Clinical trial NCT00939081: Community Based Obesity Prevention Among Blacks
Official title: Community Based Obesity Prevention Among Blacks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Women's health
Minority health
Obesity prevention
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2009-07-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Female
* 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

Primary outcomes:
measure: Adherence to the pedometer-based physical activity regimen
timeFrame: 24 weeks post baseline
Secondary outcomes:
measure: Change in physical activity
timeFrame: 24 weeks post baseline
measure: Change in BMI
timeFrame: 24 weeks post baseline
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Gary Bennett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steinberg DM, Levine EL, Askew S, Foley P, Bennett GG. Daily text messaging for weight control among racial and ethnic minority women: randomized controlled pilot study. J Med Internet Res. 2013 Nov 18;15(11):e244. doi: 10.2196/jmir.2844.