NCT03826576

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

February 21, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2020

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

1.1 years

First QC Date

January 25, 2019

Last Update Submit

December 15, 2022

Conditions

Keywords

mediterranean dietFood allergenrestaurant-based intervention

Outcome Measures

Primary Outcomes (4)

  • Number of restaurants that accomplish the nine compulsory criteria of the Mediterranean Diet certification (AMED certfication)

    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.

    12 months

  • Number of dishes per restaurant that have green colour in Traffic light system

    Number of dishes offered in the restaurant with green (good nutritional quality) in the traffic light system, used to measure the nutritional quality.

    12 months

  • Number of dishes offered without food allergens, or vegeterian/vegan options

    Number of dishes offered without food allergens, or vegeterian/vegan options

    12 months

  • Grams of macronutrients in the dishes offered in the restaurants

    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.

    12 months

Secondary Outcomes (5)

  • Number of healthy dishes offered in the restaurants

    12 months

  • Number of healthy dishes sale in the restaurants

    12 months

  • Rate of customers with high satisfaction about menu options

    12 months

  • Rate of restaurant staff with high knowledge about healthy and Mediterranean diet, and about food allergens.

    12 months

  • Annual profits per restaurant in euros

    12 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Intervention group will receive a Multicomponent Intervention.

Behavioral: Multicomponent intervention

Control Group

NO INTERVENTION

Control group will not receive any kind of intervention, only it will receive information about AMED criteria and allergens of food.

Interventions

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

Intervention Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.
  • To be an ethnic restaurant, fast-food restaurant or a restaurant with a single product like only pizza, sushi, etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Rovira i Virgili

Reus, Tarragona, 43201, Spain

Location

MeSH Terms

Conditions

Food HypersensitivityFood PreferencesFood IntoleranceFeeding Behavior

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System DiseasesBehaviorSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, Animal

Study Officials

  • Rosa Solà, Prof.

    University Rovira i Virgili

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor, MD, PhD

Study Record Dates

First Submitted

January 25, 2019

First Posted

February 1, 2019

Study Start

February 21, 2019

Primary Completion

April 1, 2020

Study Completion

December 22, 2020

Last Updated

December 20, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations