Weight Management Skills in African American Outpatients (SHARE)

This study has been completed.
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00146081
First received: September 1, 2005
Last updated: March 26, 2008
Last verified: March 2008
  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:

  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.

Condition Intervention
Obesity
Behavioral: Weight Management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Weight Management Skills in African American Outpatients

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Weight

Estimated Enrollment: 344
Study Start Date: August 2002
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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.
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.
Active Comparator: B
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.
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.
Experimental: C
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.
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.
Active Comparator: D
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.
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.

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant
  • Taking Weight Altering Medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146081

Locations
United States, Pennsylvania
3401 Market Street, Suite 202
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Shiriki K Kumanyika, PhD, MPH, RD University of Pennsylvania
  More Information

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shiriki K. Kumanyika, Ph.D., M.P.H., R.D., University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00146081     History of Changes
Other Study ID Numbers: 704086
Study First Received: September 1, 2005
Last Updated: March 26, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
African Americans
weight control
social support

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014