Optimizing Individualized and Adaptive mHealth Interventions via Control Systems Engineering Methods

通过控制系统工程方法优化个性化和适应性移动医疗干预措施

• 批准号: 10456317
• 负责人: Eric Hekler
• 金额: $ 62.03万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-14 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10456317
• 关键词: Adherence; Adult; Behavior; Body Composition; Body Weight decreased; Cancer Prevention Intervention; Chronic Disease; Colon Carcinoma; Complex; Data; Ecological momentary assessment; Education; Endometrial Carcinoma; Engineering; Event; Fatty acid glycerol esters; Feedback; Glycosylated hemoglobin A; Goals; Guidelines; Health; Hip region structure; Human; Individual; Intervention; Literature; Maintenance; Malignant Neoplasms; Malignant neoplasm of esophagus; Malignant neoplasm of lung; Malignant neoplasm of urinary bladder; Mathematics; Measurement; Measures; Mental Health; Methods; Modeling; Monitor; Nature; Obesity; Outcome; Overweight; Pain; Participant; Patient Outcomes Assessments; Persons; Physical activity; Physical activity scale; Positive Reinforcements; Public Health; Randomized Controlled Trials; Renal carcinoma; Research; Resolution; Risk; Smoking; Stress; Substance abuse problem; System; Techniques; Testing; Time; Walking; Weight maintenance regimen; Work; actigraphy; adaptive intervention; aged; base; behavior change; cancer prevention; cancer risk; cancer type; cost effectiveness; digital; digital health; exercise intervention; fitbit; global health; high risk; high risk population; improved; innovation; mHealth; malignant breast neoplasm; malignant stomach neoplasm; pilot test; prevent; randomized trial; response; simulation; social cognitive theory; tool; treatment arm; vigorous intensity; wearable device

Background: Strong evidence indicates physical activity (PA) reduces risk of bladder, breast, colon, endometrium, esophagus, gastric, and renal cancer, and there is moderate evidence for lung cancer. Individuals aged 40+ who are inactive are at high risk of developing cancers 58,65 but only 1/3 meet guidelines for PA;5-15 thus, they are an important group to target. While effective PA interventions exist, interventions often work only for some individuals or only for a limited time,16-18 thus establishing the need for interventions that can account for dynamic, idiosyncratic PA determinants in order to support each person’s PA. In response, we developed JustWalk, a modular adaptive mobile health (mHealth) intervention that makes daily N-of-1 adjustments to support PA for each person. JustWalk is based on Social Cognitive Theory (SCT) with N-of-1 adaptation driven by a mathematical dynamical model of SCT, which we have developed and validated. JustWalk can perform N-of-1 adaptation based on our innovative use of control engineering methods, which we call a control optimization trial (COT). We have a digital platform and empirical justification for our next step: to evaluate, in a randomized controlled trial (RCT), whether using a COT approach to continuously optimize a PA intervention to each individual is superior to an intervention that is identical but lacks the COT methods. Primary purpose: Evaluate differences in minutes/week of moderate-to-vigorous intensity PA (MVPA) among the COT- optimized vs. non-COT groups at 12 months. Hypotheses: We hypothesize significantly higher minutes/week of MVPA in the intervention arm (COT) relative to control (non-COT) as measured via ActiGraph (powered for effect size of ≥0.32). Methods: We will conduct this RCT with 386 adults aged 40+ who are inactive and overweight/obesity. This is a high-risk group who would benefit from a PA intervention for cancer prevention and who would benefit from an adaptive intervention because of the idiosyncratic and dynamic nature of PA that is pronounced within this group. Assessments will be conducted at baseline, 6, and 12-months using a hip-worn ActiGraph for assessing minutes/week of MVPA, as justified by guidelines. Implications: This research is highly significant because our intervention would be the first scalable PA intervention squarely grounded in SCT with N-of-1 adaptation driven by a mathematical dynamical model version of SCT. Further, favorable results would justify use of our COT methods for other complex and highly idiosyncratic and dynamic behaviors such as weight management, smoking, or substance abuse. Finally, our work should improve understanding of engagement with digital health tools. This research is highly innovative as we would be the first to conduct a COT and to empirically evaluate its utility in an RCT.

背景：有力的证据表明体育活动（PA）降低了膀胱，乳房，结肠， 子宫内膜，食道，胃癌和肾癌，并且有适度的肺癌证据。个人 不活跃的40岁以上的年龄高的癌症的高风险是58,65，但只有1/3的PA符合指南； 5-15 因此，它们是针对目标的重要群体。尽管存在有效的PA干预措施，但干预措施经常起作用 仅在某些人或仅在有限的时间内，16-18才确定了可以进行干预的需求 为了支持每个人的pa，tosyncratic pa确定了动态的帐户。作为回应，我们 开发的JustWalk是一种模块化自适应移动健康（MHealth）干预措施，使每日N-Of-1每天 调整以支持每个人的PA。 JustWalk基于社会认知理论（SCT），N-of-1 由SCT的数学动态模型驱动的适应性，我们已经开发并验证了。 Justwalk 可以根据我们对控制工程方法的创新使用来执行N-1-1适应性，我们称之为 控制优化试验（COT）。我们有一个数字平台和下一步的经验理由： 在随机对照试验（RCT）中评估是否使用COT方法连续优化PA 对每个人的干预优于相同但缺乏COT方法的干预措施。基本的 目的：评估cot-中中度至vigotim强度PA（MVPA）的分钟/周差异 在12个月时优化了与非COT组。假设：我们假设每周明显更高的分钟 通过Actigraph测量的相对于对照组（非COT）中MVPA（COT）的MVPA（COT） 效应大小≥0.32）。方法：我们将与386名40岁以上的成年人进行此RCT，他们不活跃 超重/肥胖。这是一个高风险群体，将受益于预防癌症的PA干预和 谁会因为PA的特质和动态性质而受益于自适应干预措施 在此组中发音。评估将在基线，6个和12个月中使用髋关节磨损进行 指南的正当理由为评估MVPA的分钟/周。含义：这项研究很高 意义重大，因为我们的干预措施将是首次在SCT中直接接地的可伸缩PA干预措施 由SCT的数学动态模型版本驱动的N-1适应性。此外，有利的结果将 证明将我们的COT方法用于其他复杂且高度特质和动态行为（例如体重） 管理，吸烟或滥用药物。最后，我们的工作应该改善对参与的理解 使用数字健康工具。这项研究具有很高的创新性，因为我们将是第一个进行婴儿床和 经验评估其在RCT中的效用。