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Steps Toward Adapting Physical Activity Guidelines for the Lower Mississippi Delta Population (STEPS)

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ClinicalTrials.gov Identifier: NCT01264757
Recruitment Status : Completed
First Posted : December 22, 2010
Last Update Posted : February 5, 2016
Sponsor:
Collaborator:
United States Department of Agriculture (USDA)
Information provided by (Responsible Party):
Peter T. Katzmarzyk, Pennington Biomedical Research Center

Brief Summary:
This feasibility study specifically addresses the issue of adapting US dietary guidelines physical activity recommendations to the population of the Lower Mississippi Delta. The hypothesis is that including a pedometer as a self-monitoring tool as part of adapted physical activity guidelines will result in greater immediate increases in physical activity (as monitored by an accelerometer) than an education program alone.

Condition or disease Intervention/treatment Phase
Physical Inactivity Behavioral: Physical Activity Educational Materials Behavioral: Pedometer Early Phase 1

Detailed Description:
The purpose of this study was to determine if a short-term pedometer-based intervention results in immediate increases in time spent in moderate-to-vigorous physical activity (MVPA) compared to a minimal educational intervention.A sample of 43 overweight adults 35 to 64 years of age participated in a one week pedometer-based feasibility trial monitored by accelerometry. Participants were randomized into a one-week education-only group or a group that also wore a pedometer. Accelerometer-measured MVPA was measured over 7 days at baseline and post-intervention.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Steps Toward Adapting Physical Activity Guidelines for the Lower Mississippi Delta Population
Study Start Date : February 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Education
Educational brochure about physical activity provided.
Behavioral: Physical Activity Educational Materials
A brochure was provided to participants about the health benefits of physical activity and physical activity recommendations
Experimental: Pedometer
A pedometer was provided in addition to educational materials.
Behavioral: Pedometer
A pedometer was provided to participants in addition to educational materials about the health benefits of physical activity.



Primary Outcome Measures :
  1. Minutes spent in moderate-to-vigorous physical activity (MVPA) [ Time Frame: The primary outcome is measured at baseline and after a 7-day intervention period (1 week) ]
    A GT3X accelerometer is used to monitor each participants physical activity levels for seven consecutive days at baseline and again following a 7-day intervention period. The amount of time per day spent above a threshold of 2200 accelerometer counts/min is averaged over at least three days as the measure of MVPA.



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Ages Eligible for Study:   35 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 35 to 64 years of age
  • body mass index (BMI) between 25 and 34.9 kg/m2
  • being able to walk without limitation

Exclusion Criteria:

  • cardiovascular, respiratory, gastrointestinal, neuromuscular, neurological, or psychiatric problems; musculoskeletal problems interfering with exercise
  • immunodeficiency problems
  • malignancies in the last 5 years
  • any other medical condition or life threatening disease that could be aggravated by exercise

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264757


Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
United States Department of Agriculture (USDA)
Investigators
Principal Investigator: Peter T Katzmarzyk, PhD Pennington Biomedical Research Center

Publications of Results:
Other Publications:
Responsible Party: Peter T. Katzmarzyk, Associate Executive Director for Population and Public Health, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01264757     History of Changes
Other Study ID Numbers: PBRC 29034
First Posted: December 22, 2010    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Peter T. Katzmarzyk, Pennington Biomedical Research Center:
pedometer
accelerometer
moderate-to-vigorous physical activity
adult
randomized trial