Scalable, Clinician-Supervised Generative-AI Food-Chaining Assistant for Pediatric ARFID: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 125
- 主要终点
- Nine Item ARFID Screen Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Nine Item ARFID Screen Score
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Paul Crowley
Attending Gastroenterologist, Instructor in Pediatrics
Boston Children's Hospital
