Community Based Obesity Prevention Among Black Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Community Based Obesity Prevention Among Black Women

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Obesity Prevention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Obesity Prevention<br> | Behavioral: Obesity Prevention<br>* This arm includes an action plan, tailored print materials, telephone support calls, interactive self-monitoring, and a 12-month YMCA membership for the participant.<br>|
| No Intervention: Usual Care<br>This arm includes usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI. We have set a target of BMI maintenance among those randomized to the intervention condition. |  | 6, 12 and 18 months post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in obesity risk behaviors |  | 6, 12 and 18 months post baseline | 
| Measures of body composition |  | 6, 12 and 18 months post baseline | 
| Psychosocial mediators |  | 6, 12 and 18 months post baseline | 
| Obesity related biomarkers |  | 6, 12 and 18 months post baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Women's health, Minority health, Obesity prevention