Condition category
Nutritional, Metabolic, Endocrine
Date applied
07/11/2017
Date assigned
13/11/2017
Last edited
13/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Unhealthy eating is a key risk factor in chronic non-communicable diseases such as cardiovascular disorders (like heart attacks and strokes) and diabetes (uncontrolled blood sugar, which have sharply risen and account for 60% of deaths worldwide. Public health authorities are eager to start prevention programmes promoting foods of better nutritional quality. One such policy is the recent European regulation on the provision of nutrition information to consumers, introduced in December 2016, stating that “the energy value and the amount of nutrients […] may be given by other forms of expression and/or presented using graphical forms or symbols in addition to words or numbers”. This information, provided on a voluntary basis, must be placed on the “front of pack” (FOP) of the food product. The aim of this study to measure and compare the effects of four front-of-pack (FOP) nutritional labelling systems on the nutritional quality of supermarket food purchases.

Who can participate?
Shoppers at the supermarkets during the study.

What does the study involve?
Participants are informed of the study in each tested supermarket through specific leaflets, shelf stoppers, and displays, which are controlled for similar amount of information. 1.75 million stickers are affixed to the front of the packages of 1,298 products in four categories (fresh prepared foods, pastries, breads, and canned prepared foods). Two of the tested systems provided nutrient-level information: Nutri-Repère displayed energy level per portion as well as total fat, saturated fat, sugars and salt in grams, as a percentage of Guideline Daily Amounts (GDA), and as a blue bar chart, while Nutri-Couleurs provided the same information minus the bar chart but with the green-yellow-red color coding of the British Traffic Lights system for each nutrient. The other two systems provided a synthetic evaluation based on the amount of positive and negative nutrients: SENS (Simplified Nutritional Labelling System) displayed one of four labels with recommended consumption frequency or quantity, colored from green to purple, while Nutri-Score showed the location of a cursor on a ruler with five color-coded grades, from A (green) to E (red). Retailers provided detailed purchase data of the loyalty card holders shopping in the 60 stores one year before and during the intervention period. The main outcome was the nutritional quality of the purchases measured using the nutrient profiling scoring system developed for the British Food Standard Agency (FSA). This was measured for all shoppers and for low-price shoppers.

What are the possible benefits and risks of participating?
There are no direct benefits or risks with participating.

Where is the study run from?
This study is being run by Toulouse School of Economics (France) and takes place in French supermarkets from three national chains in France.

When is the study starting and how long is it expected to run for?
February 2016 to December 2016

Who is funding the study?
1. Fonds Français pour l’Alimentation et la Santé (French Fund for Food and Health) (France)
2. French National Health-Insurance Fund for Salaried Workers (France)

Who is the main contact?
1. Professor Pierre Dubois (Scientific)
pierre.dubois@tse-fr.eu
2. Dr Olivier Allais (Scientific)
olivier.allais@inra.fr

Trial website

Contact information

Type

Scientific

Primary contact

Prof Pierre Dubois

ORCID ID

http://orcid.org/0000-0002-9077-6843

Contact details

Toulouse School of Economics
University of Toulouse 1 Capitole
21 Allée de Brienne
Toulouse
31000
France
+33 5 61 12 85 55
pierre.dubois@tse-fr.eu

Type

Scientific

Additional contact

Dr Olivier Allais

ORCID ID

Contact details

INRA ALISS
65 bd de Brandeboug
Ivry Sur Seine
94200
France
+33 1 49 59 69 31
olivier.allais@inra.fr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Impact of analytic and synthetic front-of-pack graphical nutrition labels on the nutritional quality of supermarket food purchases: Evidence from a french randomized control experiment

Acronym

Study hypothesis

Do front-of-pack (FOP) nutritional labeling systems differently affect the nutritional quality of supermarket food purchases?

Ethics approval

No ethical approval was required. The study was authorized by ministerial decree 2016-980 of 19/07/2016 signed by French Prime Minister.

Study design

A five-arm, real-life randomized control trial (RCT) with baseline (10 weeks) and intervention (10 weeks)

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

See additional files (in French)

Condition

Nutrition labelling

Intervention

The intervention assesses the effects of four validated front of package FOP nutritional labelling systems using the food purchase of 191,000 loyalty card holders in 1,298 products in four categories (fresh prepared foods, pastries, breads, and canned prepared foods).

Four labelling system are tested. Two of the tested systems provided nutrient-level information: Nutri-Repère displayed energy level per portion as well as total fat, saturated fat, sugars and salt in grams, as a percentage of Guideline Daily Amounts (GDA), and as a blue bar chart; Nutri-Couleurs the French equivalent of the British Traffic Lights system. The other two systems provided a synthetic evaluation based on the amount of positive and negative nutrients: SENS (Simplified Nutritional Labelling System) displayed one of four labels with recommended consumption frequency or quantity, colored from green to purple, while Nutri-Score showed the location of a cursor on a ruler with five color-coded grades, from A (green) to E (red).

From September 26th to December 4th 2016, the FOP labels are put on actual food products, with each system being simultaneously tested in 10 randomly selected supermarkets - four Carrefour, three Simply Market, and three Casino stores - for 10 weeks. In addition, twenty control supermarkets, with no added FOP labelling, are randomly chosen: eight Carrefour, six Simply Market, and six Casino stores. The supermarkets were selected from four French regions: Île de France (Grande Couronne), Hauts de France (Nord Pas de Calais and Picardie), Haute Normandie, Rhône-Alpes (Ain, Loire, Rhône). The random sampling of the 60 supermarkets is carried out to include at least 40% of the stores in underprivileged areas, to ensure we would have enough underprivileged consumers in our sample.

Consumers are informed of the intervention in each tested supermarket through specific leaflets, shelf stoppers, and displays, which are controlled for similar amount of information.

Retailers provided detailed purchase data of the loyalty card holders shopping in the 60 stores one year before (baseline period) and during the intervention period.

The effects of graphical FOP nutritional labeling on the nutritional quality of purchases are estimated using two statistical methods: first difference and difference in differences. The effects are estimated for all labeled products in the data set and by product category.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Nutritional quality of food purchases is measured by the quantity-weighted average of the FSA score of the labeled foods purchased by each loyalty card holder over ten weeks in 2016, September 26th and December 4th and the ten equivalent weeks in 2015, between September 28th and December 6th (baseline).

Secondary outcome measures

Nutritional quality of food purchases for low-price shopper is measured by the quantity-weighted average of the FSA score of the labeled foods purchased by each loyalty card holder that belongs the 40% of shoppers paying the lowest average price over ten weeks in 2016, September 26th and December 4th and the ten equivalent weeks in 2015, between September 28th and December 6th (baseline).

Overall trial start date

23/02/2016

Overall trial end date

04/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

All loyalty cardholders who made at least one shopping trip in one of the 60 supermarkets during the trial period, as well as the same data for the ten equivalent weeks in 2015, between September 28th and December 6th were included in the trial.

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

191,790 loyalty cardholders were selected; 26,213 (26,975; 37,875; 32,817; 67,910) individuals shopping in Nutri-Couleurs (Nutri-Repère; Nutri-Score; SENS; control) stores.

Participant exclusion criteria

All Loyalty cardholders who never made a shopping trip in one of the 60 supermarkets.

Recruitment start date

26/09/2016

Recruitment end date

01/10/2016

Locations

Countries of recruitment

France

Trial participating centre

Carrefour market stores (Carrefour)
102 avenue de Paris (Rue Alexandra David-Néel) 91300 Massy
Massy
91300
France

Trial participating centre

Simply market Store (Auchan)
Villeneuve d'Ascq
59650
France

Trial participating centre

Casino
Saint-Etienne
42008
France

Sponsor information

Organisation

French Ministry for Solidarity and Health

Sponsor details

14 Avenue Duquesne
Paris
75350
France

Sponsor type

Government

Website

Funders

Funder type

Charity

Funder name

Fonds Français pour l’Alimentation et la Santé (French Fund for Food and Health)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

French National Health-Insurance Fund for Salaried Workers

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Plans to publish in the American Journal of Clinical Nutrition. Protocol: http://solidarites-sante.gouv.fr/IMG/pdf/rapport_du_comite_scientifique_11_avril_2016.pdf
Main steps of the intervention: http://solidarites-sante.gouv.fr/archives/article/l-evaluation-en-conditions-reelles-d-achat-des-systemes-d-information-317290


IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Daniel Nairaud (d.nairaud@alimentation-sante.org). The data are the ownership of the Fond Français pour Alimentation et la Santé (the French Fund for Food and Health, FFAS), and they are available on scientific project submission.

Intention to publish date

17/01/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes