AUT-MENU: Improving Meal Experience of Subjects With Autism Spectrum Disorder
1 other identifier
interventional
200
1 country
3
Brief Summary
The main goal of this multi-center interventional study is to improve the meal experience of children and adolescents with autism spectrum disorder trough the development of menus for collective catering targeted to their nutritional and sensory needs and the drafting of nutritional indications that can be a reference for collective catering nationwide. After an initial assessment of participants' consumption of meals in the collective service, menus adapted to their nutritional and sensory needs will be administered, and consumption between the initial and adapted menus will be compared. A population subgroup will also be selected whose caregivers will be invited to participate in a nutrition education course with the aim of providing parents of subjects with ASD, with knowledge tools to learn how to identify, manage and reduce their children's attitudes of food selectivity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2024
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2024
CompletedFirst Posted
Study publicly available on registry
February 20, 2024
CompletedStudy Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2025
CompletedFebruary 20, 2024
December 1, 2023
9 months
February 9, 2024
February 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Food acceptance of canteen menus by individuals enrolled in the study
Meal evaluation forms (score range for each item: 0-1; the score number is directly proportional to the amount of the dish consumed)
8 weeks (T0); 8 weeks (T1)
Secondary Outcomes (1)
Reduction in food selectivity as a result of the targeted nutrition education course
8 weeks
Study Arms (1)
Intervention group
EXPERIMENTALChildren afferent to the elementary school where Milano Ristorazione delivers meals and adolescents and young adults enrolled in the State Agricultural Technical Institute Giuseppe Garibaldi (Rome) and Institute I.P.S.E.O.A. "Tor Carbone - A. Narducci."
Interventions
The AUT-MENU intervention study will be structured in two phases: a preliminary observation phase (T0), which will assess and describe the acceptance of standard meals in the context of collective catering in primary and high schools by the subjects enrolled in the study; and an intervention phase (T1) in which the acceptance of menus targeted to the nutritional and sensory needs of the same subjects enrolled at T0 will be assessed. The revision of the standard menus will be carried 1) balancing energy and macronutrient content, 2) promoting adequate weekly food frequencies consumption and portions, to provide an adequate and sustainable menus 3) adapting the sensory characteristics of the foods offered to the sensory needs of individuals with ASD. The acceptance of the targeted menus by the enrolled population will be evaluated through meal evaluation forms. These results will be compared with the ones collected during the first observational phase (T0).
A population subgroup will also be selected whose caregivers will be invited to participate in a nutrition education course with the aim of providing parents of subjects with ASD, with knowledge tools to learn how to identify, manage and reduce their children's attitudes of food selectivity.
Eligibility Criteria
You may qualify if:
- age 5-19 years
- Diagnosis of autism spectrum disorder (grade 1-2 or grade 3)
- Informed consent signed by their caregivers
You may not qualify if:
- Subjects who are not autonomous in feeding themselves;
- Presence of neurodevelopmental disorders and/or pathological conditions that require the use of special diets;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Milano Ristorazione S.p.A.
Milan, 20139, Italy
Istituto I.P.S.E.O.A. "Tor Carbone - A. Narducci".
Roma, 00178, Italy
Istituto Tecnico Agrario Statale "Giuseppe Garibaldi"
Roma, 00178, Italy
Related Publications (2)
Conti MV, Breda C, Basilico S, Luzzi A, Voto L, Santero S, De Filippo G, Cena H. Dietary recommendations to customize canteen menus according to the nutritional and sensory needs of individuals with autism spectrum disorder. Eat Weight Disord. 2023 Aug 1;28(1):66. doi: 10.1007/s40519-023-01590-z.
PMID: 37526770BACKGROUNDConti MV, Breda C, Basilico S, Zambon I, Sofroniou A, Ruggeri S, Scalvedi ML, Cena H. Improving Meal Acceptance of Individuals With Autism Spectrum Disorder (AUT-MENU Project): Protocol for a Bicentric Intervention Study. JMIR Res Protoc. 2025 May 21;14:e57507. doi: 10.2196/57507.
PMID: 40397941DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hellas Cena, MD
University of Pavia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2024
First Posted
February 20, 2024
Study Start
September 1, 2024
Primary Completion
June 1, 2025
Study Completion
November 30, 2025
Last Updated
February 20, 2024
Record last verified: 2023-12