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

NCT ID: NCT05158010

Last Updated: 2022-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-10
• Study Completion Date: 2022-06-25

Brief 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).

Conditions

Exposure; Health Behavior; Environment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

HELIX's follow-up

Group Type: OTHER

HELIX's follow-up

Intervention Type: OTHER

• 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

C.H.U. de Poitiers

Poitiers, , France

Countries

France

Other Identifiers

2020-A03533-36

Identifier Type: -

Identifier Source: org_study_id