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

• Sponsor: University of Iowa (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05498415
• Collaborator: (none)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Months): 9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Physical Inactivity; Sedentary Behavior; Sleep; Cognitive Function	Behavioral: Education; Behavioral: Health coaching; Behavioral: Activity Monitor	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: Participants will be randomly assigned to group A (control) or group B (treatment) but will not be told which group they are receiving.
• Primary Purpose: Prevention
• Official Title: Sleep Move Stand Study
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Physical activity [Change from baseline daily steps at 8 weeks]

   Daily steps will be measured with an ActivPAL monitor

2. Sedentary Behavior [Change from baseline daily minutes sedentary at 8 weeks]

   Daily minutes spent sedentary will be measured with an ActivPAL monitor

3. 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

1. Cognitive function [Change from baseline cognitive function at 8 weeks]

   Facets of cognitive function will be measured with the NIH Toolbox application

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Iowa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lucas Carr, Associate Professor, University of Iowa
• ClinicalTrials.gov Identifier: NCT05498415
• Other Study ID Numbers: 201812789
• First Posted: Aug 12, 2022
• Last Update Posted: Aug 12, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 12, 2022