Sedentary BehaviorNCT05281978
One Step at a Time: An Intervention to Reduce Sedentary Behavior Among Working Adults
A study testing Decrease Sedentary Time + Increase MVPA group and Increase MVPA group in people with Sedentary Behavior and Exercise, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Exercise, Middle Age
- What is being tested?
- Decrease Sedentary Time + Increase MVPA group and Increase MVPA group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeristy of Illinois Urbana-Champaign
Urbana, Illinois, 61801
About this study
Official title: 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.
- Conditions
- Sedentary Behavior, Exercise, Middle Age, Adult
- Being tested
- Decrease Sedentary Time + Increase MVPA group, Increase MVPA group
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decrease Sedentary Time + Increase MVPA groupBehavioural
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
Increase MVPA groupBehavioural
12 week home-based exercise program to promote engagement of 150 min/week of moderate-vigorous intensity exercise
| Study group | Role | What they receive |
|---|---|---|
| Decrease Sedentary Time + Increase MVPA | Experimental | 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). Receives: Behavioral: Decrease Sedentary Time + Increase MVPA group |
| Increase MVPA only | Active comparator | 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). Receives: Behavioral: Increase MVPA group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in average daily step counts
Participants will wear a hip-based pedometer for 7 days at baseline and 12 weeks
Measured: Baseline,12 weeks
Changes in average daily sedentary time
Participants will wear a hip-based accelerometer for 7 days at baseline and 12 weeks to measure their daily time spent sedentary.
Measured: Baseline,12 weeks
Changes in average daily light-intensity physical activity
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.
Measured: Baseline,12 weeks
Changes in average daily moderate-vigorous intensity physical activity
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.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start25 Apr 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neha P Gothe, MA, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281978
- Sponsor's protocol ID
- 22651
- Status last verified
- Aug 2023
- First submitted
- 7 Mar 2022
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Step at a Time: Testing the Efficacy of a Novel Social Cognitive Theory-Based Intervention to Reduce Sedentary Behavior Among Working Adults
- ClinicalTrials.gov ID
- NCT05281978
- Acronym / sponsor ID
- 22651
- Conditions
- Sedentary Behavior, Exercise, Middle Age, Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decrease Sedentary Time + Increase MVPA | Experimental | Behavioral: Decrease Sedentary Time + Increase MVPA groupParticipants 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). |
| Increase MVPA only | Active comparator | Behavioral: Increase MVPA groupParticipants 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). |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decrease Sedentary Time + Increase MVPA group12 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 | Behavioural | Decrease Sedentary Time + Increase MVPA |
| Increase MVPA group12 week home-based exercise program to promote engagement of 150 min/week of moderate-vigorous intensity exercise | Behavioural | Increase MVPA only |
Primary outcome
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
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha P Gothe, MA, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decrease Sedentary Time + Increase MVPA group and Increase MVPA group in people with Sedentary Behavior and Exercise, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in average daily step counts (time frame: Baseline,12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.