Feasibility, Acceptability, and Efficacy of the Sleep Move Stand Study (SMS)

University of Iowa

Status: Completed

Conditions: Cognitive Function; Physical Inactivity; Sleep; Sedentary Behavior

Treatments: Behavioral: Health coaching; Behavioral: Activity Monitor; Behavioral: Education

Study type: Interventional

Funder types: Other

Identifiers

NCT05498415

201812789

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Education

Active Comparator group

Description:

Participants will receive basic education information on physical activity, sedentary behavior, and sleep for 8 weeks.

Treatment:

Behavioral: Education

Education + Health Coaching + Activity Monitor

Experimental group

Description:

Participants will receive education information on physical activity, sedentary behavior and sleep plus health coaching plus a Fitbit activity monitor for 8 weeks.

Treatment:

Behavioral: Education

Behavioral: Activity Monitor

Behavioral: Health coaching