NCT06266377

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

3 active sites

Status
unknown

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

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

February 20, 2024

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

February 9, 2024

Last Update Submit

February 9, 2024

Conditions

Keywords

Food selectivityNutritionAutism spectrum disorderCollective cateringFood acceptancemealtimesustainability

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

EXPERIMENTAL

Children 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."

Other: Administration of menus of collective catering adapted to the sensory and nutritional needs of subjects with Autism Spectrum DisorderOther: Nutrition education course aimed at caregivers of individuals with Autism Spectrum Disorder

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).

Intervention group

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.

Intervention group

Eligibility Criteria

Age5 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Location

Istituto I.P.S.E.O.A. "Tor Carbone - A. Narducci".

Roma, 00178, Italy

Location

Istituto Tecnico Agrario Statale "Giuseppe Garibaldi"

Roma, 00178, Italy

Location

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: 37526770BACKGROUND
  • Conti 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.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Hellas Cena, MD

    University of Pavia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Vittoria Conti, BSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Non-randomized multi-center intervention with a single arm. Study participants will receive new adapted canteen menus according to the nutritional and sensory needs of the target population.
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

Locations