Viewing Study NCT06266377



Ignite Creation Date: 2024-05-06 @ 8:07 PM
Last Modification Date: 2024-10-26 @ 3:21 PM
Study NCT ID: NCT06266377
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-02-20
First Post: 2024-02-09

Brief Title: AUT-MENU Improving Meal Experience of Subjects With Autism Spectrum Disorder
Sponsor: University of Pavia
Organization: University of Pavia

Study Overview

Official Title: AUT-MENU Improving Meal Experience of Subjects With Autism Spectrum Disorder
Status: NOT_YET_RECRUITING
Status Verified Date: 2023-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 childrens 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 101007s40519-023-01590-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 childrens 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None