Eating DisordersEDDINCT07600671
Eating Disorder Dynamic Intervention
A study testing Eating Disorder Dynamic Intervention in people with Eating Disorders and Anorexia Nervosa, run by Trustees of Dartmouth College at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
- What is being tested?
- Eating Disorder Dynamic Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2026to 31 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dartmouth College
Lebanon, New Hampshire, 03766
Emily K Presseller, PhD, 603-646-7109, eddi.project@dartmouth.edu
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge Eating Disorder, Other Specified Feeding or Eating Disorder
- Being tested
- Eating Disorder Dynamic Intervention
- Keywords
- binge eating, eating problem, eating disorder, purging, restriction, weight control behavior, dieting
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eating Disorder Dynamic InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Eating Disorder Dynamic Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 4 months
Secondary outcomes (3)
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.
Measured: Weeks 7 through 16 of data collection
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.
Measured: Weeks 7 through 16 of data collection
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.
Measured: Weeks 7 through 16 of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start8 Jul 2026
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trustees of Dartmouth College
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Emily K. Presseller, Trustees of Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600671
- Sponsor's protocol ID
- STUDY00033481
- Other IDs
- 1DP5OD039510-01
- Acronym
- EDDI
- Status last verified
- Jul 2026
- First submitted
- 4 May 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Innovation of Precision Psychiatry Interventions Using Dynamic Systems Modeling and Ecological Quasi-Experiments
- ClinicalTrials.gov ID
- NCT07600671
- Acronym / sponsor ID
- EDDI / STUDY00033481
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Trustees of Dartmouth CollegeUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| All Participants Receive Just-In-Time Adaptive Interventions (JITAIs) through the EDDI App | Experimental | Behavioral: Eating Disorder Dynamic InterventionAll 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eating Disorder Dynamic InterventionParticipants 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. | Behavioural | All Participants Receive Just-In-Time Adaptive Interventions (JITAIs) through the EDDI App |
Primary outcome
Area under the receiver operating curve (AUC)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
Body image concerns (Eating Disorder Examination Questionnaire-Short Form)
Time frame: Weeks 7 through 16 of data collection
Cognitive dietary restraint (Eating Disorder Examination-Questionnaire)
Time frame: Weeks 7 through 16 of data collection
Negative affect (Positive and Negative Affect Schedule)
Time frame: Weeks 7 through 16 of data collection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eating Disorder Dynamic Intervention in people with Eating Disorders and Anorexia Nervosa, run by Trustees of Dartmouth College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily K Presseller, PhD ((203) 974-2949, emily.k.presseller@dartmouth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the receiver operating curve (AUC) (time frame: Weeks 5 and 6 of data collection). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.