xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05978895</url>
    </required_header>
    <id_info>
      <org_study_id>30062023</org_study_id>
      <nct_id>NCT05978895</nct_id>
    </id_info>
    <brief_title>FOOD-AUT Pilot Study Canteen Menus for Adults With Autism Spectrum Disorder</brief_title>
    <official_title>FOOD-AUT Pilot Study Developing Canteen Menus Targeted to Nutritional and Sensory Needs of Adults With Autism Spectrum Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Pavia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Pavia</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The FOOD-AUT pilot study aimed to improve the health status of adults with Autism Spectrum&#xD;
        Disorder (ASD) through a nutritional intervention at canteen service. The researchers adapted&#xD;
        the canteen menus to the nutritional and sensory needs of this vulnerable population,&#xD;
        reducing their food selectivity and improving their dietary diversity with a positive impact&#xD;
        on their health.&#xD;
  &#xD;
        This project consisted of two phases: first an observational phase (Work Package 1, WP1) and&#xD;
        secondarily an interventional phase (Work Package 2, WP2).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The FOOD-AUT project was a pilot study conducted at the daycare service of Sacra Famiglia&#xD;
        Onlus Foundation in Cesano Boscone (Milan, Italy) on adults with Autism Spectrum Disorder&#xD;
        (ASD). The project lasted 12 months.&#xD;
  &#xD;
        The main objective of the FOOD-AUT pilot study was to positively impact on the health&#xD;
        condition of adults with ASD, improving food acceptability and increasing dietary diversity&#xD;
        through the development of canteen service menus adapted to their nutritional and sensory&#xD;
        needs.&#xD;
  &#xD;
        The main outcome was the improvement of food acceptance of the canteen menus by the adults&#xD;
        with ASD.&#xD;
  &#xD;
        The FOOD-AUT pilot study deliverable were 1) the development of targeted canteen menus for&#xD;
        adults with ASD, according to the nutritional and sensory needs; 2) the elaboration of&#xD;
        dietary recommendations to customize canteen menus nutritional and sensory needs for&#xD;
        individuals with ASD.&#xD;
  &#xD;
        Participants of this study were adults (≥ 18 years old) diagnosed with an autism spectrum&#xD;
        disorder (grade 1-2 or 3), admitted to the day care center for disabled persons (CDD) at&#xD;
        Sacra Famiglia Fondazione Onlus (Cesano Boscone, Milan, Italy).&#xD;
  &#xD;
        Based on the results of WP1, new canteen menus were drafted by qualified dietitians according&#xD;
        to the nutritional and sensory needs of the targeted population. The new formulated menus 1)&#xD;
        provided adequate caloric and macronutrient content, and 2) proposed with greater frequency&#xD;
        foods having more accepted textures, colors, smells and temperatures.&#xD;
  &#xD;
        A total of 12 meal evaluation forms for each participant were collected on 3 non-consecutive&#xD;
        weekly days (for a total of 4 weeks). Both the qualitative and quantitative forms were filled&#xD;
        out by qualified operators, previously trained, of the Sacra Famiglia Onlus Foundation, who&#xD;
        assist the participants on a daily basis during lunches eaten at the facility. For the&#xD;
        quantitative evaluation of food consumption, a score was assigned to the four possible&#xD;
        amounts of dish consumed: zero consumption, ¼ of the plate, ½ of the plate, ¾ of the plate,&#xD;
        the whole dish.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 30, 2022</start_date>
    <completion_date type="Actual">March 30, 2023</completion_date>
    <primary_completion_date type="Actual">March 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_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.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Food acceptance of canteen menus by adults with Autism Spectrum Disorder</measure>
      <time_frame>4 weeks (WP1); 4 weeks (WP2)</time_frame>
      <description>Meal evaluation forms (score range for each item: 0-1; the score number is directly proportional to the amount of the dish consumed)</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">22</enrollment>
    <condition>Autism Spectrum Disorder</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Targeted canteen menus</intervention_name>
      <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.&#xD;
  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.&#xD;
  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.</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years old&#xD;
  &#xD;
            -  Diagnosis of autism spectrum disorder (grade 1-2 or grade 3)&#xD;
  &#xD;
            -  Admission to the daycare service of Sacra Famiglia Onlus Foundation in Cesano Boscone&#xD;
               (Milan, Italy)&#xD;
  &#xD;
            -  Informed consent signed by their caregivers&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt; 18 years old&#xD;
  &#xD;
            -  Not diagnosed with autism spectrum disorder (grade 1-2 or grade 3)&#xD;
  &#xD;
            -  Not admitted to the daycare service of Sacra Famiglia Onlus Foundation in Cesano&#xD;
               Boscone (Milan, Italy)&#xD;
  &#xD;
            -  Informed consent not signed by their caregivers&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hellas Cena, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Pavia</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Sacra Famiglia</name>
        <address>
          <city>Cesano Boscone</city>
          <state>Milan</state>
          <zip>20090</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>autism spectrum disorder</keyword>
    <keyword>canteen menus</keyword>
    <keyword>nutrition</keyword>
    <keyword>food acceptance</keyword>
    <keyword>sensory</keyword>
    <keyword>color</keyword>
    <keyword>texture</keyword>
    <keyword>smell</keyword>
    <keyword>sustainability</keyword>
    <keyword>mealtime</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Autistic Disorder</mesh_term>
      <mesh_term>Autism Spectrum Disorder</mesh_term>
      <mesh_term>Child Development Disorders, Pervasive</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05978895
  org study id: 30062023
  nct id: NCT05978895
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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).
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention 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.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Food acceptance of canteen menus by adults with Autism Spectrum Disorder
  time frame: 4 weeks (WP1); 4 weeks (WP2)
  description: Meal evaluation forms (score range for each item: 0-1; the score number is directly proportional to the amount of the dish consumed)
  arm group label: Intervention group
  arm group type: Experimental
  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: Targeted canteen menus
  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.
  arm group label: Intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Hellas Cena, MD
  role: Principal Investigator
  affiliation: University of Pavia
  facility: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Autistic Disorder
  mesh term: Autism Spectrum Disorder
  mesh term: Child Development Disorders, Pervasive