Precision Public Health: Enhancing Connections to Develop Just-in-Time Adaptive Intervention Strategies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Percent of person-days with same-day weighing
研究概览
简要总结
The purpose of this pilot study is to examine the effects of different types of just-in-time intervention messages on daily meeting dietary, activity, and weighing goals in a sample of young adults participating in a mobile-based weight loss program.
详细描述
Public health interventions typically rely on a set schedule of intervention delivery. Advances in technology and computer tailoring allow us to go from a "one size fits all" approach to one that uses digital health data to deliver "just-in-time adaptive interventions," or JITAIs, that can vary the timing, dose, and content of intervention messages to individuals. This pilot study is a micro-randomized trial that evaluates the effects of various intervention message options delivered in JIT moments on meeting dietary, activity, and weighing goals among young adults in a mobile-based weight loss program.
The Nudge study is a 12-week mobile health weight loss program delivered via a native smartphone application. Individuals are asked to track their red foods (high-calorie, high-fat foods) in the app daily and meet their personalized red foods goal, wear a Fitbit daily and meet their daily active minutes goal, and weigh daily on their WiFi-enabled scale. Up to 4 times each day, participants are randomized to receive or not receive intervention messages in order to examine the effects of these intervention message types on meeting daily weighing goals, red food goals, and activity goals. This is a within-subjects design in which each participant serves as their own control, and data is analyzed at the person-day level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-35
- •BMI of 25-40 kg/m²
- •Not adhering to the US physical activity guidelines of at least 150 moderate-to-vigorous intensity activity minutes/week
- •English-speaking and writing
- •No pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program, diabetes treated with insulin, history of heart attack or stroke, current treatment for cancer, or inability to walk for exercise
- •Has an iPhone with iOS 11 (or willing to download it) with internet access and text messaging plan
- •Has home wireless access compatible with Fitbit Aria 2 scale (802.11b/g/n)
排除标准
- •Current participation in another physical activity or weight control program
- •Currently pregnant, pregnant in last 6 months, or planning pregnancy in next 3 months
- •Report a heart condition, chest pain during periods of activity or rest, loss of consciousness, joint or bone problems, or prescription medicine usage for blood pressure or heart condition on the Physical Activity Readiness Questionnaire (PAR-Q)
- •Health or psychological diagnoses that preclude participation in a prescribed dietary and exercise program, including diagnosis of schizophrenia or bipolar disorder, hospitalization for a psychiatric diagnosis in the past year, diagnosis of alcohol or substance abuse
- •Occupation requires primarily night shift work
- •Owns and uses a physical activity tracker
- •Moving out of area in next 4 months
- •Out of town for a week or more during study period
- •Not willing to attend two study visits
结局指标
主要结局
Percent of person-days with same-day weighing
时间窗: from Baseline to Week 12
Percent who weighed after the message randomization time until the end of the day (at the participant-day level) across the 12-week study
Percent of person-days with next-day weighing
时间窗: from Baseline to Week 12
Percent who weighed the day after the message randomization (at the participant-day level) across the 12-week study
Percent of person-days met active minutes goal on same day
时间窗: from Baseline to Week 12
Percent who met active minutes goal after the message randomization time until the end of the day (at the participant-day level) across the 12-week study
Percent of person-days met active minutes goal on next day
时间窗: from Baseline to Week 12
Percent who met active minutes goal the day after the message randomization (at the participant-day level) across the 12-week study
Percent of person-days met red foods goal on same day
时间窗: from Baseline to Week 12
Percent who met red foods goal after the message randomization time until the end of the day (at the participant-day level) across the 12-week study
Percent of person-days met red foods goal on next day
时间窗: from Baseline to Week 12
Percent who met red foods goal the day after the message randomization (at the participant-day level) across the 12-week study
次要结局
- Number of active minutes(from Baseline to Week 12)
- Proximal effect of message on total red foods today(from Baseline to Week 12)
- Mean weight change(from Baseline to Week 12)