- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05281978
One Step at a Time: An Intervention to Reduce Sedentary Behavior Among Working Adults
August 24, 2023 updated by: University of Illinois at Urbana-Champaign
One Step at a Time: Testing the Efficacy of a Novel Social Cognitive Theory-Based Intervention to Reduce Sedentary Behavior Among Working Adults
The proposed study will test the preliminary efficacy of a novel 12-week social cognitive theory-based intervention that will target reducing daily sitting time and increasing exercise participation among middle-aged working adults.
This is a population highly susceptible to excessive sedentary time and low levels of exercise engagement.
This two-arm randomized controlled trial (RCT) will examine the preliminary efficacy of decreasing sedentary time in addition to increasing moderate-vigorous intensity physical activity (MVPA) engagement, compared to a group which only receives MVPA promotion.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
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Urbana, Illinois, United States, 61801
- Univeristy of Illinois Urbana-Champaign
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
41 years to 61 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 45-65 years of age by study start date
- Hold full-time employment (≥ 30 hours/week) at one or more jobs
- Hold a sedentary-based job (which also allows for ability to freely move about during the workday)
- Low active (engage in ≤2 days of 30+ minutes of structured moderate-vigorous intensity exercise/week)
- Physician's consent to participate in aerobic testing and/or the exercise program (if needed based on Physical Activity Readiness Questionnaire responses)
- Ambulatory
- Absence of health conditions that may be made worse by exercise
- Ability to complete all testing assessments in-person
- Access to a laptop/desktop/phone with Zoom web-conferencing software
- Fluent in English
Exclusion Criteria:
- Under 45 or over 65 years of age
- Not holding full-time employment (work < 30 hours/week at one or more jobs)
- Hold a job(s) which is classified as light, medium, heavy, or very heavy work
- Hold a sedentary-based job which does not allow for free movement throughout the workday (i.e., bus driver)
- High active (engage in > 2 days or 30+ minutes of structured moderate-vigorous intensity exercise/week)
- Non-consent of physician
- Non-ambulatory (i.e., use of walkers, wheelchair, cane, etc.)
- Presence of health conditions that may be made worse by exercise.
- Unable to complete assessments in-person
- No access to laptop/desktop/phone with Zoom software
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Decrease Sedentary Time + Increase MVPA
Participants in this group will receive a 12-week, social cognitive theory-based intervention targetting reduction of daily sedentary time.
This information will be delivered to them in the form of Zoom workshops, a program workbook, personalized step count goals, and a private social media page.
The aim of this component will be to have participants displace their daily sedentary time with light-intensity physical activity, such as casual walking.
The second component of this intervention will be increasing participants' weekly MVPA engagement.
Participants will participate in 1 live, virtual aerobics-based exercise class per week and complete 2 additional sessions on their own time.
Participants will build up to exercising 150 minutes/week (the federal physical activity recommendations).
|
12 week home-based exercise program to promote engagement of 150 min/week of moderate-vigorous intensity exercise; personalized step count goals to increase daily volume of physical activity and displacement of sedentary time
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|
Active Comparator: Increase MVPA only
Participants in this group will only receive the MVPA-promoting component (which will be the same delivery as the intervention group).
Participants in this arm will participate in 1 live, virtual aerobics-based exercise class per week (held separately from the intervention group) and will complete 2 additional exercise classes on their own time.
Participants will build up to exercising 150 minutes/week (the federal physical activity recommendations).
|
12 week home-based exercise program to promote engagement of 150 min/week of moderate-vigorous intensity exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in average daily step counts
Time Frame: Baseline,12 weeks
|
Participants will wear a hip-based pedometer for 7 days at baseline and 12 weeks
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Baseline,12 weeks
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Changes in average daily sedentary time
Time Frame: Baseline,12 weeks
|
Participants will wear a hip-based accelerometer for 7 days at baseline and 12 weeks to measure their daily time spent sedentary.
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Baseline,12 weeks
|
|
Changes in average daily light-intensity physical activity
Time Frame: Baseline,12 weeks
|
Participants will wear a hip-based accelerometer for 7 days at baseline and 12 weeks to measure their daily time spent engaged in light-intensity physical activity.
|
Baseline,12 weeks
|
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Changes in average daily moderate-vigorous intensity physical activity
Time Frame: Baseline, 12 weeks
|
Participants will wear a hip-based accelerometer for 7 days at baseline and 12 weeks to measure their daily time spent engaged in moderate-vigorous intensity physical activity.
|
Baseline, 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Neha P Gothe, MA, PhD, University of Illinois at Urbana-Champaign
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 25, 2022
Primary Completion (Actual)
August 1, 2023
Study Completion (Actual)
August 1, 2023
Study Registration Dates
First Submitted
March 7, 2022
First Submitted That Met QC Criteria
March 7, 2022
First Posted (Actual)
March 16, 2022
Study Record Updates
Last Update Posted (Actual)
August 28, 2023
Last Update Submitted That Met QC Criteria
August 24, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 22651
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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