Pedal@Work: A Worksite Wellness Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Physical Activity

Intervention / Treatment
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* Behavioral: Pedal@Work Worksite Wellness
* Behavioral: Pedal@Work


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity treatment group<br>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. | Behavioral: Pedal@Work<br>* Worksite wellness program.<br>|
| Placebo Comparator: Wait List Control<br> | Behavioral: Pedal@Work Worksite Wellness<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Step Watch - Physical Activity Minutes | 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 | 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 |