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

Not Applicable

Active, not recruiting

• Conditions: Healthy
• Interventions: Other: Summary Label; Other: No label; Other: Nutrient-specific label

• Registration Number: NCT06488079
• Lead Sponsor: Donini Lorenzo M

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-04
• Study First Submitted: 2024-06-26
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-03
• Last Update Submitted: 2024-07-03
• Study First Posted: 2024-07-05
• Last Update Posted: 2024-07-05
• Primary Completion: 2024-07-20
• Study Completion: 2024-07-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3029

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutri-Score label	Summary Label	-
No label	No label	-
NutrInform Battery label	Nutrient-specific label	-

Primary Outcome Measures

Name	Time	Method
Adherence to the Mediterranean diet	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Nutrition Knowledge	30 days	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.
Orthorexic behaviour	30 days	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.

Trial Locations

Locations (1)

Sapienza University; 🇮🇹 Roma, Rome, Italy