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Healthy Meals: A Restaurant-based Study to Promote Healthy and Allergy Adapted Diet (HealthyMeals)

Primary Purpose

Intervention, Food Allergy, Food Preferences

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multicomponent intervention
Sponsored by
University Rovira i Virgili
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intervention focused on measuring mediterranean diet, Food allergen, restaurant-based intervention

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

The inclusion and exclusion criteria were about restaurants, as a unit of randomization. This study is randomized.

Inclusion Criteria:

  • to have signed informed consent by the restaurant owner,
  • to have minimum 5 tables of service,
  • to offer local or Mediterranean food and recipes on the menu,
  • to have the recipes with ingredient and cooking steps details, and
  • to share the food products information used in the restaurant with the research team.

Exclusion Criteria:

  • To be an ethnic restaurant, fast-food restaurant or a restaurant with a single product like only pizza, sushi, etc
  • Lack of one of the inclusion criteria

Sites / Locations

  • Universitat Rovira i Virgili

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Intervention group will receive a Multicomponent Intervention.

Control group will not receive any kind of intervention, only it will receive information about AMED criteria and allergens of food.

Outcomes

Primary Outcome Measures

Number of restaurants that accomplish the nine compulsory criteria of the Mediterranean Diet certification (AMED certfication)
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.
Number of dishes per restaurant that have green colour in Traffic light system
Number of dishes offered in the restaurant with green (good nutritional quality) in the traffic light system, used to measure the nutritional quality.
Number of dishes offered without food allergens, or vegeterian/vegan options
Number of dishes offered without food allergens, or vegeterian/vegan options
Grams of macronutrients in the dishes offered in the restaurants
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.

Secondary Outcome Measures

Number of healthy dishes offered in the restaurants
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).
Number of healthy dishes sale in the restaurants
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).
Rate of customers with high satisfaction about menu options
Survey of satisfaction
Rate of restaurant staff with high knowledge about healthy and Mediterranean diet, and about food allergens.
Increase the knowledge of waiters and cookers of participant restaurants about healthy and Mediterranean diet, and about food allergens management and options
Annual profits per restaurant in euros
Annual profits per restaurant in euros

Full Information

First Posted
January 25, 2019
Last Updated
December 15, 2022
Sponsor
University Rovira i Virgili
Collaborators
Diputació de Tarragona
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1. Study Identification

Unique Protocol Identification Number
NCT03826576
Brief Title
Healthy Meals: A Restaurant-based Study to Promote Healthy and Allergy Adapted Diet
Acronym
HealthyMeals
Official Title
A Restaurant-based Intervention to Promote Healthy and Allergy Adapted Diet: A Randomized Controlled Trial in Tarragona (Spain)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 21, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
December 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Rovira i Virgili
Collaborators
Diputació de Tarragona

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
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervention, Food Allergy, Food Preferences, Food Intolerance, Diet Habit, Diet Modification
Keywords
mediterranean diet, Food allergen, restaurant-based intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Intervention group will receive a Multicomponent Intervention.
Arm Title
Control Group
Arm Type
No Intervention
Arm 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(s)
Multicomponent intervention
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
Primary Outcome Measure Information:
Title
Number of restaurants that accomplish the nine compulsory criteria of the Mediterranean Diet certification (AMED certfication)
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.
Time Frame
12 months
Title
Number of dishes per restaurant that have green colour in Traffic light system
Description
Number of dishes offered in the restaurant with green (good nutritional quality) in the traffic light system, used to measure the nutritional quality.
Time Frame
12 months
Title
Number of dishes offered without food allergens, or vegeterian/vegan options
Description
Number of dishes offered without food allergens, or vegeterian/vegan options
Time Frame
12 months
Title
Grams of macronutrients in the dishes offered in the restaurants
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of healthy dishes offered in the restaurants
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).
Time Frame
12 months
Title
Number of healthy dishes sale in the restaurants
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).
Time Frame
12 months
Title
Rate of customers with high satisfaction about menu options
Description
Survey of satisfaction
Time Frame
12 months
Title
Rate of restaurant staff with high knowledge about healthy and Mediterranean diet, and about food allergens.
Description
Increase the knowledge of waiters and cookers of participant restaurants about healthy and Mediterranean diet, and about food allergens management and options
Time Frame
12 months
Title
Annual profits per restaurant in euros
Description
Annual profits per restaurant in euros
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
The inclusion and exclusion criteria were about restaurants, as a unit of randomization. This study is randomized. Inclusion Criteria: to have signed informed consent by the restaurant owner, to have minimum 5 tables of service, to offer local or Mediterranean food and recipes on the menu, to have the recipes with ingredient and cooking steps details, and to share the food products information used in the restaurant with the research team. Exclusion Criteria: To be an ethnic restaurant, fast-food restaurant or a restaurant with a single product like only pizza, sushi, etc Lack of one of the inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa Solà, Prof.
Organizational Affiliation
University Rovira i Virgili
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitat Rovira i Virgili
City
Reus
State/Province
Tarragona
ZIP/Postal Code
43201
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Healthy Meals: A Restaurant-based Study to Promote Healthy and Allergy Adapted Diet

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