AUT-MENU: Improving Meal Experience of Subjects With Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

Official title:

AUT-MENU: Improving Meal Experience of Subjects With Autism Spectrum Disorder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06266377
• Other study ID #: 11122023
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: December 2023
• Source: University of Pavia
• Contact: Maria Vittoria Conti, BSc
• Phone: 0382987536
• Email: mariavittoria.conti[@]unipv.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 30, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 19 Years

Eligibility

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;

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

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

Locations

Country	Name	City	State
Italy	Milano Ristorazione S.p.A.	Milano
Italy	Istituto I.P.S.E.O.A. "Tor Carbone - A. Narducci".	Roma
Italy	Istituto Tecnico Agrario Statale "Giuseppe Garibaldi"	Roma

Sponsors (2)

Lead Sponsor	Collaborator
University of Pavia	Consiglio per la ricerca in agricoltura e l'analisi dell'economia agraria (CREA)

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reduction in food selectivity as a result of the targeted nutrition education course	Caregivers of a subgroup of the enrolled subjects will undergo a nutrition education course adapted to the needs of individuals with autism spectrum disorder. Caregivers will be asked to fill out questionnaires assessing food selectivity and adherence to the Mediterranean diet before and after the intervention.	8 weeks