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Obesity, ChildhoodKALI SANTENCT06128083

Evaluation of the Impact of Eating Habits on Children's Corpulence

An observational study of Obesity, Childhood, run by Centre Hospitalier Universitaire de Nice at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 6 to 11 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Childhood
How many people
202 participants
Where
1 siteFrance
Study dates
20 Feb 2024to 6 Jun 2024
Phase
Observational
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 6 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHU Nice - Hôpital Archet 1

    Nice, Alpes-Maritimes, 06000

Other trials in France

About this study

Official title: 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.

Keywords
Child, Obesity, Alimentation, Nutrition
Medical subject headings
Pediatric Obesity, Obesity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the association between the risk of overweight and/or obesity in children and family adherence to PNNS-4 recommendations.

    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.

    Measured: 1 year

Secondary outcomes (7)
  1. To assess the association between the risk of overweight and/or obesity in children and the importance of organic food in family dietary habits.

    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

    Measured: 1 year

  2. 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

    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.

    Measured: 1 year

  3. 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

    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".

    Measured: 1 year

  4. 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.

    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

    Measured: 1 year

  5. 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.

    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.

    Measured: 1 year

  6. 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.

    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.

    Measured: 1 year

  7. Collect hair samples from local children to build up a sample bank for future research into the presence of pesticides and endocrine disruptors.

    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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2023
  2. Study start20 Feb 2024
  3. Primary completion6 Jun 2024
  4. Study completion6 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06128083
Sponsor's protocol ID
22-PP-05
Acronym
KALI SANTE
Status last verified
Mar 2025
First submitted
27 Oct 2023
Last updated
18 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, Childhood, run by Centre Hospitalier Universitaire de Nice 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 2 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 18 Mar 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?

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). 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 18 Mar 2025.

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