- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02899416
Better Life by Nutrition During Adulthood (BELINDA)
Better Life by Nutrition During Adulthood : Identification of Factors Present in Adolescence Cardiovascular Risk in Young Adults
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lille, France
- CHRU,Hôpital Jeanne de Flandres
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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PDAY score (Pathobiological Determinants of Atherosclerosis in Youth)
Time Frame: one day
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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.
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one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diet Quality Index Score
Time Frame: 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 days
|
|
Ratio total energy intake
Time Frame: 2 days
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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.
|
2 days
|
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ratio of dietary n-6/n-3 polyunsaturated fatty acids (PUFA)
Time Frame: 2 days
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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.
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2 days
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consumption in dietary salt intake
Time Frame: 2 days
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data collected using HELENA-DIAT, an electronic dietary recall, data in mg/day daily intake calculated using a food composition data base.
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2 days
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Physical activity
Time Frame: 7 days
|
data collected using a GT3X accelerometer data in daily counts/min
|
7 days
|
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Endurance
Time Frame: 1 day
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data collected using Dr Leger Shuttle run test, data in VO2max ml/kg/min
|
1 day
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Ratio waist-to-hip
Time Frame: 1 day
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data collected using anthropometric measurements, data in ratio.
Data are expressed in centimeter
|
1 day
|
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Fat mass
Time Frame: 1 day
|
data collected using anthropometric measurements, data in % of fat mass, expressed in kg
|
1 day
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Education level
Time Frame: 1 day
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data collected using a Socio-economic questionnaire, data in Education level 8 digits
|
1 day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Frédéric Gottrand, MD, PhD, University Hospital, Lille
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2015_24
- 2016-A00386-45 (Other Identifier: ID-RCB number, ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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