Effectiveness of Different Front-of-Pack Nutritional Labels in Promoting Greater Adherence to the Mediterranean Diet Among Italian Consumers
NCT Number: NCT06488079
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: OTHER: Summary Label|OTHER: Nutrient-specific label|OTHER: No label
Sponsor: Donini Lorenzo M
Collaborators: Catholic University of the Sacred Heart
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3029
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-06-04
Completion Date: 2024-07-20
Locations: Sapienza University, Roma, Rome, 00185, Italy

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\&#39; 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

Primary Outcome Measures: Adherence to the Mediterranean diet, The 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., 30 days
Secondary Outcome Measures: Nutrition Knowledge, Nutrition 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., 30 days|Orthorexic behaviour, Orthorexic 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., 30 days