Log2Lose: Incenting weight loss and dietary self-monitoring in real-time to improve weight management

摘要 在过去的40年里，肥胖症的流行以惊人的速度增长。即使是适度的体重减轻 至少5%可以改善临床参数和生活质量。有效的行为减肥计划教人 参与者制定并维持卡路里不足的行为策略。两个最强的长期预测因子- 此类计划中的减肥术语是最初的减肥和饮食自我监测。随着时间的推移，这些 现象下降，限制了计划的有效性。财政激励以增加最初的减肥和自我 监测之所以吸引人，是因为它们可以相对容易和低成本地提供给大量人口。 雇主和付款人已经开始为健康行为和结果提供财政激励，尽管 证据基础不足，无法为此类干预措施的最佳设计提供信息。拟议的研究将 评估哪种激励方法具有最大的影响力和持久性--激励中期减肥， 饮食自我监控，或者两者兼而有之。测试激励这些现象的效果的研究表明 一些人有望增加短期内的减肥效果。很少有研究对长期激励效果进行评估。 减肥；检查内在或外在动机的中介作用；或计算计划成本或 财政激励干预措施的成本效益。在提议的两点随机、单盲、 纵向2x2析因研究，称为“Log2Lose”，我们通过评估个体来解决这些限制 以及激励、近乎实时的每周减肥和6个月饮食自我监控的联合效应 减肥和随后的减肥维护。来自麦迪逊社区的肥胖患者， 北卡罗来纳州的Wi和Durham将接受为期18个月的干预，包括：1.激励减肥计划 为期6个月(阶段I)，2.为期6个月的激励性体重维持计划(阶段II)，以及3.非 为期6个月的激励性体重维持计划(第三阶段)。参赛者将随机接受 每周减肥的附加激励，饮食自我监测，两者兼而有之，或者两者都不。我们将测量 在6(主要终点)、12和18岁时实现临床显著≥减重5%的参与者的比例 月份。我们将评估外部动机和内部动机是否会调节干预效果；计算 干预成本；并计算四个研究部门的成本效益比。我们的财务激励措施 干预旨在通过使用现有技术和自动化过程来扩展 分析数据以提供近乎实时的激励。这种干预可能会伴随着各种减肥 由临床医生或付款人提供的干预措施，或集成到各种面向患者和消费者的 技术。这项研究的完成将有助于我们确定和实施 有效、成本效益高、可扩展的方法，以降低肥胖率和相关健康 结果。

Abstract In the past 40 years, the prevalence of obesity has increased at an alarming rate. Even modest weight loss of at least 5% improves clinical parameters and quality of life. Efficacious behavioral weight loss programs teach participants behavioral strategies to create and maintain a caloric deficit. The two strongest predictors of long- term weight loss in such programs are initial weight loss and dietary self-monitoring. Over time, these phenomena decline, limiting program effectiveness. Financial incentives to increase initial weight loss and self- monitoring are appealing because they can be delivered to large populations with relative ease and at low cost. Employers and payers have begun to provide financial incentives for health behaviors and outcomes despite an inadequate evidence base to inform the optimal design of such interventions. The proposed study will evaluate which incentive approach has the greatest impact and durability—incentivizing interim weight loss, dietary self-monitoring, or both. Studies testing the effects of incentivizing these phenomena have showed some promise for increasing short-term weight loss. Few studies have evaluated incentive effects on long-term weight loss; examined the mediating role of intrinsic or extrinsic motivation; or calculated program costs or cost-effectiveness of financial incentive interventions. In the proposed two-site, randomized, single-blinded, longitudinal 2x2 factorial study, known as “Log2Lose,” we address these limitations by evaluating the individual and joint effects of incentivizing, in near real-time, weekly weight loss and dietary self-monitoring on 6-month weight loss and subsequent weight loss maintenance. People with obesity from the communities of Madison, WI and Durham, NC will receive an 18-month intervention comprising: 1. An incentivized weight loss program for 6 months (Phase I), 2. An incentivized weight maintenance program for 6 months (Phase II), and 3. A non- incentivized weight maintenance program for 6 months (Phase III). Participants will be randomized to receive adjunctive incentives for weekly weight loss, dietary self-monitoring, both, or neither. We will measure the proportion of participants achieving clinically significant weight loss of ≥5% at 6 (primary endpoint), 12, and 18 months. We will assess whether extrinsic and intrinsic motivation mediate intervention effect; calculate intervention costs; and calculate cost-effectiveness ratios across the four study arms. Our financial incentives intervention was designed to be scalable by using available technology and automating the process of analyzing data to provide incentives in near real-time. The intervention could be paired with various weight loss interventions offered by clinicians or payers, or integrated into a variety of patient and consumer-facing technologies. Completion of this study will contribute to our long-term goal of identifying and implementing efficacious, cost-effective, scalable approaches to reduce the prevalence of obesity and associated health outcomes.