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

Food Allergy Clinical Trial

— HealthyMeals  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03826576
• Other study ID #: Healthy Meals
• Status: Completed
• Phase: N/A
• Start date: February 21, 2019
• Est. completion date: December 22, 2020

Study information

• Verified date: December 2022
• Source: University Rovira i Virgili
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: December 22, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diet Habit
• Diet Modification
• Food Allergy
• Food Hypersensitivity
• Food Intolerance
• Food Preferences
• Hypersensitivity
• Intervention

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

Locations

Country	Name	City	State
Spain	Universitat Rovira i Virgili	Reus	Tarragona

Sponsors (2)

Lead Sponsor	Collaborator
University Rovira i Virgili	Diputació de Tarragona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Number of dishes offered without food allergens, or vegeterian/vegan options	Number of dishes offered without food allergens, or vegeterian/vegan options	12 months
Primary	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	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
Secondary	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
Secondary	Rate of customers with high satisfaction about menu options	Survey of satisfaction	12 months
Secondary	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
Secondary	Annual profits per restaurant in euros	Annual profits per restaurant in euros	12 months