Community Based Obesity Prevention Among Black Women
|ClinicalTrials.gov Identifier: NCT00938535|
Recruitment Status : Completed
First Posted : July 14, 2009
Last Update Posted : July 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Obesity Prevention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||194 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Community Based Obesity Prevention Among Black Women|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||June 2014|
|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.
- 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 ]
- Change in obesity risk behaviors [ Time Frame: 6, 12 and 18 months post baseline ]
- Measures of body composition [ Time Frame: 6, 12 and 18 months post baseline ]
- Psychosocial mediators [ Time Frame: 6, 12 and 18 months post baseline ]
- Obesity related biomarkers [ Time Frame: 6, 12 and 18 months post baseline ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938535
|United States, North Carolina|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Gary Bennett, PhD||Duke University|