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

A Restaurant-based Intervention to Promote Healthy and Allergy Adapted Diet: A Randomized Controlled Trial in Tarragona (Spain)

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).

Study Overview

• Status: Completed
• Conditions: Diet Modification; Food Preferences; Diet Habit; Food Allergy; Food Intolerance; Intervention
• Intervention / Treatment: Behavioral: Multicomponent intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Tarragona
    • Reus, Tarragona, Spain, 43201
      • Universitat Rovira i Virgili

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Intervention group will receive a Multicomponent Intervention.	Behavioral: Multicomponent intervention; 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
No Intervention: Control Group; Control group will not receive any kind of intervention, only it will receive information about AMED criteria and allergens of food.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
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.	12 months
Number of dishes offered without food allergens, or vegeterian/vegan options	Number of dishes offered without food allergens, or vegeterian/vegan options	12 months
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 months
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).	12 months
Rate of customers with high satisfaction about menu options	Survey of satisfaction	12 months
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	12 months
Annual profits per restaurant in euros	Annual profits per restaurant in euros	12 months

Collaborators and Investigators

• Sponsor: University Rovira i Virgili
• Collaborators: Diputació de Tarragona
• Investigators: Principal Investigator: Rosa Solà, Prof., University Rovira i Virgili

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2019
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): December 22, 2020

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Estimate): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: mediterranean diet; Food allergen; restaurant-based intervention
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Signs and Symptoms, Digestive; Hypersensitivity; Food Hypersensitivity; Food Intolerance
• Other Study ID Numbers: Healthy Meals

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No