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OpenTrials
Completed

NCT Number: NCT00146081

Weight Management Skills in African American Outpatients

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.

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Key information

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

3401 Market Street, Suite 202

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnant
  • Taking Weight Altering Medication

Treatment and study plan

Weight management

Behavioral

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.

Primary outcomes

  1. Weight

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: SHARE

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Sep 5, 2005
Registry last updated
Mar 31, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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