- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01371084
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
Status
Completed
Conditions
Intervention / Treatment
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
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North Carolina
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Greenville, North Carolina, United States, 27858
- East Carolina University
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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.
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Worksite wellness program.
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Placebo Comparator: Wait List Control
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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
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Participants will wear a Step Watch monitor for 7 days at baseline and post-intervention.
The intervention time period is 12 weeks.
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12 weeks between baseline and post-intervention follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiometabolic Risk
Time Frame: 12 weeks between baseline and post-intervention follow up
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Cardiometabolic risk will be assessed by blood pressure, heart rate, cardiopulmonary fitness, lipids, waist circumference, BMI, and percent body fat
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12 weeks between baseline and post-intervention follow up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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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