Eating Disorder Dynamic Intervention

NCT07600671 | Not Yet Recruiting

• 2 other identifiers: STUDY000334811DP5OD039510-01
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Binge Eating Disorder; Other Specified Feeding or Eating Disorder

Keywords

binge eating; eating problem; eating disorder; purging; restriction; weight control behavior; dieting

Outcome Measures

Primary Outcomes (10)

• Area under the receiver operating curve (AUC)

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

Secondary Outcomes (3)

• Body image concerns (Eating Disorder Examination Questionnaire-Short Form)

  Weeks 7 through 16 of data collection

• Cognitive dietary restraint (Eating Disorder Examination-Questionnaire)

  Weeks 7 through 16 of data collection

• Negative affect (Positive and Negative Affect Schedule)

  Weeks 7 through 16 of data collection

Study Arms (1)

All Participants Receive Just-In-Time Adaptive Interventions (JITAIs) through the EDDI App

EXPERIMENTAL

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.

Behavioral: Eating Disorder Dynamic Intervention

Interventions

Eating Disorder Dynamic Intervention BEHAVIORAL

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.

All Participants Receive Just-In-Time Adaptive Interventions (JITAIs) through the EDDI App

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trustees of Dartmouth College: lead
• National Institutes of Health (NIH): collaborator

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder; Bulimia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Hyperphagia

Central Study Contacts

Emily K Presseller, PhD

CONTACT

(203) 974-2949; emily.k.presseller@dartmouth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Biomedical Data Science; Principal Investigator

Model Details: The study involves a micro-randomized trial design, in which participants will all receive just-in-time adaptive interventions, the content of which will be micro-randomized (i.e., randomized in the moment of delivery). Participants will not be assigned to groups at the start of the trail but instead will be assigned a specific just-in-time adaptive intervention (or no intervention) randomly at each instance when they are at elevated risk for eating disorder behaviors. All participants may receive all types of just-in-time adaptive interventions during the course of the study, but the order of receipt (and the specific timing of receipt) will vary between participants.

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): July 31, 2030
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available starting 6 months after recruitment of the first participant and will continue indefinitely.
• Access Criteria: 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.