Weight Management Skills in African American Outpatients

Study Overview
=================
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: 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.

Official Title
-----------------
Weight Management Skills in African American Outpatients

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Weight Management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African American Men and Women Ages 35-70 years Body Mass Index 27-54 Exclusion Criteria: Pregnant Taking Weight Altering Medication

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>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<br>* 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.<br>|
| Active Comparator: B<br>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<br>* 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.<br>|
| Experimental: C<br>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<br>* 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.<br>|
| Active Comparator: D<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
African Americans, weight control, social support