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Clinical Trials/NCT00939081
NCT00939081CompletedNot Applicable

Community Based Obesity Prevention Among Blacks

Duke University2 sites in 1 country50 target enrollmentStarted: May 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
2
Primary Endpoint
Adherence to the pedometer-based physical activity regimen

Study Overview

Brief Summary

The purpose of this study is to examine whether pedometer step count recommendations (10,000 steps/day versus an adaptive recommendation) are differentially associated with the primary outcome of adherence to the pedometer-based physical activity regimen and the secondary outcomes of change in physical activity and body mass index (BMI).

Detailed Description

Long-term promotion of physical activity is necessary to achieve obesity prevention. This represents a particular challenge for our intervention design, as few studies have demonstrated positive long-term physical activity promotion outcomes among Black women. We have demonstrated the utility of pedometers among low income, ethnically diverse populations. The efficacy of pedometer utilization for the prevention of weight gain, however, hinges on long-term utilization of the devices. We hypothesize that recommendation for the step count attainment may affect individual's long-term utilization of pedometers, as well as physical activity levels and BMI.

This study is a 24-week experimental trial to examine whether intervention recommendations promote long-term adherence to a pedometer-based physical activity regimen. A two-group, block design will be used in the proposed study. Eligible women will be randomly assigned to one of two experimental conditions (n=75 per condition): 1) receiving a 10,000 steps/day recommendation and 3 health education sessions or 2) receiving an adaptive recommendation and an obesity prevention intervention. The adaptive step recommendation will update participants' recommended step counts, starting at 7,000 steps/day, then 8,000 steps/day, then finally 10,000 steps/day. Participants in the adaptive recommendation group will be provided with 3 educational sessions and will be asked to report their daily progress on weight maintenance goals via text message.

Participants will be provided pedometers and will be asked to wear them every day of the 24-week trial period.

Assessments (including self-report survey and anthropometric measurements) will be conducted at baseline, 12 weeks and 24 weeks post-baseline.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
25 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Ages 25 and over
  • BMI 25 and over
  • English fluency
  • Not currently pregnant
  • No restrictions to ambulatory activity

Exclusion Criteria

  • Current pregnancy
  • Childbearing in the past 12 months
  • History of myocardial infarction or stroke in last 2 years

Outcomes

Primary Outcomes

Adherence to the pedometer-based physical activity regimen

Time Frame: 24 weeks post baseline

Secondary Outcomes

  • Change in physical activity(24 weeks post baseline)
  • Change in BMI(24 weeks post baseline)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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