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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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.
Mexico1 site, 1 recruiting
- 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
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.
- Conditions
- Autism Spectrum Disorder, Food Selectivity
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Education as Usual (EAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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
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)
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.
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.
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.
- First posted27 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Baja California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Connie Johanne Lopez Verdugo, Universidad Autonoma de Baja California
- Investigators
- Genaro Rodriguez Uribe, PHD, Study director, Universidad Autonoma de Baja California
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 30642268Galpin 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 36880722Damsbo-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 28242312Kennedy 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 35671902Jara 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 35883911Meguid 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 27275232Kahathuduwa 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 31595678Landa 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