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Feasibility, Acceptability, and Efficacy of the Sleep Move Stand Study

Sleep Move Stand Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05498415
Acronym
SMS
Enrollment
62
Registered
2022-08-12
Start date
2022-09-01
Completion date
2023-03-27
Last updated
2023-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Function, Physical Inactivity, Sedentary Behavior, Sleep

Brief 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. 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.

Interventions

BEHAVIORALEducation

Participants will receive standard of care education information on physical activity, sedentary behavior, and sleep via a mobile app for 8 weeks.

BEHAVIORALHealth coaching

Participants will meet with a health coach weekly for 8 weeks

BEHAVIORALActivity Monitor

Participants will receive a Fitbit activity monitor to support goal setting and self monitoring of behaviors.

Sponsors

University of Iowa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Participants will be randomly assigned to group A (control) or group B (treatment) but will not be told which group they are receiving.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Physically inactive * Overweight or obese * Healthy enough to safely engage in regular physical activity

Exclusion criteria

* \<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 * Self report mobility issues or diagnosed diseases that prevent safely engaging in regular physical activity * Planned surgery in the next 12 weeks * Pregnant

Design outcomes

Primary

MeasureTime frameDescription
Physical activityChange from baseline daily steps at 8 weeksDaily steps will be measured with an ActivPAL monitor
Sedentary BehaviorChange from baseline daily minutes sedentary at 8 weeksDaily minutes spent sedentary will be measured with an ActivPAL monitor
SleepChange from baseline daily minutes spent sleeping at 8 weeksDaily minutes spent sleeping will be measured with an ActivPAL monitor

Secondary

MeasureTime frameDescription
Cognitive functionChange from baseline cognitive function at 8 weeksFacets of cognitive function will be measured with the NIH Toolbox application

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026