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Autism Spectrum DisorderNCT07727018

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

A study testing Exploradores de Sabores Parent-Mediated Nutrition Intervention and Education as Usual (EAU) in people with Autism Spectrum Disorder and Food Selectivity, run by Universidad Autonoma de Baja California at 1 site in Mexico.

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Sites and contacts
Official record

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Trial 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… Read more about this study

Who is it for?
Ages 4 to 11 years
Conditions the study is for
Autism Spectrum Disorder, Food Selectivity
What is being tested?
Exploradores de Sabores Parent-Mediated Nutrition Intervention and Education as Usual (EAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteMexico
Study dates
Aug 2026to Jul 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Connie Johame López Verdugo, PHD. Candidate contact

+526642588810

lopez.connie@uabc.edu.mx

Mexico1 site, 1 recruiting
  • Facultad de Medicina y Psicología, UABC

    Tijuana, Estado de Baja California, 21100

    Connie Johanne Lòpez Verdugo, PHD. Candidate, +5216642588810, lopez.connie@uabc.edu.mx

    Recruiting

Other trials in Mexico

About this study

Official title: 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:

Read more
  • 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.
Being tested
Exploradores de Sabores Parent-Mediated Nutrition Intervention, Education as Usual (EAU)
Keywords
Food Selectivity, Food Neophobia, Dietary Variety, Mealtime Behavior, Parent-Mediated Intervention, Nutrition Intervention, Nutritional Status, Autism Spectrum Disorder, Children, Gastrointestinal Symptoms
Medical subject headings
Autism Spectrum Disorder, Avoidant Restrictive Food Intake Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exploradores de Sabores Parent-Mediated Nutrition InterventionBehavioural

    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 groups in NCT07727018
Study groupRoleWhat they receive
Exploradores de SaboresExperimentalChildren 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.
Receives: Behavioral: Exploradores de Sabores Parent-Mediated Nutrition Intervention
Education as Usual (EAU)Active comparatorChildren 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.
Receives: Other: Education as Usual (EAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, mid-intervention, and immediately after completion of the 15-week intervention.

  2. 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.

    Measured: From enrollment to the end of treatment at 15 weeks

  3. 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.

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

Secondary outcomes (3)
  1. Food Selectivity

    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.

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

  2. Gastrointestinal health

    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.

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

  3. Caregiver Satisfaction with the Intervention

    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..

    Measured: At the end of the intervention, week 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07727018
Sponsor's protocol ID
0305_26-1
Status last verified
Jul 2026
First submitted
21 Jul 2026
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vázquez FL, Torres Á, Otero P, Blanco V, Clifford Attkisson C. Psychometric properties of the Castilian Spanish version of the Client Satisfaction Questionnaire (CSQ-8). Curr Psychol. 2019;38(3):829-835. doi:10.1007/s12144-017-9641-2

  • Aiemjoy K, Altan E, Aragie S, Fry DM, Phan TG, Deng X, Chanyalew M, Tadesse Z, Callahan EK, Delwart E, Keenan JD. Viral species richness and composition in young children with loose or watery stool in Ethiopia. BMC Infect Dis. 2019 Jan 14;19(1):53. doi: 10.1186/s12879-019-3674-3.

    PubMed 30642268
  • 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

  • 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.

  • Osorio-Alamillo Y, Fuentes-Cummings J, Ruiz-Barranco A, Bidart-Behar P, Clark P, Melendez-Mier G, Bueno Hernandez N. [Adaptation in Spanish and validation in Mexico of the Screening Tool for the Assessment of Malnutrition in Paediatrics (STAMP]. Nutr Hosp. 2023 Apr 20;40(2):354-361. doi: 10.20960/nh.04333. Spanish.

    PubMed 36880722
  • 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.

    PubMed 28242312
  • Kennedy G, Ballard T, Dop M. Guía para medir la diversidad alimentaria a nivel individual y del hogar. Rome: FAO; 2019.

  • Gray HL, Pang T, Agazzi H, Shaffer-Hudkins E, Kim E, Miltenberger RG, Waters KA, Jimenez C, Harris M, Stern M. A nutrition education intervention to improve eating behaviors of children with autism spectrum disorder: Study protocol for a pilot randomized controlled trial. Contemp Clin Trials. 2022 Aug;119:106814. doi: 10.1016/j.cct.2022.106814. Epub 2022 Jun 4.

    PubMed 35671902
  • 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.

  • 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.

  • Cejudo CM, Losada AV. Influencia de la nutrición biológica en niños con trastorno del espectro autista residentes del Partido de San Miguel en la Provincia de Buenos Aires. Rev Neuronum. 2021;7(1).

  • 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.

    PubMed 35883911
  • 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.

    PubMed 27275232
  • Kahathuduwa CN, West BD, Blume J, Dharavath N, Moustaid-Moussa N, Mastergeorge A. The risk of overweight and obesity in children with autism spectrum disorders: A systematic review and meta-analysis. Obes Rev. 2019 Dec;20(12):1667-1679. doi: 10.1111/obr.12933. Epub 2019 Oct 8.

    PubMed 31595678
  • Landa RJ, Reetzke R, Holingue CB, Herman D, Hess CR. Diagnostic Stability and Phenotypic Differences Among School-Age Children Diagnosed With ASD Before Age 2. Front Psychiatry. 2022 Mar 15;13:805686. doi: 10.3389/fpsyt.2022.805686. eCollection 2022.

    PubMed 35370852

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