Phone Coaching as a Rescue Strategy for Early Non-Responders Enrolled in an Internet-Delivered Weight Loss Program

项目摘要 需要有效的、可负担的和可扩展的减肥（WL）干预措施来降低肥胖患病率 率和改善肥胖相关的合并症。通过互联网提供的行为WL程序提供了一个 低成本替代传统的面对面的方案，并具有很高的传播潜力，因为 干预可以完全远程进行。虽然这些标准化的互联网程序对 许多人，很大一部分人仍然不能达到临床上显著的WL， 更个性化的治疗方法。一种改善互联网提供的WL（IDWL）治疗的策略， 在仍然限制分娩成本的同时，使用阶梯式护理干预方法， 标准化的互联网程序和更密集的干预是为那些次优WL保留的 结果。先前的研究表明，4周WL与长期WL密切相关;因此4周 似乎是一个合适的时机，以确定和提供早期救援工作，以最初不响应 个体我们的研究团队已经证明，提供一个短暂的个性化辅导， 对于参加IDWL治疗的早期无应答者， 治疗WL，与未接受指导的早期无应答者相比。目前的研究建立在 这些调查结果，并探讨是否可以通过使用扩展的WL结果进一步改善 辅导，一旦电话辅导（PC）被删除，这些影响是否持续，以及这些 从成本角度来看，干预措施是有效的。450名受试者将被随机分配至：1）IDWL+Brief PC， 早期无应答者（“简报”），2）IDWL+早期无应答者的扩展PC（“扩展”），或3）仅IDWL （`Control '）。所有参与者将获得一个自动化的4个月IDWL计划和一个8个月IDWL 维护程序随机分配至“Brief”组的早期无应答者（4周WL <4%）将接受3个单独的 电话，而那些随机分配到“扩展”的人将在整个WL计划中每周收到电话 (12总计）。随机分配至“对照组”的早期无应答者将不接受PC。体重、饮食、 将在基线、4个月和12个月时进行体力活动和体重相关行为。主 目的是比较4个月和12个月时WL的“简要”、“扩展”和“控制”。这项研究还将评估 调节因素的影响（性别、种族/民族和早期无应答者亚组：4周WL <2% vs. 2-4%），以及 体重变化的介质（饮食、体力活动、干预依从性）以及WL的成本/kg 在3个治疗组中。这项研究的结果可以用来开发选择算法， 早期无应答者参加IDWL计划的最佳PC量。如果有效的话，这个项目可以 为接受IDWL治疗的“高危”个人提供低成本、个性化的治疗方法。 互联网程序，包括个人电脑的早期无反应者，然后可以转化为医疗保健， 社区设置。

PROJECT SUMMARY Effective, affordable, and scalable weight loss (WL) interventions are needed to reduce obesity prevalence rates and improve obesity-related co-morbidities. Behavioral WL programs delivered via the Internet offer a low-cost alternative to traditional face-to-face programs and have high dissemination potential, as the intervention can be delivered entirely remotely. While these standardized Internet programs are effective for many, a significant proportion of individuals still fail to achieve a clinically significant WL and may require a more personalized treatment approach. One strategy for improving Internet-delivered WL (IDWL) treatment, while still limiting delivery costs, is to use a stepped-care intervention approach, in which all individuals receive a standardized Internet program and a more intensive intervention is reserved for those with suboptimal WL outcomes. Previous research indicates that 4-week WL is strongly associated with long-term WL; thus 4 weeks appears to be an opportune time to identify and provide early rescue efforts to initially non-responsive individuals. Our research team has demonstrated that the provision of a brief period of individualized coaching to early non-responders enrolled in IDWL treatment significantly improved intervention adherence and post- treatment WL, when compared to early non-responders who received no coaching. The current study builds on these findings and examines whether WL outcomes can be further improved through the use of extended coaching, whether these effects are sustained once the phone coaching (PC) is removed, and whether these interventions are effective from a cost perspective. 450 individuals will be randomized to: 1) IDWL+Brief PC for early non-responders (`Brief'), 2) IDWL+Extended PC for early non-responders (`Extended'), or 3) IDWL only (`Control'). All participants will receive an automated 4-month IDWL program and an 8-month IDWL maintenance program. Early non-responders (4-wk WL <4%) randomized to `Brief' will receive 3 individual phone calls, while those randomized to `Extended' will receive weekly phone calls throughout the WL program (12 in total). Early non-responders randomized to `Control' will receive no PC. Assessments of weight, diet, physical activity, and weight-related behaviors will be performed at baseline, 4, and 12 months. The primary aim is to compare `Brief', `Extended' and `Control' on WL at 4 and 12 months. This study will also assess the effect of moderators (sex, race/ethnicity, and early non-responder subgroup: 4-wk WL <2% vs. 2-4%) and mediators (diet, physical activity, intervention adherence) on weight change, as well as the cost/kg of WL across the 3 treatment arms. Findings from this study can be used to develop algorithms for choosing the optimal amount of PC for early non-responders enrolled in an IDWL program. If effective, this program could provide a low cost, yet personalized treatment approach for `at-risk' individuals receiving IDWL treatment. Internet programs which incorporate PC for early non-responders could then be translated into healthcare and community settings.