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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
Last Updated

September 21, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

July 19, 2023

Last Update Submit

September 19, 2023

Conditions

Keywords

autism spectrum disordercanteen menusnutritionfood acceptancesensorycolortexturesmellsustainabilitymealtime

Outcome Measures

Primary Outcomes (1)

  • 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)

    4 weeks (WP1); 4 weeks (WP2)

Study Arms (1)

Intervention group

EXPERIMENTAL

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)

Other: Targeted canteen menus

Interventions

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.

Intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sacra Famiglia

Cesano Boscone, Milan, 20090, Italy

Location

Related Publications (2)

  • 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.

    PMID: 37526770BACKGROUND
  • Conti MV, Santero S, Breda C, Basilico S, de Filippo G, Luzzi A, Voto L, Cavagnola R, Tomasinelli CE, Cena H. Autism Spectrum Disorder and collective catering service: results of the pilot study FOOD-AUT. Front Nutr. 2024 Jan 10;10:1298469. doi: 10.3389/fnut.2023.1298469. eCollection 2023.

MeSH Terms

Conditions

Autism Spectrum DisorderAnosmia

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersOlfaction DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hellas Cena, MD

    University of Pavia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2023

First Posted

August 7, 2023

Study Start

March 30, 2022

Primary Completion

March 30, 2023

Study Completion

March 30, 2023

Last Updated

September 21, 2023

Record last verified: 2023-07

Locations