Weight Management Skills in African American Outpatients
NCT00146081 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 344
Last updated 2008-03-31
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.
Conditions
Interventions
- BEHAVIORAL
-
Weight Management
Participants (Index Participants) who identify 1 or 2 family members or friends (Co-Participants) to enroll with them are randomly assigned into either program A or B, and those who choose to enroll by themselves are randomly assigned to either program C or D. All Index Participants are invited to attend weekly group behavior change educational sessions; weekly in first 6 months, biweekly in next 6 months, and monthly in year 2. Co-Participants in program A are invited to attend all sessions with their Index Participant, but only the field workshops and personal counseling sessions if enrolled in program B.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Shiriki K Kumanyika, PhD, MPH, RD · University of Pennsylvania
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-08-31
- Primary Completion
- 2006-10-31
- Completion
- 2006-10-31
Countries
- United States
Study Locations
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