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| Sponsored by: |
Duke University |
|---|---|
| Information provided by: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00939081 |
Purpose
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).
| Condition | Intervention |
|---|---|
|
Obesity |
Behavioral: Adaptive step recommendation Behavioral: 10,000 step/day recommendation |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Community Based Obesity Prevention Among Blacks |
| Estimated Enrollment: | 226 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
10,000 step/day recommendation: Active Comparator
Participants will receive a standard 10,000 step/day recommendation.
|
Behavioral: 10,000 step/day recommendation
Participants will receive a standard 10,000 step/day recommendation.
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|
Adaptive recommendation: Experimental
The adaptive recommendation will update the participant's recommended step count attainment in 2500 steps/d increments, until she reaches the 10,000 steps/d threshold. For example, if during Week One, a participant reports a mean of 5000 step/d, her adaptive recommendation will be 7500 steps/d. Once she reaches the 7500 steps/d level, she will receive a new recommendation of 10,000 steps/d.
|
Behavioral: Adaptive step recommendation
The adaptive recommendation will update the participant's recommended step count attainment in 2500 steps/d increments, until she reaches the 10,000 steps/d threshold. For example, if during Week One, a participant reports a mean of 5000 step/d, her adaptive recommendation will be 7500 steps/d. Once she reaches the 7500 steps/d level, she will receive a new recommendation of 10,000 steps/d.
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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=113 per condition): 1) receiving a 10,000 steps/day recommendation or 2) receiving an adaptive recommendation. The adaptive recommendation will update the participant's recommended step count attainment in 2500 steps/d increments, until she reaches the 10,000 steps/d threshold. For example, if during Week One, a participant reports a mean of 5000 step/d, her adaptive recommendation will be 7500 steps/d. Once she reaches the 7500 steps/d level, she will receive a new recommendation of 10,000 steps/d.
Participants will be provided pedometers and will be asked to report their step counts weekly, using an interactive voice response system. Brief non-intervention feedback will be provided during these calls.
Assessments (including self-report survey and anthropometric measurements) will be conducted at baseline and 24-weeks post baseline.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Duke University ( Gary G. Bennett, PhD ) |
| Study ID Numbers: | 2794 |
| Study First Received: | July 10, 2009 |
| Last Updated: | July 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00939081 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Obesity Women's health Minority health Obesity prevention |
|
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |
|
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |
