Phase 1 Clinical Trial to Develop a Personalized Adaptive Text Message Intervention Using Control Systems Engineering Tools to Increase Physical Activity in Early Adulthood
试验速览
- 阶段
- 1 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Acceptability of messaging at 6 months
研究概览
简要总结
Our goal is to develop personalized decision rules for selecting the frequency, timing, and content of messages to promote physical activity. The objective of this project is to evaluate the acceptability and feasibility of two strategies for calibrating decision rules used to send those messages. Participants will wear an activity monitor for the collection of PA data and be randomly assigned to one of two adaptive intervention strategies. The decision rule for each participant will be refined on a monthly basis throughout the 6-month study based upon the accumulating data on how each participant is responding to different messages under different conditions. Our hypothesis is that more intensive intervention strategies will offer a better user experience because the resulting treatments will be experienced as more personalized.
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 (Investigator)
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
- •Participants capable of reading, speaking and understanding English and of giving informed consent.
- •Participants between the ages of 18-29 years.
- •Participants must be free of visual impairment that would interfere with the receipt of text messages on their phone.
- •Participants must be willing to wear a Fitbit Versa 3 almost continually (23.5 hours/day) for a 6- month period of time.
- •Participants must own an iPhone or Android smartphone that they would be willing to download the custom Precision AIM and Fitbit app onto and sync with a Fitbit Versa
- •Participants interested in setting goals to increase their physical activity levels over the 6-month study.
排除标准
- •Participants engaging in 150 or more minutes of moderate- or greater intensity PA /week as assessed by a research grade accelerometer.
- •Participants engaged in organized programs with mandated physical activity (e.g., varsity sports, ROTC).
- •Participants with contraindications to normal physical activity on the Physical Activity Readiness Questionnaire.
- •Participants who require an assistive device for mobility or have any other condition that may limit or prevent participation in moderate-intensity physical activity.
- •Participants who are pregnant or planning to become pregnant within the next 6 months.
- •Participants with a prior diagnosis of cancer, cardiovascular disease, diabetes or metabolic syndrome.
研究组 & 干预措施
Aggressive adaptation strategy
Participants receive up to 6 messages/day to support achievement of their behavior change goal. Messages are only delivered outside of a participant-specific Do Not Disturb window (e.g., 11pm-8am). Messages with coordinating images are selected from three content domains: Move More, Sit Less, and Inspirational Quotes Unrelated to Movement within the first month. The decision rule for each participant will be refined on a monthly basis throughout the 6-month study based upon the accumulating data on how each participant is responding to different messages under different conditions.
干预措施: Digital message (text + image) (Behavioral)
Moderate adaptation strategy
Participants receive up to 3 messages/day to support achievement of their behavior change goal. Messages are only delivered outside of a participant-specific Do Not Disturb window (e.g., 11pm-8am). Messages with coordinating images are selected randomly from three content domains: Move More, Sit Less, and Inspirational Quotes Unrelated to Movement within the first month. The decision rule for each participant will be refined on a monthly basis throughout the 6-month study based upon the accumulating data on how each participant is responding to different messages under different conditions.
干预措施: Digital message (text + image) (Behavioral)
结局指标
主要结局
Acceptability of messaging at 6 months
时间窗: 6 months
Self-reported preference for more, no change or fewer messages/day based on participant exit interviews coded by two blinded research assistants
次要结局
- Change in moderate-to-vigorous physical activity duration from run-in period (baseline) to 6 months(baseline) to 6 months(Baseline and 6 months)
- Change in total physical activity volume from run-in period(Baseline and 6 months)
研究者
David E Conroy
Professor
Penn State University