Clinical trial NCT06266377: AUT-MENU: Improving Meal Experience of Subjects With Autism Spectrum Disorder
Official title: AUT-MENU: Improving Meal Experience of Subjects With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Food selectivity
Nutrition
Autism spectrum disorder
Collective catering
Food acceptance
mealtime
sustainability
Lead sponsor: University of Pavia
Sponsor class: OTHER
Collaborators: name: Consiglio per la ricerca in agricoltura e l'analisi dell'economia agraria (CREA)
First posted: 2024-02-20
Enrollment: 200
Sex: ALL
Minimum age (years): 5
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The AUT MENU project is a multi-center interventional study conducted on children and adolescents with Autism Spectrum Disorder (ASD) in Milan and Rome.

The main objective of the AUT-MENU project is to improve the meal experience of individuals with Autism Spectrum Disorder (ASD) by developing and disseminating customized menus based on specific dietary recommendations, via collective catering services in schools. The dietary recommendations consider the nutritional and sensory food needs of this population (10.1007/s40519-023-01590-z).

As secondary objective the researchers will evaluate the effect of a nutrition education intervention to the caregivers of the individuals with ASD participating in the study, on reducing their food selectivity. The feasibility of the nutrition education intervention will also be evaluated.

The AUT MENU study deliverable are 1) the development of targeted canteen menus for adults with ASD, according to the nutritional and sensory needs; 2) the elaboration of dietary recommendations to customize canteen menus nutritional and sensory needs for individuals with ASD 3) the development of a nutrition education course aimed at caregivers of a subgroup of the participants.

A total of 16 meal evaluation forms for each participant will be collected on 2 non-consecutive weekly days (for a total of 8 weeks). Both the qualitative and quantitative forms will be filled out by qualified operators, previously trained who assist the participants on a daily basis during lunches eaten at school. For the quantitative evaluation of food consumption, a score will be assigned to the four possible amounts of dish consumed: zero consumption, ¼ of the plate, ½ of the plate, ¾ of the plate, the whole dish.

The nutrition education course aimed at caregivers will be developed in 6 modules. Before and after the course, caregivers will be asked to fill out:

* a questionnaire regarding their children's adherence to the Mediterranean diet
* a validated questionnaire to evaluate their children food selectivity
* a Nutrition Knowledge Questionnaire
* a Satisfaction Questionnaire (of the course)

Eligibility criteria: Inclusion Criteria:

* age 5-19 years
* Diagnosis of autism spectrum disorder (grade 1-2 or grade 3)
* Informed consent signed by their caregivers

Exclusion Criteria:

* Subjects who are not autonomous in feeding themselves;
* Presence of neurodevelopmental disorders and/or pathological conditions that require the use of special diets;

Primary outcomes:
measure: Food acceptance of canteen menus by individuals enrolled in the study
timeFrame: 8 weeks (T0); 8 weeks (T1)
Secondary outcomes:
measure: Reduction in food selectivity as a result of the targeted nutrition education course
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Milano Ristorazione S.p.A.
city: Roma
country: Italy
facility: Istituto I.P.S.E.O.A. "Tor Carbone - A. Narducci".
city: Roma
country: Italy
facility: Istituto Tecnico Agrario Statale "Giuseppe Garibaldi"
Study officials:
affiliation: University of Pavia
name: Hellas Cena, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.