Evaluation of the Impact of Eating Habits on Children's Corpulence (KALI SANTE)

March 17, 2025 updated by: Centre Hospitalier Universitaire de Nice

Prelimenary Observational Study of the Influence of Adherence to the Recommandations Issued by the National Nutrition and Health Program on the Risk of Overweiht and Obesity in Children : the Case of a Municipality That Has Signed the " Ville Active PNNS " Charter

Childhood obesity has been rising steadily over the past 40 years. In 2016, the World Health Organization (WHO) observed around 340 million overweight or obese children and adolescents worldwide, including one in five in France. The causes are complex, both individual (genetic, biological, behavioral) and collective (social, economic, cultural). Childhood obesity encourages the development of chronic diseases such as diabetes and hypertension, and can affect mental health. Without early treatment, the risk of obesity persisting into adulthood is high.

In the Alpes-Maritimes region, the commune of Mouans-Sartoux has been promoting a local diet in line with PNNS-4 recommendations since 2011.

We wish to study the impact of these actions on the health of Mouans children. We propose a preliminary observational study to assess the relationship between family adherence to PNNS recommendations and the prevalence of overweight and obesity in Mouans-Sartoux elementary school children.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

202

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

    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06000
        • CHU Nice - Hôpital Archet 1

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

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

All children enrolled in one of Mouans-Sartoux's 3 public elementary school.

  • Schools (3): A. Legall / F. Jacob / Orée du bois.
  • Classes: CP to CM2 inclusive.
  • There are no age or gender restrictions. Children not enrolled in the school canteen may participate.

Description

Inclusion Criteria:

  • The child must be enrolled in one of Mouans-Sartoux's three public elementary school (A. Legall / F. Jacob / Orée du bois) at the start of the 2023 school year
  • Social Security affiliation
  • Non-opposition of the legal representative(s) of parental authority

Exclusion Criteria:

  • Opposition to participation in research involving the human person
  • In the event of disagreement between the parents, we will take non-participation into account

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the association between the risk of overweight and/or obesity in children and family adherence to PNNS-4 recommendations.
Time Frame: 1 year
Calculation of the odd-ratio (OR) between the risk of "overweight and/or obesity" in children (corresponding to a BMI z-score > 1) and family adherence to PNNS recommendations estimated from the "PNNS-GS2" score using a univariate logistic regression model.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the association between the risk of overweight and/or obesity in children and the importance of organic food in family dietary habits.
Time Frame: 1 year

The "Organic and Local Food Consumption" questionnaire (18) is used to estimate household consumption of organic products. The score obtained from this questionnaire will be evaluated in a similar way to the "PNNS-GS2" score.

We will study the prevalence of overweight and obesity according to the presence or absence of each listed risk factor belonging to the following categories:

  • Children's physical activity and sports
  • Favorable behaviors
  • Household socio-demographic data
  • Child's environment
  • Parents' lifestyle
  • Declarative medical data
1 year
Evaluate the influence of children's school canteen enrolment on family adherence to the National Health Nutrition Program 4 (PNNS-4) recommendations by PNNS-GS2) score
Time Frame: 1 year
We will assess the impact of whether or not children are enrolled in the canteen by studying for each group the distribution of the National Health Nutrition Program - Guidelines Score 2 (PNNS-GS2) score; The "PNNS-GS2" score assesses families' adherence to the PNNS-4 recommendations, based on a list of items relating to eating habits. Responses are grouped into quartiles to form comparison groups. In this study, the score is assessed at family level.
1 year
Evaluate the influence of children's school canteen enrolment on family adherence to the National Health Nutrition Program 4 (PNNS-4) recommendations by "Organic and Local Food Consumption" score
Time Frame: 1 year

We will assess the impact of whether or not children are enrolled in the canteen by studying for each group the distribution of the "Organic and Local Food Consumption" score.

List of food groups

  1. Fruit
  2. Vegetables
  3. Soy
  4. Dairy products
  5. Meat and fish
  6. Eggs
  7. Grains and pulses
  8. Bread and cereals
  9. Flour
  10. Vegetable oils and condiments
  11. Prepared dishes
  12. Coffee/tea/tea tea
  13. Sweet products
  14. Food supplements
  15. Other foods

For each group, participants indicated their frequency of consumption

  • Organic: "Most of the time", "From time to time", "Never".
  • Locally produced: "Most of the time", "From time to time", "Never".

Two scores are created: "organic food score" for organically sourced food, and "local food score" for locally produced food, awarding:

  • 2 points for "Most of the time
  • 1 point for "Once in a while
  • 0 points for "Never The two scores are added together to obtain the "organic and local food score".
1 year
Evaluate the influence of children's school canteen enrolment on family adherence to the National Health Nutrition Program 4 (PNNS-4) recommendations by the distribution of the z-score.
Time Frame: 1 year

We will assess the impact of whether or not children are enrolled in the canteen by studying for each group the distribution of the z-score and the prevalence of overweight and obesity.

In children, BMI is not a good representation of corpulence, as individual growth varies according to sex and age. We therefore use the BMI z-score (called "Z-score" in this study), which expresses the deviation of a child's BMI from the reference value according to sex and age.

The Z-score can be used to classify children into several categories according to the following limits:

  • Extreme thinness
  • Thin
  • Normal build
  • Overweight
  • Obese
1 year
Evaluate the influence of children's school canteen enrolment on family adherence to the National Health Nutrition Program 4 (PNNS-4) recommendations by prevalence of risks factors.
Time Frame: 1 year
We will assess the impact of whether or not children are enrolled in the canteen by studying for each group prevalence of risk factors studied.
1 year
Compare the observed proportion of mouansois children who are overweight or obese with data from the Alpes-Maritimes department's maternal and child protection service.
Time Frame: 1 year
We will calculate the difference between the observed proportion of overweight or obese children in Mouans and that expected according to the data presented by the Protection Maternelle et Infantile des Alpes-Maritimes.
1 year
Collect hair samples from local children to build up a sample bank for future research into the presence of pesticides and endocrine disruptors.
Time Frame: 1 year
We will be collecting hair samples from volunteer children in Mouans, in order to build up a sample bank in parallel with the study, with a view to future work on measuring the presence of endocrine disruptors / pesticides.
1 year

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Kevin LEGUEULT, MD, CHU Nice

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)

February 20, 2024

Primary Completion (Actual)

June 6, 2024

Study Completion (Actual)

June 6, 2024

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

November 9, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 22-PP-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Obesity, Childhood

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