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NCT07727018

Overview

NCT ID: NCT07727018
Lead Sponsor: Universidad Autonoma de Baja CaliforniaOTHER
Official Title: A Clinical Trial of the "Exploradores de Sabores" Intervention to Improve Food Variety and Nutritional Status in Children With Autism Spectrum Disorder
Brief 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.

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 27, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Dec 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Children diagnosed with Autism Spectrum Disorder (ASD) requiring support levels 1, 2, or 3, without cognitive impairment.

Primary caregivers with sufficient availability to participate in and implement the intervention.

Children with or without mild functional gastrointestinal symptoms.

Children experiencing difficulties with the introduction or acceptance of new foods.

Children with clinically significant food selectivity, as determined by AUT-EAT

Children with malnutrition.

Exclusion Criteria:

Current use of medications known to substantially affect appetite or feeding behavior (e.g., cyproheptadine, clonidine, or other appetite-modifying medications).

Syndromic Autism Spectrum Disorder (ASD).

Clinically significant gastrointestinal disorders requiring active medical treatment.

Medical conditions that significantly affect nutritional status, growth, or feeding behavior (e.g., phenylketonuria, cystic fibrosis, inflammatory bowel disease, endocrine disorders, or eating disorders).

Cases in which the parent or legal guardian attending the training sessions is not the individual responsible for implementing the intervention activities with the child at home.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 72Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Connie Johame López Verdugo, PHD. CandidateContact
lopez.connie@uabc.edu.mx

Similar Studies

Participant Group/Arms

Exploradores de SaboresExperimental

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.

Behavioral: Exploradores de Sabores Parent-Mediated Nutrition Intervention

Education as Usual (EAU)Active Comparator

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.

Other: Education as Usual (EAU)