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Clinical Trials/NCT06266377
NCT06266377
Not yet recruiting
Not Applicable

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

University of Pavia3 sites in 1 country200 target enrollmentSeptember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
University of Pavia
Enrollment
200
Locations
3
Primary Endpoint
Food acceptance of canteen menus by individuals enrolled in the study
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
November 30, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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;

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Reduction in food selectivity as a result of the targeted nutrition education course(8 weeks)

Study Sites (3)

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