NCT03410316

Brief 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. 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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,671

participants targeted

Target at P75+ for all trials

Timeline
88mo left

Started Aug 2008

Longer than P75 for all trials

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Aug 2008Sep 2033

Study Start

First participant enrolled

August 4, 2008

Completed
9.4 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
15.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2033

Last Updated

March 26, 2019

Status Verified

February 1, 2019

Enrollment Period

25.1 years

First QC Date

January 10, 2018

Last Update Submit

March 25, 2019

Conditions

Keywords

ObesityCommon diseasesEpidemiologyEtiology

Outcome Measures

Primary Outcomes (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)

    Around each 5 years

Study Arms (1)

Participants of the NEO study

Men and women aged 45 oy 65 years, with an oversampling of individuals with a BMI of 27 kg/m2 or higher

Other: No intervention

Interventions

Participants of the NEO study

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 23576214BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

* Urine * Plasma * Serum

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Frits R Rosendaal

    Department of Clinical Epidemiology, Leiden University Medical Center

    PRINCIPAL INVESTIGATOR
  • Renée de Mutsert

    Department of Clinical Epidemiology, Leiden University Medical Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 25, 2018

Study Start

August 4, 2008

Primary Completion (Estimated)

September 1, 2033

Study Completion (Estimated)

September 1, 2033

Last Updated

March 26, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share

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