NCT04252898

Brief Summary

This controlled trial investigates the impact of the implementation of a front-of-pack nutrition label, namely Nutri-Score, on foods and beverages sold in a contract catering in France on the nutritional quality of purchases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,082

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 24, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2020

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

January 24, 2020

Last Update Submit

August 5, 2021

Conditions

Keywords

Food labelingnutritional qualityfood purchases

Outcome Measures

Primary Outcomes (1)

  • Change in the overall nutritional quality of purchases over time

    Score using the Food Standards Agency nutrient profiling system modified by the HCSP, allocating points depending on the amounts in unfavourable elements (energy, saturates, sugars, sodium) and favorable elements (fibres, proteins and fruits, vegetables, nuts and oils (olive, colza, nuts))

    Through study completion, an average of 6 months

Secondary Outcomes (7)

  • Change in energy content of purchases

    Through study completion, an average of 6 months

  • Change in Saturated fat content of purchases

    Through study completion, an average of 6 months

  • Change in Sugar content of purchases

    Through study completion, an average of 6 months

  • Change in Sodium content of purchases

    Through study completion, an average of 6 months

  • Change in Protein content of purchases

    Through study completion, an average of 6 months

  • +2 more secondary outcomes

Study Arms (2)

Intervention arm

EXPERIMENTAL

In this arm (site n°1), participants will purchase their products in the restaurant first in a control phase and then in an interventional phase with the Nutri-Score affixed on food products.

Behavioral: Front-of-pack nutrition label Nutri-Score

Control arm

NO INTERVENTION

In this arm (site n°2), participants will purchase their products in the restaurant during the whole study without any label affixed on food products.

Interventions

The intervention consists of displaying the Nutri-Score on dishes and pre-packed foods.

Intervention arm

Eligibility Criteria

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

You may qualify if:

  • all individuals purchasing in the contract catering restaurants will be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Equipe de Recherche en Epidémiologie Nutritionnelle

Bobigny, 93017, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The trial will include four sites (two pairs, with an intervention site and a control site) and two phases. For each pair of sites: * site n°1: one control phase with no intervention followed by an interventional phase with the Nutri-Score applied on products * site n°2: control phases only, without the Nutri-Score applied during any of the two phases
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 24, 2020

First Posted

February 5, 2020

Study Start

December 16, 2019

Primary Completion

March 13, 2020

Study Completion

March 13, 2020

Last Updated

August 6, 2021

Record last verified: 2021-08

Locations