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

NCT07727018 | Recruiting DMC

• 1 other identifier: 0305_26-1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Food Selectivity

Keywords

Food Selectivity; Food Neophobia; Dietary Variety; Mealtime Behavior; Parent-Mediated Intervention; Nutrition Intervention; Nutritional Status; Autism Spectrum Disorder; Children; Gastrointestinal Symptoms

Outcome Measures

Primary Outcomes (3)

• Food Variety

  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

  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

  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 Outcomes (3)

• Food Selectivity

  Baseline and immediately after completion of the 15-week intervention.

• Gastrointestinal health

  Baseline and immediately after completion of the 15-week intervention.

• Caregiver Satisfaction with the Intervention

  At the end of the intervention, week 15

Study Arms (2)

Exploradores de Sabores

EXPERIMENTAL

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)

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.

Exploradores de Sabores

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.

Education as Usual (EAU)

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Baja California: lead

Study Sites (1)

Facultad de Medicina y Psicología, UABC

Tijuana, Estado de Baja California, 21100, Mexico

RECRUITING

Related Publications (19)

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• Galpin J, Osman L, Paramore C. Sensory snack time: a school-based intervention addressing food selectivity in autistic children. Front Educ. 2018;3:77. doi:10.3389/feduc.2018.00077

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• Navarro-Gómez, N., & Trigueros-Ramos, R. (2025). Adaptación y validación española del AUT-EAT Questionnaire (AEQ). Revista de psicopatología y psicología clínica, 30(1), 49-59.

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  PMID: 36880722 BACKGROUND

• Damsbo-Svendsen M, Frost MB, Olsen A. Development of novel tools to measure food neophobia in children. Appetite. 2017 Jun 1;113:255-263. doi: 10.1016/j.appet.2017.02.035. Epub 2017 Feb 24.

  PMID: 28242312 BACKGROUND

• Kennedy G, Ballard T, Dop M. Guía para medir la diversidad alimentaria a nivel individual y del hogar. Rome: FAO; 2019.

  BACKGROUND

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  PMID: 35671902 BACKGROUND

• Jara V, Aros C, Ibacache D. Programa nutricional para la selectividad alimentaria de niños y niñas con espectro autista. J Health Med Sci. 2024;10(1):15-22.

  BACKGROUND

• Baratas M, Hernando N, Mata MJ, Villalba L. Guía de alimentación ante los trastornos de alimentación en niños y niñas con Trastorno del Espectro Autista (TEA). Federación Autismo Madrid; 2013.

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• Zulkifli MN, Kadar M, Hamzaid NH. Weight Status and Associated Risk Factors of Mealtime Behaviours among Children with Autism Spectrum Disorder. Children (Basel). 2022 Jun 21;9(7):927. doi: 10.3390/children9070927.

  PMID: 35883911 BACKGROUND

• Meguid N, Anwar M, Zaki S, Kandeel W, Ahmed N, Tewfik I. Dietary Patterns of Children with Autism Spectrum Disorder: A Study Based in Egypt. Open Access Maced J Med Sci. 2015 Jun 15;3(2):262-7. doi: 10.3889/oamjms.2015.051. Epub 2015 May 7.

  PMID: 27275232 BACKGROUND

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  PMID: 31595678 BACKGROUND

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  PMID: 35370852 BACKGROUND

• Navarrete. Integración sensorial para reducir la ansiedad en trastornos del espectro autista. Inventio. 2021. doi:10.30973/inventio/2021.17.41/1

  BACKGROUND

• Morocho Fajardo KA, Sánchez Álvarez DE, Patiño Zambrano VP. Perfil epidemiológico del autismo en Latinoamérica. Salud Cienc Med. 2021;1(2):14-25.

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  BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Avoidant Restrictive Food Intake Disorder

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Feeding and Eating Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Genaro Rodriguez Uribe, PHD

  Universidad Autonoma de Baja California

  STUDY DIRECTOR

Central Study Contacts

Connie Johame López Verdugo, PHD. Candidate

CONTACT

+526642588810; lopez.connie@uabc.edu.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to participants' group assignment throughout data collection and outcome assessment. Due to the nature of the parent-mediated behavioral intervention, participants, caregivers, and intervention providers cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Candidate

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the Exploradores de Sabores intervention group or the Education as Usual (EAU) control group. The intervention group will receive a standardized 15-week parent-mediated nutrition program, while the control group will continue receiving usual healthcare and educational services. Outcomes will be assessed at baseline and immediately after the intervention by assessors blinded to group allocation.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 27, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)