Plain English Summary
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
Study website
Contact information
Type
Scientific
Contact name
Prof Hans-Georg Predel
ORCID ID
Contact details
German Sports University Cologne
Cologne (Koeln)
50931
Germany
-
predel@dshs-koeln.de
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Multimodal intervention for prímary prevention of cardiovascular disease in current and former employees of the Ford motor company, Germany - the PreFord trial
Acronym
PreFord
Study hypothesis
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
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
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Overall study end date
31/07/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
447
Total final enrolment
447
Participant exclusion criteria
Severe somatic or psychiatric morbidity, e.g. malignancies, psychosis, drug addiction
Recruitment start date
01/08/2004
Recruitment end date
31/07/2013
Locations
Countries of recruitment
Germany
Study participating centre
German Sports University Cologne
Cologne (Koeln)
50931
Germany
Sponsor information
Organisation
German Sports University (Germany)
Sponsor details
c/o Prof Dr HG Predel
Cologne
50931
Germany
-
predel@dshs-koeln.de
Sponsor type
University/education
Website
https://www.dshs-koeln.de/wps/portal
ROR
Funders
Funder type
Industry
Funder name
Bayer Vital (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Pronova BKK (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
AstraZeneca (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
Not provided at time of registration
IPD sharing plan summary
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 |