Obesity Clinical Trial
— NEOOfficial title:
The Netherlands Epidemiology of Obesity Study
Verified date | February 2019 |
Source | Leiden University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The Netherlands Epidemiology of Obesity (NEO) study is a population-based cohort study in
6671 men and women aged 45 to 65 years, with an oversampling of individuals with a BMI of 27
kg/m2 or higher. The NEO study is designed to investigate pathways that lead to common
diseases and conditions.
Men and women aged between 45 and 65 years with a self-reported BMI of 27 kg/m2 or higher
living in the greater area of Leiden, the Netherlands, were eligible to participate in the
NEO study. Participants were recruited via three recruitment strategies. First, participants
were recruited by general practitioners in the area of Leiden, in the West of The
Netherlands. Second, participants were recruited through advertisements in local newspapers
and through posters distributed in public areas of Leiden and surroundings. Third,
participants were recruited via the registries of three municipalities surrounding Leiden
(Katwijk, Leiderdorp and Teylingen). Inhabitants of Katwijk and Teylingen aged between 45 and
65 years were invited to participate if they had a self-reported BMI of 27 kg/m2 or higher.
All inhabitants aged between 45 and 65 years of Leiderdorp were invited to participate
irrespective of their BMI, allowing for a reference distribution of BMI.
Participants were invited to a baseline visit at NEO study centre of the LUMC after an
overnight fast. Prior to this study visit, participants collected their urine over 24 h and
completed a general questionnaire at home to report demographic, lifestyle and clinical
information. The participants were asked to bring all medication they were using to the study
visit. At the baseline visit an extensive physical examination was performed, including
measurements of anthropometry, blood pressure, both fasting and postprandial blood sampling
(30 minutes and 2.5 hours after a liquid mixed meal), ECG, carotid artery IMT, and pulmonary
function tests. In random subsets of participants MRI of abdominal fat, brain, knee, heart
function, and pulse wave velocity of the aorta was performed, as well as indirect
calorimetry, accelerometry combined with continuous heart rate, and total sleep time with
actigraphy. Participants are followed via their general practitioners and hospital registries
for the incidence of common diseases and mortality.
Status | Active, not recruiting |
Enrollment | 6671 |
Est. completion date | September 2033 |
Est. primary completion date | September 2033 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Men and women - Aged 45 to 65 - Self-reported BMI of 27kg/m2 or higher - Subgroup of participants irrespective of their BMI Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center |
de Mutsert R, den Heijer M, Rabelink TJ, Smit JW, Romijn JA, Jukema JW, de Roos A, Cobbaert CM, Kloppenburg M, le Cessie S, Middeldorp S, Rosendaal FR. The Netherlands Epidemiology of Obesity (NEO) study: study design and data collection. Eur J Epidemiol. 2013 Jun;28(6):513-23. doi: 10.1007/s10654-013-9801-3. Epub 2013 Apr 11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of common diseases | e.g. type 2 diabetes (yes/no), cardiovascular diseases (y/n), thrombosis (y/n), chronic kidney disease (y/n), asthma (y/n), chronic obstructive pulmonary disease (y/n), osteoarthritis (y/n), cirrhosis (y/n), depression (y/n) | Around each 5 years |
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