Community Based Obesity Prevention Among Black Women

July 28, 2014 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

194

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6, 12 and 18 months post baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Gary Bennett, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

July 10, 2009

First Submitted That Met QC Criteria

July 13, 2009

First Posted (Estimate)

July 14, 2009

Study Record Updates

Last Update Posted (Estimate)

July 29, 2014

Last Update Submitted That Met QC Criteria

July 28, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2628
  • 1R01DK078798 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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