Clinical trial NCT05498415: Feasibility, Acceptability, and Efficacy of the Sleep Move Stand Study
Official title: Sleep Move Stand Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Sedentary Behavior
Sleep
Cognitive Function
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical activity
timeFrame: Change from baseline daily steps at 8 weeks
measure: Sedentary Behavior
timeFrame: Change from baseline daily minutes sedentary at 8 weeks
measure: Sleep
timeFrame: Change from baseline daily minutes spent sleeping at 8 weeks
Secondary outcomes:
measure: Cognitive function
timeFrame: Change from baseline cognitive function at 8 weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
References: