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

ConditionAvoidant Restrictive Food Intake Disorder

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age3-17

SponsorBoston Children's Hospital

About this 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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Crossover

Treatments tested in this trial

Generative AI-based food chaining device
Other intervention
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.

Treatment groups

125 Participants

are divided into 2 treatment groups

Group A: InterventionExperimental treatment 1 intervention

Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame

30 days

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.

Time frame

30 days

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Children's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: