NCT05610930

Brief Summary

A modified version of the Nutri-Score (Nutri-Score 2.0), containing an additional graphic mention when the product is ultra-processed, has been proposed. The investigators aim to study, in a randomised controlled trial design nested in the NutriNet-Santé cohort, the impact of this modified version on the objective understanding of foods' nutritional quality, and on the identification of UPFs as primary outcomes. They also aim to study as secondary outcomes the impact of this label on purchasing intentions and the product perceived as the healthiest.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21,159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 9, 2022

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

October 28, 2022

Last Update Submit

May 10, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Objective understanding the nutritional quality.

    The answers of the participants on the corresponding questionnaire (via the NutriNet-Santé website) were expected to match the order according to which Nutri-Score ranks the 3 products (highest nutritional quality, second highest, third highest). In case of ex-æquos (i.e., two products having the same Nutri-Score), both were considered correct. Therefore, the number of correct answers for the nutritional dimension could range between 0 (no correct answers) to 9 (3 best products\*3 food categories, all correct answers).

    Between 30 minutes and 1 hour (the time needed to fill the questionnaire)

  • Objective understanding the ultra-processing dimension.

    Participants were expected to identify all UPFs on the corresponding questionnaire (via the NutriNet-Santé website). For each product, the answer was considered correct if an UPF was identified as such by the participant (the gold standard being the presence of the black banner of the Nutri-Score 2.0, corresponding to the NOVA 4 "ultra-processed" definition), and a non-UPF was identified as such. Therefore, the number of correct answers for the food processing dimension could range between 0 (no correct answers) and 22 (correct answer for all 22 products).

    Between 30 minutes and 1 hour (the time needed to fill the questionnaire)

Secondary Outcomes (2)

  • Purchasing intentions

    Between 30 minutes and 1 hour (the time needed to fill the questionnaire)

  • Product perceived as the healthiest

    Between 30 minutes and 1 hour (the time needed to fill the questionnaire)

Study Arms (2)

Control arm

NO INTERVENTION

Participants received a questionnaire including 3 sets of images of food packaging, (brand blinded), categorized by food groups: 8 cookies, 7 breakfast cereals, and 7 ready-to-eat meals, but without front-of-pack nutritional label (in case the original Nutri-Score was displayed on the product, it was hidden by the investigators). They had the possibility to check the back-of-pack nutrition facts and ingredient information. First, they were asked which product they would intend to purchase in each category, and which product they thought to be the "healthiest". Then, participants were asked 1) to rank them according to their nutritional quality by identifying the first, the second and the third products with the best nutritional quality (in this order) and 2) to identify those that were ultra-processed.

Experimental arm

EXPERIMENTAL

Participants received a questionnaire including 3 sets of images of real food product packaging (brand blinded), categorized by food groups: 8 cookies, 7 breakfast cereals, and 7 ready-to-eat meals, with the Nutri-Score 2.0 displayed on the front-of-pack of each product. First, they were asked which product they would intend to purchase in each category, and which product they thought to be the "healthiest". Then, participants were asked 1) to rank them according to their nutritional quality by identifying the first, the second and the third products with the best nutritional quality (in this order) and 2) to identify those that were ultra-processed. Last, a series of questions evaluated how participants of this arm perceived the Nutri-Score 2.0 and whether they found it helpful.

Other: Front-of-pack label NutriScore 2.0

Interventions

Participants in the experimental arm can see, in case the product is ultra-processed, a black banner surrounding the Nutri-Score, with the word "ultra-transformé", meaning ultra-processed, and no black banner otherwise. Participants in the control arm had no label at all. The intervention (the Nutri-Score 2.0) was added on the packaging on the products included in the 3 sets of images that participants recieved via the questionnaire.

Experimental arm

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled in the NutriNet-Santé cohort

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Equipe de recherche en Epidémiologie nutritionnelle

Bobigny, 93017, France

Location

Related Publications (1)

  • Srour B, Hercberg S, Galan P, Monteiro CA, Szabo de Edelenyi F, Bourhis L, Fialon M, Sarda B, Druesne-Pecollo N, Esseddik Y, Deschasaux-Tanguy M, Julia C, Touvier M. Effect of a new graphically modified Nutri-Score on the objective understanding of foods' nutrient profile and ultraprocessing: a randomised controlled trial. BMJ Nutr Prev Health. 2023 Jun;6(1):108-118. doi: 10.1136/bmjnph-2022-000599. Epub 2023 Jun 8.

Study Officials

  • Bernard Srour, PhD, PharmD

    Institut National de la Santé Et de la Recherche Médicale, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Epidemiologist

Study Record Dates

First Submitted

October 28, 2022

First Posted

November 9, 2022

Study Start

May 1, 2022

Primary Completion

July 7, 2022

Study Completion

July 7, 2022

Last Updated

May 12, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations