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Avoidant Restrictive Food Intake DisorderNCT07006961

Scalable, Clinician-Supervised Generative-AI Food-Chaining Assistant for Pediatric ARFID

A study testing Generative AI-based food chaining device in people with Avoidant Restrictive Food Intake Disorder, run by Boston Children's Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Children with Avoidant/Restrictive Food Intake Disorder (ARFID) often lack access to specialty dietitians, and scalable nutritional guidance/food chaining tools are currently not available. Read more about this study

Who is it for?
Ages 3 to 17 years
What is being tested?
Generative AI-based food chaining device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
No sites listed yet
Study dates
15 Jun 2025to 31 Oct 2025
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 3 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children must be aged 3-17 years
  • Children must have caregiver- or participant-reported DSM-5 ARFID diagnosis and/or EDYQ-screen-positive Avoidant Restrictive Food Intake Disorder
  • English proficiency.

Who cannot join

  • Lack of English proficiency [As there is no validated non-English version of the NIAS, we must exclude caregivers who do not have English proficiency]
  • Participants must not have been previously treated at Boston Children's for ARFID

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Scalable, Clinician-Supervised Generative-AI Food-Chaining Assistant for Pediatric ARFID: A Pilot Randomized Controlled Trial

Children with Avoidant/Restrictive Food Intake Disorder (ARFID) often lack access to specialty dietitians, and scalable nutritional guidance/food chaining tools are currently not available. The investigators will evaluate a web-based, clinician-supervised, generative-AI assistant that produces individualized food-chaining plans.

Develop an AI assistant that generates ≥15 allergy-safe, evidence-based chaining steps per participant and meets ≥90 % expert agreement for safety/appropriateness.

Read more

Validate the assistant against gold-standard clinician recommendations (Cohen's κ ≥ 0.80).

Test clinical impact in a three-month pilot RCT (n = 96) by comparing change in Nine-Item ARFID Screen (NIAS) scores between intervention and usual-care groups.

Hypothesis: AI-generated plans will reduce NIAS scores by ≥3 points relative to controls.

Read the detailed description

ARFID is an eating disorder marked by highly selective eating that can lead to significant nutrient and energy deficiencies. Patients may show low interest in food because of certain tastes, textures, or smells; have chronically low appetite; and/or avoid eating out of fear (e.g., choking, vomiting), resulting in inadequate oral intake. A recent systematic review estimates the prevalence of ARFID in children and adolescents at 0.3-15.5%. Unlike anorexia nervosa or bulimia nervosa, body image concerns do not drive ARFID. Comorbidities-including autism spectrum disorder, attention-deficit/hyperactivity disorder, anxiety, and depression-are common.

Care is provided either by frontline clinicians (e.g., pediatricians, community dietitians) or multidisciplinary specialty teams. Outpatient management may combine cognitive-behavioral therapy adapted for ARFID (CBT-AR), family-based or exposure therapy, and dietitian-guided food-repertoire expansion via food chaining. Food chaining gradually introduces foods similar to an individual's "safe" items, creating an actionable, stepwise plan that accumulates meaningful dietary change.

Large-language models such as ChatGPT are increasingly used in health care. By constraining model output via an application programming interface (API), these models can power domain-specific chatbots. While ChatGPT excels at general queries, it is not inherently expert in ARFID or food chaining; however, with appropriate fine-tuning, LLMs could deliver scalable, personalized, high-quality chaining plans.

AI tools still pose risks. In 2023, the National Eating Disorders Association released "Tessa," an AI chatbot intended for eating-disorder support. Although a clinical trial showed modest reductions in weight/shape concerns at three and six months (d ≈ -0.2; p ≈ 0.03-0.04), the bot later provided harmful weight-loss advice, recommending calorie restriction and other disordered behaviors, leading to its shutdown. This case underscores the need for rigorous clinician oversight during early deployment of medical chatbots.

This research group has developed the only generative-AI tool that produces allergy-safe food-chaining recommendations, but it has not yet been clinically tested. This proposal builds on that proof of concept to evaluate its effectiveness in a broader pediatric ARFID population.

For this study, the investigators will be using two validated assessments of eating disorders:

EDYQ: The Eating Disorder in Youth Questionnaire (EDY-Q) is a brief, 14-item self-report screening tool designed for children and adolescents (roughly ages 8-13) to identify behaviors and attitudes consistent with DSM-5 feeding and eating disorders, especially ARFID. Each item is rated on a 5-point Likert scale (0 = "never" to 4 = "always"), yielding subscores for restrictive/avoidant eating and for weight- or shape-related concerns. Higher scores flag youths who may require a full clinical assessment for an eating disorder.

NIAS: The Nine-Item ARFID Screen (NIAS) is a concise, self-report questionnaire developed to detect symptoms of avoidant/restrictive food intake disorder across three DSM-5-aligned domains: sensory-based avoidance ("picky eating"), low appetite/lack of interest, and fear of aversive consequences. Respondents rate each item on a 0-5 Likert scale, producing domain scores and a total score that collectively gauge ARFID severity. Higher scores signal greater clinical concern and help clinicians identify individuals who warrant a full diagnostic evaluation and intervention.

The first phase of this project will be tool refinement, including GPT prompt refinement and testing, rule-based allergy filter creation, output of sample artificial participant food chaining recommendation sets, and refinement of recommendation set structure.

The second phase of this project will be validation of the tool, wherein the investigating RD and MD will independently assess the artificial recommendation sets for safety and appropriateness, with determination of Cohen's kappa, performed in a double-blinded manner.

The third phase of this project will be a pilot randomized controlled trial (with a subsequent crossover step to provide intervention for the control cohort). This phase involves publicizing the trial on websites and social media sites frequented by patients and families of children with ARFID, the primary means of recruitment. Prospective study participants will complete a comprehensive survey, including baseline demographic data, comorbidity data, and dietary preferences/dislikes, along with completion of the NIAS and EDY-Q questionnaires. A subset of participants who meet inclusion criteria (see below) will be randomized to either Arm 1 (Intervention Cohort) or Arm 2 (Control Cohort).

Arm 1 participants will be provided with 15 food chaining recommendations based on individual child dietary preferences, and will be assessed at the one month point to identify the number of food chaining interventions that have been undertaken and the number of recommendations that have been successful, along with a follow-up NIAS survey to determine differences in pre- and post-intervention ARFID severity. Arm 1 participants will exit the study at this point.

Arm 2 participants at the time of enrollment will not be provided food chaining recommendations, but will be assessed at the one month point to identify the number of food chaining interventions/new foods that have been introduced, along with a follow-up NIAS survey to determine baseline ARFID severity. At the one month point, Arm 2 participants will be provided with 15 food chaining recommendations based on individual child dietary preferences, and will be assessed after one month to identify the number of food chaining interventions that have been undertaken and the number of recommendations that have been successful, along with a follow-up NIAS survey to determine differences in pre- and post-intervention ARFID severity. Arm 2 participants will exit the study at this point.

Inclusion criteria: Children aged 3-17 years, with caregiver- or participant-reported DSM-5 ARFID diagnosis and/or EDYQ-screen-positive ARFID. English proficiency.

Exclusion criteria: As there is no validated non-English version of the NIAS, the investigators must exclude caregivers who do not have English proficiency. Participants must not have been previously treated at Boston Children's for ARFID.

Exposure: Generative AI-developed, respondent-specific set of food chaining recommendations Predictors: Age, gender, comorbid conditions, NIAS score, EDY-Q score, presence/absence of food allergies, presence/absence of celiac disease, subtypes of food preferences and aversions Primary: Change in NIAS total score (NIASΔ) at 4 weeks, number of interventions successfully trialed, number of new foods Secondary: Caregiver-reported trust-in-AI scale Phase 1: Preliminary Work Prototype (React + Python) ingests 15 peer-reviewed chaining papers; generates 15-item plans.

Expert rating (n = 40 plans) showed κ = 0.72, <1% unsafe items. Phase 2: Refinement (Months 0-1) Expand training set to 50 articles, add structured allergen ontology, and embed caloric-adequacy rules.

Guardrail testing on 1,000 adversarial prompts; target false-negative rate < 1 %.

Phase 2: Validation (Months 2-3) Design. Double-blind rating of 100 artificial patient cases; each plan scored by an ARFID MD and RD.

Analysis. Cohen's κ with 95 % CI; success threshold κ ≥ 0.80. Unsafe-item rate monitored.

Phase 3: Pilot RCT (Months 3-5) Trial. Recruitment and screening of participants, assignment of participants to intervention or control arms, evaluation by MD or RD of proposed plans, post-intervention survey; data analysis

Being tested
Generative AI-based food chaining device
Keywords
ARFID, artificial intelligence, food chaining
Medical subject headings
Avoidant Restrictive Food Intake Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Generative AI-based food chaining deviceOther

    Our group has developed the only generative-AI tool that produces allergy-safe food-chaining recommendations, but it has not yet been clinically tested. This proposal builds on that proof of concept to evaluate its effectiveness in a broader pediatric ARFID population.

Study groups in NCT07006961
Study groupRoleWhat they receive
InterventionExperimentalArm 1 participants will be provided with 15 food chaining recommendations based on individual child dietary preferences, and will be assessed at the one month point to identify the number of food chaining interventions that have been undertaken and the number of recommendations that have been successful, along with a follow-up NIAS survey to determine differences in pre- and post-intervention ARFID severity. Arm 1 participants will exit the study at this point.
Receives: Other: Generative AI-based food chaining device
ControlNo interventionArm 2 participants at the time of enrollment will not be provided food chaining recommendations, but will be assessed at the one month point to identify the number of food chaining interventions/new foods that have been introduced, along with a follow-up NIAS survey to determine baseline ARFID severity. At the one month point, Arm 2 participants will be provided with 15 food chaining recommendations based on individual child dietary preferences, and will be assessed after one month to identify the number of food chaining interventions that have been undertaken and the number of recommendations that have been successful, along with a follow-up NIAS survey to determine differences in pre- and post-intervention ARFID severity. Arm 2 participants will exit the study at this point.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nine Item ARFID Screen Score

    Nine Item ARFID Screen Score/NIAS Description: Individuals respond to each question on a scale from 0 (Strongly Disagree) to 5 (Strongly Agree). Subscales are each scored on a scale from 0-15, with higher scores indicating higher levels of each metric (picky eating, lack of interest, and fear). All items may also be summed to calculate a total score, ranging from 0-45, with higher scores indicating higher levels of avoidant/restrictive eating broadly. The investigators will assess the NIAS at the beginning of the intervention and then after four weeks of intervention and determine the difference (NIASΔ). A lower NIAS will be interpreted as improvement in ARFID symptoms.

    Measured: 30 days

  2. Interventions Attempted

    Number of food chaining interventions attempted will be assessed. Success in the number of food chaining interventions that have led to introduction of a new food or a "lost" previously tolerated food will be assessed.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2025
  2. Study start15 Jun 2025 (estimated)
  3. Primary completion31 Oct 2025 (estimated)
  4. Study completion31 Oct 2025 (estimated)

Resources

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
Randomised
Intervention model
Crossover
Model description
Arm 1 participants will be provided with 15 food chaining recommendations based on individual child dietary preferences, and will be assessed at the one month point to identify the number of food chaining interventions that have been undertaken and the number of recommendations that have been successful, along with a follow-up NIAS survey to determine differences in pre- and post-intervention ARFID severity. Arm 1 participants will exit the study at this point. Arm 2 participants at the time of enrollment will not be provided food chaining recommendations, but will be assessed at the one month point to identify the number of food chaining interventions/new foods that have been introduced, along with a follow-up NIAS survey to determine baseline ARFID severity. At the one month point, Arm 2 participants will be provided with 15 food chaining recommendations based on individual child dietary preferences, and will be assessed after one month to identify the number of food chaining interve
Masking
None (open label)
Enrolment
125 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07006961
Sponsor's protocol ID
IRB-P000051713
Status last verified
Jun 2025
First submitted
28 May 2025
Last updated
6 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Age, comorbid diagnoses, NIAS and EDYQ scores

Publications

  • Fitzsimmons-Craft EE, Chan WW, Smith AC, Firebaugh ML, Fowler LA, Topooco N, DePietro B, Wilfley DE, Taylor CB, Jacobson NC. Effectiveness of a chatbot for eating disorders prevention: A randomized clinical trial. Int J Eat Disord. 2022 Mar;55(3):343-353. doi: 10.1002/eat.23662. Epub 2021 Dec 28.

    PubMed 35274362
  • Sanchez-Cerezo J, Nagularaj L, Gledhill J, Nicholls D. What do we know about the epidemiology of avoidant/restrictive food intake disorder in children and adolescents? A systematic review of the literature. Eur Eat Disord Rev. 2023 Mar;31(2):226-246. doi: 10.1002/erv.2964. Epub 2022 Dec 16.

    PubMed 36527163
  • Bialek-Dratwa A, Szymanska D, Grajek M, Krupa-Kotara K, Szczepanska E, Kowalski O. ARFID-Strategies for Dietary Management in Children. Nutrients. 2022 Apr 22;14(9):1739. doi: 10.3390/nu14091739.

    PubMed 35565707

Questions about this trial

What is this clinical trial studying?

A study testing Generative AI-based food chaining device in people with Avoidant Restrictive Food Intake Disorder, run by Boston Children's Hospital.

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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

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 PAUL CROWLEY, MD (16177106519, paul.crowley@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nine Item ARFID Screen Score (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07006961, which also lists 3 linked publications.

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 6 Jun 2025.

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