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OpenTrials
Completed

NCT Number: NCT05498415

Feasibility, Acceptability, and Efficacy of the 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education

Behavioral

Participants will receive standard of care education information on physical activity, sedentary behavior, and sleep via a mobile app for 8 weeks.

Health Coaching

Behavioral

Participants will meet with a health coach weekly for 8 weeks

Activity Monitor

Behavioral

Participants will receive a Fitbit activity monitor to support goal setting and self monitoring of behaviors.

Primary outcomes

  1. Physical activity

    Time frame: Change from baseline daily steps at 8 weeks

    Daily steps will be measured with an ActivPAL monitor

  2. Sedentary Behavior

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

    Daily minutes spent sedentary will be measured with an ActivPAL monitor

  3. Sleep

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

    Daily minutes spent sleeping will be measured with an ActivPAL monitor

Secondary outcomes

  1. Cognitive function

    Time frame: Change from baseline cognitive function at 8 weeks

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

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Official study title

Sleep Move Stand Study

Acronym: SMS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 12, 2022
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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