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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-03-27

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.

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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.

Conditions

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Physical Inactivity Sedentary Behavior Sleep Cognitive Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

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

Study Groups

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Education

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

Group Type ACTIVE_COMPARATOR

Education

Intervention Type BEHAVIORAL

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

Education + Health Coaching + 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.

Group Type EXPERIMENTAL

Education

Intervention Type BEHAVIORAL

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

Health coaching

Intervention Type BEHAVIORAL

Participants will meet with a health coach weekly for 8 weeks

Activity Monitor

Intervention Type BEHAVIORAL

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

Interventions

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Education

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

Intervention Type BEHAVIORAL

Health coaching

Participants will meet with a health coach weekly for 8 weeks

Intervention Type BEHAVIORAL

Activity Monitor

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

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes