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Pedal@Work: A Worksite Wellness Program

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by East Carolina University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
East Carolina University
ClinicalTrials.gov Identifier:
NCT01371084
First received: June 8, 2011
Last updated: June 9, 2011
Last verified: June 2011
History of Changes

June 8, 2011
June 9, 2011
June 2011
June 2012   (final data collection date for primary outcome measure)
Step Watch - Physical Activity Minutes [ Time Frame: 12 weeks between baseline and post-intervention follow up ] [ Designated as safety issue: No ]
Participants will wear a Step Watch monitor for 7 days at baseline and post-intervention. The intervention time period is 12 weeks.
Same as current
Complete list of historical versions of study NCT01371084 on ClinicalTrials.gov Archive Site
Cardiometabolic Risk [ Time Frame: 12 weeks between baseline and post-intervention follow up ] [ Designated as safety issue: No ]
Cardiometabolic risk will be assessed by blood pressure, heart rate, cardiopulmonary fitness, lipids, waist circumference, BMI, and percent body fat
Same as current
Not Provided
Not Provided
 
Pedal@Work: A Worksite Wellness Program
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.

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Physical Activity
  • 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.
  • Behavioral: Pedal@Work
    Worksite wellness program.
  • 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.
    Intervention: Behavioral: Pedal@Work
  • No Intervention: Wait List Control
    Participants randomized to the control group will be asked to maintain their current behaviors for the next 16 weeks.
    Intervention: Behavioral: Pedal@Work Worksite Wellness
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
August 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
21 Years to 65 Years
Yes
Contact: Lucas J Carr, Ph.D. 252-328-0009 carrl@ecu.edu
United States
 
NCT01371084
212112
No
Lucas J. Carr, Ph.D. - Assistant Professor, East Carolina University
East Carolina University
Not Provided
Principal Investigator: Lucas J Carr, Ph.D. East Carolina University
East Carolina University
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP