Using Continuous Glucose Monitoring to Detect and Intervene on Maintenance Factors for Transdiagnostic Binge Eating Pathology

使用连续血糖监测来检测和干预跨诊断性暴食病理学的维持因素

• 批准号: 9908791
• 负责人: ADRIENNE SARAH JUARASCIO
• 金额: $ 44.97万
• 依托单位: PROMPTWORKS, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-24 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9908791
• 关键词: Accountability; Adherence; Adoption; Aftercare; Algorithm Design; Algorithms; Award; Binge Eating; Binge eating disorder; Bulimia; Clinical; Clinical Trials; Cognitive Therapy; Collection; Consumption; Data; Data Collection; Dietary Practices; Disease; Eating; Eating Behavior; Eating Disorders; Evaluation; Goals; Health Personnel; Hour; Individual; Intervention; Link; Literature; Maintenance; Manuals; Meta-Analysis; Methods; Monitor; Motivation; Notification; Patients; Pattern; Pennsylvania; Persons; Phase; Phase II Clinical Trials; Positioning Attribute; Records; Recurrence; Research; Risk Factors; Schedule; Sensitivity and Specificity; Small Business Technology Transfer Research; Symptoms; System; Testing; Therapeutic; Time; Treatment Protocols; Treatment outcome; United States; Universities; Validation; Vomiting; Work; base; clinically significant; data sharing; design; dietary restriction; eating pathology; effective therapy; experience; glucose monitor; improved; improved outcome; innovation; mHealth; member; monitoring device; product development; success; systematic review; tool; treatment program

PROJECT SUMMARY Although CBT is an effective treatment for many individuals with transdiagnostic binge eating, recent systematic reviews and meta-analyses have found that 40-50% of patients with binge eating disorder (BED) and nearly 70% of patients with bulimia nervosa (BN) remain fully or partially symptomatic after a full course of CBT. Reducing rigid dietary restriction is one of the only mechanisms of action that has been consistently identified in treatments for binge eating. In particular, adherence to a regular eating schedule (e.g. eating three meals and one-two snacks per day and not going more than four waking hours without eating) is one of the biggest predictors of treatment success in both BN and BED. Although one of the primary goals of CBT for binge eating is the reduction of dietary restriction (with over 50% of session content dedicated to this goal in most treatment manuals), many patients continue to engage in restrictive eating behaviors during and after treatment, suggesting that CBT is failing to sufficiently improve this clinical target. This pattern of results suggests a critical need both to understand why many individuals fail to improve in existing treatments and to develop new intervention approaches or augmentations that can produce superior treatment outcomes. The primary goal of this STTR Phase 1 application is to develop and pilot an mHealth intervention system (SenseSupport) that can be used as an augmentation to traditional CBT for transdiagnostic binge eating that can better target dietary restriction. Our proposed mHealth intervention system will use continuous glucose monitoring (CGM) to 1) accurately detect dietary restriction as it occurs, 2) accurately detect known risk-factors for a reoccurrence of dietary restriction (e.g. binge eating and self-induced vomiting episodes), 3) deliver real- time push notifications linked to brief CBT-based interventions when dietary restriction, binge eating, or self- induced vomiting is detected, and 4) share objective data on eating behaviors with a treatment provider to enhance the therapeutic work occurring during in-person CBT. In months 0-6, we will collect data from 30 individuals with clinically significant binge eating who will wear a Dexcom G6 CGM for four weeks while electronically tracking all eating behaviors and disordered eating symptoms. While data collection is ongoing, we will also use months 0-6 to the SenseSupport system. During months 7-24, we will conduct a small (n=30) clinical trial using an ABAB design (A= SenseSupport On, B=SenseSupport Off) to test the feasibility, acceptability, and target engagement of the SenseSupport System. Receipt of this award will allow members of PromptWorks, Drexel University, the University of Pennsylvania, and Dexcom to develop an innovative intervention system that we believe can reduce dietary restriction and improve treatment outcomes for individuals with clinically significant binge eating. The proposed system would be the first of its kind for the treatment of eating pathology with high potential to market to the over 42 million individuals who experience clinically significant binge eating in the United States as well as to treatment facilities that could use our tool as a way to augment existing treatment approaches.

项目总结 尽管CBT是治疗许多跨诊断暴饮暴食的有效方法，但最近系统性的 综述和荟萃分析发现，40%-50%的暴食障碍(Bed)患者和近 70%的神经性贪食症(BN)患者在整个CBT疗程后仍有全部或部分症状。 减少严格的饮食限制是唯一一直被确认的行动机制之一 暴饮暴食的治疗方法。特别是，坚持规律的进食时间表(例如，吃三顿饭和 每天吃一到两个零食，并且醒着不吃东西不超过四个小时)是最大的 BN和BED治疗成功的预测因素。尽管CBT的主要目标之一是暴饮暴食 减少饮食限制(在大多数治疗中，超过50%的会议内容致力于实现这一目标 手册)，许多患者在治疗期间和治疗后继续进行限食行为， 这表明CBT未能充分改善这一临床目标。这种结果模式表明了一个关键的 既需要理解为什么许多人在现有治疗中未能改善，也需要开发新的治疗方法 能够产生更好的治疗结果的干预方法或扩大。 这个STTR第1阶段应用程序的主要目标是开发和试验mHealth干预系统 (SenseSupport)可用作传统CBT的补充，用于跨诊断狂欢 可以更好地针对饮食限制。我们提议的移动健康干预系统将使用持续葡萄糖 监测(CGM)以1)在饮食限制发生时准确检测它，2)准确检测已知的危险因素 对于再次出现的饮食限制(例如暴饮暴食和自我诱导的呕吐发作)，3)提供真实的- 当饮食限制、暴饮暴食或自我控制时，与基于CBT的简短干预相关联的时间推送通知 检测到诱发呕吐，并且4)与治疗提供者共享关于饮食行为的客观数据以 加强面对面CBT期间的治疗工作。在0-6个月内，我们将从30个月收集数据 有临床意义的暴饮暴食的个人将佩戴Dexcom G6 CGM四周，同时 电子跟踪所有的进食行为和进食障碍症状。当数据收集正在进行时， 我们还将使用0-6个月的SenseSupport系统。在7-24个月期间，我们将进行一次小型(n=30) 使用ABAB设计的临床试验(A=SenseSupport打开，B=SenseSupport关闭)以测试可行性， SenseSupport系统的可接受性和目标参与度。获得此奖项将允许以下成员 PromptWorks、德雷克塞尔大学、宾夕法尼亚大学和Dexcom共同开发一种创新的 我们认为可以减少饮食限制并改善治疗结果的干预系统 有临床意义的暴饮暴食的人。拟议中的系统将是第一个此类系统 饮食病理治疗具有向4200多万体验过的个人销售的巨大潜力 在美国临床意义重大的暴饮暴食，以及可以使用我们的工具作为 一种增强现有治疗方法的方法。