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

February 9, 2024 updated by: University of Pavia
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milano, Italy, 20139
        • Milano Ristorazione S.p.A.
      • Roma, Italy, 00178
        • Istituto I.P.S.E.O.A. "Tor Carbone - A. Narducci".
      • Roma, Italy, 00178
        • Istituto Tecnico Agrario Statale "Giuseppe Garibaldi"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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 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).

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food acceptance of canteen menus by individuals enrolled in the study
Time Frame: 8 weeks (T0); 8 weeks (T1)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in food selectivity as a result of the targeted nutrition education course
Time Frame: 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Collaborators

Consiglio per la ricerca in agricoltura e l'analisi dell'economia agraria (CREA)

Investigators

  • Principal Investigator: Hellas Cena, MD, University of Pavia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

February 9, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11122023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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