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临床试验/NCT06266377
NCT06266377尚未招募不适用

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

University of Pavia6 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
6
主要终点
Food acceptance of canteen menus by individuals enrolled in the study

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
5 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Intervention group

Experimental

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."

干预措施: Nutrition education course aimed at caregivers of individuals with Autism Spectrum Disorder (Other)

Intervention group

Experimental

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."

干预措施: Administration of menus of collective catering adapted to the sensory and nutritional needs of subjects with Autism Spectrum Disorder (Other)

结局指标

主要结局

Food acceptance of canteen menus by individuals enrolled in the study

时间窗: 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)

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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