Clinical trial NCT01371084: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2011-06-10
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Step Watch - Physical Activity Minutes
timeFrame: 12 weeks between baseline and post-intervention follow up
Secondary outcomes:
measure: Cardiometabolic Risk
timeFrame: 12 weeks between baseline and post-intervention follow up
Other outcomes:
Locations:
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
Study officials:
affiliation: East Carolina University
name: Lucas J Carr, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carr LJ, Karvinen K, Peavler M, Smith R, Cangelosi K. Multicomponent intervention to reduce daily sedentary time: a randomised controlled trial. BMJ Open. 2013 Oct 18;3(10):e003261. doi: 10.1136/bmjopen-2013-003261.