Examination of the Acceptance and Feasibility of Implementing the American Diabetes Association's Camp Power Up Program on Changes in Body Weight and Quality of Life Measures in Children
Phase: NA
Conditions: Obesity, Childhood, Weight Change, Body, Quality of Life
Sponsor: Pennington Biomedical Research Center

Study Title: Feasibility of the Camp Power Up Program on Children's Body Weight and Quality of 
Life 
NCT #: NCT03235440 
Document date: September 1, 2020 

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PBRC Institutional Review Board
Federal Wide Assurance 00006218  
IRB Registration 00000708
PBRC IRB # 2017-014 
Acronym: Power Up
PROTOCOL TITLE:  “Camp Power Up”
PRINCIPAL INVESTIGATOR:
Amanda E. Staiano, Ph.D.
MEDICAL INVESTIGATOR:  
Daniel Hsia, M.D.
FUNDING SOURCE: Institutional funds
DATE: 08/26/2020
IRB Review History:  Submission # 4
Objectives
The objective of this study will be to evaluate the effects of a one week weight 
management summer camp on children’s weight, self-reported health behaviors, quality 
of life, mood and feelings, self-esteem, weight management efficacy, enjoyment of 
physical activity, and body image. Children will also report acceptability and enjoyment 
of technology-supported physical activity options, specifically the HD Expresso 
stationary bicycles (“cybercycling”). 
Background
Obesity affects 17% of children and adolescents in the U.S.1 Children are entrenched in 
an obesogenic environment, often with little support in the home, school, or medical 
environment to make healthy choices. Obesity is increasingly common in underserved 
communities that lack access and resources for physical activity and healthy eating. 
Louisiana is a prime example of the need for effective obesity treatment, ranking 1st 
nationally for adult obesity and 4th for adolescent obesity with the highest obesity 
prevalence among African American adolescents.1 We urgently need evidence-based 
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programs to help children and families change lifestyle behaviors, achieve clinically 
significant weight loss, and thereby reduce the prevalence of pediatric obesity. 
The U.S. Preventive Services Task Force identifies behavioral treatment including 
dietary, physical activity, and behavioral counseling components as a viable option for 
pediatric obesity treatment,2 yet a key challenge is how to implement these programs to 
maximize access and participation. Summer (between school years) represents an 
opportunity for intensive intervention to change health behaviors and help children to 
lose weight. During the summer months, children gain weight at a more rapid pace3,4 
and spend more time engaged in sedentary behavior5 compared to the school year. 
The American Diabetes Association launched Camp Power Up as a summer week-long 
day camp for youth who are obese and/or at high risk for developing type 2 diabetes. 
The camp will focus on wellness education, nutrition, physical activity, and obesity 
prevention. The purpose of the proposed study is to examine effects of Camp Power Up 
on children’s weight status and their psychosocial health.
Inclusion and Exclusion Criteria
Children must meet the following eligibility criteria to participate in the study:

Aged 6 to 14 years 

Enrolled in the ADA Camp Power Up
Number of Subjects
We plan to enroll up to 62 participants total. A total of 12 participants were 
enrolled in summer 2017 and an additional 50 are anticipated for summer 2018. 
Recruitment Methods
All children selected to participate in the ADA summer camp program will be 
asked to participate in this study.  The ADA anticipated enrollment of approximately 50 
children for the one week session each summer (summer 2017, summer 2018). 
Recruiting efforts include, but are not limited to the institution’s email listserv, social 
media posts, and flyer drops.
Study Timelines
The enrollment and participant’s participation in the study will last approximately 
one week (five daytime sessions).  The primary analyses will be completed by January 
1, 2018 for the summer 2017 camp. The primary analyses for the summer 2018 camp 
will be completed by January 1, 2019.
Study Endpoints
AIM 1: Evaluate the effects of a one-week obesity prevention summer camp on 
children’s weight, self-reported health behaviors, quality of life, mood and feelings, self-
esteem, weight management efficacy, enjoyment of physical activity, and body image.  
Difference scores will be calculated between initial and final assessment, and effect 
sizes will be calculated using linear mixed models to determine clinical significance of 
weight-related and psychosocial changes throughout the program.
AIM 2: Examine the acceptance and feasibility of implementing the program at 
Pennington Biomedical Research Center’s TReCC.  
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Acceptance and feasibility will be assessed by the number of participants enrolled and 
the number of camp sessions attended. Cybercycling acceptability and enjoyment will 
be assessed by a survey administered to the child after cybercycling for about 15 
minutes.
Endpoints
The primary endpoint is the change in body weight.  The secondary endpoints 
include self-reported changes in health behaviors, quality of life, mood and feelings, 
self-esteem, weight management efficacy, enjoyment of physical activity, and body 
image, as well as acceptability/enjoyment of cybercycling.
Procedures Involved
All participants will be explicitly told that their participation is voluntary and that 
they may terminate their participation at any time.
Consent and Assent Process. Informed consent for the child will be obtained 
from one of the participant’s parents/legally authorized representatives prior to 
conducting any study procedures. The parent/legally authorized representative will be 
given an informed consent form to read and sign indicating their permission to allow 
their child to participate in the study. Parents will return this consent form to the study 
staff before the child’s first visit. Because there is not a greater than minimal risk, 
informed consent will be obtained from one parent even if the other parent is alive, 
known, competent, reasonably available, and shares legal responsibility for the care 
and custody of the child. 
Participants 12 years of age and older will be given a written assent form to read 
and sign before participating in any study procedures. Participants 6-11 years of age will 
be read an assent script and asked to verbally assent before participating in any study 
procedures. Participants 9-11 years of age with a high reading comprehension and 
maturity level may give written assent, rather than verbal assent, if deemed appropriate 
by the investigator or research staff member performing the assent. The study 
procedures will be explained using age appropriate terms, and children will be given the 
opportunity to ask questions about the study. 
Parent survey. Parents will be asked to complete a questionnaire that will provide 
information on the child’s sociodemographic characteristics, including sex, date of birth, 
and parents’ marital status, highest level of education, family income, occupation, and 
employment status, as well as brief medical history. Parents will report their own height, 
weight, age, and sex.
Anthropometric measurements. Height and weight of each child will be measured 
in a private setting with the child dressed in light clothing. Height will be measured to the 
nearest 1.0 cm using a portable stadiometer. Weight will be measured to the nearest 
0.1 kg using high-precision electronic scale. Percent body fat will be recorded from this 
scale. Body mass index (BMI) z-score will be calculated based on the child’s age, sex, 
height, and weight, then compared to the 2000 Centers for Disease Control and 
Prevention (CDC) Growth Charts to calculate percentile and z-score.
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Surveys. A pre-test and post-test psychosocial questionnaire will be completed 
by each participant at the beginning (session 1 or orientation) and end (session 5) of the 
program. The questionnaire will collect information about lifestyle, including diet and 
physical activity habits, media use, and sleep.
During summer 2017 camp only, children will be asked to complete a friendship 
nomination survey at the start and end of the 5-day ADA camp. On day 1, each child will 
be asked whether they know any other child participating in the camp. On day 5, 
another friendship nomination survey will be completed detailing the friends that the 
child met during the course of the camp. These friendship nomination data will be used 
to provide a longitudinal illustration of the ego-centric and overall social network 
developed during the span of the camp. This friendship nomination method has been 
used in the National Longitudinal Study of Adolescent Health, a nationally 
representative study in which one of the primary aims were to measure the association 
between adolescent social contexts and health and well-being.The survey questions will 
be from the following validated scales: 
Impact of Weight on Quality of Life (IWQOL-Kids) (Summer 2017 only): The 
IWQOL-Kids is a 27-item measure of weight-related quality of life. Each item begins 
with the phrase, “Because of my weight,” and contains five response options, ranging 
from “always true” to “never true.” In addition to a total score, there are scores on four 
domains: Physical Comfort, Body Esteem, Social Life, and Family Relations. Scores 
range from 0–100, with higher scores representing better quality of life. The IWQOL-
Kids has demonstrated good internal consistency, as well as sensitivity and 
responsiveness.6,7 The IWQOL-Kids will be administered to participants aged 11 and 
older. 
PedsQL (Summer 2017 and 2018): The PedsQL is a general health related 
quality of life self-report measure with complementary scales for children (ages 6–14).8 
The measure assesses physical, emotional, social, and school functioning, and 
provides a psychosocial summary score as well as a total score. Scores range from 0–
100, with higher scores representing better quality of life. The PedsQL has been shown 
to be both reliable and valid in this age range.8
Weight Efficacy Lifestyle questionnaire (WEL; Summer 2017 and 2018): The 
WEL assesses self-reported eating habits and perceived self-efficacy in regards to 
eating and weight loss.9 The WEL consists of 20 items designed to measure five 
hypothetical dimensions of efficacy for weight management: availability, negative 
emotions, physical discomfort, positive activities, and social pressure. The items were 
slightly reworded to make them easily understandable to a pre-adolescent population. 
Good reliability and validity have been reported for the WEL in adult populations9,10 and 
adequate scale reliability in children (α=0.94).11
The Physical Activity Enjoyment Scale (PACES; Summer 2017 and 2018): 
The PACES is a 16-item measure of enjoyment during physical activity.12 
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The Body Image Assessment of Preadolescents (BIA-P; Summer 2017 
only): The BIA-P is a reliable and valid measure of body image in children ages 6 to 
14.13,14 
During summer 2018 camp only, children will be allowed to use the HD Expresso 
cybercycling stationary bicycles in the TReCC for 15 minutes each. Afterwards, they will 
complete a brief survey on their enjoyment and acceptability of the cybercycling.
(Summer 2018) One month after the conclusion of the camp, an optional post-
camp celebration will be hosted at a local community center for all parents and camp 
participants. Participants’ height and weight will be measured. Participants will be asked 
to complete a brief survey. 
The following is the train schedule for procedures:
PRE-
VISIT
V1  
Day 1
V2 
Day 
5
1 
month 
Post-
Visit
Consent
x
Parent 
Questionnaire
x
Assent
x
Height
x
x
x
Weight
x
x
x
Child Questionnaires
x
x
x
Power analysis.
Difference scores will be calculated between initial and final assessment, and 
effect sizes will be calculated using linear mixed models to determine clinical 
significance of weight-related and psychosocial changes throughout the program. 
Acceptance and feasibility will be assessed by the number of participants enrolled and 
the number of camp sessions attended.
Data and Specimen Management
The Pediatric Obesity and Health Behavior Laboratory, supervised by Dr. 
Staiano, will have primary responsibility for data collection, data management, manual 
data entry, and data analysis. All electronic data will be stored in the secure Pennington 
database, with access given to only necessary, HIPAA-certified staff. All hard copies of 
data will be stored in a secure, locked cabinet at Pennington Biomedical Research 
Center. Access to data files can be made only with permission of the Academic 
Principal Investigator. Data will be stored for 5 years following study completion.
Provisions to Monitor the Data to Ensure the Safety of Subjects
This study does not involve more than minimal risk to participants. All data will be 
collected through non-invasive observations or surveys. 
Withdrawal of Subjects
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Participation is voluntary, so participants may withdraw from the program at any 
time.  During the program, participants may be withdrawn from the program due to the 
unwillingness of the child/adolescent or the parent/legally authorized representative to 
cooperate with the study staff.  Data that have already been collected during the course 
of the study from a withdrawn participant will be used, unless a specific request is 
otherwise received.
Risks to Subjects
The study contains no foreseeable risks, discomforts, or hazards to participants 
or family members.
Potential Benefits to Subjects
There is no direct benefit for the participant.
Vulnerable Populations
The ADA Power Up program will involve children as participants (6-14 years of 
age). As such, their parents and/or legally authorized representative will provide written 
informed consent allowing their child to participate in the study. In addition, participating 
children will provide verbal or written assent (depending on age and maturity level). 
All participants will be explicitly told that their participation is voluntary and that 
they may terminate their participation at any time. If a participant indicates that they 
wish to stop participating, all study procedures they are undertaking at that time will be 
stopped to protect their rights and welfare. 
Sharing of Results with Subjects
Individual participant results will be provided if the participant or parent requests 
them. Results from the study will be submitted for manuscripts in scholarly journals and 
presentations. All study reports for publication will present only aggregated data to 
minimize the risks that a participant can be identified from their participation in the 
study.
Setting
Program sessions will take place primarily at the TReCC or in the Conference 
Center.  Anthropometry will be measured in the TReCC anthropometry room or in the 
Conference Center in private classrooms. The outpatient clinic and anthropometry room 
will be used as a back-up location if required.
Resources Available
Pennington Biomedical is a model for clinical research, since it houses basic, 
clinical and population research programs in one facility. TReCC is well-equipped to 
administer and support this study. Program-related assessments will be completed in 
TReCC, which has all the necessary equipment needed to perform the procedures 
described herein. The program personnel are highly qualified with extensive diabetes 
and obesity-related backgrounds and experience conducting research involving human 
participants, both here at Pennington Biomedical, and at other institutions.
Compensation
Subjects will not be compensated for participation in the study.
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Confidentiality
All data collected in this project will be subject to the same confidentiality 
requirements that are in place for our other studies at the Pennington Biomedical. Study 
files will be kept in locked cabinets and access restricted to program staff. Personal 
identifiers are not included in computer files. No individual’s data will be released 
without their specific written consent. Research staff, members of the Institutional 
Review Board, and personnel in charge of maintaining data security from the 
Pennington Biomedical Research may inspect and/or copy the medical records related 
to the study. Results of the study may be published; however, names and other 
identifying information will be kept private. Other than as set forth above, the 
participant’s identity will remain confidential unless disclosure is required by law.
 
Provisions to Protect the Privacy Interests of Subjects
Privacy in the context of this study includes confidentiality of data and personal 
information. During interviews, measurements, and program sessions, the program staff 
will ensure full privacy of participants and will ensure that the data are stored in a 
secured area. Participant weight measurements will be conducted individually in private 
to protect the privacy interest of the subject.
Compensation for Research-Related Injury
No form of compensation for medical treatment or for other damages (i.e., lost 
wages, time lost from work, etc.) will be available for this research study. In the event of 
injury or medical illness resulting from the research procedures, participants will be 
referred to a treatment facility.
Economic Burden to Subjects
Participants and participating families will be required to bear the cost of 
transportation to and from all camp and study sessions.
Consent Process
Informed consent and assent will be obtained prior to conducting any program 
procedures. Because there is not a greater than minimal risk, informed consent will be 
obtained from one parent even if the other parent is alive, known, competent, 
reasonably available, and shares legal responsibility for the care and custody of the 
child. The study procedures will be explained to parent(s) and prospective participants 
(6-14 years of age). The parent/legally authorized representative and prospective 
participant will be asked if they have any questions about the study. The parent/legally 
authorized representative and prospective participant will be offered a waiting period 
between informing the prospective participant and obtaining the consent. When the 
parent/legally authorized representative and prospective participant are both ready, the 
informed consent process will then proceed as follows.
For participants 12-14 years of age:
• 
Parent/legally authorized representative will be given an informed consent form 
to read and sign indicating their permission to allow their child to participate in the 
study.
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• 
Following the obtainment of written parental consent, participants 12 years of age 
will be given a written assent form to read and sign before participating in any 
study procedures.
For participants between 6-11 years of age:
• 
Parent/legally authorized representative will be given an informed consent form 
to read and sign indicating their permission to allow their child to participate in the 
study.
• 
Following the obtainment of written parental consent, participants 6-11 years of 
age will be read an assent script and asked to verbally assent before 
participating in any study procedures. Participants 9-11 years of age with a high 
reading comprehension and maturity level may give written assent, rather than 
verbal assent, if deemed appropriate by the investigator or the research staff 
conducting the assent.
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References 
1.
Centers for Disease Control and Prevention (CDC) LDoE, Division of School and 
Student Learning Support, Health and Wellness Services Section,. Louisiana 
Youth Risk Behavior Survey (YRBS). . 2011. 
http://apps.nccd.cdc.gov/youthonline/App/Results.aspx?LID=LA. Accessed 
December 3, 2013.
2.
Barton M. Screening for obesity in children and adolescents: US Preventive 
Services Task Force recommendation statement. Pediatrics. Feb 
2010;125(2):361-367.
3.
von Hippel PT, Powell B, Downey DB, Rowland NJ. The effect of school on 
overweight in childhood: gain in body mass index during the school year and 
during summer vacation. Am J Public Health. Apr 2007;97(4):696-702.
4.
von Hippel PT, Workman J. From Kindergarten Through Second Grade, US 
Children's Obesity Prevalence Grows Only During Summer Vacations. Obesity. 
2016;24(11):2296-2300.
5.
Staiano AE, Broyles ST, Katzmarzyk PT. School Term vs. School Holiday: 
Associations with Children's Physical Activity, Screen-Time, Diet and Sleep. 
International journal of environmental research and public health. Aug 
2015;12(8):8861-8870.
6.
Kolotkin RL, Crosby RD, Kosloski KD, Williams GR. Development of a brief 
measure to assess quality of life in obesity. Obes Res. 2001;9(2):102-111.
7.
Kolotkin RL, Zeller M, Modi AC, et al. Assessing weight-related quality of life in 
adolescents. Obesity (Silver Spring). Mar 2006;14(3):448-457.
8.
Varni JW, Seid M, Kurtin PS. PedsQL™ 4.0: Reliability and validity of the 
Pediatric Quality of Life Inventory™ Version 4.0 Generic Core Scales in healthy 
and patient populations. Medical care. 2001;39(8):800-812.
9.
Clark MM, Abrams DB, Niaura RS, Eaton CA, Rossi JS. Self-efficacy in weight 
management. Journal of consulting and clinical psychology. 1991;59(5):739.
10.
Prochaska JO, Norcross JC, Fowler JL, Follick MJ, Abrams DB. Attendance and 
outcome in a work site weight control program: Processes and stages of change 
as process and predictor variables. Addictive behaviors. 1992;17(1):35-45.
11.
Quinlan NP, Kolotkin RL, Fuemmeler BF, Costanzo PR. Psychosocial outcomes 
in a weight loss camp for overweight youth. International Journal of Pediatric 
Obesity. 2009;4(3):134-142.
12.
Moore JB, Yin Z, Hanes J, Duda J, Gutin B, Barbeau P. Measuring enjoyment of 
physical activity in children: validation of the Physical Activity Enjoyment Scale. 
Journal of applied sport psychology. 2009;21(S1):S116-S129.
13.
Veron‐Guidry S, Williamson DA. Development of a body image assessment 
procedure for children and preadolescents. International Journal of Eating 
Disorders. 1996;20(3):287-293.
14.
Truby H, Paxton SJ. Development of the children's body image scale. British 
Journal of Clinical Psychology. 2002;41(2):185-203.
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