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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sleep Move Stand Study

Conditions
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Physical Inactivity, Sedentary Behavior, Sleep, Cognitive Function

Intervention / Treatment
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* Behavioral: Education
* Behavioral: Health coaching
* Behavioral: Activity Monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Education<br>Participants will receive basic education information on physical activity, sedentary behavior, and sleep for 8 weeks. | Behavioral: Education<br>* Participants will receive standard of care education information on physical activity, sedentary behavior, and sleep via a mobile app for 8 weeks.<br>|
| Experimental: Education + Health Coaching + Activity Monitor<br>Participants will receive education information on physical activity, sedentary behavior and sleep plus health coaching plus a Fitbit activity monitor for 8 weeks. | Behavioral: Education<br>* Participants will receive standard of care education information on physical activity, sedentary behavior, and sleep via a mobile app for 8 weeks.<br>Behavioral: Health coaching<br>* Participants will meet with a health coach weekly for 8 weeks<br>Behavioral: Activity Monitor<br>* Participants will receive a Fitbit activity monitor to support goal setting and self monitoring of behaviors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | Daily steps will be measured with an ActivPAL monitor | Change from baseline daily steps at 8 weeks | 
| Sedentary Behavior | Daily minutes spent sedentary will be measured with an ActivPAL monitor | Change from baseline daily minutes sedentary at 8 weeks | 
| Sleep | Daily minutes spent sleeping will be measured with an ActivPAL monitor | Change from baseline daily minutes spent sleeping at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function | Facets of cognitive function will be measured with the NIH Toolbox application | Change from baseline cognitive function at 8 weeks |