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

Sleep Clinical Trial

— SMS  

Official title:

Sleep Move Stand Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05498415
• Other study ID #: 201812789
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: March 27, 2023

Study information

• Verified date: May 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 27, 2023
• Est. primary completion date: March 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Function
• Physical Inactivity
• Sedentary Behavior
• Sleep

Intervention

Behavioral:
• Education
Participants will receive standard of care education information on physical activity, sedentary behavior, and sleep via a mobile app for 8 weeks.
• Health coaching
Participants will meet with a health coach weekly for 8 weeks
• Activity Monitor
Participants will receive a Fitbit activity monitor to support goal setting and self monitoring of behaviors.

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity	Daily steps will be measured with an ActivPAL monitor	Change from baseline daily steps at 8 weeks
Primary	Sedentary Behavior	Daily minutes spent sedentary will be measured with an ActivPAL monitor	Change from baseline daily minutes sedentary at 8 weeks
Primary	Sleep	Daily minutes spent sleeping will be measured with an ActivPAL monitor	Change from baseline daily minutes spent sleeping at 8 weeks
Secondary	Cognitive function	Facets of cognitive function will be measured with the NIH Toolbox application	Change from baseline cognitive function at 8 weeks