About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Eating Disorder Dynamic Intervention
BehavioralParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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).
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).
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).
Secondary outcomes
Body image concerns (Eating Disorder Examination Questionnaire-Short Form)
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.
Cognitive dietary restraint (Eating Disorder Examination-Questionnaire)
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.
Negative affect (Positive and Negative Affect Schedule)
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.
Sponsors and contacts
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Trustees of Dartmouth College
Lead sponsor
National Institutes of Health (NIH)
Collaborator