Condition category
Circulatory System
Date applied
04/08/2005
Date assigned
04/08/2005
Last edited
04/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Helma IJzelenberg

ORCID ID

Contact details

De Boelelaan 1085
Amsterdam
1081 HV
Netherlands
+31 (0)20 598 9951
helma.ijzelenberg@falw.vu.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR42

Study information

Scientific title

Acronym

ALANT

Study hypothesis

To evaluate cost-effectiveness of a lifestyle intervention in patients with cardiovascular disease.

Ethics approval

Ethics approval received from the local ethics committee

Study design

Randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Cardiovascular disease

Intervention

Patients of the VU University Medical Centre will be randomised into two groups. One group will receive a six-month lifestyle intervention which includes a physical activity program and when appropriate smoking cessation and weight loss. The other group will continue to receive usual care.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Cost-effectiveness of a lifestyle intervention in patients with cardiovascular disease

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2005

Overall trial end date

01/03/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. The patient has manifest cardiovascular suffering in combination with at least one lifestyle related risk factor (physical inactivity, smokes, obesity)
2. The patient must be able to participate in a training program
3. The patients' insurance company will cover the costs of the intervention program

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600

Participant exclusion criteria

1. A recent cardiovascular incident (within less than 3 months)
2. Unstable (co)-morbidity
3. A planned operation or undergoing investigations which can directly lead to an operation
4. Younger than 18 years
5. The patient has already attended the intervention program
6. Insufficient knowledge of the Dutch language

Recruitment start date

01/04/2005

Recruitment end date

01/03/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

De Boelelaan 1085
Amsterdam
1081 HV
Netherlands

Sponsor information

Organisation

Vrije University Medical Centre (VUMC) (The Netherlands)

Sponsor details

Faculty of Earth and Life Sciences
Institute of Health Sciences
De Boelelaan 1085
Amsterdam
1081 HV
Netherlands
+31 (0)20 598 6985
jaap.seidell@falw.vu.nl

Sponsor type

University/education

Website

http://www.vumc.nl

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

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. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22962863

Publication citations

  1. Results

    Ijzelenberg W, Hellemans IM, van Tulder MW, Heymans MW, Rauwerda JA, van Rossum AC, Seidell JC, The effect of a comprehensive lifestyle intervention on cardiovascular risk factors in pharmacologically treated patients with stable cardiovascular disease compared to usual care: a randomised controlled trial., BMC Cardiovasc Disord, 2012, 12, 71, doi: 10.1186/1471-2261-12-71.

Additional files

Editorial Notes