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

July 23, 2026 updated by: Connie Johanne Lopez Verdugo, Universidad Autonoma de Baja California

A Clinical Trial of the "Exploradores de Sabores" Intervention to Improve Food Variety and Nutritional Status in Children With Autism Spectrum Disorder

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
    • Estado de Baja California
      • Tijuana, Estado de Baja California, Mexico, 21100
        • Recruiting
        • Facultad de Medicina y Psicología, UABC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food Variety
Time Frame: 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.
Baseline, mid-intervention, and immediately after completion of the 15-week intervention.
Nutritional status
Time Frame: 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.
From enrollment to the end of treatment at 15 weeks
Food Neophobia
Time Frame: 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.
Baseline and immediately after completion of the 15-week intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food Selectivity
Time Frame: Baseline and immediately after completion of the 15-week intervention.

Food selectivity will be assessed using the Autism Eating Assessment Tool (AUT-EAT). The caregiver-reported questionnaire evaluates eating difficulties across multiple domains, including food selectivity, sensory sensitivity, mealtime behaviors, eating habits, and the impact of feeding difficulties on daily functioning.

The questionnaire consists of 41 items rated on a 5-point Likert scale , The questionnaire comprises six factors: food Uniformity and Rituals: 12 items, overeating: 7 items, chewing and swallowing problems: 7 items, food selectivity: 7 items, problematic mealtime behaviors: 4 items and food avoidance: 3 items

Parents rate each item using a 5-point Likert scale, ranging from 0 (never) to 5 (very frequently).with total scores ranging from 41 to 205. Higher scores indicate greater eating difficulties and more severe feeding-related problems; therefore, higher scores represent a worse outcome.
Baseline and immediately after completion of the 15-week intervention.
Gastrointestinal health
Time Frame: Baseline and immediately after completion of the 15-week intervention.
Gastrointestinal health will be assessed using the Bristol Stool Form Scale (BSFS), a validated 7-point visual scale that classifies stool consistency from Type 1 (hard stools) to Type 7 (watery stools). The BSFS is used to evaluate bowel habits and gastrointestinal function, with changes in stool consistency indicating improvements or alterations in gastrointestinal health.
Baseline and immediately after completion of the 15-week intervention.
Caregiver Satisfaction with the Intervention
Time Frame: At the end of the intervention, week 15
Caregiver satisfaction with the intervention will be assessed using the Client Satisfaction Questionnaire (CSQ-8), an 8-item validated questionnaire that measures participants satisfaction with the services received. Each item is rated on a 4-point Likert scale. The total score ranges from 8 to 32, with higher scores indicating greater satisfaction with the intervention and therefore a better outcome..
At the end of the intervention, week 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de Baja California

Investigators

  • Study Director: Genaro Rodriguez Uribe, PHD, Universidad Autonoma de Baja California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

July 21, 2026

First Submitted That Met QC Criteria

July 23, 2026

First Posted (Actual)

July 27, 2026

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0305_26-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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