Physical InactivitySMSNCT05498415
Feasibility, Acceptability, and Efficacy of the Sleep Move Stand Study
A study testing Education, Health coaching and Activity Monitor in people with Physical Inactivity and Sedentary Behavior, run by University of Iowa at 1 site in United States.
Trial summary
The overarching goal for this project is to develop a service-learning program that provides students excellent hands on training and patients with an excellent service that advances their health and well-being. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Sedentary Behavior, Sleep
- What is being tested?
- Education, Health coaching and Activity Monitor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 27 Mar 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physically inactive
- Overweight or obese
- Healthy enough to safely engage in regular physical activity
Who cannot join
- <18 years or >80 years
- Report achieving more than 75 minutes/week of moderate to vigorous intensity physical activity
- Underweight or normal weight (BMI <25.0 mg/kg2)
- Do not intend on becoming more active in the next 3 months
- Not able to commit to a 8 week physical activity program
- No access to smartphone capable of sending and receiving text messages
Show all 9Show fewer
- Self report mobility issues or diagnosed diseases that prevent safely engaging in regular physical activity
- Planned surgery in the next 12 weeks
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Move Stand Study
The overarching goal for this project is to develop a service-learning program that provides students excellent hands on training and patients with an excellent service that advances their health and well-being. The aim of this study is to test the feasibility, acceptability and efficacy of an 8 week intervention on physical behaviors, cognitive function, and health outcomes compared to a control condition among sedentary, overweight and obese adults.
Read the detailed description
The overarching goal for this project is to develop and test a service-learning health promotion intervention that provides students hands on training and patients with a service that advances their health and well-being. Inactive but healthy community members and patients being treated at our local hospital will be recruited to participate. Interested volunteers will be randomized into one of two 8 week interventions. The control group will receive basic education information on physical activity, sedentary behavior, and sleep that is consistent with standard of care. These materials will be accessed via a health coaching software program called Healthie. The treatment group will receive the same education information plus health coaching and a Fitbit activity monitor to further support behavior change. Participants will be blinded to their group assignment. Major outcomes include physical activity, sedentary behavior, sleep, cognitive function, and several health outcomes. Success on whether or not the program is found to be feasible, acceptable, and effective.
- Conditions
- Physical Inactivity, Sedentary Behavior, Sleep, Cognitive Function
- Being tested
- Education, Health coaching, Activity Monitor
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Participants will receive standard of care education information on physical activity, sedentary behavior, and sleep via a mobile app for 8 weeks.
Health coachingBehavioural
Participants will meet with a health coach weekly for 8 weeks
Activity MonitorBehavioural
Participants will receive a Fitbit activity monitor to support goal setting and self monitoring of behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Education | Active comparator | Participants will receive basic education information on physical activity, sedentary behavior, and sleep for 8 weeks. Receives: Behavioral: Education |
| Education + Health Coaching + Activity Monitor | Experimental | Participants will receive education information on physical activity, sedentary behavior and sleep plus health coaching plus a Fitbit activity monitor for 8 weeks. Receives: Behavioral: Education; Behavioral: Health coaching; Behavioral: Activity Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Daily steps will be measured with an ActivPAL monitor
Measured: Change from baseline daily steps at 8 weeks
Sedentary Behavior
Daily minutes spent sedentary will be measured with an ActivPAL monitor
Measured: Change from baseline daily minutes sedentary at 8 weeks
Sleep
Daily minutes spent sleeping will be measured with an ActivPAL monitor
Measured: Change from baseline daily minutes spent sleeping at 8 weeks
Secondary outcomes (1)
Cognitive function
Facets of cognitive function will be measured with the NIH Toolbox application
Measured: Change from baseline cognitive function at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Sep 2022
- Primary completion27 Mar 2023
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucas Carr, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498415
- Sponsor's protocol ID
- 201812789
- Acronym
- SMS
- Status last verified
- May 2023
- First submitted
- 28 Jul 2022
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to share IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Move Stand Study
- ClinicalTrials.gov ID
- NCT05498415
- Acronym / sponsor ID
- SMS / 201812789
- Conditions
- Physical Inactivity, Sedentary Behavior, Sleep, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 12 Aug 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 overarching goal for this project is to develop a service-learning program that provides students excellent hands on training and patients with an excellent service that advances their health and well-being. The aim of this study is to test the feasibility, acceptability and efficacy of an 8 week intervention on physical behaviors, cognitive function, and health outcomes compared to a control condition among sedentary, overweight and obese adults.
Detailed description
The overarching goal for this project is to develop and test a service-learning health promotion intervention that provides students hands on training and patients with a service that advances their health and well-being. Inactive but healthy community members and patients being treated at our local hospital will be recruited to participate. Interested volunteers will be randomized into one of two 8 week interventions. The control group will receive basic education information on physical activity, sedentary behavior, and sleep that is consistent with standard of care. These materials will be accessed via a health coaching software program called Healthie. The treatment group will receive the same education information plus health coaching and a Fitbit activity monitor to further support behavior change. Participants will be blinded to their group assignment. Major outcomes include physical activity, sedentary behavior, sleep, cognitive function, and several health outcomes. Success on whether or not the program is found to be feasible, acceptable, and effective.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education | Active comparator | Behavioral: EducationParticipants will receive basic education information on physical activity, sedentary behavior, and sleep for 8 weeks. |
| Education + Health Coaching + Activity Monitor | Experimental | Behavioral: Education, Behavioral: Health coaching, Behavioral: Activity MonitorParticipants will receive education information on physical activity, sedentary behavior and sleep plus health coaching plus a Fitbit activity monitor for 8 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Physically inactive
- Overweight or obese
- Healthy enough to safely engage in regular physical activity
Key exclusion criteria (9 listed)
- <18 years or >80 years
- Report achieving more than 75 minutes/week of moderate to vigorous intensity physical activity
- Underweight or normal weight (BMI <25.0 mg/kg2)
- Do not intend on becoming more active in the next 3 months
- Not able to commit to a 8 week physical activity program
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 |
|---|---|---|
| EducationParticipants will receive standard of care education information on physical activity, sedentary behavior, and sleep via a mobile app for 8 weeks. | Behavioural | Education, Education + Health Coaching + Activity Monitor |
| Health coachingParticipants will meet with a health coach weekly for 8 weeks | Behavioural | Education + Health Coaching + Activity Monitor |
| Activity MonitorParticipants will receive a Fitbit activity monitor to support goal setting and self monitoring of behaviors. | Behavioural | Education + Health Coaching + Activity Monitor |
Primary outcome
Physical activity
Time frame: Change from baseline daily steps at 8 weeks
Daily steps will be measured with an ActivPAL monitor
Sedentary Behavior
Time frame: Change from baseline daily minutes sedentary at 8 weeks
Daily minutes spent sedentary will be measured with an ActivPAL monitor
Sleep
Time frame: Change from baseline daily minutes spent sleeping at 8 weeks
Daily minutes spent sleeping will be measured with an ActivPAL monitor
1 secondary outcome
Cognitive function
Time frame: Change from baseline cognitive function at 8 weeks
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 12 May 2023.
- Individual participant dataSharing planned: No. The investigators do not plan to share IPD with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education, Health coaching and Activity Monitor in people with Physical Inactivity and Sedentary Behavior, run by University of Iowa 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 3 inclusion and 9 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 12 May 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?
Physical activity (time frame: Change from baseline daily steps at 8 weeks). The study lists 3 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 12 May 2023.