Advancing Tools for Human Early Lifecourse Exposome Research and Translation- Adolescence Follow-up of the HELIX Subcohort

Health Behavior Clinical Trial

— ATHLETE  

Official title:

Advancing Tools for Human Early Lifecourse Exposome Research and Translation- Adolescence Follow-up of the HELIX Subcohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05158010
• Other study ID #: 2020-A03533-36
• Status: Completed
• Phase: N/A
• Start date: November 10, 2021
• Est. completion date: June 25, 2022

Study information

• Verified date: June 2022
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

ATHLETE will set up a prospective Europe-wide exposome cohort covering the first 2 decades of the life course, which will integrate data on the external, chemical, physical,behavioral, and social domains of the exposome, as well as on health outcomes and biological omics responses, from preconception until adolescence. As part of ATHLETE, the investigators will follow up a unique existing exposome cohort into adolescence (the HELIX Subcohort).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 25, 2022
• Est. primary completion date: June 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 18 Years

Eligibility

Inclusion Criteria:

For the adolescent :

• Subject of the EDEN cohort included in the Helix cohort in 2014-2015 in Poitiers (16-19 years old)
• Subject benefiting from a Social Security scheme or benefiting through a third party

For the person legally responsible :

• The legal guardian, if possible the mother, of the adolescent included in Athlete ;
• Subject benefiting from a Social Security scheme or benefiting through a third person;
• Free subject, without tutorship or guardianship or subordination.

Exclusion Criteria:

• Concomitant participation in another clinical research study.
• Persons not benefiting from a Social Security scheme or not benefiting through a third party.
• Adolescents who are incapable or who do not give their consent to follow the study procedures

Related Conditions & MeSH terms

• Environment
• Exposure
• Health Behavior

Intervention

Other:
• HELIX's follow-up
Visit 1 (Day 0): clinical examination (anthropometry, bioimpedance, blood pressure,spirometry), neurodevelopment computer testing, questionnaires (Physical activity,diet, psychological distress, tobacco exposure, pubertal development, sleeping patterns, light exposure before going to sleep, outdoor environment (green spaces, noise), address history, home environment, socio-economic status, noise, psychological distress, medical history, medication use) 7 consecutive days (minimum) of personal exposure monitoring including wearing an actigraph, a Smartphone (GPS data), carrying a NO2 diffusion tube, collection of hair, stool, urines (2 urines during 6 consecutive days) and filling a sleep and physical activity diary Visit 2 (Day 8): blood collection early in the morning and collection of all the 7- days personal monitoring material, and stools and urines samples.

Locations

Country	Name	City	State
France	C.H.U. de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary biomarkers exposure	Measure of phtalates, phenols, pesticides, (organophosphorus pesticides, metabolites of pyrethroids, 2,4-dichlorophenoxyacid, boscalid, imazalil), cotinine, glycol ethers, polycyclic aromatic hydrocarbon, creatinine, exogenous metabolomics, in a weekly pool of urine collection	One week