NCT02899416

Brief Summary

BELINDA is a follow'up of subjects included 10 years ago in HELENA study which was a cross-sectional study carried out from 2006 to 2007 in more than 3500 adolescents aged from 12.5 to 17.5 years old through 10 Europeans towns from 9 countries. BELINDA main objective is to assess CV risk using PDAY score (Pathobiological Determinants of Atherosclerosis in Youth) during young adulthood (20 to 31 years) and analyze lifestyle risk factors from adolescence (12 to 18 years). This analyze may define new CV risk factors and risk population cluster.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 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

August 24, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

February 23, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2022

Completed
Last Updated

December 23, 2025

Status Verified

September 1, 2022

Enrollment Period

5.1 years

First QC Date

August 24, 2016

Last Update Submit

December 16, 2025

Conditions

Keywords

cardiovascular riskyoung adulthood

Outcome Measures

Primary Outcomes (1)

  • PDAY score (Pathobiological Determinants of Atherosclerosis in Youth)

    PDAY score is a composite score which will be calculated using adult data including Gender, HDL non cholesterol, HDL cholesterol. Glucose level, Blood pressure, Tobacco consumption and BMI.

    one day

Secondary Outcomes (9)

  • Diet Quality Index Score

    2 days

  • Ratio total energy intake

    2 days

  • ratio of dietary n-6/n-3 polyunsaturated fatty acids (PUFA)

    2 days

  • consumption in dietary salt intake

    2 days

  • Physical activity

    7 days

  • +4 more secondary outcomes

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

BELINDA is a follow'up of subjects included 10 years ago in HELENA study which was a cross-sectional study carried out from 2006 to 2007 in more than 3500 adolescents aged from 12.5 to 17.5 years old through 10 Europeans towns from 9 countries. BELINDA will retest subjects from Lille and Ghent

You may qualify if:

  • Women of men participating to HELENA study 2006-2007
  • Aged from 20 to 35 years.
  • Signed informed consent

You may not qualify if:

  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU,Hôpital Jeanne de Flandres

Lille, France

Location

Related Publications (1)

  • Morcel J, Beghin L, Michels N, De Ruyter T, Drumez E, Cailliau E, Polito A, Le Donne C, Barnaba L, Azzini E, De Henauw S, Miguel Berges ML, Cacau LT, Moreno LA, Gottrand F. Nutritional and physical fitness parameters in adolescence impact cardiovascular health in adulthood. Clin Nutr. 2024 Aug;43(8):1857-1864. doi: 10.1016/j.clnu.2024.06.022. Epub 2024 Jun 26.

Biospecimen

Retention: SAMPLES WITH DNA

DNA used for telemore length

Study Officials

  • Frédéric Gottrand, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2016

First Posted

September 14, 2016

Study Start

February 23, 2017

Primary Completion

March 25, 2022

Study Completion

March 25, 2022

Last Updated

December 23, 2025

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations