Clinical Trial of "Exploradores de Sabores" to Improve Food Selectivity in ASD Kids

Condition(s) studied

Investigational drug(s) / intervention(s)

Exploradores de Sabores Parent-Mediated Nutrition Intervention: The Exploradores de Sabores intervention is a standardized, parent-mediated parent-mediated nutrition intervention designed to reduce food selectivity and improve dietary variety among children aged 4-11 years with Autism Spectrum Disorder (ASD). Parents participate in weekly group sessions led by a registered dietitian, combining nutrition education, responsive feeding strategies, sensory-based approaches, behavioral techniques, and gradual food exposure. Following each session, parents implement structured home-based activities using the intervention manual and educational materials, including repeated non-coercive food exposure, food play, sensory exploration, modeling, positive reinforcement, and mealtime environment modifications. The program consists of 15 weekly 40-minute sessions organized into an introductory session, three intervention phases, reinforcement sessions, and a final evaluation.

Education as Usual (EAU): Participants assigned to the control group receive Education as Usual (EAU), consisting of general nutrition and healthy eating recommendations routinely provided to families of children with Autism Spectrum Disorder (ASD). Educational content includes national dietary recommendations, healthy meal planning, hydration, and general guidance for promoting balanced eating habits. To control for attention and contact time, participants attend 15 weekly 40-minute sessions led by a registered dietitian following the same schedule as the experimental group. However, they do not receive the behavioral feeding strategies, sensory-based approaches, or systematic food exposure techniques that are unique to the Exploradores de Sabores intervention. Families continue receiving their usual healthcare and educational services throughout the study.

Study summary

The goal of this randomized, single-blind clinical trial is to evaluate the effectiveness of the Exploradores de Sabores parent-mediated nutrition intervention in reducing food selectivity and improving dietary variety, mealtime behaviors, nutritional status, and gastrointestinal symptoms among children aged 4 to 11 years with Autism Spectrum Disorder (ASD). The intervention consists of a standardized 15-week parent training program that combines nutrition education, behavioral feeding strategies, sensory-based approaches, and structured food exposure activities implemented by caregivers at home.

The main questions it aims to answer are:

* Does the Exploradores de Sabores intervention improve food selectivity and dietary variety in children with Autism Spectrum Disorder compared with Education as Usual (EAU)?
* Does the intervention improve mealtime behaviors, nutritional status, and gastrointestinal symptoms compared with Education as Usual (EAU)?

Researchers will compare participants assigned to the Exploradores de Sabores intervention with those receiving Education as Usual (EAU) to determine whether the intervention results in greater improvements in food selectivity, dietary variety, mealtime behaviors, nutritional status, and gastrointestinal symptoms.

Participants will:

* Complete study assessments at baseline and immediately after completion of the 15-week intervention.
* Be randomly assigned to either the Exploradores de Sabores intervention or the Education as Usual (EAU) control group.
* If assigned to the intervention group, caregivers will participate in a standardized 15-week parent training program and implement structured home-based feeding activities using the intervention manual and educational materials.
* If assigned to the Education as Usual (EAU) control group, caregivers will receive 15-week parent training in general recomendations that include healthy meal planning, hydration, and general guidance for promoting balanced eating habits. Children will undergo assessments of food selectivity, dietary variety, mealtime behaviors, nutritional status, and gastrointestinal symptoms at each study visit.

Eligibility

Primary outcome measure(s)

• Food Variety — Baseline, mid-intervention, and immediately after completion of the 15-week intervention.
  Dietary variety will be assessed using the Food Variety Questionnaire developed by the Food and Agriculture Organization (FAO). The questionnaire records foods consumed from predefined food groups over a specified reference period. A dietary variety score is calculated based on the number of different food groups consumed, Scores range from 0 to 16, corresponding to the number of food groups consumed. Higher scores indicate greater dietary variety and a better dietary outcome.The questionnaire will be completed by the child's primary caregiver.
• Nutritional status — From enrollment to the end of treatment at 15 weeks
  Nutritional status will be assessed using the Screening Tool for the Assessment of Malnutrition in Paediatrics (STAMP). STAMP evaluates nutritional risk based on the child's clinical diagnosis, recent nutritional intake, weight and height measurements, and anthropometric indicators. Scores range from 0 to 9. A score of 0-1 indicates low nutritional risk, 2-3 indicates medium risk, and ≥4 indicates high nutritional risk. Higher scores indicate a greater risk of malnutrition and therefore a worse outcome. Higher scores indicate a greater risk of malnutrition.
• Food Neophobia — Baseline and immediately after completion of the 15-week intervention.
  Food neophobia will be assessed using the Food Neophobia Test Tool, a validated caregiver-reported questionnaire that measures children's reluctance to try unfamiliar foods. The instrument uses a 7 Likert-type scale ranging from "Strongly disagree" to "Strongly agree," The total score ranges from 10 to 70, obtained by summing the responses to the 10 items after reverse-scoring the appropriate items. Higher scores indicate greater food neophobia and therefore a worse outcome.

Trial sites (1)

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