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Clinical Trials/NCT00938535
NCT00938535
Completed
Not Applicable

Community Based Obesity Prevention Among Black Women

Duke University1 site in 1 country194 target enrollmentNovember 2009
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Duke University
Enrollment
194
Locations
1
Primary Endpoint
Change in BMI. We have set a target of BMI maintenance among those randomized to the intervention condition.
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
November 2009
End Date
June 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • African-American
  • 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Obesity related biomarkers(6, 12 and 18 months post baseline)
  • 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)

Study Sites (1)

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