Prevention of cardiovascular disease in current and former employees of the Ford motor company, Germany

ISRCTN	ISRCTN23536103
DOI	https://doi.org/10.1186/ISRCTN23536103
Secondary identifying numbers	N/A

Submission date: 26/05/2011
Registration date: 28/07/2011
Last edited: 14/03/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Cardiovascular diseases (CVD), including heart disease, heart attack and stroke, are a major cause of suffering and disability in many patients. Therefore, there is an urgent need for treatment strategies to prevent CVD, especially in healthy individuals at high risk for CVD. Decades of research have shown that CVD results from multiple risk factors, including smoking, high blood cholesterol, high blood pressure, obesity, chronic stress and depression. Treatment strategies for single risk factors are available, but, until now, only very few studies have targeted all of the aforementioned risk factors at the same time in a larger sample of healthy individuals at high risk for CVD. This study aims to fill this gap. The aim of this study is to find out whether the PreFord intervention reduces the risk of CVD.

Who can participate?
Adults with no evidence of existing CVD, but at high risk for CVD in the future

What does the study involve?
Participants are randomly allocated to either the PreFord intervention or routine care by their GPs. The PreFord intervention consists of 75 hours (total), divided into 30 sessions (2.5 hours each), two times a week, over a period of 15 weeks. It includes health education (e.g., the heart and vessels, healthy food, heart medication, etc), exercise, a smoking cessation programme if necessary, and LifeSkills, an approach to enhance stress resilience and social relationships at work and leisure time. The intervention is accompanied by a guideline-based drug treatment for high blood cholesterol and high blood pressure, if necessary. Well being, health behaviour and CVD risk factors are assessed before and after the intervention, and annually for 5 years. The intervention and each follow-up assessment are free of charge, and participants are free to join or leave the study whenever they wish.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
German Sports University Cologne

When is the study starting and how long is it expected to run for?
August 2004 to July 2013

Who is funding the study?
Bayer Vital (Germany), Pronova BKK (Germany) and AstraZeneca (Germany)

Who is the main contact?
Prof. Hans-Georg Predel
predel@dshs-koeln.de

Contact information

Prof Hans-Georg Predel
Scientific

German Sports University Cologne
Cologne (Koeln)
50931
Germany

Email	predel@dshs-koeln.de

Study information

Study design	Two-armed randomized controlled clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Multimodal intervention for prímary prevention of cardiovascular disease in current and former employees of the Ford motor company, Germany - the PreFord trial
Study acronym	PreFord
Study objectives	A multimodal intervention for primary prevention of cardiovascular disease (CVD) will reduce multiple biological and psychosocial cardiac risk factors and cardiac events. Re-evaluation of cardiovascular risk and cardiac events annually up to 5 years.
Ethics approval(s)	1. North Rhine Medical Association (Aerztekammer North Rhine) Ethics Committee, 20/12/2004, ref: 2004079 2. Faculty of Medicine Ethics Committee, University of Cologne, 02/02/2004, ref: 03-217
Health condition(s) or problem(s) studied	Prevention of cardiovascular disease
Intervention	Multimodal intervention for outpatients, two sessions a week in the afternoon for three months (75 hours total): 1. Health education 2. Exercise therapy 3. Smoking cessation programme 4. Stress management (LifeSkills)
Intervention type	Other
Primary outcome measure	European Society of Cardiology risk score
Secondary outcome measures	1. Health behaviour (physical fitness, smoking, BMI) 2. CVD risk factors, e.g. low-density-lipoprotein cholesterol (LDL-C), total cholesterol, trigycerides, blood pressure, diabetes mellitus, depression and anxiety (HADS), Type-D pattern (DS-14)
Overall study start date	01/08/2004
Completion date	31/07/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	447
Total final enrolment	447
Key inclusion criteria	1. Adult men and women with no evidence for CVD and elevated risk according to the (European Society of Cardiology) ESC risk score > 5% 2. Informed consent
Key exclusion criteria	Severe somatic or psychiatric morbidity, e.g. malignancies, psychosis, drug addiction
Date of first enrolment	01/08/2004
Date of final enrolment	31/07/2013

Locations

Countries of recruitment

Germany

Study participating centre

German Sports University Cologne

Cologne (Koeln)
50931
Germany

Sponsor information

German Sports University (Germany)
University/education

c/o Prof Dr HG Predel
Cologne
50931
Germany

Email	predel@dshs-koeln.de
Website	https://www.dshs-koeln.de/wps/portal
"ROR"	https://ror.org/0189raq88

Funders

Funder type

Industry

Bayer Vital (Germany)

No information available

Pronova BKK (Germany)

No information available

AstraZeneca (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2004		Yes	No
Results article	results	01/02/2012		Yes	No
Results article	results	01/09/2017		Yes	No
Other publications	Secondary analysis	23/02/2023	14/03/2023	Yes	No

Editorial Notes

14/03/2023: Publication reference and total final enrolment added.
12/07/2017: Publication reference added.
19/02/2016: Plain English summary added.