Role of the Environment in Pediatric Obesity (REOP)

Childhood obesity is a particular concern in developed countries such as the United States, the United Kingdom, Canada, and certain European countries. According to the World Health Organization (WHO), approximately 6% of children under the age of 5 worldwide were obese in 2016, a figure that continues to rise.

The pathophysiology of pediatric obesity can be explained by several interconnected biological and behavioral mechanisms. In particular, it involves dysfunctions in the hormones that regulate appetite and satiety, as well as dysfunctions in lipid metabolism.

Per- and polyfluoroalkyl substances (PFAS) are a large family of synthetic chemical compounds. The main PFAS are perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), perfluorononanoic acid (PFNA), and perfluorohexanesulfonic acid (PFHxS). PFAS are present in many everyday consumer products.

Bisphenol A (BPA) is a chemical compound used primarily in the manufacture of plastics and resins. It is commonly found in polycarbonate plastics, used to make food containers and water bottles, as well as in epoxy resins, which are used to coat the inside of food cans and water pipes.

Non-persistent pesticides, such as organophosphates and polychlorinated biphenyls, are chemicals used primarily in agriculture to control insects and other pests.

There are arguments suggesting that PFAS, bisphenol A, and non-persistent pesticides may play a role in the onset of pediatric obesity, particularly by acting.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity (Disorder)
• Intervention / Treatment: Other: Blood test; Other: Urine sample; Other: Hair sample

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julien LEJEUNE; Phone Number: +332 47 47 72 34; Email: j.leujeune@chu-tours.fr
• Study Contact Backup: Name: Coralie TAILLEBUIS; Phone Number: +332 47 47 39 09; Email: c.taillebuis@chu-tours.fr

Study Locations

• France
  • Tours, France
    • Chru De Tours
    • Contact: Karine BERNARDO; Phone Number: +332 47 47 78 28; Email: k.bernardo@chu-tours.fr
    • Principal Investigator: Karine BERNARDO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Patient with Obesity disorder :

• Children with obesity (according to the BMI curves of the International Obesity Task Force/IOTF)
• Follow-up within the obesity network of the Centre Val de Loire region (ObeCentre)

Control group:

• Children who are not obese (according to the BMI curves of the International Obesity Task Force/IOTF)

All:

• Children aged 6 to 15 at the time of inclusion (inclusive)
• Whose two parents, or legal guardian, have signed an informed consent form
• Patients affiliated with or covered by a social security system

Exclusion Criteria:

• Disorder preventing understanding of trial information or informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Obesity disorder; Patient with Obesity disorder	Other: Blood test; Inclusion visit: during the routine blood test, one additional tube of blood will be collected for the study.; Other: Urine sample; Inclusion visit: a urine sample will be collected for the study.; Other: Hair sample; Inclusion visit: a hair sample will be taken from the patient.
Other: Control; Control group: patient without obesity disorder	Other: Blood test; Inclusion visit: during the routine blood test, one additional tube of blood will be collected for the study.; Other: Urine sample; Inclusion visit: a urine sample will be collected for the study.; Other: Hair sample; Inclusion visit: a hair sample will be taken from the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFOA concentration	Difference in plasma PFOA concentration measured in ng/mL between obese and non-obese children (control group). PFOA will be measured in plasma using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) at the Laberca laboratory.	At the enrollment visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFOS concentration	Difference in plasma concentration of perfluorooctane sulfate (PFOS) measured in ng/mL between obese children and non-obese children.	At the enrollment visit
PFNA concentration	Difference in plasma concentration of perfluorononanoic acid (PFNA) measured in ng/mL between obese children and non-obese children	At the enrollment visit
PFHxS concentration	Difference in plasma concentration of perfluorohexanesulfonic acid (PFHxS) measured in ng/mL between obese children and non-obese children.	At the enrollment visit
BPA concentration	Differences in urinary BPA concentrations measured in ng/mL between obese and non-obese children	At the enrollment visit
Non-persistent pesticides concentration	Differences in urinary concentrations of non-persistent pesticides (organophosphates and polychlorinated biphenyls) in ng/mL between obese and non-obese children	At the enrollment visit
Number of DNA breaks	Differences in the number of DNA breaks in hair follicles between obese and non-obese children	At the enrollment visit

Collaborators and Investigators

• Sponsor: University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Environment; PFAS
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests
• Other Study ID Numbers: DR240165; 2025-A01227-42 (Other Identifier: ANSM - RECHERCHES ET COLLECTIONS BIOLOGIQUES (RCB))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No