Scientific Concept of the National Cohort (status ... - Nationale Kohorte

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A.1 Introduction and overview
The local study centers are organized in eight geographic clusters throughout Germany,
covering the population of almost all federal states. At each of the centers, study participants
will be drawn from local municipal population registries within defined strata of age
and gender, and covering metropolitan, urban, and rural regions. Eligible subjects will be
invited by letter, with written reminders and, when needed, further contacts by telephone. An
overall study participation proportion of at least 50% will be targeted.
As described in detail in Sect. A.3.1, study participants will be invited to a local study center;
data collection will include a computer-assisted personal interview, computer-aided questionnaires,
several physical and medical examinations, and biosampling. Information will be
collected at different levels of intensity:
Level 3
The National Cohort
Level 1 (200,000)
Level 3
Level 2 (40,000)
MRI
(40,000)
figure 1.2: The National Cohort will be organized on several levels
Level 1: 200,000 participants in all study centers; Level 2: 40,000 participants in all study centers;
MRI: 40,000 participants in 4 study centers; Level 3: possible other activities with separate funding
Baseline Assessment
� At the basic study level (“Level 1”), applying to all 200,000 study participants,
baseline interviews, questionnaire and examinations will be performed by using a
2.5-h examination protocol. Physical and medical examinations will include measurements
of anthropometric indices (height, weight, waist, and hip circumferences),
a dual-energy x-ray absorptiometry (DXA) of body composition and bone
density, blood pressure measurements, measurements of arterial stiffness, an electrocardiogram
(ECG), three-dimensional echocardiography (3D-ECG), spirometry,
measurements of physical activity through accelerometry (7 days), a basic test of
physical fitness, and an assessment of cognitive function.
� A further key element of the core study protocol (Level 1) is the collection of biomaterials
from all study participants. A blood sampling protocol will be used that leaves
open the greatest possible choice of future laboratory analyses, and includes the collection
and storage of intact mononuclear leukocytes. For each study subject, aliquots
of plasma, serum, dimethylsulfoxide (DMSO)-preserved viable white blood cells (in a
A.1