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Eating Disorder Dynamic Intervention (EDDI)

2026年7月15日 更新者：Emily K. Presseller、Trustees of Dartmouth College

Rapid Innovation of Precision Psychiatry Interventions Using Dynamic Systems Modeling and Ecological Quasi-Experiments

The goal of this study is to develop and test a digital program to help people with eating disorders in their everyday lives. The program uses brief surveys and sensor data collected by smartphones to understand when someone may be at higher risk for behaviors like restricting food, binge eating, or using unhealthy weight control behaviors.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

In this study, 170 adults with eating disorders will take part. They will regularly report on their thoughts, feelings, and behaviors throughout the day. Based on this information, the program will send "just-in-time" support, which involves short, tailored suggestions that encourage the use of helpful coping skills right when they are most needed.

The study has three main goals:

  1. To better understand risk patterns:

    The investigators will use real-time data to build personalized models that predict when someone is at higher risk for eating disorder behaviors based on their own data and patterns.

  2. To test which therapy skills work best and why:

    The investigators will examine how different evidence-based therapy skills (such as managing urges, improving mood, reducing strict dieting, and improving body image) help reduce eating disorder behaviors in daily life, and what psychological factors explain these effects.

  3. To evaluate the program's usability:

The investigators will assess whether participants find the digital support helpful, easy to use, and acceptable in their daily routines.

研究类型

介入性

注册 (估计的)

170

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • New Hampshire
      • Lebanon、New Hampshire、美国、03766

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Age 18-70
  2. At least 12 ED behaviors from the same behavioral category in the past 12 weeks (i.e., at least 12 binge eating episodes, at least 12 compensatory behaviors, and/or at least 12 instances of dietary restriction)
  3. Ownership of a smartphone
  4. Willingness to complete ecological momentary assessment (EMA) and sensor data collection
  5. Live in the United States
  6. Has a primary care provider or is willing to establish a primary care provider

Exclusion Criteria:

  1. Inability to fluently speak, read, and write in English
  2. Body mass index < 17.5 kg/m2
  3. Medical complications of ED symptoms requiring immediate treatment
  4. Current ED-focused therapy
  5. Severe psychopathology (i.e., active suicidal ideation, psychosis, bipolar disorder, or substance use disorder) or intellectual disability inhibiting engagement in study protocols

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：All Participants Receive Just-In-Time Adaptive Interventions (JITAIs) through the EDDI App
All participants will receive just-in-time adaptive interventions when their personalized model identifies that they are at risk for an eating disorder behavior. The content of the just-in-time adaptive intervention (i.e., the therapy skill targeted) will be randomized at the point of just-in-time adaptive intervention delivery.
行为的：Eating Disorder Dynamic Intervention
Participants will use a smartphone-based program designed to support eating disorder recovery in daily life. Participants will complete brief surveys about their mood, thoughts, and behaviors, and the smartphone will also passively collect activity-related data. This information is used to detect times when a person may be at higher risk for eating disorder behaviors. Participants will watch 4 video modules that introduce the core enhanced cognitive-behavioral therapy skills for eating disorders (reducing dietary restraint, urge management, emotion regulation, and improving body image), provide rationale, and prompt participants to complete interactive activities to practice these skills. Participants will then receive micro-randomized JITAIs prompting them to use these skills in their daily lives; micro-randomization will be used to deliver a JITAI from one of the 4 skill categories (reducing dietary restraint, urge management, emotion regulation, improving body image) or no JITAI.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Area under the receiver operating curve (AUC)
大体时间：Weeks 5 and 6 of data collection
Performance of the eating disorder behavior prediction models will be evaluated by computing the area under the receiver operating curve (AUC) for each participants' models on two-weeks of held out (test) data (collected during weeks 5 and 6 of the data collection procedure). The AUC can take on values between 0 and 1, with higher values indicating superior model performance.
Weeks 5 and 6 of data collection
Brier Score
大体时间：Weeks 5 and 6 of data collection
Performance of the eating disorder behavior prediction models will be evaluated by computing the Brier score for each participants' models on two-weeks of held out (test) data (collected during weeks 5 and 6 of the data collection procedure). The Brier score can range from 0 to 1 with lower values indicating less model error (i.e., better model performance).
Weeks 5 and 6 of data collection
Binge eating
大体时间：Weeks 7 through 16 of data collection
Binge eating occurrence during the data collection protocol will be measured. Binge eating at each ecological momentary assessment survey will be assessed by the question, "Thinking about your most recent eating episode, did you experience loss of control?" (Answer choices = Yes or No).
Weeks 7 through 16 of data collection
Dietary restriction
大体时间：Weeks 7 through 16 of data collection
Dietary restriction will be measured during the data collection protocol. Dietary restriction will be assessed at each ecological momentary assessment survey by the questions, "Thinking about your most recent eating episode, did you limit the amount of food you ate to influence your shape?", "Thinking about your most recent eating episode, did you exclude specific foods to influence your shape or weight?", and Since the last survey, have you skipped a meal or snack?" (Answer Choices = Yes or No).
Weeks 7 through 16 of data collection
Compensatory behaviors
大体时间：Weeks 7 through 16 of data collection
Dietary restriction will be measured during the data collection protocol. Dietary restriction will be assessed at each ecological momentary assessment survey by the questions, "Since the last survey, have you engaged in any of the following? Self-induced vomiting," "Laxative use (to influence shape or weight)," "Diuretic use (to influence shape or weight)," "Diet pill use (to influence shape or weight)," "Exercise (to influence shape or weight)," and "Other behavior to influence shape or weight" (Answer Choices = Yes or No).
Weeks 7 through 16 of data collection
Feasibility and Acceptability Questionnaire
大体时间：End of study assessment (after week 16 of data collection)
Acceptability will be evaluated via the Feasibility and Acceptability Questionnaire. These data will be collected after participants have completed the 16 weeks of data collection using the EDDI app. Mean ratings ≥ 5 (on the seven-point Likert rating scales) on acceptability items will be considered to indicate acceptability. The response scale is as follows: 1=Strongly Disagree 2=Disagree 3=Disagree a little 4=Neither agree nor disagree 5=Agree a little 6=Agree 7=Strongly Agree, with higher scores indicating greater acceptability.
End of study assessment (after week 16 of data collection)
System Usability Scale
大体时间：End of study assessment (after week 16 of data collection)
Acceptability will be evaluated via the System Usability Scale. These data will be collected after participants have completed the 16 weeks of data collection using the EDDI app. Mean ratings ≥ 4 (on the five-point Likert rating scale) on System Usability Scale items will be considered to indicate acceptability. The response scale runs from 1 = Strongly Disagree (minimum value) to 5 = Strongly Agree (maximum value), with higher ratings indicating greater usability. Items 2, 4, 6, 8, and 10 will be reverse coded to align with higher ratings indicating greater usability.
End of study assessment (after week 16 of data collection)
Percentage of Eligible Participants Enrolled
大体时间：Through study completion, an average of 4 months
Feasibility of the EDDI app will be evaluated by computing the percentage of eligible participants enrolled. This will be computed by dividing the number of enrolled participants by the total number of eligible participants and multiplying by 100. At least 85% of eligible participants enrolled will be considered to demonstrate feasibility.
Through study completion, an average of 4 months
Attrition Rate
大体时间：Through study completion, an average of 4 months
Feasibility of the EDDI app will be evaluated by computing the attrition (drop out) rate. This will be computed by dividing the number of participants who discontinue the study prior to the end of study assessment by the total number of enrolled participants and multiplying by 100. An attrition rate of less than 15% will be considered to demonstrate feasibility.
Through study completion, an average of 4 months
Percentage of JITAIs Producing Skill Use
大体时间：Through study completion, an average of 4 months
Feasibility of the EDDI app will be evaluated by computing the percentage of JITAIs that produce participant-reported skill use. This will be computed by dividing the instances of reported skills used by the total number of delivered JITAIs and multiplying by 100. JITAIs producing skill use at least 80% of the time will be considered to demonstrate feasibility.
Through study completion, an average of 4 months

次要结果测量

结果测量
措施说明
大体时间
Body image concerns (Eating Disorder Examination Questionnaire-Short Form)
大体时间：Weeks 7 through 16 of data collection
Body image concerns will be measured as a possible mediator of the effect of JITAIs on eating disorder behaviors. Body image concerns will be quantified as the mean rating across the body image items on the Eating Disorder Examination Questionnaire-Short Form, adapted to be rated on a five-point Likert scale as follows: 0=Very slightly/not at all 1 = A little 2 =Moderately 3 = Quite a bit 4= Extremely. Higher mean ratings indicate great body image concerns. Minimum mean score on the items is 0 and maximum is 4.
Weeks 7 through 16 of data collection
Cognitive dietary restraint (Eating Disorder Examination-Questionnaire)
大体时间：Weeks 7 through 16 of data collection
Cognitive dietary restraint will be measured as a possible mediator of the effects of JITAIs on eating disorder behaviors. Cognitive dietary restraint is assessed by the mean score across four selected dietary restraint items from the Eating Disorder Examination Questionnaire, modified to be assessed on the following response scale: 0=Very slightly/not at all 1 = A little 2 =Moderately 3 = Quite a bit 4= Extremely. The minimum mean score is 0 and the maximum mean score is 4, with higher scores indicating greater dietary restraint.
Weeks 7 through 16 of data collection
Negative affect (Positive and Negative Affect Schedule)
大体时间：Weeks 7 through 16 of data collection
Negative affect will be measured as a possible mediator of the effects of JITAIs on eating disorder behaviors. Negative affect is assessed by the mean score across six selected negative affect items (upset, hostile, ashamed, afraid, nervous, guilty from the Positive and Negative Affect Schedule, modified to be assessed on the following response scale: 0=Very slightly/not at all 1 = A little 2 =Moderately 3 = Quite a bit 4= Extremely. The minimum mean score is 0 and the maximum mean score is 4, with higher scores indicating greater negative affect.
Weeks 7 through 16 of data collection

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Trustees of Dartmouth College

合作者

National Institutes of Health (NIH)

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月8日

初级完成 (估计的)

2030年1月31日

研究完成 (估计的)

2030年7月31日

研究注册日期

首次提交

2026年5月4日

首先提交符合 QC 标准的

2026年5月15日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年7月16日

上次提交的符合 QC 标准的更新

2026年7月15日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • STUDY00033481
  • 1DP5OD039510-01 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

To facilitate open science, all de-identified data from the present study will be shared via National Data Archive (NDA), unless doing so would violate research ethics or privacy of participants (e.g., raw smartphone location sensor data will not be shared as this would violate participants' privacy and confidentiality). In addition to the subject level data described above, subject level data on adherence to the ecological momentary assessment protocol and responsivity to just-in-time adaptive interventions will also be shared via NDA.

IPD 共享时间框架

Data will be made available starting 6 months after recruitment of the first participant and will continue indefinitely.

IPD 共享访问标准

Study protocols and all intervention content (just-in-time adaptive intervention text, skill repository text, video modules) will be available upon request from the study team.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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