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.
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
- Conditions the study is for
- Avoidant Restrictive Food Intake Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: Generative AI-based food chaining device |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
- First posted5 Jun 2025
- Study start15 Jun 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Avoidant Restrictive Food Intake DisorderStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- 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)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Crowley, Boston Children's Hospital
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 35274362Sanchez-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 36527163Bialek-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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scalable, Clinician-Supervised Generative-AI Food-Chaining Assistant for Pediatric ARFID: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07006961
- Acronym / sponsor ID
- IRB-P000051713
- Keywords
- ARFID, artificial intelligence, food chaining
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 5 Jun 2025 (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.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Generative AI-based food chaining deviceArm 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Generative AI-based food chaining deviceOur 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. | Other | Intervention |
Primary outcome
Nine Item ARFID Screen Score
Time frame: 30 days
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.
Interventions Attempted
Time frame: 30 days
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.
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 6 Jun 2025.
- Background: PubMed 35274362Fitzsimmons-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.
- Background: PubMed 36527163Sanchez-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.
- Background: PubMed 35565707Bialek-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.
- News article on chatbotLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Age, comorbid diagnoses, NIAS and EDYQ scores
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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.
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.