Peer-enhanced Intervention to Support Teen Weight Loss

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00285558
First received: January 31, 2006
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Obesity
Behavioral: cognitive-behavioral group treatment with peer component
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Peer-Enhanced Intervention to Support Teen Weight Loss

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Change in Adolescent Body Mass Index (BMI) at end of treatment as well as 12 & 24 months follow-up

Secondary Outcome Measures:
  • Measures of self-efficacy, physical self-worth, self-esteem, and social functioning at end of treatment as well as 12 & 24 month follow-up.

Estimated Enrollment: 150
Study Start Date: March 2002
Estimated Study Completion Date: April 2008
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.

  Eligibility

Ages Eligible for Study:   13 Years to 16 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285558

Locations
United States, Rhode Island
Bradley Hasbro Children's Research Center
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Investigators
Principal Investigator: Elissa Jelalian, PhD Brown University Medical School; Lifespan Corporation
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00285558     History of Changes
Other Study ID Numbers: DK62916 (completed), R01DK062916-03
Study First Received: January 31, 2006
Last Updated: January 12, 2010
Health Authority: United States: Federal Government

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:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on September 30, 2014