The LEAD (Lung, Heart, Social, Body) Study: Objectives, Methodology, and External Validity of the Population-Based Cohort Study

Abstract

Background The Lung, hEart, sociAl, boDy (LEAD) Study (ClinicalTrials.gov; NCT01727518; http://clinicaltrials.gov ) is a longitudinal, observational, population-based Austrian cohort that aims to investigate the relationship between genetic, environmental, social, developmental and ageing factors influencing respiratory health and comorbidities through life. The general working hypothesis of LEAD is the interaction of these genetic, environmental and socioeconomic factors influences lung development and ageing, the risk of occurrence of several non-communicable diseases (respiratory, cardiovascular, metabolic and neurologic), as well as their phenotypic (ie, clinical) presentation. Methods LEAD invited from 2011–2016 a random sample (stratified by age, gender, residential area) of Vienna inhabitants (urban cohort) and all the inhabitants of six villages from Lower Austria (rural cohort). Participants will be followed-up every four years. A number of investigations and measurements were obtained in each of the four domains of the study (Lung, hEart, sociAl, boDy) including data to screen for lung, cardiovascular and metabolic diseases, osteoporosis, and cognitive function. Blood and urine samples are stored in a biobank for future investigations. Results A total of 11.423 males (47.6%) and females (52.4%), aged 6–80 years have been included in the cohort. Compared to governmental statistics, the external validity of LEAD with respect to age, gender, citizenship, and smoking status was high. Conclusions In conclusion, the LEAD cohort has been established following high quality standards; it is representative of the Austrian population and offers a platform to understand lung development and ageing as a key mechanism of human health both in early and late adulthood.

Reference values of body composition parameters and visceral adipose tissue (VAT) by DXA in adults aged 18–81 years—results from the LEAD cohort

“…It investigates a random sample of Caucasian participants, recruited from the general population of Austria stratified by age, sex, and residential area (based on the inhabitants' register). Comparison with the governmental data of Austria showed almost identical distribution of age and gender, supporting the representativeness of the LEAD cohort for the Austrian population [21]. Further details concerning the objectives, methodology, and external validity of the LEAD study can be found elsewhere [21].…”

Reference charts for body composition parameters by dual‐energy X‐ray absorptiometry in European children and adolescents aged 6 to 18 years—Results from the Austrian LEAD (Lung, hEart, sociAl, boDy) cohort

“…18 In short, the study cohort was recruited, stratified by age, sex and residential area, based on the Austrian inhabitants' register and is representative of the Austrian population in terms of age and gender distribution. 18 It should be considered that the study population is only representative for Caucasians. For this analysis, only cross-sectional data of participants from the age of 6 to 18 years with valid whole-body DXA scans, which were examined between 2011 and 2019, were included.…”

Marked differences in prediabetes‐ and diabetes‐associated comorbidities between men and women—Epidemiological results from a general population‐based cohort aged 6‐80 years—The LEAD (Lung, hEart, sociAl, boDy) study

“…The Lung, hEart, sociAl, boDy (LEAD) study (ClinicalTrials.gov; NCT01727518; http://clinicaltrials.gov) is a longitudinal, observational, population‐based cohort study including a random sample of Austrian inhabitants stratified by age, sex and residential area. Details of the objectives, methodology and external validity and representativeness of the sample can be found elsewhere . Exclusion criteria were current pregnancy and breastfeeding.…”

“…Comorbidities were either measured and additionally confirmed by current medication use and/or recorded by interviewer based questionnaire asking for physician‐diagnosed comorbidities. Detailed information on measurements can be found elsewhere …”

“…Details of the objectives, methodology and external validity and representativeness of the sample can be found elsewhere. 19 Exclusion criteria were current pregnancy and breastfeeding.…”