Effects of front-of-pack nutrition labels on food purchases: a randomised controlled trial

ISRCTN ISRCTN58212763
DOI https://doi.org/10.1186/ISRCTN58212763
Secondary identifying numbers N/A
Submission date
07/11/2017
Registration date
13/11/2017
Last edited
01/04/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Pierre Dubois
Scientific

Toulouse School of Economics
University of Toulouse 1 Capitole
21 Allée de Brienne
Toulouse
31000
France

ORCiD logoORCID ID 0000-0002-9077-6843
Phone +33 5 61 12 85 55
Email pierre.dubois@tse-fr.eu
Dr Olivier Allais
Scientific

INRA ALISS
65 bd de Brandeboug
Ivry Sur Seine
94200
France

Phone +33 1 49 59 69 31
Email olivier.allais@inra.fr

Study information

Study designA five-arm, real-life randomized control trial (RCT) with baseline (10 weeks) and intervention (10 weeks)
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Other
Study typePrevention
Participant information sheet ISRCTN58212763_PIS_Nutr CouleursDEF_13Nov17.pdf
Scientific titleImpact 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
Study objectivesDo front-of-pack (FOP) nutritional labeling systems differently affect the nutritional quality of supermarket food purchases?
Ethics approval(s)No ethical approval was required. The study was authorized by ministerial decree 2016-980 of 19/07/2016 signed by French Prime Minister.
Health condition(s) or problem(s) studiedNutrition labelling
InterventionThe 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 typeBehavioural
Primary outcome measureNutritional 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 measuresNutritional 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 study start date23/02/2016
Completion date04/12/2016

Eligibility

Participant type(s)Other
Age groupAdult
SexBoth
Target number of participants191,790 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.
Key inclusion criteriaAll 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.
Key exclusion criteriaAll Loyalty cardholders who never made a shopping trip in one of the 60 supermarkets.
Date of first enrolment26/09/2016
Date of final enrolment01/10/2016

Locations

Countries of recruitment

  • France

Study participating centres

Carrefour market stores (Carrefour)
102 avenue de Paris (Rue Alexandra David-Néel)
91300 Massy
Massy
91300
France
Simply market Store (Auchan)
Villeneuve d'Ascq
59650
France
Casino
Saint-Etienne
42008
France

Sponsor information

French Ministry for Solidarity and Health
Government

14 Avenue Duquesne
Paris
75350
France

Funders

Funder type

Charity

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

No information available

French National Health-Insurance Fund for Salaried Workers

No information available

Results and Publications

Intention to publish date17/01/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlans 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 planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet 13/11/2017 01/04/2019 No Yes
Participant information sheet 13/11/2017 01/04/2019 No Yes
Participant information sheet 13/11/2017 01/04/2019 No Yes
Participant information sheet 13/11/2017 01/04/2019 No Yes

Additional files

ISRCTN58212763_PIS_Nutr CouleursDEF_13Nov17.pdf
Uploaded 01/04/2019
ISRCTN58212763_PIS_NutriRepere_13Nov17.pdf
Uploaded 01/04/2019
ISRCTN58212763_PIS_Nutri-Score_13Nov17.pdf
Uploaded 01/04/2019
ISRCTN58212763_PIS_SENSDEF_13Nov17.pdf
Uploaded 01/04/2019

Editorial Notes

01/04/2019: The participant information sheets have been uploaded.