The Netherlands Epidemiology of Obesity Study (NEO)
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.
調査の概要
詳細な説明
Hypotheses
- Overweight and obesity affect major systemic responses, such as inflammation and coagulation that lead to the occurrence of major common diseases.
- 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
- To study the pathways that lead to common diseases in overweight and obese individuals.
- To identify novel determinants of various diseases and conditions in overweight and obese individuals.
- To study interrelationships between diseases, newly identified determinants with each other and with classical, established risk factors.
Secondary general objectives of the NEO Study
- To identify novel determinants of various subclinical conditions in overweight and obese individuals.
- 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.
- To assess the burden of disease in a population-based cohort of overweight and obese individuals.
- To investigate the optimal diagnostic method to define overweight and obesity in terms of predicting various diseases.
研究の種類
入学 (実際)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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:
- NA
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
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
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Incidence of common diseases
時間枠:Around each 5 years
|
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
|
協力者と研究者
捜査官
- 主任研究者:Frits R Rosendaal、Department of Clinical Epidemiology, Leiden University Medical Center
- スタディディレクター:Renée de Mutsert、Department of Clinical Epidemiology, Leiden University Medical Center
出版物と役立つリンク
一般刊行物
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
介入なしの臨床試験
-
University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research Program完了
-
University of MichiganNational Institute on Drug Abuse (NIDA)募集
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University of PittsburghCenters for Disease Control and Preventionまだ募集していません暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ
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University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない
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Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Bostonまだ募集していません自殺念慮 | 自殺未遂 | 自殺