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

Not Applicable

Completed

• Conditions: Sleep; Sedentary Behavior; Physical Inactivity; Cognitive Function
• Interventions: Behavioral: Education; Behavioral: Health coaching; Behavioral: Activity Monitor

• Registration Number: NCT05498415
• Lead Sponsor: University of Iowa

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.

Study Timeline

• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-12
• Study Start: 2022-09-01
• Primary Completion: 2023-03-27
• Study Completion: 2023-03-27
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education + Health Coaching + Activity Monitor	Education	Participants will receive education information on physical activity, sedentary behavior and sleep plus health coaching plus a Fitbit activity monitor for 8 weeks.
Education	Education	Participants will receive basic education information on physical activity, sedentary behavior, and sleep for 8 weeks.
Education + Health Coaching + Activity Monitor	Health coaching	Participants will receive education information on physical activity, sedentary behavior and sleep plus health coaching plus a Fitbit activity monitor for 8 weeks.
Education + Health Coaching + Activity Monitor	Activity Monitor	Participants will receive education information on physical activity, sedentary behavior and sleep plus health coaching plus a Fitbit activity monitor for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Physical activity	Change from baseline daily steps at 8 weeks	Daily steps will be measured with an ActivPAL monitor
Sedentary Behavior	Change from baseline daily minutes sedentary at 8 weeks	Daily minutes spent sedentary will be measured with an ActivPAL monitor
Sleep	Change from baseline daily minutes spent sleeping at 8 weeks	Daily minutes spent sleeping will be measured with an ActivPAL monitor

Secondary Outcome Measures

Name	Time	Method
Cognitive function	Change from baseline cognitive function at 8 weeks	Facets of cognitive function will be measured with the NIH Toolbox application

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States