Anorexia Nervosa, Binge Eating Disorder, Bulimia Nervosa, Eating Disorders, Other Specified Feeding or Eating Disorder
Conditions
Keywords
binge eating, eating problem, eating disorder, purging, restriction, weight control behavior, dieting
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.
Detailed description
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.
Interventions
BEHAVIORALEating 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.
Sponsors
Trustees of Dartmouth College
National Institutes of Health (NIH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the receiver operating curve (AUC) | 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. |
| Brier Score | 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). |
| Binge eating | 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). |
| Dietary restriction | 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). |
| Compensatory behaviors | 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). |
| Feasibility and Acceptability Questionnaire | 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. |
| System Usability Scale | 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. |
| Percentage of Eligible Participants Enrolled | 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. |
| Attrition Rate | 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. |
| Percentage of JITAIs Producing Skill Use | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body image concerns (Eating Disorder Examination Questionnaire-Short Form) | 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. |
| Cognitive dietary restraint (Eating Disorder Examination-Questionnaire) | 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. |
| Negative affect (Positive and Negative Affect Schedule) | 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. |
Countries
United States
Contacts
CONTACTEmily K Presseller, PhD
Outcome results
None listed