- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02720809
Health2016: Monitoring Chronic Disease and Risk Factors in the General Population
March 25, 2016 updated by: Allan Linneberg, Glostrup University Hospital, Copenhagen
Helbred2016: Monitorering af Kroniske Sygdomme og Risikofaktorer i Befolkningen
Health2016 is a general population cross-sectional study aimed at completing af monitoring program for monitoring chronic disease and risk factors in the period 2006 to 2016.
Similar studies have been performed in 2006, 2010, and 2013.
Study Overview
Status
Unknown
Detailed Description
A random sample of 18-69 year-olds living in 10 municipalities in the Capital Region of Denmark is invited to a health examination including measurements of anthropometry, lifestyles, symptoms and diagnoses of diseases, blood pressure, resting heart rate, muscle strength, fitness, lung function, allergy tests, and biochemistry (lipids, liver and kidney function, vitamin D status, salt excretion, iodine status).
Trends in these parameters over time will be assessed.
Study Type
Observational
Enrollment (Anticipated)
1500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Allan Linneberg, MD, PhD
- Phone Number: +45 38633260
- Email: allan.linneberg@regionh.dk
Study Locations
-
-
Glostrup
-
Copenhagen, Glostrup, Denmark, DK-2600
- Research Centre for Prevention and Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
General population sample randomly selected from persons living in 10 municipalities in the Capital Region of Denmark.
Age 18-69 years.
Description
Inclusion Criteria: General population sample randomly selected from persons living in 10 municipalities in the Capital Region of Denmark. Age 18-69 years. Danish citizenship, born in Denmark
Exclusion Criteria:
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in micronutrient status from 2006 to 2016
Time Frame: 10 years
|
Serum 25-OH Vitamin D status (nmol/l) in serum from 2006 to 2016
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in HbA1C from 2006 to 2016
Time Frame: 10
|
Changes in HbA1C from 2006 to 2016
|
10
|
Change in allergic respiratory disease from 2006 to 2016
Time Frame: 10 years
|
Changes in prevalence of skin prick test reactivity to inhalant allergens
|
10 years
|
Change in prevalence of hypertension from 2006 to 2016
Time Frame: 10 years
|
Blood pressure above 140/90 or treatment for hypertension
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Allan Linneberg, MD, PhD, Center for Health, The Capital Region of Denmark
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Anticipated)
August 1, 2017
Study Completion (Anticipated)
October 1, 2017
Study Registration Dates
First Submitted
March 22, 2016
First Submitted That Met QC Criteria
March 25, 2016
First Posted (Estimate)
March 28, 2016
Study Record Updates
Last Update Posted (Estimate)
March 28, 2016
Last Update Submitted That Met QC Criteria
March 25, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-15017277
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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