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

Physical Inactivity Clinical Trial

— STEPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264757
• Other study ID #: PBRC 29034
• Status: Completed
• Phase: Phase 0
• First received: December 3, 2010
• Last updated: February 4, 2016
• Start date: February 2010
• Est. completion date: June 2010

Study information

• Verified date: February 2016
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Physical Inactivity

Intervention

Behavioral:
• Physical Activity Educational Materials
A brochure was provided to participants about the health benefits of physical activity and physical activity recommendations
• Pedometer
A pedometer was provided to participants in addition to educational materials about the health benefits of physical activity.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Harrington DM, Tudor-Locke C, Champagne CM, Broyles ST, Harsha DW, Kennedy BM, Johnson WD, Allen R, Katzmarzyk PT. Step-based translation of physical activity guidelines in the Lower Mississippi Delta. Appl Physiol Nutr Metab. 2011 Aug;36(4):583-5. doi: 1 — View Citation

Katzmarzyk PT, Champagne CM, Tudor-Locke C, Broyles ST, Harsha D, Kennedy BM, Johnson WD. A short-term physical activity randomized trial in the Lower Mississippi Delta. PLoS One. 2011;6(10):e26667. doi: 10.1371/journal.pone.0026667. Epub 2011 Oct 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minutes spent in moderate-to-vigorous physical activity (MVPA)	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.	The primary outcome is measured at baseline and after a 7-day intervention period (1 week)	No