Eating Disorder Dynamic Intervention (EDDI)
2026년 5월 15일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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:
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.
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.
- 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.
연구 유형
중재적
등록 (추정된)
170
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Emily K Presseller, PhD
- 전화번호: (203) 974-2949
- 이메일: emily.k.presseller@dartmouth.edu
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Age 18-70
- 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)
- Ownership of a smartphone
- Willingness to complete ecological momentary assessment (EMA) and sensor data collection
- Live in the United States
- Has a primary care provider or is willing to establish a primary care provider
Exclusion Criteria:
- Inability to fluently speak, read, and write in English
- Body mass index < 17.5 kg/m2
- Medical complications of ED symptoms requiring immediate treatment
- Current ED-focused therapy
- Severe psychopathology (i.e., active suicidal ideation, psychosis, bipolar disorder, or substance use disorder) or intellectual disability inhibiting engagement in study protocols
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Area under the receiver operating curve (AUC)
기간: Weeks 5 and 6 of data collection
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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.
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Weeks 5 and 6 of data collection
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Brier Score
기간: Weeks 5 and 6 of data collection
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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).
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Weeks 5 and 6 of data collection
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Binge eating
기간: Weeks 7 through 16 of data collection
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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).
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Weeks 7 through 16 of data collection
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Dietary restriction
기간: Weeks 7 through 16 of data collection
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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).
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Weeks 7 through 16 of data collection
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Compensatory behaviors
기간: Weeks 7 through 16 of data collection
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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).
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Weeks 7 through 16 of data collection
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Feasibility and Acceptability Questionnaire
기간: End of study assessment (after week 16 of data collection)
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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.
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End of study assessment (after week 16 of data collection)
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System Usability Scale
기간: End of study assessment (after week 16 of data collection)
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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.
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End of study assessment (after week 16 of data collection)
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Percentage of Eligible Participants Enrolled
기간: Through study completion, an average of 4 months
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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.
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Through study completion, an average of 4 months
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Attrition Rate
기간: Through study completion, an average of 4 months
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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.
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Through study completion, an average of 4 months
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Percentage of JITAIs Producing Skill Use
기간: Through study completion, an average of 4 months
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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.
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Through study completion, an average of 4 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Body image concerns (Eating Disorder Examination Questionnaire-Short Form)
기간: Weeks 7 through 16 of data collection
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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.
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Weeks 7 through 16 of data collection
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Cognitive dietary restraint (Eating Disorder Examination-Questionnaire)
기간: Weeks 7 through 16 of data collection
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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.
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Weeks 7 through 16 of data collection
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Negative affect (Positive and Negative Affect Schedule)
기간: Weeks 7 through 16 of data collection
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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.
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Weeks 7 through 16 of data collection
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 1일
기본 완료 (추정된)
2030년 1월 31일
연구 완료 (추정된)
2030년 7월 31일
연구 등록 날짜
최초 제출
2026년 5월 4일
QC 기준을 충족하는 최초 제출
2026년 5월 15일
처음 게시됨 (실제)
2026년 5월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 15일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00033481
- 1DP5OD039510-01 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
Data will be made available starting 6 months after recruitment of the first participant and will continue indefinitely.
IPD 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .