Clinical trial NCT00146081: Weight Management Skills in African American Outpatients
Official title: Weight Management Skills in African American Outpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: African Americans
weight control
social support
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2005-09-05
Enrollment: 344
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.


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

Primary outcomes:
measure: Weight
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: 3401 Market Street, Suite 202
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Shiriki K Kumanyika, PhD, MPH, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumanyika SK, Wadden TA, Shults J, Fassbender JE, Brown SD, Bowman MA, Brake V, West W, Frazier J, Whitt-Glover MC, Kallan MJ, Desnouee E, Wu X. Trial of family and friend support for weight loss in African American adults. Arch Intern Med. 2009 Oct 26;169(19):1795-804. doi: 10.1001/archinternmed.2009.337.