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

项目总结 需要有效、负担得起且可扩展的减肥(WL)干预措施来降低肥胖率 提高肥胖率，改善与肥胖相关的并发症。通过互联网提供的行为WL计划提供了 传统面对面节目的低成本替代方案，具有很高的传播潜力，如 干预可以完全远程进行。虽然这些标准化的互联网计划对 许多，相当大比例的人仍然无法达到临床上有意义的WL，并可能需要 更加个性化的治疗方式。一种用于改进互联网传递的WL(IDWL)治疗的策略， 在仍然限制交付成本的同时，使用分步护理干预方法，在这种方法中，所有个人都可以 标准化的互联网计划和更密集的干预措施是为那些WL不佳的人保留的 结果。先前的研究表明，4周的工作时间与长期工作时间密切相关；因此，4周的工作时间 似乎是识别和提供早期救援努力的好时机，因为最初没有反应 个人。我们的研究团队已经证明，提供短暂的个性化教练 对于参加IDWL治疗的早期无应答者，显著提高了干预依从性和干预后 与没有接受任何指导的早期无应答者相比，治疗WL。目前的研究建立在 这些发现和检验是否可以通过使用扩展的WL结果来进一步改善 指导，一旦电话指导(PC)被移除，这些影响是否持续，以及这些 从成本的角度来看，干预措施是有效的。450人将被随机分配到：1)IDWL+Brief PC 早期无响应者(‘Brief’)，2)针对早期无响应者的IDWL+扩展PC(‘Extended’)，或3)仅IDWL (`Control‘)。所有参与者将获得为期4个月的自动IDWL计划和为期8个月的IDWL 维护计划。早期无响应者(4-wk WL&lt；4%)被随机分配到‘Brief’将收到3个人 电话，而那些被随机分配到延长时间的人将在整个WL计划中每周收到电话 (共12个)。早期无应答者被随机分配到“对照”组，将不会收到PC。评估体重，饮食， 体力活动和与体重相关的行为将在基线、4个月和12个月进行。初级阶段 目的是在4个月和12个月时比较“Brief”、“Extended”和“Control”对WL的影响。这项研究还将评估 主持人的影响(性别、种族/民族和早期无应答者亚组：4wk WL&lt；2%vs.2-4%)和 影响体重变化的中介因素(饮食、体力活动、干预依从性)以及WL的成本/公斤 横跨三个治疗臂。这项研究的结果可以用来开发选择 参加IDWL计划的早期无应答者的最佳PC数量。如果有效，这个计划可能会 为接受IDWL治疗的“高危”个人提供低成本但个性化的治疗方法。 为早期非应答者整合PC的互联网计划随后可以转化为医疗保健和 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.