Eating Disorder Dynamic Intervention (EDDI)
15 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
170
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Emily K Presseller, PhD
- Número de teléfono: (203) 974-2949
- Correo electrónico: emily.k.presseller@dartmouth.edu
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Area under the receiver operating curve (AUC)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Body image concerns (Eating Disorder Examination Questionnaire-Short Form)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de mayo de 2026
Finalización primaria (Estimado)
31 de enero de 2030
Finalización del estudio (Estimado)
31 de julio de 2030
Fechas de registro del estudio
Enviado por primera vez
4 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
15 de mayo de 2026
Publicado por primera vez (Actual)
22 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
15 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00033481
- 1DP5OD039510-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
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.
Marco de tiempo para compartir IPD
Data will be made available starting 6 months after recruitment of the first participant and will continue indefinitely.
Criterios de acceso compartido de IPD
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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .