Obesity and Weight Management |
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Clinical Trial: Weight Management Skills in African American Outpatients
This study is no longer recruiting patients.
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Purpose
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:
- 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;
- 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);
- 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:
- weight loss from 0 to 12 months and from 0 to 24 months will be significantly greater in Group A vs. Group B;
- weight maintenance from 12 to 24 months will be significantly greater in Group A vs. Group B;
- weight loss from 0 to 12 months and from 0 to 24 months will be significantly greater in Group C vs. Group D;
- 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.
| Condition | Intervention |
|---|---|
| Obesity | Behavior: Weight Management |
MedlinePlus related topics: Obesity
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Expected Total Enrollment: 344
Study start: August 2002; Study completion: June 2007
Last follow-up: June 2007; Data entry closure: June 2007
Eligibility
Inclusion Criteria:
- African American Men and Women
- Ages 35-70 years
- Body Mass Index 27-54
Exclusion Criteria:
- Pregnant
- Taking Weight Altering Medication
Location Information
Pennsylvania
3401 Market Street, Suite 202, Philadelphia, Pennsylvania, 19104, United States
Shiriki K Kumanyika, PhD, MPH, RD, Principal Investigator, University of Pennsylvania
More Information
Last Updated: September 2, 2005
Record first received: September 1, 2005
ClinicalTrials.gov Identifier: NCT00146081
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13

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