Pedal@Work: A Worksite Wellness Program

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lucas J. Carr, East Carolina University
ClinicalTrials.gov Identifier:
NCT01371084
First received: June 8, 2011
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Physical Activity
Behavioral: Pedal@Work Worksite Wellness
Behavioral: Pedal@Work

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

Resource links provided by NLM:


Further study details as provided by East Carolina University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 40
Study Start Date: June 2011
Study Completion Date: August 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Pedal@Work
Worksite wellness program.
Placebo Comparator: Wait List Control 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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371084

Locations
United States, North Carolina
East Carolina University
Greenville, North Carolina, United States, 27858
Sponsors and Collaborators
East Carolina University
Investigators
Principal Investigator: Lucas J Carr, Ph.D. East Carolina University
  More Information

No publications provided

Responsible Party: Lucas J. Carr, Assistant Professor, East Carolina University
ClinicalTrials.gov Identifier: NCT01371084     History of Changes
Other Study ID Numbers: 212112
Study First Received: June 8, 2011
Last Updated: January 16, 2014
Health Authority: USA: University and Medical Center Institutional Review Board

ClinicalTrials.gov processed this record on September 22, 2014