NCT06796244

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

January 17, 2025

Last Update Submit

January 26, 2025

Conditions

Keywords

food literacyschool-based interventionnutrition educationprevention programhealth promotion

Outcome Measures

Primary Outcomes (1)

  • Food literacy

    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.

Study Arms (2)

Intervention

EXPERIMENTAL

Schools receiving the Croq'Santé program

Other: Croq'Santé nutrition education program

Control

NO INTERVENTION

Schools delivering usual nutrition education

Interventions

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.

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- classes that took part in the questionnaire pre-test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation JDB Prévention cancer

Fontenay-lès-Briis, 91640, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Public Health

Study Record Dates

First Submitted

January 17, 2025

First Posted

January 28, 2025

Study Start

November 22, 2022

Primary Completion

June 19, 2023

Study Completion

June 19, 2023

Last Updated

January 28, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

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

Locations