Community Based Obesity Prevention Among Black Women
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity |
Behavioral: Obesity Prevention |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 194 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 25 Years to 44 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- African-American
- Female
- Ages 25-44
- BMI between 25-34.9 kg/m2
- Patients with at least 1 visit in the previous 24 months to a participating Community Health Center
Exclusion Criteria:
- Not currently pregnant
- Not given birth within the past 12 months
- No history of myocardial infarction or stroke in last 2 years
Contacts and Locations
More Information
Additional Information:
No publications provided by Duke University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00938535 History of Changes |
| Other Study ID Numbers: | 2628, 1R01-DK078798 |
| Study First Received: | July 10, 2009 |
| Last Updated: | April 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
Obesity Women's health Minority health Obesity prevention |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013