Effectiveness of the Croq'Santé Nutrition Education Program in Improving Food Literacy in Schoolchildren

January 26, 2025 updated by: Marie HERR

Effectiveness of the Croq'Santé Nutrition Education Program in Improving Food Literacy in Schoolchildren: a Controlled Before-and-after Study in France

Background: Nutritional factors including diet, physical activity, weight status and alcohol consumption are among the most important preventable risk factors for cancer. Interventions are needed to help children make the right choices in a complex food environment. The JDB Foundation designs primary cancer prevention projects through health education targeted at young people. It has designed the "Croq'Santé" project, which aimed to reduce the risks associated with overweight and obesity by improving food literacy of children aged 8 to 11, corresponding to the 4th and 5th grades. Briefly, food literacy refers to having the knowledge, skills and attitudes to choose, prepare and enjoy healthy foods. Accompanied by their teacher, a class will create a balanced recipe (or re-adapt an existing one) through a series of stages (10 sessions in total), allowing children to explore the foods and stakeholders in the food chain, understand nutrition, cook and taste new flavors. Objectives: The primary objective of this study is to evaluate whether the intervention successfuly improves the food literacy of 8- to 11-year-olds. Secondary objectives include examining the influence of socioeconomic factors on the program's effectiveness and process evaluation. Methods: We intent to conduct a quasi-experimental before-and-after study including 60 classes (approximately 1500 children). The classes in the intervention group will receive the Croq'Santé program, while the classes in the control group will receive usual school nutrition education. The schools participating in the control group will have the possibility to receive the Croq'Santé program the following year if they wish. The primary outcome will focus on changes in food literacy, measured using a child-friendly questionnaire administered before and after the intervention. Other information will be collected at child level (e.g. gender, age, family composition) and school level (e.g. socioeconomic indicators). Expected results: Cancer remains the leading cause of death in France and the production of knowledge on the effectiveness of public health interventions is essential to guide prevention strategies. If the Croq'Santé programme actually shows its effectiveness, it could be scaled up and adapted to different contexts.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1205

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Fontenay-les-Briis, France, 91640
        • Fondation JDB Prévention cancer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • children in 4th and 5th grades
  • attending a school participating in the study
  • child and parental consent

Exclusion Criteria:

- classes that took part in the questionnaire pre-test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Schools receiving the Croq'Santé program
Other: Croq'Santé nutrition education program
The Croq'Santé program aims to develop food literacy in children aged 8 to 11 years. It is based on the creation or adaptation of a recipe chosen by the children. The program is designed to run over the course of one school year, with approximately ten sessions. These sessions are delivered in schools by teachers, following a 3-hour training course. Teachers receive an intervention kit that includes a guide for conducting the different sessions, food images, and a mascot, which children can accessorize as they complete sessions and challenges. The sessions are organized around four stages: discover, invent, cook, and taste. Challenges are to be completed at the end of each stage with the child's family. At the end of the program, children are invited to cook and taste their recipe in a dedicated environment.
No Intervention: Control
Schools delivering usual nutrition education

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Food literacy
Time Frame: The food knowledge questionnaire was administered before the start of the program and at the end of the program, i.e. up to 6 months after the first administration.
Food literacy was assessed using a score (ranging from 0 to 25, the higher the better) computed from 25 items covering cooking skills, food and nutrition knowledge, attitude towards food, and eating habits (Dallant, Appetite 2024).
The food knowledge questionnaire was administered before the start of the program and at the end of the program, i.e. up to 6 months after the first administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marie HERR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 19, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 19, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UVersailles

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data collected in this study are intended for the evaluation of the Croq'Santé program.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings