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Register:	ISRCTN
Last refreshed on:	27 March 2023
Main ID:	ISRCTN23536103
Date of registration:	28/07/2011
Prospective Registration:	No
Primary sponsor:	German Sports University (Germany)
Public title:	Prevention of cardiovascular disease in current and former employees of the Ford motor company, Germany
Scientific title:	Multimodal intervention for prímary prevention of cardiovascular disease in current and former employees of the Ford motor company, Germany - the PreFord trial
Date of first enrolment:	01/08/2004
Target sample size:	447
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN23536103
Study type:	Interventional
Study design:	Two-armed randomized controlled clinical trial (Prevention)
Phase:	Not Applicable

Countries of recruitment
Germany

Contacts

Name:	Hans-Georg Predel
Address:	German Sports University Cologne 50931 Cologne (Koeln) Germany
Telephone:	-
Email:	predel@dshs-koeln.de
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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

Exclusion criteria: Severe somatic or psychiatric morbidity, e.g. malignancies, psychosis, drug addiction

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Prevention of cardiovascular disease
Circulatory System
Cardiovascular disease

Intervention(s)

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)

Primary Outcome(s)

European Society of Cardiology risk score

Secondary Outcome(s)

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)

Secondary ID(s)

N/A

Source(s) of Monetary Support

Bayer Vital (Germany), Pronova BKK (Germany), AstraZeneca (Germany)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

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

Results

Results available:	Yes
Date Posted:
Date Completed:	31/07/2013
URL:

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