to study search History No further version available for comparison

Mobile diagnostics and consultation for the prevention of the metabolic syndrome and its secondary diseases in Brandenburg

Organizational Data

DRKS-ID:
DRKS00022764
Recruitment Status:
Recruiting complete, study continuing
Date of registration in DRKS:
2020-10-07
Last update in DRKS:
2020-10-07
Registration type:
Retrospective

Acronym/abbreviation of the study

Mobile Brandenburg Cohort

URL of the study

No Entry

Brief summary in lay language

The metabolic syndrome, which is characterized by overweight, high blood pressure and an impaired sugar and fat metabolism, is a major risk factor for the development of secondary diseases. These can be influenced positively by a change in lifestyle such as diet and exercise, but an improved early detection, especially in rural, structurally weak regions such as the Federal State of Brandenburg, is needed. The aim of this study is therefore to develop mobile examination units and to examine people aged between 40 and 70 years for the presence of a metabolic syndrome and its secondary diseases in a mobile way and close to their homes. It is to be evaluated whether mobile diagnostics and counselling is feasible. In addition, causes and factors that may increase the risk of developing the metabolic syndrome and its secondary diseases in Brandenburg are to be investigated.

Brief summary in scientific language

The metabolic syndrome is an important risk factor for the development of metabolic and cardiovascular as well as musculoskeletal and cognitive diseases. To reduce the high prevalence of the metabolic syndrome and its secondary diseases, an early detection of persons at risk and the implementation of appropriate prevention strategies are necessary. However, especially in structurally weak regions such as the Federal State of Brandenburg (Germany), access to health care providers is limited. In addition, other factors such as socio-demographic influences could contribute to the high burden of disease in Brandenburg. It is therefore necessary to develop and implement an innovative near-to-home diagnostic and prevention approach as well as to analyse risk-increasing factors. The aim of this study was to develop, validate and test the feasibility of a setup for mobile diagnostics of the metabolic syndrome and its secondary diseases. Study participants aged between 40 and 70 years are to be examined on a mobile basis and close to their homes in order to determine the prevalence of the metabolic syndrome and its risk factors in Brandenburg and to evaluate their correlation with moderating factors while establishing a "Mobile Brandenburg Cohort".

Health condition or problem studied

Free text:
Metabolic Syndrome
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Persons in Brandenburg aged between 40 and 70 years; Risk factors of the metabolic syndrome (blood analysis and anthropometry), sociodemographic and socioeconomic factors, life events, physical activity (IPAQ-SF), stress perception (PSS-4) are recorded; some of the participants receive a (mobile) examination for secondary diseases of the metabolic syndrome (clinical full-body examination (cardiovascular system and internal organs, musculoskeletal system, orienting neurological examination), ECG at rest and during exercise, recording of depressive symptoms (PHQ-9), recording of possible cognitive limitations (MoCA). Persons who are not able to participate to the mobile examination of part B are interviewed via telephone. All participants receive a short consultation on primary/secondary prevention (especially nutrition and physical activity)

Endpoints

Primary outcome:
Testing the feasibility of mobile diagnostics of the metabolic syndrome and its secondary diseases (validity and reliability of the mobile examination unit; evaluation of the prevalence of the metabolic syndrome and its components in Brandenburg; feasibility of mobile measurements (recruitment rates, number of complete measurements)
Secondary outcome:
Association of the occurrence of the risk factors of the metabolic syndrome and possible secondary diseases with other factors such as socio-demographic and socio-economic factors, living conditions, urbanity, the perception of stress, physical activity; to reveal causative and risk factors of MetS

Study Design

Purpose:
Prevention
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study continuing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
No Entry

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2016-08-19
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
5000
Final Sample Size:
3931

Inclusion Criteria

Sex:
All
Minimum Age:
40 Years
Maximum Age:
70 Years
Additional Inclusion Criteria:
Adults in Brandenburg aged between 40 and 70 years

Exclusion Criteria

Acute infection (during examination for possible secondary diseases of the metabolic syndrome)

Addresses

Primary Sponsor

Universität Potsdam, Professur für Sportmedizin und Sportorthopädie/Hochschulambulanz
Am Neuen Palais 10
14469 Potsdam
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universität Potsdam, Professur für Sportmedizin und Sportorthopädie/Hochschulambulanz
Prof. Dr. Frank Mayer
Am Neuen Palais 10
14469 Potsdam
Germany
Telephone:
03319771768
Fax:
03319771296
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Universität Potsdam, Professur für Sportmedizin und Sportorthopädie/Hochschulambulanz
Dr. Anne Schraplau
Am Neuen Palais 10
14469 Potsdam
Germany
Telephone:
03319771768
Fax:
03319771296
Contact per E-Mail
URL:
No Entry

Principal Investigator

Universität Potsdam, Professur für Sportmedizin und Sportorthopädie/Hochschulambulanz
Prof. Dr. Frank Mayer
Am Neuen Palais 10
14469 Potsdam
Germany
Telephone:
03319771768
Fax:
03319771296
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Investitionsbank des Landes Brandenburg (Europäischer Fonds für Regionale Entwicklung, EFRE)
14473 Potsdam
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission der Universität Potsdam
Am Neuen Palais 10
14469 Potsdam
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
https://www.uni-potsdam.de/de/senat/kommissionen-des-senats/ek

Vote of leading Ethics Committee

Date of ethics committee application:
2016-06-10
Ethics committee number:
40/2016
Vote of the Ethics Committee:
Approved
Date of the vote:
2016-07-19

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry