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临床试验/NCT05498415
NCT05498415已完成不适用

Sleep Move Stand Study

University of Iowa1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2022年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
Sedentary Behavior

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Participants will be randomly assigned to group A (control) or group B (treatment) but will not be told which group they are receiving.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Physically inactive
  • •Overweight or obese
  • •Healthy enough to safely engage in regular physical activity

排除标准

  • •<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

研究组 & 干预措施

Education

Active Comparator

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

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: Activity Monitor (Behavioral)

结局指标

主要结局

Sedentary Behavior

时间窗: Change from baseline daily minutes sedentary at 8 weeks

Daily minutes spent sedentary will be measured with an ActivPAL monitor

Sleep

时间窗: Change from baseline daily minutes spent sleeping at 8 weeks

Daily minutes spent sleeping will be measured with an ActivPAL monitor

Physical activity

时间窗: Change from baseline daily steps at 8 weeks

Daily steps will be measured with an ActivPAL monitor

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lucas Carr

Associate Professor

University of Iowa

研究点 (1)

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