Testing Responses of Young Adults to Intervention Messages (TRY AIM) for Promoting Physical Activity Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 360
- 试验地点
- 4
- 主要终点
- Average daily step counts (6 months)
研究概览
简要总结
The goal of this clinical trial is to test a precision (person-specific and context-sensitive) messaging algorithm for increasing physical activity and slowing weight gain in insufficiently-active young adults. The main questions it aims to answer are:
- Does physical activity increase more when text messages are sent based on a precision rule for selecting and timing messages compared to when the same message content is selected and sent at random or not at all?
- Do biological or social characteristics of young adults make them more likely to respond positively to the precision messaging intervention than either of the other two interventions?
Participants will be provided with education about health-enhancing physical activity and given an activity tracker to wear for 12 months. They will then be randomly assigned to one of three groups. Participants in one group (Precision AIM) will receive up to 4 messages/day selected and timed based on a person-specific algorithm that forecasts possible message effects periodically throughout the day. Messages will be drawn from one of three content libraries: move more, sit less, or inspirational quotes. Participants in a second group (Random AIM) will receive 4 messages/day selected at random from the same three content libraries and delivered at random times within their availability window. Participants in the third group (No AIM) will receive not motivational messages but will randomly assigned to the Random AIM group will receive up to 4 messages/day drawn at random from three content libraries at randomly-selected times. Step counts and weight will be assessed at baseline, and at 3 months, 6 months, 12 months, and 18 months. Researchers will compare Precision AIM, Random AIM and No AIM groups to see if physical activity increased more and weight gain was slower in Precision AIM than Random AIM or No AIM after 3, 6, and 12 months of intervention, and 6 months after the intervention is complete (18 months).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •own an iPhone or Android smartphone that they would be willing to download the Fitbit app onto and sync with a Fitbit tracker and a custom, AIM app
- •willing to wear a Fitbit tracker almost continually (23.5 hours/day) for a 12- month period of time
- •free of visual impairment that would interfere with the receipt of text messages on their phone
- •capable of reading, speaking and understanding English and of giving informed consent
- •willing to complete a full 18-month study protocol
排除标准
- •self-report sufficient aerobic activity to meet 2018 Physical Activity Guidelines for American adults
- •research-grade accelerometer records sufficient aerobic physical activity to meet 2018 Physical Activity Guidelines for American adults
- •living outside the continental US
- •one or more contraindications to physical activity
- •require an assistive device for mobility or have any other condition that may limit or prevent participation in moderate-intensity physical activity
- •pregnant or planning to become pregnant within the next 12 months
- •prior diagnosis of cancer, cardiovascular disease, diabetes or metabolic syndrome
- •concurrent participation in another research study involving physical activity or weight loss
- •planning to have surgery or relocate outside the continental US within the next year.
研究组 & 干预措施
Precision AIM
Education + activity monitor + up to 4 text messages/day, each drawn from one of 3 content libraries and timed based on a person- and context-specific algorithm that will be updated monthly based on incoming data (within a participant-defined availability window)
干预措施: Education (Behavioral)
Precision AIM
Education + activity monitor + up to 4 text messages/day, each drawn from one of 3 content libraries and timed based on a person- and context-specific algorithm that will be updated monthly based on incoming data (within a participant-defined availability window)
干预措施: Activity tracker (Behavioral)
Precision AIM
Education + activity monitor + up to 4 text messages/day, each drawn from one of 3 content libraries and timed based on a person- and context-specific algorithm that will be updated monthly based on incoming data (within a participant-defined availability window)
干预措施: Text messaging (precision dosing) (Behavioral)
Random AIM
Education + activity monitor + up to 4 text messages/day, each drawn from one of 3 content libraries and timed at random (within a participant-defined availability window).
干预措施: Education (Behavioral)
Random AIM
Education + activity monitor + up to 4 text messages/day, each drawn from one of 3 content libraries and timed at random (within a participant-defined availability window).
干预措施: Activity tracker (Behavioral)
Random AIM
Education + activity monitor + up to 4 text messages/day, each drawn from one of 3 content libraries and timed at random (within a participant-defined availability window).
干预措施: Text messaging (random timing and selection) (Behavioral)
No AIM
Education + activity monitor
干预措施: Education (Behavioral)
No AIM
Education + activity monitor
干预措施: Activity tracker (Behavioral)
结局指标
主要结局
Average daily step counts (6 months)
时间窗: Change from baseline to 6 months
Average daily step counts recorded by Actigraph accelerometer over a 7-day monitoring period
次要结局
- Average daily step counts (18 months)(Change from 12 months to 18 months)
- Weight (6 months)(Change from baseline to 6 months)
- Weight (12 months)(Change from baseline to 12 months)
- Moderate-to-vigorous intensity physical activity duration (6 months)(Change from baseline to 6 months)
- Light intensity physical activity duration (18 months)(Change from 12 months to 18 months)
- Light intensity physical activity duration (6 months)(Change from baseline to 6 months)
- Average daily step counts (12 months)(Change from baseline to 12 months)
- Weight (18 months)(Change from 12 months to 18 months)
- Moderate-to-vigorous intensity physical activity duration (12 months)(Change from baseline to 12 months)
- Moderate-to-vigorous intensity physical activity duration (18 months)(Change from 12 months to 18 months)
- Light intensity physical activity duration (12 months)(Change from baseline to 12 months)
- Sedentary behavior duration (6 months)(Change from baseline to 6 months)
- Sedentary behavior duration (12 months)(Change from baseline to 12 months)
- Sedentary behavior duration (18 months)(Change from 12 months to 18 months)
研究者
David Conroy
Bickner Chair of Kinesiology and Professor of Kinesiology, School of Kinesiology
University of Michigan