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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04641689
Other study ID # IRB8886
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 21, 2020
Est. completion date July 2021

Study information

Verified date November 2020
Source Kansas State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project will examine the effectiveness of an intervention to reduce sedentary behavior in Kansas State University employees who are primarily working from home. We will recruit 100 employees to participate. Participants will be randomly assigned to one of four conditions: desk only, program only, desk + program, or waitlist control. The program will consist of strategies to reduce sitting and increase physical activity in the home environment. We will assess whether the intervention successfully elicits reductions in sitting among employees, as well as changes in cardiometabolic and work-related outcomes.


Description:

For this project we will conduct a 12-week intervention that incorporates multiple strategies to reduce sedentary behavior among university employees who are primarily working from home. Participants will be recruited via campus networks. Participants will attend an initial testing visit, during which anthropometric and health outcome data (blood pressure, blood glucose and cholesterol) will be collected. Following the testing visit, all participants will complete an activity log for the next 5 work days, and a subsample will wear an activPAL 4 device for 7 days. All participants will complete a series of questionnaires (measuring physical activity, fatigue, stress, productivity, mood, and diet) online. After all baseline data have been collected, participants will be randomized to one of four conditions: desk only, program only, desk + program, or waitlist control. Those in the desk only and desk+program conditions will receive a height-adjustable desk. They will be asked to set up the desk at their home workstation and send a photo of the setup to our research team within one week. Those in the program only and control conditions will receive their height-adjustable desks after completing the post-intervention assessments. Participants assigned to the program only and desk+program conditions will have access to a website that includes a variety of resources for reducing sedentary behavior and increasing physical activity in the home environment. The intervention program will be based on social cognitive theory and will be designed to promote self-efficacy, self-regulation, positive outcome expectations, and social and environmental support. Participants will complete weekly modules that include activities such as goal setting and self-monitoring, action and coping planning, group discussions, etc. The program will also provide suggestions for changes to the home work environment, access to virtual stretching and strengthening videos, examples of technology to prompt breaks, etc. Participants will also receive 2 small group coaching calls via Zoom (at 3 and 8 weeks) to assist them in setting goals for reducing sedentary behavior and overcoming barriers. Participants in the desk only and waitlist control groups will receive access to the program after completing the post-intervention assessments. All measures will be repeated following the 12-week intervention.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date July 2021
Est. primary completion date March 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Full-time employee (works >30 hours per week) - Sedentary job (>75% of workday seated) - Working primarily at home (>80% of typical week) - Able to safely engage in light intensity physical activity - No ambulatory limitations Exclusion Criteria: - Working <30 hours per week - Standing or physically active >25% of typical workday - Working on campus >20% of a typical week OR planning to resume work on campus in the next 3 months - Uncontrolled stage 2 (severe) hypertension without a medical release signed by a physician

Study Design


Intervention

Device:
Desk Only
Provision of height-adjustable desk
Behavioral:
Program Only
Online modules will promote goal setting, self-monitoring, habit formation, social support, barrier identification, and environmental modifications

Locations

Country Name City State
United States Kansas State University Manhattan Kansas

Sponsors (2)

Lead Sponsor Collaborator
Kansas State University University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in sedentary behavior during the workday Measured via 5-day activity log Baseline and 12 weeks
Secondary Change in physical activity International Physical Activity Questionnaire (long form) Baseline and 12 weeks
Secondary Changes in sitting, standing and stepping activPAL (subsample) Baseline and 12 weeks
Secondary Change in productivity Health and Work Questionnaire Baseline and 12 weeks
Secondary Change in stress Perceived Stress Scale (4-item) Baseline and 12 weeks
Secondary Change in fatigue Fatigue Symptom Inventory Baseline and 12 weeks
Secondary Change in mood Positive and Negative Affect Schedule Baseline and 12 weeks
Secondary Change in diet Rapid Eating Assessment for Participants - Shortened Version Baseline and 12 weeks
Secondary Change in blood pressure Measured using automatic blood pressure cuff Baseline and 12 weeks
Secondary Change in fasting blood glucose Blood sample obtained via finger stick Baseline and 12 weeks
Secondary Change in cholesterol Total, HDL, and LDL; Blood sample obtained via finger stick Baseline and 12 weeks
Secondary Change in triglycerides Blood sample obtained via finger stick Baseline and 12 weeks
Secondary Change in waist circumference Measured to the nearest 0.5 cm Baseline and 12 weeks
Secondary Change in weight Measured in kg Baseline and 12 weeks
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