Community Based Obesity Prevention Among Black Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00938535
Recruitment Status : Completed
First Posted : July 14, 2009
Last Update Posted : July 29, 2014
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Obesity Prevention Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in obesity risk behaviors [ Time Frame: 6, 12 and 18 months post baseline ]
  2. Measures of body composition [ Time Frame: 6, 12 and 18 months post baseline ]
  3. Psychosocial mediators [ Time Frame: 6, 12 and 18 months post baseline ]
  4. Obesity related biomarkers [ Time Frame: 6, 12 and 18 months post baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 44 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00938535

United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Principal Investigator: Gary Bennett, PhD Duke University

Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Duke University Identifier: NCT00938535     History of Changes
Other Study ID Numbers: 2628
1R01DK078798 ( U.S. NIH Grant/Contract )
First Posted: July 14, 2009    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: July 2014

Keywords provided by Duke University:
Women's health
Minority health
Obesity prevention

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms