Primary Care Research Network for the Treatment of Adolescent Obesity

NCT01073215 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2012-02-20

No results posted yet for this study

Summary

The "Primary Care Research Network for the Treatment of Adolescent Obesity" will establish infrastructure within the primary care setting to support programmatic research on weight loss for underserved adolescents, primarily urban African Americans, rural Caucasians, and Latinos. Using primary care settings, to which many youths already have entry, may increase access for underserved adolescents to participate in obesity treatment and research. The primary project will be a 12 month randomized controlled study comparing the relative effectiveness of two interventions for weight reduction: Group Condition (a family based lifestyle modification program delivered by health care providers in 23 sessions); Self-Guided Condition (a family based lifestyle modification program that combines a self-guided, home-based approach with 6 sessions delivered by health care providers).

Conditions

Interventions

BEHAVIORAL

Family-Based Lifestyle Modification

The Self-Guided condition will receive the same manual content and recommendations for eating and physical activity as the Group Condition. Since this approach is primarily home-based, participants in this condition will also receive additional tips and guidelines to assist the family in following the program at home. There will be 6 visits with the health coach at weeks 01, 04, 08, 24, 40, and 52. Participants will receive 2 phone calls from health coach at weeks 16 and 32. Parents and teens will be encouraged to hold weekly meetings at home to discuss program goals and progress.

BEHAVIORAL

Family-Based Lifestyle Modification Program

The Group condition will consist of a comprehensive family based lifestyle modification program of 23 visits (8 weekly, 8 bi-weekly, 7 monthly). Intervention visits include a combination of 17 group sessions and 6 individual meetings with health coach. There will be 7 phone calls two weeks after each monthly visit. Adolescents and their parents attend concurrent group meetings. The content of the sessions will include topics related to nutrition, physical activity, and behavior modification for weight management.

Sponsors & Collaborators

Principal Investigators

  • Robert I Berkowitz, MD · Children's Hospital of Philadelphia and University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2010-05-31
Completion
2010-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01073215 on ClinicalTrials.gov