- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06128083
Evaluation of the Impact of Eating Habits on Children's Corpulence (KALI SANTE)
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
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Alpes-Maritimes
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Nice, Alpes-Maritimes, France, 06000
- CHU Nice - Hôpital Archet 1
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
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
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
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1 year
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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:
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1 year
|
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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
|
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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
For each group, participants indicated their frequency of consumption
Two scores are created: "organic food score" for organically sourced food, and "local food score" for locally produced food, awarding:
|
1 year
|
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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:
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1 year
|
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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.
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1 year
|
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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
|
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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.
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1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kevin LEGUEULT, MD, CHU Nice
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-PP-05
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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