BELINDA: Better Life by Nutrition During Adulthood

Sponsor
University Hospital, Lille (Other)
Overall Status
Recruiting
CT.gov ID
NCT02899416
Collaborator
(none)
330
1
60.2
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    BELINDA subjects from Lille, Ghent , Zaragoza and Roma will be re-tested using a part of HELENA test battery and some new evaluation criteria.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    330 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Better Life by Nutrition During Adulthood : Identification of Factors Present in Adolescence Cardiovascular Risk in Young Adults
    Actual Study Start Date :
    Feb 23, 2017
    Anticipated Primary Completion Date :
    Mar 1, 2022
    Anticipated Study Completion Date :
    Mar 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. PDAY score (Pathobiological Determinants of Atherosclerosis in Youth) [one day]

      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.

    Secondary Outcome Measures

    1. Diet Quality Index Score [2 days]

      data collected using HELENA-DIAT, an electronic dietary recall, data in DQI score unit. DQI score is ranking from 0 to 9 unit and is based on three basic principles for a healthy diet: quality; diversity; balance. Furthermore, the daily diet was divided into nine recommended food groups, namely (1) water, (2) bread and cereals, (3) grains and potatoes, (4) vegetables, (5) fruit, (6) milk products (7), cheese, (8) meat, fish, eggs and substitutes, and (9) fats and oils.

    2. Ratio total energy intake [2 days]

      data collected using HELENA-DIAT, an electronic dietary recall, data in kcal/d, data for recommended total energy intake will be collected using national reference chart.

    3. ratio of dietary n-6/n-3 polyunsaturated fatty acids (PUFA) [2 days]

      data collected using HELENA-DIAT, an electronic dietary recall, data in ratio calculated using a food composition data base. PUFA is expressed in mg/day daily intake.

    4. consumption in dietary salt intake [2 days]

      data collected using HELENA-DIAT, an electronic dietary recall, data in mg/day daily intake calculated using a food composition data base.

    5. Physical activity [7 days]

      data collected using a GT3X accelerometer data in daily counts/min

    6. Endurance [1 day]

      data collected using Dr Leger Shuttle run test, data in VO2max ml/kg/min

    7. Ratio waist-to-hip [1 day]

      data collected using anthropometric measurements, data in ratio. Data are expressed in centimeter

    8. Fat mass [1 day]

      data collected using anthropometric measurements, data in % of fat mass, expressed in kg

    9. Education level [1 day]

      data collected using a Socio-economic questionnaire, data in Education level 8 digits

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Women of men participating to HELENA study 2006-2007

    • Aged from 20 to 35 years.

    • Signed informed consent

    Exclusion Criteria:
    • Pregnant or lactating women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU,Hôpital Jeanne de Flandres Lille France

    Sponsors and Collaborators

    • University Hospital, Lille

    Investigators

    • Principal Investigator: Frédéric Gottrand, MD, PhD, University Hospital, Lille

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT02899416
    Other Study ID Numbers:
    • 2015_24
    • 2016-A00386-45
    First Posted:
    Sep 14, 2016
    Last Update Posted:
    Oct 5, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Lille

    Study Results

    No Results Posted as of Oct 5, 2021