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Peer-enhanced Intervention to Support Teen Weight Loss

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT with peer-enhanced activities
CBT with supervised aerobic exercise
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, adolescent, weight loss, body mass index, evaluation studies, peer group, behavior therapy, diet, exercise, self efficacy, parents

Eligibility Criteria

13 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adolescents 13-16 years old 20-90% overweight with reference gender and age At least 1 parent who can participate English speaking Agree to study participation and random assignment Be available for long-term follow-up Exclusion Criteria: Current involvement in another weight loss program Unable to adhere to prescribed dietary plan and physical activity due to medical condition Unable to understand intervention materials In treatment for or diagnosed with psychiatric disorder

Sites / Locations

  • Bradley Hasbro Children's Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT with peer-enhanced activities

CBT with supervised aerobic exercise

Arm Description

Cognitive behavioral treatment (CBT) with peer-enhanced adventure therapy. The peer intervention, ''adventure therapy,'' is based on the principles of Outward Bound and was expected to affect weight status through a positive effect on self-concept.

Cognitive behavioral treatment (CBT) with supervised aerobic exercise. Activities for the supervised exercise intervention included use of treadmills, stationary bicycles, and other aerobic activities selected by participants, including dance videos and brisk walking within the clinic setting.

Outcomes

Primary Outcome Measures

Change in Adolescent Body Mass Index (BMI)

Secondary Outcome Measures

Self concept
Self- Perception Profile for Adolescents and the Physical Self-Worth Scale

Full Information

First Posted
January 31, 2006
Last Updated
October 5, 2017
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00285558
Brief Title
Peer-enhanced Intervention to Support Teen Weight Loss
Official Title
Peer-Enhanced Intervention to Support Teen Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 2003 (Actual)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether adding a peer-based intervention based on an outward bound model is more effective than a standard behavioral weight intervention for helping adolescents lose weight.
Detailed Description
The prevalence of overweight in children and adolescents has increased significantly during the last two decades. While there are empirically supported weight management interventions for school age children, treatment findings with overweight adolescents are not as consistent. A potential limitation of weight control interventions for adolescents is the minimal attention given to the peer group as an active component of treatment. We have promising findings from a pilot study that involves adding an innovative peer-based intervention (peer-based skills training; PBST) to cognitive- behavioral weight management treatment for adolescents. The purpose of the proposed study is to expand the pilot by: 1) increasing our sample size, 2) assessing weight loss over a longer time period, and 3) evaluating the role of psychosocial variables, as well as physical activity and diet, in mediating treatment outcome. It is hypothesized that overweight adolescents randomized to cognitive-behavioral treatment with peer enhancement will demonstrate greater weight loss at long term follow-up than adolescents randomized to cognitive-behavioral treatment with exercise. One hundred and fifty adolescents between the ages of 13 and 16 years and 20% and 90% overweight will be randomized to one of two treatment conditions: 1) Cognitive-Behavioral Weight Loss Treatment with Peer-Based Skills Training (CBT+PBST) or 2) Cognitive-Behavioral Weight Loss Treatment with Exercise (CBT+EXER). Measures of height, weight, physical activity, diet, and psychosocial functioning will be obtained at baseline, end of treatment, 12 months, and 24 months after randomization. A between-groups t-test will be conducted to evaluate group differences in change in percent overweight between baseline and 24-month follow-up. Hierarchical linear modeling will be used to assess the pattern of weight loss for the two treatment groups across four time points: baseline, end of treatment, 12 month, and 24 month follow-up. Effects of treatment on psychosocial measures will be analyzed using mixed analysis of variance with treatment condition as the between subjects factor and a within subject factor of time. Finally, a series of regression analyses will be conducted to evaluate the role of psychosocial variables, physical activity, and diet, as mediators of treatment outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, adolescent, weight loss, body mass index, evaluation studies, peer group, behavior therapy, diet, exercise, self efficacy, parents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT with peer-enhanced activities
Arm Type
Experimental
Arm Description
Cognitive behavioral treatment (CBT) with peer-enhanced adventure therapy. The peer intervention, ''adventure therapy,'' is based on the principles of Outward Bound and was expected to affect weight status through a positive effect on self-concept.
Arm Title
CBT with supervised aerobic exercise
Arm Type
Active Comparator
Arm Description
Cognitive behavioral treatment (CBT) with supervised aerobic exercise. Activities for the supervised exercise intervention included use of treadmills, stationary bicycles, and other aerobic activities selected by participants, including dance videos and brisk walking within the clinic setting.
Intervention Type
Behavioral
Intervention Name(s)
CBT with peer-enhanced activities
Intervention Type
Behavioral
Intervention Name(s)
CBT with supervised aerobic exercise
Primary Outcome Measure Information:
Title
Change in Adolescent Body Mass Index (BMI)
Time Frame
12 and 24 months
Secondary Outcome Measure Information:
Title
Self concept
Description
Self- Perception Profile for Adolescents and the Physical Self-Worth Scale
Time Frame
12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adolescents 13-16 years old 20-90% overweight with reference gender and age At least 1 parent who can participate English speaking Agree to study participation and random assignment Be available for long-term follow-up Exclusion Criteria: Current involvement in another weight loss program Unable to adhere to prescribed dietary plan and physical activity due to medical condition Unable to understand intervention materials In treatment for or diagnosed with psychiatric disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elissa Jelalian, PhD
Organizational Affiliation
Brown University Medical School; Lifespan Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bradley Hasbro Children's Research Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20655544
Citation
Jelalian E, Lloyd-Richardson EE, Mehlenbeck RS, Hart CN, Flynn-O'Brien K, Kaplan J, Neill M, Wing RR. Behavioral weight control treatment with supervised exercise or peer-enhanced adventure for overweight adolescents. J Pediatr. 2010 Dec;157(6):923-928.e1. doi: 10.1016/j.jpeds.2010.05.047. Epub 2010 Jul 23.
Results Reference
result
PubMed Identifier
29525290
Citation
Rancourt D, Barker DH, Jelalian E. Sex as a Moderator of Adolescents' Weight Loss Treatment Outcomes. J Adolesc Health. 2018 May;62(5):591-597. doi: 10.1016/j.jadohealth.2017.12.002. Epub 2018 Mar 7.
Results Reference
derived

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Peer-enhanced Intervention to Support Teen Weight Loss

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