Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

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Description Module


Ignite Creation Date: 2025-12-24 @ 2:04 PM
Ignite Modification Date: 2025-12-24 @ 2:04 PM
NCT ID: NCT05978895
Brief Summary: The FOOD-AUT pilot study aimed to improve the health status of adults with Autism Spectrum Disorder (ASD) through a nutritional intervention at canteen service. The researchers adapted the canteen menus to the nutritional and sensory needs of this vulnerable population, reducing their food selectivity and improving their dietary diversity with a positive impact on their health. This project consisted of two phases: first an observational phase (Work Package 1, WP1) and secondarily an interventional phase (Work Package 2, WP2).
Detailed Description: The FOOD-AUT project was a pilot study conducted at the daycare service of Sacra Famiglia Onlus Foundation in Cesano Boscone (Milan, Italy) on adults with Autism Spectrum Disorder (ASD). The project lasted 12 months. The main objective of the FOOD-AUT pilot study was to positively impact on the health condition of adults with ASD, improving food acceptability and increasing dietary diversity through the development of canteen service menus adapted to their nutritional and sensory needs. The main outcome was the improvement of food acceptance of the canteen menus by the adults with ASD. The FOOD-AUT pilot study deliverable were 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. Participants of this study were adults (≥ 18 years old) diagnosed with an autism spectrum disorder (grade 1-2 or 3), admitted to the day care center for disabled persons (CDD) at Sacra Famiglia Fondazione Onlus (Cesano Boscone, Milan, Italy). Based on the results of WP1, new canteen menus were drafted by qualified dietitians according to the nutritional and sensory needs of the targeted population. The new formulated menus 1) provided adequate caloric and macronutrient content, and 2) proposed with greater frequency foods having more accepted textures, colors, smells and temperatures. A total of 12 meal evaluation forms for each participant were collected on 3 non-consecutive weekly days (for a total of 4 weeks). Both the qualitative and quantitative forms were filled out by qualified operators, previously trained, of the Sacra Famiglia Onlus Foundation, who assist the participants on a daily basis during lunches eaten at the facility. For the quantitative evaluation of food consumption, a score was 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.
Study: NCT05978895
Study Brief:
Protocol Section: NCT05978895