SMART: Study protocol for a sequential multiple assignment randomized controlled trial to optimize weight loss management
SMART: Study protocol for a sequential multiple assignment randomized controlled trial to optimize weight loss management
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DOI：
10.1016/j.cct.2019.05.007
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发表时间：
2019-07-01
影响因子：
2.2
通讯作者：
Spring, Bonnie
中科院分区：
文献类型：
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作者：
Pfammatter, Angela Fidler;Nahum-Shani, Inbal;Spring, Bonnie
背景：阶梯式保健是减少人群肥胖的一种合理的资源分配方法。缺乏证据来指导使用低成本治疗组件（如移动的健康（mHealth）工具）的决策，而不影响那些需要更昂贵的传统治疗组件（例如，指导、代餐）。一个连续的多分配随机试验（SMART）将进行通知的发展经验为基础的阶梯式护理干预，包括mHealth和传统的治疗components.Objective：主要目的测试的非劣效性的应用程序单独相比，应用程序加教练，一线肥胖治疗，从基线到6个月的体重变化。研究设计：400名年龄在18-60岁之间，体重指数在27 - 45 kg/m2之间的受试者将被随机分配接受减肥智能手机应用程序（APP）或应用程序加每周指导（APP + C），为期12周。那些达到< 0.5磅。在第2、4和8周通过无线量表评估的每周平均体重减轻将被归类为无应答者，并在剩余治疗期内重新随机分配一次，以适度增加（添加另一个mHealth组件）或剧烈增加（添加mHealth和传统治疗组件）。体重将在基线，3，6，和12 months.Significance的人进行评估：结果将告知肥胖治疗算法的建设，平衡减肥结果与资源消耗。
Background: Stepped care is a rational resource allocation approach to reduce population obesity. Evidence is lacking to guide decisions on use of low cost treatment components such as mobile health (mHealth) tools without compromising weight loss of those needing more expensive traditional treatment components (e.g., coaching, meal replacement). A sequential multiple assignment randomization trial (SMART) will be conducted to inform the development of an empirically based stepped care intervention that incorporates mHealth and traditional treatment components.Objective: The primary aim tests the non-inferiority of app alone, compared to app plus coaching, as first line obesity treatment, measured by weight change from baseline to 6 months. Secondary aims are to identify the best tactic to address early treatment non-response and the optimal treatment sequence for resource efficient weight loss.Study design: Four hundred participants, 18-60 years old with Body Mass Index between 27 and 45 kg/m(2) will be randomized to receive a weight loss smartphone app (APP) or the app plus weekly coaching (APP + C) for a 12 week period. Those achieving < 0.5 Ib. weight loss on average per week, assessed by wireless scale at 2, 4, and 8 weeks, will be classified as non-responders and re-randomized once to step-up modestly (adding another mHealth component) or vigorously (adding mHealth and traditional treatment components) for the remaining treatment period. Weight will be assessed in person at baseline, 3, 6, and 12 months.Significance: Results will inform construction of an obesity treatment algorithm that balances weight loss outcomes with resource consumption.