Clinical trial NCT03826576: Healthy Meals: A Restaurant-based Study to Promote Healthy and Allergy Adapted Diet
Official title: A Restaurant-based Intervention to Promote Healthy and Allergy Adapted Diet: A Randomized Controlled Trial in Tarragona (Spain)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervention
Food Allergy
Food Preferences
Food Intolerance
Diet Habit
Diet Modification
Keywords: mediterranean diet
Food allergen
restaurant-based intervention
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
Collaborators: name: Diputació de Tarragona
First posted: 2019-02-01
Enrollment: 164
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel randomized controlled trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of restaurants that accomplish the nine compulsory criteria of the Mediterranean Diet certification (AMED certfication)
timeFrame: 12 months
measure: Number of dishes per restaurant that have green colour in Traffic light system
timeFrame: 12 months
measure: Number of dishes offered without food allergens, or vegeterian/vegan options
timeFrame: 12 months
measure: Grams of macronutrients in the dishes offered in the restaurants
timeFrame: 12 months
Secondary outcomes:
measure: Number of healthy dishes offered in the restaurants
timeFrame: 12 months
measure: Number of healthy dishes sale in the restaurants
timeFrame: 12 months
measure: Rate of customers with high satisfaction about menu options
timeFrame: 12 months
measure: Rate of restaurant staff with high knowledge about healthy and Mediterranean diet, and about food allergens.
timeFrame: 12 months
measure: Annual profits per restaurant in euros
timeFrame: 12 months
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Universitat Rovira i Virgili
state: Tarragona
Study officials:
affiliation: University Rovira i Virgili
name: Rosa Solà, Prof.
role: PRINCIPAL_INVESTIGATOR
References: