Community Based Obesity Prevention Among Black Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00938535
First received: July 10, 2009
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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 Intervention
Obesity
Behavioral: Obesity Prevention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Community Based Obesity Prevention Among Black Women

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 194
Study Start Date: November 2009
Study Completion Date: June 2014
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   25 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938535

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00938535     History of Changes
Other Study ID Numbers: 2628, 1R01-DK078798
Study First Received: July 10, 2009
Last Updated: July 28, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 29, 2014