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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02546505
Other study ID # EREN-BVA
Secondary ID
Status Completed
Phase N/A
First received August 28, 2015
Last updated December 1, 2015
Start date October 2015
Est. completion date November 2015

Study information

Verified date December 2015
Source University of Paris 13
Contact n/a
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Interventional

Clinical Trial Summary

Introducing 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. In France, a recent report to the Minister of Health has proposed the introduction of a Front-of-Pack nutrition label, the 5-Colour nutrition label. Existing studies on FOP labels mainly focused on assessment of consumers' acceptability/liking and understanding. If most of the studies on purchasing behavior, conducted in real supermarkets, suggested a positive effect of FOP labels on consumers' food choices, the impact of the 5-CNL has not been evaluated.

The main objective is to evaluate the impact of a Front-of-pack nutrition label, the 5-Colour Nutrition Label on consumer purchases in a controlled environment close to real-world settings. Nutritional quality of the items purchased will be compared using the Food Standards Agency nutrient profiling system (FSA score). The study relies on a comparison across three independent samples :

- Control group: The current situation with current way brands show or not nutritional information on Front of Pack (FoP) - without consumer information

- Intervention n°1: Introduction of a Front-of-pack nutrition label (5-CNL) on selected categories of foods. No additional consumer information

- Intervention n°3: Introduction of a Front-of-pack nutrition label (5-CNL) on selected categories of foods. Additional consumer information specifically targeting nutritional information and explaining the 5-CNL will be performed (this information will consist in a concept shown to respondents before the shopping session).

Participants are recruited in the street through quota sampling, based on criteria of gender, age and purchasing habits on the products categories selected for the introduction of the FOP nutrition label.

The study relies on LabStores®, i.e. shopper laboratory stores, which are controlled study spaces in which a store is recreated in reality.The real lab store mimics a store environment with real shelves, product, and cash register, and presents several product categories in a realistic shopping environment. At the end of the shopping session, the respondents proceed to the cashier but don't actually pay for their purchases.

The selected foodstuffs come from actual retailers' brand products available on the French market. Three categories of products were selected, based on expected variability in nutritional quality of the products and logistic criteria (exclusion of fresh products):

- Breakfast cereals

- Sweet biscuits

- Salty snacks The impact of the different labels on nutritional quality (FSA score, calories, lipids, saturated fatty acids, sugars, proteins, fibre, sodium) of the shopping cart is investigated using one way ANOVA. Pairwise comparisons among FOP labels are assessed by using Tukey's multiple comparisons tests.

All tests of significance are two-sided, and a P value <0.05 is considered significant. Statistical analyses are performed using SAS software (version 9.3; SAS Institute Inc.).


Recruitment information / eligibility

Status Completed
Enrollment 900
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults >18 years old

- Usually purchasing the selected categories of foods (Breakfast cereals, appetizers, biscuits)

Exclusion Criteria:

- Not used to purchasing the selected categories of foods

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Front-of-pack nutrition labeling
Introduction of a Front-of-pack nutrition label (5-CNL) on selected categories of foods.
Consumer information
Information specifically targeting nutritional information and explaining the 5-CNL is presented to the subject (this information will consist in a concept shown to respondents before the shopping session).

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Paris 13 BVA nudge unit

Outcome

Type Measure Description Time frame Safety issue
Primary FSA score to evaluate nutritional quality of the items purchased Mean Food Standards Agency nutrient profiling system (FSA score) of the items purchased Estimated time frame 6 weeks No
Secondary Energy content of the items purchased Energy content (Kcal) for 100g of the items purchased Estimated time frame 6 weeks No
Secondary Saturated fatty acid content of the items purchased Saturated fatty acids content (g) for 100g of the items purchased Estimated time frame 6 weeks No
Secondary Sodium content of the items purchased Sodium content (mg) for 100g of the items purchased Estimated time frame 6 weeks No
Secondary Sugar content of the items purchased Sugar content (mg) for 100g of the items purchased Estimated time frame 6 weeks No
Secondary Protein content of the items purchased Protein content (mg) for 100g of the items purchased Estimated time frame 6 weeks No
Secondary Fiber content of the items purchased Fiber content (mg) for 100g of the items purchased Estimated time frame 6 weeks No
Secondary Number of purchased items labelled in green/yellow/orange/pink/red Estimated time frame 6 weeks No
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