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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: Summary Label; Other: Nutrient-specific label; Other: No label

• Study Type: Interventional
• Enrollment (Actual): 3029
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome
    • Roma, Rome, Italy, 00185
      • Sapienza University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutri-Score label	Other: Summary Label; The Nutri-Score Front-of-Pack nutritional label
Experimental: NutrInform Battery label	Other: Nutrient-specific label; The NutrInform Battery Front-of-Pack nutritional label
Sham Comparator: No label	Other: No label; Conventional food educational flyer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Donini Lorenzo M
• Collaborators: Catholic University of the Sacred Heart
• Investigators: Principal Investigator: Lorenzo Maria Donini, Sapienza University

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2024
• Primary Completion (Estimated): July 20, 2024
• Study Completion (Estimated): July 20, 2024

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CERT_18F2F1CDB00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: By decision of the ethics committee data can be shared only in an aggregated form

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No