Community Based Obesity Prevention Among Blacks

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00939081
First received: July 10, 2009
Last updated: July 28, 2014
Last verified: July 2014
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Community Based Obesity Prevention Among Blacks

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Adherence to the pedometer-based physical activity regimen [ Time Frame: 24 weeks post baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in physical activity [ Time Frame: 24 weeks post baseline ] [ Designated as safety issue: No ]
  • Change in BMI [ Time Frame: 24 weeks post baseline ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: May 2010
Study Completion Date: June 2014
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 10,000 step/day recommendation
Participants will receive a standard 10,000 step/day recommendation and 3 education sessions: at baseline, at 3 months and at 6 months.
Behavioral: 10,000 step/day recommendation
Participants will receive a standard 10,000 step/day recommendation and 3 education sessions: at baseline, at 3 months and at 6 months.
Experimental: Adaptive recommendation
The adaptive recommendation will update the participant's recommended step count attainment from 7,000 to 8,000, then 10,000 steps/day. The SMS-based self-monitoring system will collect three data points each day from participants in this group: 1) total number of steps/d recorded by the pedometer during the previous day (steps/d); 2) performance on 2nd weight loss goal; and 3) performance on 3rd weight loss goal.
Behavioral: Adaptive step recommendation
Participants in this group receive 3 education sessions: at baseline, at 3 months and at 6 months. The adaptive recommendation will update the participant's recommended step count attainment from 7,000 to 8,000, then 10,000 steps/day. The SMS-based self-monitoring system will collect three data points each day from participants in this group: 1) total number of steps/d recorded by the pedometer during the previous day (steps/d); 2) performance on 2nd weight loss goal; and 3) performance on 3rd weight loss goal.

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

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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: NCT00939081

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:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00939081     History of Changes
Other Study ID Numbers: 2794
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 30, 2014