Pedal@Work: A Worksite Wellness Program

Physical Activity Clinical Trial

— Pedal@Work  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371084
• Other study ID #: 212112
• Status: Completed
• Phase: N/A
• First received: June 8, 2011
• Last updated: January 16, 2014
• Start date: June 2011
• Est. completion date: August 2012

Study information

• Verified date: January 2014
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Health authority: USA: University and Medical Center Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Pedal@Work Worksite Wellness
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.
• Pedal@Work
Worksite wellness program.

Locations

Country	Name	City	State
United States	East Carolina University	Greenville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
East Carolina University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No