Healthy Meals: A Restaurant-based Study to Promote Healthy and Allergy Adapted Diet (HealthyMeals)
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|ClinicalTrials.gov Identifier: NCT03826576|
Recruitment Status : Not yet recruiting
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Intervention Food Allergy Food Preferences Food Intolerance Diet Habit Diet Modification||Behavioral: Multicomponent intervention||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel-cluster randomized controlled trial|
|Masking:||None (Open Label)|
|Official Title:||A Restaurant-based Intervention to Promote Healthy and Allergy Adapted Diet: A Cluster-randomized Controlled Trial in Tarragona (Spain)|
|Estimated Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||April 1, 2020|
|Estimated Study Completion Date :||April 1, 2021|
Experimental: Intervention Group
Intervention group will receive a Multicomponent Intervention.
Behavioral: Multicomponent intervention
The multicomponent intervention will be consist of:
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.
- Number of restaurants that accomplish the nine compulsory criteria of the Mediterranean Diet certification (AMED certfication) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months ]Number of dishes offered without food allergens, or vegeterian/vegan options
- Grams of macronutrients in the dishes offered in the restaurants [ Time Frame: 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.
- Number of healthy dishes offered in the restaurants [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months ]Survey of satisfaction
- Rate of restaurant staff with high knowledge about healthy and Mediterranean diet, and about food allergens. [ Time Frame: 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 [ Time Frame: 12 months ]Annual profits per restaurant in euros
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826576
|Contact: Rosa Solà, Prof.||(+0034) email@example.com|
|Universitat Rovira i Virgili||Not yet recruiting|
|Reus, Tarragona, Spain, 43201|
|Contact: Rosa Solà, Prof. (+0034) 609906991 firstname.lastname@example.org|
|Sub-Investigator: Lucia Tarro, PhD|
|Sub-Investigator: Elisabet Llauradó, PhD|
|Sub-Investigator: Rosa M Valls, PhD|
|Sub-Investigator: Floriana Mandracchia, MS|
|Principal Investigator:||Rosa Solà, Prof.||Universitat Rovira i Virgili|