
questions that the participant or parent may have regarding procedures, risks and 
alternatives.  The consent process will be documented on the informed consent 
progress note. A copy of the signed consent(s) will be kept in the patient’s medical 
record.
The study team will monitor the age of each participant. If a participant turns 18 during 
their study participation, the investigator or study coordinator will approach the 
participant during a routine clinic visit to confirm they would like to continue their 
participation in the study. The participant will be asked to sign a fresh consent form, 
documenting their consent. 
7.
DATA COLLECTION AND MANAGEMENT
7.1.
Data Management
The Data Management Center (DMC) at CCHMC will provide full data management 
support to the project. The DMC will develop the data capture system using a web-
based data collection system, REDCap, as the primary source of data entry and 
storage. Data will be recorded on study specific case report forms (CRFs) and entered 
into the REDCap data base. Some data may be entered directly into the REDCap data 
base from source documents. Participants will be given a study identification number 
that will be reported on all CRFs.  REDCap is a software toolset and workflow 
methodology for electronic collection and management of research and clinical trial data 
developed by Vanderbilt University, with collaboration from a consortium of institutional 
partners including the University of Cincinnati, Academic Health Center. The DMC will 
develop, test and maintain the REDCap data entry system, the data management plan, 
data quality checks and query management, and preparation of the data for analysis. 
The REDCap system provides a secure, web-based application that is flexible and 
provides: 1) an intuitive interface for users to enter data and have real time validation 
rules (with automated data type and range checks) at the time of entry; 2) HIPAA-
compliant and 21 CFR Part 11-ready audit trails for tracking page views, data 
manipulation and export procedures; 3) record locking and electronic signature 
functions; 4) fine grained control of user rights to view and manipulate data, and tool to 
sequester data access for multiple sites; 5) a report builder for reporting, monitoring and 
querying patient records; and 6) automated export procedures for seamless data 
downloads to common statistical packages (SPSS, SAS, Stata, R/S-Plus). 
REDCap is hosted on a network specially designed to support the rigorous security and 
compliance requirements of basic, clinical and translational research projects. 
Administered by the Division of Biomedical Informatics (BMI), this network features 

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multiple firewalls as well as a central facility for managing hosted systems and users. 
The result is another layer of access control and audit capability on top of what REDCap 
already provides. For example, a user’s ability to access a REDCap study or even a 
specific questionnaire can be monitored and controlled at the network level without 
making any changes within REDCap itself. These capabilities are available to 
authorized BMI network administrators and REDCap study owners only, and all user 
access changes are documented by an automatic audit trail.
8.
DATA ANALYSIS
8.1.
Study Endpoints
Demographic and clinical characteristics will be summarized overall and within each 
center using frequency and percent for categorical data and median and interquartile 
range for the continuous measurements. For each aim below, the two-sided 95% 
confidence intervals will be calculated using the Score Confidence Interval.34 All 
comparisons between the intervention and control groups will be tested at the two-
sided, 5% level of significance. 
Aim 1: For patients in the intervention group only, percentages and two-sided 95% 
confidence intervals will be presented for the each of the components of the “Bundle of 
Program enhancements (BPE)”: a) percent of participants attending the program 
orientation; b) percent of participants completing each of the mental health 
questionnaires; 3) percent of participants completing the “readiness to change” clinical 
assessment; 4) percentage of participants that complete scheduling of interactive 
encounters (FIE) between clinic visits for 1st month of treatment; and 5) Percent of 
participants that complete scheduling of FIE between clinical visits for each of months 2-
6 of treatment. Each confidence interval will be examined to determine if the 
hypothesized value of 80% is contained within the interval. 

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Aim 2: For patients in the intervention group only, the percentages and two-sided 95% 
confidence intervals will be calculated for the intervention group only for the percent of 
patients that complete at least 26 contact hours during the 6-month treatment period. 
The confidence interval will be examined to determine if the hypothesized value of 70% 
is contained within the interval. In addition, the mean and 95% confidence interval will 
be presented for the percent of FIE completed by each patient and also for the total 
number of contact hours completed by each patient. These measures will also be 
provided for the subset of patients in the intervention group that are identified with 
mental health problems and descriptively compared to the subset of patients in the 
intervention group without mental health problems. 

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Aim 3: The rate of participation in on-site scheduled visits (i.e. clinic visits, group 
sessions) will be calculated for each patient in both the intervention group and the 
control group as the percentage of all scheduled visits during the 6-month period that 
was attended by the patient. These percentages will be compared between groups 
using the mixed effects model with treatment as a factor and site as a random effect. 
Additional covariates in the model may include baseline weight status as measured by 
percent of the 95th percentile, sex, race, ethnicity, socioeconomic status, and distance 
from clinic site. To the extent possible, interactions of covariates with treatment group 
will be examined and discussed if significant at p<0.10 level of significance. 
Transformations will be used (e.g. arcsin square root, log, rank) if needed to satisfy the 
assumptions of the model. The percentage of patients that complete the 6-month 
program will be analyzed using the same approach discussed above. In addition to 
doing hypothesis testing, treatment differences (unadjusted and also adjusted for 
covariates) and 95% confidence intervals will be presented. 
Aim 4: Health outcomes measured by weight status, body composition, and blood 
pressure will be compared between the intervention and control groups using the 
repeated measures mixed effects analysis with center as a random effect. The outcome 
metric for weight status in the proposed study will be the change in percent of the 95th 
percentile for BMI (based on age and sex). 
For each outcome, change from baseline will be calculated and included as the 
dependent variable. Terms in the model will include treatment, month (i.e. 3, 6 month) 
and the interaction of treatment by month. If the interaction is not significant at the two-
sided p<0.10 level, it will be removed from the model. Appropriate contrasts will be used 
to compare the treatment groups at 3 months and at 6 months. Covariates in the model 
may be the same as those listed in Aim 3. The respective baseline measure may also 
be included as a covariate in the model for each health outcome. Laboratory measures 
will be measured at baseline and at 6 months of treatment. The mixed effects model 
using change in laboratory measure as the dependent variable and treatment as 
independent variable and center as random effect will be used. Covariates may include 
those listed for Aim 3 and the respective baseline laboratory measure. 
8.2.
Sample Size Calculation
Sixty subjects will be enrolled in this study across the two sites with 40 subjects 
randomized to the Intervention group and 20 subjects to the Control group. This is a 
pilot study and therefore confirmatory hypothesis testing will not be done. Therefore, 
formal power calculations were not done. Table 2 shows the width of the two-sided 95% 
confidence intervals for various percentages and sample sizes. Table 3 provides the 
treatment effects that are detectable with various sample sizes.

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9.
RISKS AND BENEFITS
9.1.
Potential Benefits
There is potential for direct benefit for participating in this study. The intervention may 
help participants to lose weight, which has well documented emotional and physical 
health benefits.  In addition, the information learned from this research study may 
benefit other patients in the future.
9.2.
Potential Risks
The potential risk to patients include an individual’s frustration with efforts at weight loss.
There is also a potential loss of confidentiality, though study staff will work 
9.3.
Risk/Benefit Analysis  
The proposed study has minimal risks associated with it, which are reasonable in 
relation to the knowledge that will be gained and used to create interventional programs 
in this high-risk population. 
10.
ADVERSE EVENTS
Events that are unexpected and considered to be related or possibly related to the study 
procedures as well as breaches of confidentiality, and protocol violations must be 
reported to the site PI and the site’s IRB as soon as possible. The site is responsible for 

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informing the PI at CCHMC of the adverse event in a prompt and timely manner. The 
IRB at CCHMC will be notified of the event in a prompt manner after discovery of the 
event. 
11.
DATA SAFETY AND MONITORING PLAN 
For the proposed pilot study, participants randomly assigned to the Intervention or 
Control group will be participating in a multi-component pediatric weight management 
(PWM) program for a 6-month treatment period. The PWM program for this study will be 
offered at two sites: Cincinnati Children’s Hospital Medical Center (CCHMC), Cincinnati, 
OH and Helen DeVos Children’s Hospital (HDVCH), Grand Rapids, MI. Robert Siegel, 
MD at CCHMC and William Stratbucker, MD at HDVCH, both serving as Co-
Investigators for the proposed study, will be responsible for the oversight of the clinical 
management of study participants, their data collection, and address any medical issues 
that arise.    
In addition as a requirement of all NIH-sponsored clinical trials, a Data and Safety 
Monitoring Board (DSMB) will be established to 1) evaluate all physiological and 
psychological data obtained for indications of adverse reactions; 2) investigate potential 
adverse events reported by the participants and/or clinical staff of the proposed study; 
and 3) evaluate the potential impact of these adverse events on the participants’ health 
status and their continuation in the proposed study. The DSMB, an independent group 
of experts from Cincinnati Children’s Hospital Medical Center (CCHMC) and the 
Connecticut Children's Medical Center, will be reviewing the data from this research 
throughout the study at both participating sites (CCHMC and Helen DeVos Children’s 
Hospital (HDVCH), Grand Rapids, MI. The DSMB will be comprised of a physician, 
psychologist and biostatistician. The DSMB will meet via conference call at 3 months 
into the study and every 6 months thereafter, or more often as deemed necessary by 
the occurrence of adverse events.  The “GoToMeeting” platform will be used in order to 
review documents during these conference calls.  During the program orientation 
session for participants assigned to the Intervention group, and during the 6-month 
treatment period for the Intervention and Control groups of the proposed study, 
participants will be screened for adverse events by members of the multi-disciplinary 
clinical team when seen for clinic visits as part of the PWM program at each 
participating site, and during follow-up interactive encounters for participants in the 
Intervention group. Any adverse event will be appropriately documented and reported to 
the Principal Investigator, Shelley Kirk, PhD, RD, LD who will in turn forward all reports 
to the DSMB as well as the respective Institutional Review Board for CCHMC and 
HDVCH.  
All recommendations by the DSMB will be communicated to the Principal Investigator, 
Shelley Kirk, PhD, RD, LD who will then take appropriate action as indicated.  The 
DSMB will operate independently of the study investigators. The investigator will keep 
participants informed about any new information from this or other studies that may 

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affect the health, welfare, or their willingness to remain in the study. The individuals 
listed below have agreed to be members of the DSMB. 
 
Stavra A. Xanthakos, PhD, MD
Associate Professor of Pediatrics, Division of Gastroenterology, Hepatology and 
Nutrition
Cincinnati Children’s Hospital Medical Center 
Director, Steatohepatitis Center; 
Medical Director, Surgical Weight Loss Program for Teens
Associate Director, Gastroenterology Fellowship Program
Department of Pediatrics, University of Cincinnati, College of Medicine, Cincinnati, OH
Melissa Santos, Ph.D.
Assistant Professor of Pediatrics 
University of Connecticut School of Medicine
Clinical Director of the Pediatric Obesity Center
Senior Pediatric Psychologist, 
Connecticut Children's Medical Center, Hartford, CT
Jessica G. Woo, MSHA, PhD 
Professor of Pediatrics, Division of Epidemiology and Biostatistics
Cincinnati Children’s Hospital Medical Center
Department of Pediatrics
University of Cincinnati, College of Medicine, Cincinnati, OH
12.
PRIVACY & CONFIDENTIALITY
The privacy and confidentiality of patient information will be maintained in accordance 
with Health Insurance Portability and Accountability Act (HIPAA) regulations. All 
research personnel who work on this study must complete HIPPA and the Collaborative 
Institutional Training Initiative module on human research with direct subject interaction. 
No identifying data will be used in any publications that were a result from this work. 
13.
PARTICIPATION COST AND PAYMENTS
There is no cost to participate in this study. Participants will not be charged for the tests 
that are done for research purposes however, participants will still be responsible for the 
usual costs of medical care.  Participants will be compensated for time and expenses 
incurred after completing the 3-month assessment ($25.00) and the 6-month 
assessment ($50.00). Payment will be made using “Clin-Card”, a type of debit card.

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