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

Sponsor
Universidad Autonoma de Baja California
Study ID
NCT07727018
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
4 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • Exploradores de Sabores Parent-Mediated Nutrition Intervention — BEHAVIORAL
    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) — OTHER
    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 Details

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.

Key Dates

First listed
Jul 27, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Exploradores de Sabores
    Children aged 4-11 years with Autism Spectrum Disorder (ASD) who present food selectivity. Their parents or primary caregivers will participate in the Exploradores de Sabores parent-mediated nutrition intervention. The intervention consists of a standardized 15-week parent training program including nutrition education, behavioral feeding strategies, sensory-based approaches, and structured home-based food exposure activities.
  • Active Comparator: Education as Usual (EAU)
    Children aged 4-11 years with Autism Spectrum Disorder (ASD) and food selectivity whose parents or primary caregivers will continue receiving education and healthcare services as usual throughout the study. Participants will not receive the Exploradores de Sabores intervention but will continue receiving Education as Usual (EAU) throughout the study.

Primary Outcome Measure

Food Variety [ Time Frame: Baseline, mid-intervention, and immediately after completion of the 15-week intervention. ]

Central Contacts

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