Weight Management Skills in African American Outpatients

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Weight Management

• Registration Number: NCT00146081
• Lead Sponsor: University of Pennsylvania

Brief Summary

Our long-term goal is to identify new insights about effective approaches to obesity management and related lifestyle changes in African Americans and about factors that enhance or limit the response to specific treatment approaches. Our primary interest is in "natural social support" from family members or friends. However, since not all individuals seeking obesity treatment desire or are able to name family members or friends to participate with them, we will also study the benefits of social support by creating a "team" condition among individuals recruited alone.

Specific aims are to:

1. Recruit overweight or obese "index" participants together with 1 or 2 family members or friend co-participants who are also overweight or obese, for enrollment in a 2 year weight loss program;

2. Conduct a randomized comparison of the effects, on weight loss and related behavioral and clinical outcomes of the index participants, of involving both index and co-participants (Group A) in the counseling program with those obtained when co-participants are not directly involved (Group B);

3. Enroll otherwise eligible index participants who do not name co-participants in a parallel 2 year weight loss study; Conduct a randomized comparison of the effects, on weight loss and related behavioral and clinical outcomes of individual participants, of creating social support teams of unrelated individuals (Group C) with those obtained when no such teams are created (Group D).

Primary hypotheses are that:

1. weight loss from 0 to 12 months and from 0 to 24 months will be significantly greater in Group A vs. Group B;

2. weight maintenance from 12 to 24 months will be significantly greater in Group A vs. Group B;

3. weight loss from 0 to 12 months and from 0 to 24 months will be significantly greater in Group C vs. Group D;

4. weight maintenance from 12 to 24 months will be significantly greater in Group C vs. Group D. Secondary analyses will compare the respective treatment and control groups on changes in diet, physical activity, and clinical CVD risk factor changes over time and will assess predictors of outcomes and cost-effectiveness.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-05
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-26
• Last Update Posted: 2008-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 344

Inclusion Criteria

• African American Men and Women
• Ages 35-70 years
• Body Mass Index 27-54

Exclusion Criteria

• Pregnant
• Taking Weight Altering Medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Weight Management	Family Program: Participants who have identified at least 1 family member or friend to enroll in SHARE with them, who are randomly assigned to program A, are invited to bring their enrolled family member or friend (co-participant) with them to the study intervention group sessions as their supportive team member.
B	Weight Management	Coach Program: Participants who identify 1 or 2 family members or friends to enroll in SHARE with them, who are randomly assigned to program B, are invited to attend the study intervention group sessions without their enrolled family or friend (co-participants). The co-participants receive the same written materials, but act as supportive team members outside of the group sessions only. They are invited to attend special field workshops and personal counseling sessions with their co-participants.
C	Weight Management	Team Program: Participants who do not identify 1 or 2 family or friend co-participants, and are randomly assigned to program C, are paired with other unrelated enrollees in their group sessions as supportive team members.
D	Weight Management	Individual Program: Participants who do not identify 1 or 2 family members or friends to enroll in SHARE with them, and are randomly assigned to program D, attend group sessions as individuals.

Primary Outcome Measures

Name	Time	Method
Weight

Trial Locations

Locations (1)

3401 Market Street, Suite 202; 🇺🇸 Philadelphia, Pennsylvania, United States