Pedal@Work: A Worksite Wellness Program (Pedal@Work)

January 16, 2014 updated by: Lucas J. Carr, East Carolina University

Pilot Study to Test the Efficacy of a Worksite Intervention for Reducing Daily Sedentary Time and Improving Risk Factors for Cardiometabolic Disease Among Sedentary, Overweight, Full-time Working Adults

The primary aim of this pilot study is to test the efficacy of a worksite intervention for reducing daily sedentary time and improving risk factors for cardiometabolic disease (e.g., measures of adiposity, anthropometrics, cardiorespiratory fitness) among sedentary, overweight, full-time working adults as compared to a waitlist control. A secondary aim will be to test pedal time at work as a measure of compliance with the intervention.

Study Overview

Detailed Description

Recent research indicates prolonged sedentary behaviors such as computer use and workplace sitting are particularly damaging resulting in increased risk for chronic diseases such as cardiovascular disease, type 2 diabetes and obesity. Few interventions have been tested with the specific purpose of reducing sedentary time to improve risk factors for cardiometabolic diseases. The primary aim of this pilot study is to test the efficacy of a worksite intervention for reducing daily sedentary time and improving risk factors for cardiometabolic disease (e.g., measures of adiposity, anthropometrics, cardiorespiratory fitness) among sedentary, overweight, full-time working adults as compared to a waitlist control. A secondary aim will be to test pedal time at work as a measure of compliance with the intervention. Participants will be followed for 12 weeks and randomized to either a treatment or wait list control group which will have the option to crossover into the intervention after 12 weeks.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Greenville, North Carolina, United States, 27858
        • East Carolina University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults between 21 and 65 years
  • Sedentary (engaging in moderate intensity physical activity for less than 60 minutes per week)
  • Working full time (35+ hours/week) at a sedentary desk dependant occupation
  • Overweight (Body Mass Index > 25.0 kg/m2 but less than 40.0 kg/2)
  • Apparently healthy as assessed by a health history screening survey
  • Devoid of overt complicated or acute cardiovascular, metabolic, respiratory, or neurological diseases
  • Free from exercise/physical activity limitations

Exclusion Criteria:

  • Adults with significant health problems exacerbated by exercise, such as uncontrolled hypertension, diabetes, orthopedic limitations, etc. will be excluded from the study. Note, with physician approval and adequate control of these health problems, these conditions will not necessarily preclude participation.
  • Being unable to exercise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical activity treatment group
Participants randomized to the intervention group will be provided access to a portable pedal exercise machine, a pedometer and a worksite wellness motivational website for 12 weeks. As part of this website, participants will be emailed behavioral intervention materials a maximum of three times per week targeted at reducing sedentary time.
Worksite wellness program.
Placebo Comparator: Wait List Control
Participants randomized to the intervention group will be provided access to a portable pedal exercise machine, a pedometer and a worksite wellness motivational website for 12 weeks. As part of this website, participants will be emailed behavioral intervention materials a maximum of three times per week targeted at reducing sedentary time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Step Watch - Physical Activity Minutes
Time Frame: 12 weeks between baseline and post-intervention follow up
Participants will wear a Step Watch monitor for 7 days at baseline and post-intervention. The intervention time period is 12 weeks.
12 weeks between baseline and post-intervention follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiometabolic Risk
Time Frame: 12 weeks between baseline and post-intervention follow up
Cardiometabolic risk will be assessed by blood pressure, heart rate, cardiopulmonary fitness, lipids, waist circumference, BMI, and percent body fat
12 weeks between baseline and post-intervention follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lucas J Carr, Ph.D., East Carolina University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

June 8, 2011

First Submitted That Met QC Criteria

June 9, 2011

First Posted (Estimate)

June 10, 2011

Study Record Updates

Last Update Posted (Estimate)

January 17, 2014

Last Update Submitted That Met QC Criteria

January 16, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 212112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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