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

Sponsor

University Rovira i Virgili (Other)

Overall Status

Completed

CT.gov ID

NCT03826576

Collaborator

Diputació de Tarragona (Other)

164

Enrollment

Location

Arms

Actual Duration (Months)

7.5

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Intervention Food Allergy Food Preferences Food Intolerance Diet Habit Diet Modification	Behavioral: Multicomponent intervention	N/A

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, cluster-randomized, controlled and parallel.

Study Design

Study Type:

Interventional

Actual Enrollment :

164 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel-cluster randomized controlled trialParallel-cluster randomized controlled trial

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 21, 2019

Actual Primary Completion Date :

Apr 1, 2020

Actual Study Completion Date :

Dec 22, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Number of restaurants that accomplish the nine compulsory criteria of the Mediterranean Diet certification (AMED certfication) [12 months]
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 [12 months]
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 [12 months]
Number of dishes offered without food allergens, or vegeterian/vegan options
Grams of macronutrients in the dishes offered in the restaurants [12 months]
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 [12 months]
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 [12 months]
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 [12 months]
Survey of satisfaction
Rate of restaurant staff with high knowledge about healthy and Mediterranean diet, and about food allergens. [12 months]
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 [12 months]
Annual profits per restaurant in euros

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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