Skip to main content
OpenTrials
Completed

NCT Number: NCT00938535

Community Based Obesity Prevention Among Black Women

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

25 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Obesity Prevention

Behavioral

This arm includes an action plan, tailored print materials, telephone support calls, interactive self-monitoring, and a 12-month YMCA membership for the participant.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2014
First posted
Jul 14, 2009
Registry last updated
Jul 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.