Primary Care Research Network for the Treatment of Adolescent Obesity
TEENS
2 other identifiers
interventional
173
0 countries
N/A
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Jul 2006
Longer than P75 for not_applicable obesity
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 19, 2010
CompletedFirst Posted
Study publicly available on registry
February 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedFebruary 20, 2012
February 1, 2012
3.8 years
February 19, 2010
February 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage change in initial body mass index (BMI) at 12 months
12 months
Secondary Outcomes (3)
Compare mean reduction in percentage of initial BMI in the two treatments within each ethnic group/site (CHOP: urban African American adolescents and GHS: rural Caucasian adolescents
12 months
Compare the effectiveness of the two treatment approaches on improving risk factors for cardiovascular disease and diabetes (Total, HDL, and LDL cholesterol, triglycerides, glucose, insulin, and blood pressure) and on improving liver function
12 months
Compare mean reduction in percentage of initial BMI in each treatment group at month 6
6 months
Study Arms (2)
Group Condition
ACTIVE COMPARATORSelf-Guided Condition
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Male or female adolescents
- Age 12 to 16 years
- Body Mass Index (BMI) of 28 kg/m2
- Adolescent expresses desire to lose weight
- Parent willing to participate
- Live within 40 minutes from study clinic at CHOP or 60 minutes at Geisinger
You may not qualify if:
- Uncontrolled hypertension (blood pressure \> 140/90 mm HG)
- Diabetes mellitus (fasting glucose \> 126 mg/dl)
- Any serious uncontrolled medical disorder that would complicate participation in a weight loss program
- Bipolar disorder or psychosis (depression ok if adolescent is receiving treatment)
- Use of any medication affecting body weight, appetite or metabolism within 30 days prior to the start of treatment
- Positive pregnancy test at medical evaluation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital of Philadelphialead
- Pennsylvania Department of Healthcollaborator
- Geisinger Cliniccollaborator
- University of Pennsylvaniacollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert I Berkowitz, MD
Children's Hospital of Philadelphia and University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2010
First Posted
February 23, 2010
Study Start
July 1, 2006
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
February 20, 2012
Record last verified: 2012-02