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Clinical Trials/NCT05498415
NCT05498415CompletedNot Applicable

Sleep Move Stand Study

University of Iowa1 site in 1 country62 target enrollmentStarted: September 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
62
Locations
1
Primary Endpoint
Sedentary Behavior

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
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.

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

Education

Active Comparator

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

Intervention: Education (Behavioral)

Education + Health Coaching + Activity Monitor

Experimental

Participants will receive education information on physical activity, sedentary behavior and sleep plus health coaching plus a Fitbit activity monitor for 8 weeks.

Intervention: Education (Behavioral)

Education + Health Coaching + Activity Monitor

Experimental

Participants will receive education information on physical activity, sedentary behavior and sleep plus health coaching plus a Fitbit activity monitor for 8 weeks.

Intervention: Health coaching (Behavioral)

Education + Health Coaching + Activity Monitor

Experimental

Participants will receive education information on physical activity, sedentary behavior and sleep plus health coaching plus a Fitbit activity monitor for 8 weeks.

Intervention: Activity Monitor (Behavioral)

Outcomes

Primary Outcomes

Sedentary Behavior

Time Frame: Change from baseline daily minutes sedentary at 8 weeks

Daily minutes spent sedentary will be measured with an ActivPAL monitor

Sleep

Time Frame: Change from baseline daily minutes spent sleeping at 8 weeks

Daily minutes spent sleeping will be measured with an ActivPAL monitor

Physical activity

Time Frame: Change from baseline daily steps at 8 weeks

Daily steps will be measured with an ActivPAL monitor

Secondary Outcomes

  • Cognitive function(Change from baseline cognitive function at 8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lucas Carr

Associate Professor

University of Iowa

Study Sites (1)

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