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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
Sponsor:
Collaborator:
Diputació de Tarragona
Information provided by (Responsible Party):
Rosa SOLÀ, University Rovira i Virgili

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel-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)
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Intervention Group
Intervention group will receive a Multicomponent Intervention.
Behavioral: Multicomponent intervention

The multicomponent intervention will be consist of:

  1. Training of the restaurant staff (waiters and cookers) about Mediterranean and Healthy Diet and food allergens,
  2. Nutritional and food allergen analysis of the menu of the restaurant
  3. 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
  4. 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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.



Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. Rate of customers with high satisfaction about menu options [ Time Frame: 12 months ]
    Survey of satisfaction

  4. 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

  5. Annual profits per restaurant in euros [ Time Frame: 12 months ]
    Annual profits per restaurant in euros



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Rosa Solà, Prof. (+0034) 609906991 rosa.sola@urv.cat

Locations
Spain
Universitat Rovira i Virgili Not yet recruiting
Reus, Tarragona, Spain, 43201
Contact: Rosa Solà, Prof.    (+0034) 609906991    rosa.sola@urv.cat   
Sub-Investigator: Lucia Tarro, PhD         
Sub-Investigator: Elisabet Llauradó, PhD         
Sub-Investigator: Rosa M Valls, PhD         
Sub-Investigator: Floriana Mandracchia, MS         
Sponsors and Collaborators
University Rovira i Virgili
Diputació de Tarragona
Investigators
Principal Investigator: Rosa Solà, Prof. Universitat Rovira i Virgili

Responsible Party: Rosa SOLÀ, Full Professor, MD, PhD, University Rovira i Virgili
ClinicalTrials.gov Identifier: NCT03826576     History of Changes
Other Study ID Numbers: Healthy Meals
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rosa SOLÀ, University Rovira i Virgili:
mediterranean diet
Food allergen
restaurant-based intervention

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate