<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/NCT03826576</url>
  </required_header>
  <id_info>
    <org_study_id>Healthy Meals</org_study_id>
    <nct_id>NCT03826576</nct_id>
  </id_info>
  <brief_title>Healthy Meals: A Restaurant-based Study to Promote Healthy and Allergy Adapted Diet</brief_title>
  <acronym>HealthyMeals</acronym>
  <official_title>A Restaurant-based Intervention to Promote Healthy and Allergy Adapted Diet: A Randomized Controlled Trial in Tarragona (Spain)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Rovira i Virgili</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Diputació de Tarragona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Rovira i Virgili</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>
      This study evaluates the effect of a multicomponent intervention applied to restaurant staff&#xD;
      about training and nutritional quality of menu improvement, in order to promote a healthy&#xD;
      diet and a better management of allergies and intolerances addressed to each family member&#xD;
      satisfying the customers with specific needs (allergies and intolerances of food).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim is to test the effect of a multicomponent intervention applied to restaurant staff&#xD;
      about training and nutritional quality of menu improvement, in order to promote a healthy&#xD;
      diet and a better management of allergies and intolerances addressed to each family member&#xD;
      satisfying the customers with specific needs (allergies and intolerances of food).&#xD;
&#xD;
      The study is a 12-month restaurant-based intervention study, randomized, controlled and&#xD;
      parallel.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2019</start_date>
  <completion_date type="Actual">December 22, 2020</completion_date>
  <primary_completion_date type="Actual">April 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Parallel randomized controlled trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of restaurants that accomplish the nine compulsory criteria of the Mediterranean Diet certification (AMED certfication)</measure>
    <time_frame>12 months</time_frame>
    <description>Number of restaurants that accomplish the nine compulsory criteria of the Mediterranean Diet certification (AMED certfication). The Mediterranean Diet criteria (AMED Criteria) is a questionnaire based on 9 compulsory criteria, and if the restaurants accomplish this criteria could request the certification of the Mediterranean Diet in their restaurant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of dishes per restaurant that have green colour in Traffic light system</measure>
    <time_frame>12 months</time_frame>
    <description>Number of dishes offered in the restaurant with green (good nutritional quality) in the traffic light system, used to measure the nutritional quality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of dishes offered without food allergens, or vegeterian/vegan options</measure>
    <time_frame>12 months</time_frame>
    <description>Number of dishes offered without food allergens, or vegeterian/vegan options</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Grams of macronutrients in the dishes offered in the restaurants</measure>
    <time_frame>12 months</time_frame>
    <description>Reduction of salt, saturated fat and sugar; and increase of fiber in the dishes offered in the restaurants.&#xD;
The improvement of nutritional quality of the dishes offered in the restaurant menu through macronutrients assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of healthy dishes offered in the restaurants</measure>
    <time_frame>12 months</time_frame>
    <description>Number of healthy dishes offered in the restaurants. The healthy dishes considers dishes with traffic light in green in all the macronutrients (sugar, saturated fat, protein, and fiber).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of healthy dishes sale in the restaurants</measure>
    <time_frame>12 months</time_frame>
    <description>Number of healthy dishes sale in the restaurants. The healthy dishes considers dishes with traffic light in green in all the macronutrients (sugar, saturated fat, protein, and fiber).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of customers with high satisfaction about menu options</measure>
    <time_frame>12 months</time_frame>
    <description>Survey of satisfaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of restaurant staff with high knowledge about healthy and Mediterranean diet, and about food allergens.</measure>
    <time_frame>12 months</time_frame>
    <description>Increase the knowledge of waiters and cookers of participant restaurants about healthy and Mediterranean diet, and about food allergens management and options</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annual profits per restaurant in euros</measure>
    <time_frame>12 months</time_frame>
    <description>Annual profits per restaurant in euros</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">164</enrollment>
  <condition>Intervention</condition>
  <condition>Food Allergy</condition>
  <condition>Food Preferences</condition>
  <condition>Food Intolerance</condition>
  <condition>Diet Habit</condition>
  <condition>Diet Modification</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention group will receive a Multicomponent Intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group will not receive any kind of intervention, only it will receive information about AMED criteria and allergens of food.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Multicomponent intervention</intervention_name>
    <description>The multicomponent intervention will be consist of:&#xD;
Training of the restaurant staff (waiters and cookers) about Mediterranean and Healthy Diet and food allergens,&#xD;
Nutritional and food allergen analysis of the menu of the restaurant&#xD;
Improvement of the menu to follow the Mediterranian diet standards (AMED criteria), the nutritional quality of the menu and the adaptations of the menu for food allergies and food intolerances&#xD;
Marketing campaign about healthy and food allergen adapted menus in the restaurants</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The inclusion and exclusion criteria were about restaurants, as a unit of randomization.&#xD;
        This study is randomized.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  to have signed informed consent by the restaurant owner,&#xD;
&#xD;
          -  to have minimum 5 tables of service,&#xD;
&#xD;
          -  to offer local or Mediterranean food and recipes on the menu,&#xD;
&#xD;
          -  to have the recipes with ingredient and cooking steps details, and&#xD;
&#xD;
          -  to share the food products information used in the restaurant with the research team.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To be an ethnic restaurant, fast-food restaurant or a restaurant with a single product&#xD;
             like only pizza, sushi, etc&#xD;
&#xD;
          -  Lack of one of the inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rosa Solà, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Rovira i Virgili</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitat Rovira i Virgili</name>
      <address>
        <city>Reus</city>
        <state>Tarragona</state>
        <zip>43201</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>December 15, 2022</last_update_submitted>
  <last_update_submitted_qc>December 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Rovira i Virgili</investigator_affiliation>
    <investigator_full_name>Rosa Sola</investigator_full_name>
    <investigator_title>Full Professor, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>mediterranean diet</keyword>
  <keyword>Food allergen</keyword>
  <keyword>restaurant-based intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Food Hypersensitivity</mesh_term>
    <mesh_term>Food Intolerance</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03826576
org study id: Healthy Meals
nct id: NCT03826576
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effect of a multicomponent intervention applied to restaurant staff
      about training and nutritional quality of menu improvement, in order to promote a healthy
      diet and a better management of allergies and intolerances addressed to each family member
      satisfying the customers with specific needs (allergies and intolerances of food).
The aim is to test the effect of a multicomponent intervention applied to restaurant staff
      about training and nutritional quality of menu improvement, in order to promote a healthy
      diet and a better management of allergies and intolerances addressed to each family member
      satisfying the customers with specific needs (allergies and intolerances of food).

      The study is a 12-month restaurant-based intervention study, randomized, controlled and
      parallel.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel randomized controlled trial
primary purpose: Prevention
masking: None (Open Label)
measure: Number of restaurants that accomplish the nine compulsory criteria of the Mediterranean Diet certification (AMED certfication)
time frame: 12 months
description: Number of restaurants that accomplish the nine compulsory criteria of the Mediterranean Diet certification (AMED certfication). The Mediterranean Diet criteria (AMED Criteria) is a questionnaire based on 9 compulsory criteria, and if the restaurants accomplish this criteria could request the certification of the Mediterranean Diet in their restaurant.
measure: Number of dishes per restaurant that have green colour in Traffic light system
time frame: 12 months
description: Number of dishes offered in the restaurant with green (good nutritional quality) in the traffic light system, used to measure the nutritional quality.
measure: Number of dishes offered without food allergens, or vegeterian/vegan options
time frame: 12 months
description: Number of dishes offered without food allergens, or vegeterian/vegan options
measure: Grams of macronutrients in the dishes offered in the restaurants
time frame: 12 months
description: Reduction of salt, saturated fat and sugar; and increase of fiber in the dishes offered in the restaurants.
The improvement of nutritional quality of the dishes offered in the restaurant menu through macronutrients assessment.
measure: Number of healthy dishes offered in the restaurants
time frame: 12 months
description: Number of healthy dishes offered in the restaurants. The healthy dishes considers dishes with traffic light in green in all the macronutrients (sugar, saturated fat, protein, and fiber).
measure: Number of healthy dishes sale in the restaurants
time frame: 12 months
description: Number of healthy dishes sale in the restaurants. The healthy dishes considers dishes with traffic light in green in all the macronutrients (sugar, saturated fat, protein, and fiber).
measure: Rate of customers with high satisfaction about menu options
time frame: 12 months
description: Survey of satisfaction
measure: Rate of restaurant staff with high knowledge about healthy and Mediterranean diet, and about food allergens.
time frame: 12 months
description: Increase the knowledge of waiters and cookers of participant restaurants about healthy and Mediterranean diet, and about food allergens management and options
measure: Annual profits per restaurant in euros
time frame: 12 months
description: Annual profits per restaurant in euros
arm group label: Intervention Group
arm group type: Experimental
description: Intervention group will receive a Multicomponent Intervention.
arm group label: Control Group
arm group type: No Intervention
description: Control group will not receive any kind of intervention, only it will receive information about AMED criteria and allergens of food.
intervention type: Behavioral
intervention name: Multicomponent intervention
description: The multicomponent intervention will be consist of:
Training of the restaurant staff (waiters and cookers) about Mediterranean and Healthy Diet and food allergens,
Nutritional and food allergen analysis of the menu of the restaurant
Improvement of the menu to follow the Mediterranian diet standards (AMED criteria), the nutritional quality of the menu and the adaptations of the menu for food allergies and food intolerances
Marketing campaign about healthy and food allergen adapted menus in the restaurants
arm group label: Intervention Group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rosa Solà, Prof.
role: Principal Investigator
affiliation: University Rovira i Virgili
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University Rovira i Virgili
investigator full name: Rosa Sola
investigator title: Full Professor, MD, PhD
mesh term: Hypersensitivity
mesh term: Food Hypersensitivity
mesh term: Food Intolerance
sharing ipd: No