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ObesityNEONCT03410316

The Netherlands Epidemiology of Obesity Study

An observational study of Obesity, run by Leiden University Medical Center.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 45 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
How many people
6,671 participants
Where
No sites listed yet
Study dates
4 Aug 2008to Sep 2033
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Men and women living in the greater area of Leiden (in the West of the Netherlands) were invited by letters sent by general practitioners, and via municipalities and by local advertisements.

Who may be able to join

  • Men and women
  • Aged 45 to 65
  • Self-reported BMI of 27kg/m2 or higher
  • Subgroup of participants irrespective of their BMI

Who cannot join

  • NA

About this study

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.

Read the detailed description

Hypotheses

  1. Overweight and obesity affect major systemic responses, such as inflammation and coagulation that lead to the occurrence of major common diseases.
  2. The occurrence of these diseases is related to individual make-up, including genetics and fat type and location, and environment, and the interaction between the various systemic responses, and the (subclinical) disease outcomes.

Primary general objectives of the NEO study

  1. To study the pathways that lead to common diseases in overweight and obese individuals.
  2. To identify novel determinants of various diseases and conditions in overweight and obese individuals.
  3. To study interrelationships between diseases, newly identified determinants with each other and with classical, established risk factors.

Secondary general objectives of the NEO Study

  1. To identify novel determinants of various subclinical conditions in overweight and obese individuals.
  2. To develop novel methods for determining the risk of various diseases and conditions in asymptomatic overweight and obese individuals, in addition to established prognostic markers.
  3. To assess the burden of disease in a population-based cohort of overweight and obese individuals.
  4. To investigate the optimal diagnostic method to define overweight and obesity in terms of predicting various diseases.
Conditions
Obesity
Being tested
No intervention
Keywords
Obesity, Common diseases, Epidemiology, Etiology
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

Study groups in NCT03410316
Study groupRoleWhat they receive
Participants of the NEO studyMen and women aged 45 oy 65 years, with an oversampling of individuals with a BMI of 27 kg/m2 or higher
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Around each 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2018
  2. Study start4 Aug 2008
  3. Primary completionSep 2033 (estimated)
  4. Study completionSep 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6,671 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03410316
Sponsor's protocol ID
P08.109
Acronym
NEO
Status last verified
Feb 2019
First submitted
10 Jan 2018
Last updated
26 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: This is a publicly funded observational study, all data are owned by the university and open to researchers after consultation and according to internal procedures

Publications

  • 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.

    PubMed 23576214

  • Oosterom-Eijmael MJP, le Cessie S, Slats AM, Hiemstra PS, Thijs W, Lamb HJ, Willems van Dijk K, Rosendaal FR, de Mutsert R. The relation between visceral fat and lung function in the general population is in part mediated by CRP and leptin. Expert Rev Respir Med. 2025 Aug;19(8):887-897. doi: 10.1080/17476348.2025.2502557. Epub 2025 Jun 4.

    PubMed 40468646

  • Winters-VAN Eekelen E, VAN DER Velde JHPM, Boone SC, Westgate K, Brage S, Lamb HJ, Rosendaal FR, DE Mutsert R. Objectively Measured Physical Activity and Body Fatness: Associations with Total Body Fat, Visceral Fat, and Liver Fat. Med Sci Sports Exerc. 2021 Nov 1;53(11):2309-2317. doi: 10.1249/MSS.0000000000002712.

    PubMed 34081059

  • van Eekelen E, Beulens JWJ, Geelen A, Schrauwen-Hinderling VB, Lamb H, de Roos A, Rosendaal F, de Mutsert R. Consumption of Alcoholic and Sugar-Sweetened Beverages is Associated with Increased Liver Fat Content in Middle-Aged Men and Women. J Nutr. 2019 Apr 1;149(4):649-658. doi: 10.1093/jn/nxy313.

    PubMed 30949667

  • van Eekelen E, Geelen A, Alssema M, Lamb HJ, de Roos A, Rosendaal FR, de Mutsert R. Sweet Snacks Are Positively and Fruits and Vegetables Are Negatively Associated with Visceral or Liver Fat Content in Middle-Aged Men and Women. J Nutr. 2019 Feb 1;149(2):304-313. doi: 10.1093/jn/nxy260.

    PubMed 30657914

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by Leiden University Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of common diseases (time frame: Around each 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03410316, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.

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