Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||N/A and Over|
The inclusion and exclusion criteria were about restaurants, as a unit of randomization. This study is a cluster randomized.
- - 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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University Rovira i Virgili|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Rosa Solà, Prof.|
|Principal Investigator Affiliation||Universitat Rovira i Virgili|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Intervention, Food Allergy, Food Preferences, Food Intolerance, Diet Habit, Diet Modification|
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.
Experimental: Intervention Group
Intervention group will receive a Multicomponent Intervention.
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.
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
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.