NCT01264757

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Feb 2010

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2010

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 22, 2010

Completed
Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

4 months

First QC Date

December 3, 2010

Last Update Submit

February 4, 2016

Conditions

Keywords

pedometeraccelerometermoderate-to-vigorous physical activityadultrandomized trial

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Education

ACTIVE COMPARATOR

Educational brochure about physical activity provided.

Behavioral: Physical Activity Educational Materials

Pedometer

EXPERIMENTAL

A pedometer was provided in addition to educational materials.

Behavioral: Pedometer

Interventions

A brochure was provided to participants about the health benefits of physical activity and physical activity recommendations

Education
PedometerBEHAVIORAL

A pedometer was provided to participants in addition to educational materials about the health benefits of physical activity.

Pedometer

Eligibility Criteria

Age35 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (2)

  • 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.

    PMID: 22046325BACKGROUND
  • 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: 10.1139/h11-053. Epub 2011 Aug 19.

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Peter T Katzmarzyk, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Executive Director for Population and Public Health

Study Record Dates

First Submitted

December 3, 2010

First Posted

December 22, 2010

Study Start

February 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

February 5, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations