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Clinical Trials/NCT06488079
NCT06488079Active, not recruitingNot Applicable

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

Donini Lorenzo M2 sites in 1 country3,029 target enrollmentStarted: June 4, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
3,029
Locations
2
Primary Endpoint
Adherence to the Mediterranean diet

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Adherence to the Mediterranean diet

Time Frame: 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 Outcomes

  • Nutrition Knowledge(30 days)
  • Orthorexic behaviour(30 days)

Investigators

Sponsor
Donini Lorenzo M
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Donini Lorenzo M

Full Professor

University of Roma La Sapienza

Study Sites (2)

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