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

Sleep Move Stand Study

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.

Study Overview

• Status: Completed
• Conditions: Sleep; Cognitive Function; Sedentary Behavior; Physical Inactivity
• Intervention / Treatment: Behavioral: Education; Behavioral: Health coaching; Behavioral: Activity Monitor

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): March 27, 2023
• Study Completion (Actual): March 27, 2023

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 201812789

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigators do not plan to share IPD with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No