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Effectiveness of Different Front-of-Pack Nutritional Labels in Promoting Greater Adherence to the Mediterranean Diet Among Italian Consumers

Effectiveness of Front-of-Pack Nutritional Labels in Promoting Greater Adherence to the Mediterranean Diet

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06488079
Enrollment
3029
Registered
2024-07-05
Start date
2024-06-04
Completion date
2024-07-20
Last updated
2024-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

The goal of this clinical trial is to learn if Front-of-Pack labels, namely Nutri-Score and NutrInform Battery, work to improve adherence to the Mediterranean diet among healthy Italian adult participants. It will also learn about the label's ability to increase nutritional knowledge and participant's response in terms of orthorexic behaviour. The main questions it aims to answer are: * Does FOP nutritional labels work to guide participants' food choices towards healthier diets? * Do they increase participants' nutritional knowledge? * To what extent are they related to obsessive focus on healthy eating, such as orthorexia nervosa? Researchers will compare the labels to a no label condition (in which participants were only given a conventional nutrition education flyer) to see if labels work to improve healthiness in individual diets. Participants will: * Complete an initial questionnaire's battery * Use the assigned FOP label every day for 1 month to orient their food choices * Answer to final questionnaires

Interventions

OTHERSummary Label

The Nutri-Score Front-of-Pack nutritional label

OTHERNutrient-specific label

The NutrInform Battery Front-of-Pack nutritional label

Conventional food educational flyer

Sponsors

Catholic University of the Sacred Heart
CollaboratorOTHER
Donini Lorenzo M
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* limited to participants older than 18 years

Exclusion criteria

* people currently on a diet for religious/ethical/personal choice or medical prescription * people with a degree or a professional expertise in the area of field, nutrition, and physical exercise * people who know one of the interventions

Design outcomes

Primary

MeasureTime frameDescription
Adherence to the Mediterranean diet30 daysThe adherence is measured with the PREDIMED (PREvención con DIeta MEDiterránea) PLUS questionnaire adapted for the Italian population. The questionnaire asks about the frequency of consumption of traditional Mediterranean food (daily or weekly) by defining the portion size, or asking about the use of food with yes or no options, or identifying preferences between different food options. Possible values range from 0 to 17. Higher values correspond to a higher adherence.

Secondary

MeasureTime frameDescription
Nutrition Knowledge30 daysNutrition knowledge is measured by the General Nutrition Knowledge Questionnaire (GNKQ) adapted for the Italian population (I-NK Questionnaire). It is composed of four sections exploring different aspects of NK: (NK1) Experts' recommendations (9 questions); (NK2) Food composition (10 questions); (NK3) Food choices and nutrition labels (11 questions); (NK4) Diet-disease associations (16 questions). Possible values range from 0 to 88. Higher values correspond to a higher knowledge.
Orthorexic behaviour30 daysOrthorexic behaviour is measured by the ORTO-R Questionnaire. The ORTO-R is an adaptation of the ORTO-15, from which it contains six items which were identified as the best markers of orthorexia nervosa. The response scale is a five-point Likert-type scale and a higher score reflects higher intensity of orthorexia nervosa thoughts and behaviors.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026