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FOOD-AUT Pilot Study Canteen Menus for Adults With Autism Spectrum Disorder

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Targeted canteen menus
Sponsored by
University of Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorder focused on measuring autism spectrum disorder, canteen menus, nutrition, food acceptance, sensory, color, texture, smell, sustainability, mealtime

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 years old Diagnosis of autism spectrum disorder (grade 1-2 or grade 3) Admission to the daycare service of Sacra Famiglia Onlus Foundation in Cesano Boscone (Milan, Italy) Informed consent signed by their caregivers Exclusion Criteria: Age < 18 years old Not diagnosed with autism spectrum disorder (grade 1-2 or grade 3) Not admitted to the daycare service of Sacra Famiglia Onlus Foundation in Cesano Boscone (Milan, Italy) Informed consent not signed by their caregivers

Sites / Locations

  • Sacra Famiglia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

22 adults with autism spectrum disorder (grade 1-2 or 3), admitted to the daycare service of Sacra Famiglia Onlus Foundation in Cesano Boscone (Milan, Italy)

Outcomes

Primary Outcome Measures

Food acceptance of canteen menus by adults with Autism Spectrum Disorder
Meal evaluation forms (score range for each item: 0-1; the score number is directly proportional to the amount of the dish consumed)

Secondary Outcome Measures

Full Information

First Posted
July 19, 2023
Last Updated
September 19, 2023
Sponsor
University of Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT05978895
Brief Title
FOOD-AUT Pilot Study Canteen Menus for Adults With Autism Spectrum Disorder
Official Title
FOOD-AUT Pilot Study Developing Canteen Menus Targeted to Nutritional and Sensory Needs of Adults With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
March 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pavia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
autism spectrum disorder, canteen menus, nutrition, food acceptance, sensory, color, texture, smell, sustainability, mealtime

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Non-randomized intervention with a single arm. Study participants received new adapted canteen menus according to the nutritional and sensory needs of the target population.
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
22 adults with autism spectrum disorder (grade 1-2 or 3), admitted to the daycare service of Sacra Famiglia Onlus Foundation in Cesano Boscone (Milan, Italy)
Intervention Type
Other
Intervention Name(s)
Targeted canteen menus
Intervention Description
The nutritional intervention consisted in the development of targeted menus aiming at the needs of individuals with ASD and in assessing their acceptance of the targeted menus. The revision of the standard menus was carried 1) balancing energy and macronutrient content, according to LARN 2014; 2) promoting adequate weekly food frequencies consumption and portions, to provide an adequate and sustainable menus according to CREA 2018; 3) adapting the sensory characteristics of the foods offered to the sensory needs of individuals with ASD. The acceptance of the targeted menus by the enrolled population was evaluated through meal evaluation forms. These results were compared with the ones collected during the first observational phase (WP1). In fact, referring to the results of WP1, new canteen menus were drafted according to the nutritional and sensory needs of the population.
Primary Outcome Measure Information:
Title
Food acceptance of canteen menus by adults with Autism Spectrum Disorder
Description
Meal evaluation forms (score range for each item: 0-1; the score number is directly proportional to the amount of the dish consumed)
Time Frame
4 weeks (WP1); 4 weeks (WP2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years old Diagnosis of autism spectrum disorder (grade 1-2 or grade 3) Admission to the daycare service of Sacra Famiglia Onlus Foundation in Cesano Boscone (Milan, Italy) Informed consent signed by their caregivers Exclusion Criteria: Age < 18 years old Not diagnosed with autism spectrum disorder (grade 1-2 or grade 3) Not admitted to the daycare service of Sacra Famiglia Onlus Foundation in Cesano Boscone (Milan, Italy) Informed consent not signed by their caregivers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hellas Cena, MD
Organizational Affiliation
University of Pavia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sacra Famiglia
City
Cesano Boscone
State/Province
Milan
ZIP/Postal Code
20090
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
37526770
Citation
Conti MV, Breda C, Basilico S, Luzzi A, Voto L, Santero S, De Filippo G, Cena H. Dietary recommendations to customize canteen menus according to the nutritional and sensory needs of individuals with autism spectrum disorder. Eat Weight Disord. 2023 Aug 1;28(1):66. doi: 10.1007/s40519-023-01590-z.
Results Reference
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FOOD-AUT Pilot Study Canteen Menus for Adults With Autism Spectrum Disorder

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