Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05978895 |
Other study ID # |
30062023 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 30, 2022 |
Est. completion date |
March 30, 2023 |
Study information
Verified date |
July 2023 |
Source |
University of Pavia |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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).
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.