Community Based Obesity Prevention Among Black Women

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00938535
First received: July 10, 2009
Last updated: April 22, 2013
Last verified: April 2013

July 10, 2009
April 22, 2013
November 2009
August 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00938535 on ClinicalTrials.gov Archive Site
  • Change in obesity risk behaviors [ Time Frame: 6, 12 and 18 months post baseline ] [ Designated as safety issue: No ]
  • Measures of body composition [ Time Frame: 6, 12 and 18 months post baseline ] [ Designated as safety issue: No ]
  • Psychosocial mediators [ Time Frame: 6, 12 and 18 months post baseline ] [ Designated as safety issue: No ]
  • Obesity related biomarkers [ Time Frame: 6, 12 and 18 months post baseline ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Community Based Obesity Prevention Among Black Women
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Obesity
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.
  • Experimental: Obesity Prevention
    Intervention: Behavioral: Obesity Prevention
  • No Intervention: Usual Care
    This arm includes usual care.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
194
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Female
25 Years to 44 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00938535
2628, 1R01-DK078798
No
Duke University
Duke University
Not Provided
Principal Investigator: Gary Bennett, PhD Duke University
Duke University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP