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Trial record 1 of 1 for:    20655544 [PUBMED-IDS]
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Peer-enhanced Intervention to Support Teen Weight Loss

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ClinicalTrials.gov Identifier: NCT00285558
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: CBT with peer-enhanced activities Behavioral: CBT with supervised aerobic exercise Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peer-Enhanced Intervention to Support Teen Weight Loss
Actual Study Start Date : August 2003
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CBT with peer-enhanced activities
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.
Behavioral: CBT with peer-enhanced activities
Active Comparator: CBT with supervised aerobic exercise
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.
Behavioral: CBT with supervised aerobic exercise



Primary Outcome Measures :
  1. Change in Adolescent Body Mass Index (BMI) [ Time Frame: 12 and 24 months ]

Secondary Outcome Measures :
  1. Self concept [ Time Frame: 12 and 24 months ]
    Self- Perception Profile for Adolescents and the Physical Self-Worth Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00285558


Locations
United States, Rhode Island
Bradley Hasbro Children's Research Center
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Elissa Jelalian, PhD Brown University Medical School; Lifespan Corporation

Publications of Results:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00285558     History of Changes
Other Study ID Numbers: DK62916 (completed)
R01DK062916 ( U.S. NIH Grant/Contract )
First Posted: February 2, 2006    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
obesity
adolescent
weight loss
body mass index
evaluation studies
peer group
behavior therapy
diet
exercise
self efficacy
parents

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms