NCT06128083

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
202

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

October 27, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 20, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2024

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

October 27, 2023

Last Update Submit

March 17, 2025

Conditions

Obesity, Childhood

Keywords

ChildObesityAlimentationNutrition

Outcome Measures

Primary Outcomes (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.

    1 year

Secondary Outcomes (7)

  • To assess the association between the risk of overweight and/or obesity in children and the importance of organic food in family dietary habits.

    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

    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

    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.

    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.

    1 year

  • +2 more secondary outcomes

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nice - Hôpital Archet 1

Nice, Alpes-Maritimes, 06000, France

Location

MeSH Terms

Conditions

Pediatric ObesityObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kevin LEGUEULT, MD

    CHU NICE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 13, 2023

Study Start

February 20, 2024

Primary Completion

June 6, 2024

Study Completion

June 6, 2024

Last Updated

March 18, 2025

Record last verified: 2025-03

Locations

FR(1)