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

NCT06488079 | Active Not Recruiting

• 1 other identifier: CERT_18F2F1CDB00
• Study Type: interventional
• Target: 3,029
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Nutrition Knowledge

  30 days

• Orthorexic behaviour

  30 days

Study Arms (3)

Nutri-Score label

EXPERIMENTAL

Other: Summary Label

NutrInform Battery label

EXPERIMENTAL

Other: Nutrient-specific label

No label

SHAM COMPARATOR

Other: No label

Interventions

Summary Label OTHER

The Nutri-Score Front-of-Pack nutritional label

Nutri-Score label

Nutrient-specific label OTHER

The NutrInform Battery Front-of-Pack nutritional label

NutrInform Battery label

No label OTHER

Conventional food educational flyer

No label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• limited to participants older than 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Donini Lorenzo M: lead
• Catholic University of the Sacred Heart: collaborator

Study Sites (1)

Sapienza University

Roma, Rome, 00185, Italy

Location

Study Officials

• Lorenzo Maria Donini

  Sapienza University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 5, 2024
• Study Start: June 4, 2024
• Primary Completion: July 20, 2024
• Study Completion: July 20, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)