Obesity PreventionNCT06796244
Effectiveness of the Croq'Santé Nutrition Education Program in Improving Food Literacy in Schoolchildren
A study testing Croq'Santé nutrition education program in people with Obesity Prevention and Cancer Prevention, run by Marie HERR at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obesity Prevention, Cancer Prevention
- What is being tested?
- Croq'Santé nutrition education program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,205 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2022to 19 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- children in 4th and 5th grades
- attending a school participating in the study
- child and parental consent
Who cannot join
- classes that took part in the questionnaire pre-test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity Prevention, Cancer Prevention
- Being tested
- Croq'Santé nutrition education program
- Keywords
- food literacy, school-based intervention, nutrition education, prevention program, health promotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Croq'Santé nutrition education programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Schools receiving the Croq'Santé program Receives: Other: Croq'Santé nutrition education program |
| Control | No intervention | Schools delivering usual nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start22 Nov 2022
- Primary completion19 Jun 2023
- Study completion19 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marie HERR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marie HERR, University of Versailles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796244
- Sponsor's protocol ID
- UVersailles
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data collected in this study are intended for the evaluation of the Croq'Santé program.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Croq'Santé Nutrition Education Program in Improving Food Literacy in Schoolchildren: a Controlled Before-and-after Study in France
- ClinicalTrials.gov ID
- NCT06796244
- Acronym / sponsor ID
- UVersailles
- Conditions
- Obesity Prevention, Cancer Prevention
- Keywords
- food literacy, school-based intervention, nutrition education, prevention program, health promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,205 participants (actual)
- Lead sponsor
- Marie HERRUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Croq'Santé nutrition education programSchools receiving the Croq'Santé program |
| Control | No intervention | –Schools delivering usual nutrition education |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- children in 4th and 5th grades
- attending a school participating in the study
- child and parental consent
Key exclusion criteria (1 listed)
- classes that took part in the questionnaire pre-test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Croq'Santé nutrition education programThe 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. | Other | Intervention |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: No. The data collected in this study are intended for the evaluation of the Croq'Santé program.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Croq'Santé nutrition education program in people with Obesity Prevention and Cancer Prevention, run by Marie HERR at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.