Community Based Obesity Prevention Among Black Women
This study will evaluate the efficacy of a behavioral intervention, designed to prevent weight gain among overweight and low obese (25-34.9 kg/m2) Black women (aged 25-44), compared to usual care.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Community Based Obesity Prevention Among Black Women|
- Change in BMI. We have set a target of BMI maintenance among those randomized to the intervention condition. [ Time Frame: 6, 12 and 18 months post baseline ] [ Designated as safety issue: No ]
- Change in obesity risk behaviors [ Time Frame: 6, 12 and 18 months post baseline ] [ Designated as safety issue: No ]
- Measures of body composition [ Time Frame: 6, 12 and 18 months post baseline ] [ Designated as safety issue: No ]
- Psychosocial mediators [ Time Frame: 6, 12 and 18 months post baseline ] [ Designated as safety issue: No ]
- Obesity related biomarkers [ Time Frame: 6, 12 and 18 months post baseline ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Study Completion Date:||June 2014|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
|Experimental: Obesity Prevention||
Behavioral: Obesity Prevention
This arm includes an action plan, tailored print materials, telephone support calls, interactive self-monitoring, and a 12-month YMCA membership for the participant.
No Intervention: Usual Care
This arm includes usual care.
Obesity prevention among Black women is a major public health priority; presently, nearly 54% of the adult Black female population is obese. To date, most intervention attention has been focused on weight reduction among the overweight and obese. However, both conditions are notoriously recalcitrant to treatment, particularly among Blacks. We posit that obesity prevention might represent a particularly effective intervention strategy for overweight Black women. Most studies have shown that Black women have a greater social acceptance of overweight, less body weight dissatisfaction, and higher ideal body weights, compared to Whites. Furthermore, numerous studies have shown that obesity is less lethal and causes fewer co-morbidities among Black vs. White women, suggesting that maintaining overweight may be an appropriate public health goal for Black women. We posit that an intervention approach that emphasizes maintaining overweight, while preventing the transition to obesity will resonate among the target population. Very few obesity prevention RCTs appear in the published literature and, to our knowledge, none have been conducted solely among Black women.
We propose to randomize overweight, Black women (n=184) to either usual care (UC) or an obesity prevention (OP) intervention condition. The OP condition is comprised of several intervention components that will be delivered over 12 months; each participant will receive a tailored action plan, tailored print materials, monthly coaching calls, and weekly self-monitoring via an interactive voice response system. Assessments will be taken at baseline, 6, 12, and 18 months post baseline.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00938535
|United States, North Carolina|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Gary Bennett, PhD||Duke University|