NCT02769455

Brief Summary

Front-Of-Pack (FOP) nutrition labelling, providing simplified information on nutritional content at a glance, in order to help consumer make informed choices, has been identified as of major interest by public health specialists of many countries. French health authorities are currently considering the endorsement of a FOP nutrition label, but no specific format has yet been determined. A more simplified FOP nutrition label has been put forward in France, the 5-Colour Nutrition Label (5-CNL). Recent data suggests that the 5-CNL FOP label is well perceived and understood by consumers. The introduction of a FOP nutrition labelling system has been identified as challenging in certain population groups, due to their lower level of nutrition knowledge and unhealthier diets. The aim of the investigators is to evaluate the impact of FOP nutrition labels on the nutritional quality of the shopping cart in an online experimental supermarket in various nutritionally at-risk populations. Two FOP systems will be tested to a control situation without FOP labelling: the Reference Intakes (RI), currently in use by some manufacturers and present in a portion of food products sold in France, and the 5-Colour Nutrition Label (5-CNL). Three 3 arm parallel arm randomized trials are designed, each targeting a specific population. The methodology and interventions are identical across trials. Trials will be conducted in: 1) Working adults between 30-50 years old with low income, 2) Students and 3) Older subjects with identified chronic diseases. The intervention consists in the application of FOP nutrition labels on all food products, either the RI label, currently in use in some products in France, and the 5-CNL label. A control situation with no FOP will also be used. Participants will be asked to perform a shopping session in an experimental online supermarket, in one of the three experimental conditions described. The main outcome will be the overall nutritional quality of the shopping cart, assessed using the mean Food Standards Agency Nutrient profiling system score of the items in the shopping cart.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

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

First Submitted

Initial submission to the registry

May 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

October 3, 2017

Status Verified

September 1, 2017

Enrollment Period

9 months

First QC Date

May 9, 2016

Last Update Submit

September 29, 2017

Conditions

Keywords

Food Labelling

Outcome Measures

Primary Outcomes (1)

  • FSA Score

    Mean nutritional quality of the items in the shopping cart, using the mean Food Standards Agency nutrient profiling system (FSA score) of the items in the shopping cart. The FSA score for foods and beverages is computed taking into account nutrient content for 100g. It allocates positive points (0-10) for content in energy (KJ), total sugar (g), saturated fatty acids (g) and sodium (mg). Negative points (0-5) are allocated to content in fruits, vegetables, legumes and nuts (%), fibers (g) and proteins (g). Scores for foods and beverages were therefore based on a discrete continuous scale from -15 (most healthy) to +40 (less healthy). Modifications to the original score were used in order to ensure a higher consistency with French nutritional recommendations for beverages, cheese and added fats

    3 months

Secondary Outcomes (7)

  • Calories (/100g)

    3 months

  • Saturates (g/100g)

    3 months

  • Sugar (g/100g)

    3 months

  • Sodium (mg/100g)

    3 months

  • Fibers (g/100g)

    3 months

  • +2 more secondary outcomes

Study Arms (3)

Control

NO INTERVENTION

The control group will not be exposed to any FOP nutrition labels

Front-of-pack labelling (Reference Intakes)

EXPERIMENTAL

The second group will be exposed to a FOP nutrition label which is already in use on a portion of food products in France: the 'Reference Intakes' (RIs). The RIs are presented in the form of a chain of rectangles presenting the contribution of a portion of the product to a reference balanced diet of an average person (2000kcal) for each of the following nutrients: energy, lipids, saturated fat, sugars and sodium.

Other: Reference intakes

Front-of-pack labelling (5-CNL)

EXPERIMENTAL

The 5-CNL was developed as a colour-coded summary system nutrition label, following the elements pointed out in reviews. The format of the 5-CNL system therefore includes five categories of nutritional quality of food products, ranging from green (Associated with the A grade) for foods of the highest nutritional quality to red (associated with the E grade), for products with lower nutritional quality. The format is presented in the form of a continuous chain of rectangles, each with its own letter/colour, the letter/colour corresponding to the product being enlarged.

Other: 5-CNL

Interventions

FOP nutrition label which is already in use on a portion of food products in France: the 'Reference Intakes' (RIs). The RIs are a chain of rectangles presenting the contribution of a portion of the product to a reference balanced diet of an average person (2000kcal) for each of the following nutrients: energy, lipids, saturated fat, sugars and sodium. The presentation of the products will always include the label affixed on it. Moreover, the product pages will include two pictures of the product: one with only the package (including the RI as FOP labelling), and a picture with both the package and a larger version of the label, so that it is more visible to the participant. These elements ensure higher visibility, awareness and understanding of the label.

Front-of-pack labelling (Reference Intakes)
5-CNLOTHER

The 5-CNL was developed as a colour-coded summary system nutrition label, following the elements pointed out in reviews. The format includes five categories, ranging from green (Associated with the A grade) for foods of the highest nutritional quality to red (associated with the E grade), for products with lower nutritional quality. The format is presented in the form of a continuous chain of rectangles, each with its own letter/colour, the one corresponding to the product being enlarged. The presentation of the products will always include the label affixed on it. Two pictures of the product will be included: one with only the package (including the 5-CNL as FOP labelling), and a picture with both the package and a larger version of the label, so that it is more visible to the participant.

Front-of-pack labelling (5-CNL)

Eligibility Criteria

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

You may qualify if:

  • Subjects 30-50 years old
  • Having finished their studies and currently active (either working or unemployed)
  • Income/UC \<1200€/month

You may not qualify if:

  • Student, retired
  • Subjects living outside of mainland France
  • Subjects never engaging in grocery shopping
  • TRIAL N°2
  • Subject 18-25 years old
  • Self-declared as student
  • Subjects never engaging in grocery shopping
  • TRIAL N°3
  • Subjects \>50 years-old
  • Diagnosed with one or more of the following chronic conditions (self-reported) : type 2 diabetes, dislipidemia (elevated cholesterol levels, low HDL cholesterol levels, elevated triglycerides levels), hypertension, cardiovascular disease, obesity
  • Subjects declaring suffering from none of the mentioned chronic conditions
  • Subjects never engaging in grocery shopping

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Equipe de Recherche en Epidémiologie Nutritionnelle

Bobigny, 93017, France

Location

Related Publications (3)

  • Egnell M, Boutron I, Peneau S, Ducrot P, Touvier M, Galan P, Fezeu L, Porcher R, Ravaud P, Hercberg S, Kesse-Guyot E, Julia C. Impact of the Nutri-Score front-of-pack nutrition label on purchasing intentions of individuals with chronic diseases: results of a randomised trial. BMJ Open. 2022 Aug 29;12(8):e058139. doi: 10.1136/bmjopen-2021-058139.

  • Egnell M, Galan P, Fialon M, Touvier M, Peneau S, Kesse-Guyot E, Hercberg S, Julia C. The impact of the Nutri-Score front-of-pack nutrition label on purchasing intentions of unprocessed and processed foods: post-hoc analyses from three randomized controlled trials. Int J Behav Nutr Phys Act. 2021 Mar 17;18(1):38. doi: 10.1186/s12966-021-01108-9.

  • Egnell M, Boutron I, Peneau S, Ducrot P, Touvier M, Galan P, Buscail C, Porcher R, Ravaud P, Hercberg S, Kesse-Guyot E, Julia C. Randomised controlled trial in an experimental online supermarket testing the effects of front-of-pack nutrition labelling on food purchasing intentions in a low-income population. BMJ Open. 2021 Feb 8;11(2):e041196. doi: 10.1136/bmjopen-2020-041196.

MeSH Terms

Conditions

Food Preferences

Interventions

Recommended Dietary Allowances

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Nutritional RequirementsNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaNutrition PolicyHealth PolicyPublic PolicySocial Control PoliciesPolicyHealth Care Economics and Organizations

Study Officials

  • Serge Hercberg

    Nutritional Epidemiology Research Team

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Nutritional Epidemiology Research Team

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 11, 2016

Study Start

August 1, 2016

Primary Completion

May 1, 2017

Study Completion

July 1, 2017

Last Updated

October 3, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations