Expired Study
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Greenville, North Carolina 27858


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.


Study summary:

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.


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


Study is Available At:


Original ID:

212112


NCT ID:

NCT01371084


Secondary ID:


Study Acronym:

Pedal@Work


Brief Title:

Pedal@Work: A Worksite Wellness Program


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

East Carolina University


Oversight Authority:

USA: University and Medical Center Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Actual


Overall Contact Information

Official Name:Lucas J Carr, Ph.D.
Principal Investigator
East Carolina University

Study Dates

Start Date:June 2011
Completion Date:August 2012
Completion Type:Actual
Primary Completion Date:June 2012
Primary Completion Type:Actual
Verification Date:January 2014
Last Changed Date:January 16, 2014
First Received Date:June 8, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Step Watch - Physical Activity Minutes
Time Frame:12 weeks between baseline and post-intervention follow up
Safety Issues:False
Description:Participants will wear a Step Watch monitor for 7 days at baseline and post-intervention. The intervention time period is 12 weeks.
Outcome Type:Secondary Outcome
Measure:Cardiometabolic Risk
Time Frame:12 weeks between baseline and post-intervention follow up
Safety Issues:False
Description:Cardiometabolic risk will be assessed by blood pressure, heart rate, cardiopulmonary fitness, lipids, waist circumference, BMI, and percent body fat

Study Interventions

Intervention Type:Behavioral
Name:Pedal@Work Worksite Wellness
Description: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.
Arm Name:Wait List Control
Intervention Type:Behavioral
Name:Pedal@Work
Description:Worksite wellness program.
Arm Name:Physical activity treatment group

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Wait List Control
Study Arm Type:Experimental
Arm Name:Physical activity treatment group
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:East Carolina University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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