- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06796244
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1205
Phase
- 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
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Schools receiving the Croq'Santé 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
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
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)
November 22, 2022
Primary Completion (Actual)
June 19, 2023
Study Completion (Actual)
June 19, 2023
Study Registration Dates
First Submitted
January 17, 2025
First Submitted That Met QC Criteria
January 26, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 26, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID 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.
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