InterventionHealthyMealsNCT03826576
Healthy Meals: A Restaurant-based Study to Promote Healthy and Allergy Adapted Diet
A study testing Multicomponent intervention in people with Intervention and Food Allergy, run by University Rovira i Virgili at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intervention, Food Allergy, Food Preferences
- What is being tested?
- Multicomponent intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteSpain
- Study dates
- 21 Feb 2019to 22 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Restaurant-based Intervention to Promote Healthy and Allergy Adapted Diet: A Randomized Controlled Trial in Tarragona (Spain)
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).
Read the 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.
- Conditions
- Intervention, Food Allergy, Food Preferences, Food Intolerance, Diet Habit, Diet Modification
- Being tested
- Multicomponent intervention
- Keywords
- mediterranean diet, Food allergen, restaurant-based intervention
- Medical subject headings
- Food Hypersensitivity, Food Preferences, Food Intolerance, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Intervention group will receive a Multicomponent Intervention. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Number of dishes offered without food allergens, or vegeterian/vegan options
Number of dishes offered without food allergens, or vegeterian/vegan options
Measured: 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.
Measured: 12 months
Secondary outcomes (5)
Number of healthy dishes offered in the restaurants
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).
Measured: 12 months
Number of healthy dishes sale in the restaurants
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).
Measured: 12 months
Rate of customers with high satisfaction about menu options
Survey of satisfaction
Measured: 12 months
Rate of restaurant staff with high knowledge about healthy and Mediterranean diet, and about food allergens.
Increase the knowledge of waiters and cookers of participant restaurants about healthy and Mediterranean diet, and about food allergens management and options
Measured: 12 months
Annual profits per restaurant in euros
Annual profits per restaurant in euros
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start21 Feb 2019
- Primary completion1 Apr 2020
- Study completion22 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Diputació de Tarragona
- Responsible party
- Principal investigator, Rosa Sola, University Rovira i Virgili
- Investigators
- Rosa Solà, Prof., Principal investigator, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826576
- Sponsor's protocol ID
- Healthy Meals
- Acronym
- HealthyMeals
- Status last verified
- Dec 2022
- First submitted
- 25 Jan 2019
- Last updated
- 20 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Restaurant-based Intervention to Promote Healthy and Allergy Adapted Diet: A Randomized Controlled Trial in Tarragona (Spain)
- ClinicalTrials.gov ID
- NCT03826576
- Acronym / sponsor ID
- HealthyMeals / Healthy Meals
- Conditions
- Intervention, Food Allergy, Food Preferences, Food Intolerance, Diet Habit, Diet Modification
- Keywords
- mediterranean diet, Food allergen, restaurant-based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Collaborators
- Diputació de Tarragona
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Multicomponent interventionIntervention group will receive a 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent interventionThe 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 | Behavioural | Intervention Group |
Primary outcome
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.
5 secondary outcomes
Number of healthy dishes offered in the restaurants
Time frame: 12 months
Number of healthy dishes sale in the restaurants
Time frame: 12 months
Rate of customers with high satisfaction about menu options
Time frame: 12 months
Rate of restaurant staff with high knowledge about healthy and Mediterranean diet, and about food allergens.
Time frame: 12 months
Annual profits per restaurant in euros
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Solà, Prof. principal investigator
University Rovira i Virgili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent intervention in people with Intervention and Food Allergy, run by University Rovira i Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of restaurants that accomplish the nine compulsory criteria of the Mediterranean Diet certification (AMED certfication) (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.