Condition category
Circulatory System
Date applied
26/05/2011
Date assigned
28/07/2011
Last edited
19/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hans-Georg Predel

ORCID ID

Contact details

German Sports University Cologne
Cologne (Koeln)
50931
Germany
-
predel@dshs-koeln.de

Additional identifiers

EudraCT 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

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

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/08/2004

Overall trial end date

31/07/2013

Reason abandoned

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

Patient

Age group

Adult

Gender

Both

Target number of participants

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

Trial 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

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

Astra Zeneca (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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/14963679
2. 2011 results in Albus C, Bjarnason-Wehrens B, Gysan DB et al. Psychosom Med 2011;73: A-48
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22095021

Publication citations

  1. Results

    Gysan DB, Latsch J, Bjarnason-Wehrens B, Albus C, Falkowski G, Herold G, Mey E, Heinzler R, Montiel G, Schneider CA, Stützer H, Türk S, Weisbrod M, Predel HG, [The PreFord Study. A prospective cohort study to evaluate the risk of a cardiovascular event (overall-collective) as well as a prospective, randomized, controlled, multicentre clinical intervention study (high-risk-collective) on primary prevention of cardiovascular diseases in the Ford Motor Company employees in Germany]., Z Kardiol, 2004, 93, 2, 131-136, doi: 10.1007/s00392-004-0990-3.

  2. Results

    Albus C, Bjarnson-Wehrens B, Gysan DB, Herold G, Schneider CA, zu Eulenburg C, Predel HG, , [The effects of multimodal intervention for the primary prevention of cardiovascular diseases on depression, anxiety, and Type-D pattern: initial results of the randomized controlled PreFord trial]., Herz, 2012, 37, 1, 59-62, doi: 10.1007/s00059-011-3542-4.

Additional files

Editorial Notes

19/02/2016: Plain English summary added.