|- candidate number||0|
|- NTR Number||NTR42|
|- Date ISRCTN created||5-aug-2005|
|- date ISRCTN requested||18-jul-2005|
|- Date Registered NTR||15-mei-2005|
|- Secondary IDs||Projectnumber ZON-MW 945-04-266 |
|- Public Title||Activity, Lifestyle And Nutrition and Therapy study.|
|- Scientific Title||Activity, Lifestyle And Nutrition and Therapy study.|
|- Healt Condition(s) or Problem(s) studied||Cardiovascular disease|
|- Inclusion criteria||The patient has manifest cardiovascular suffering in combination with at least one lifestyle related risk factor (physical inactivity, smokes, obesities).|
The patient must be able to participate in a training program, the patientsí insurance company will cover the costs of the intervention program.
|- Exclusion criteria||A recent cardiovascular incident (within less than 3 months), unstable (co)-morbidity, a planned operation or undergoing investigations which can directly lead to an operation, younger than 18 years, the patient has already attended the intervention program, insufficient knowledge of the Dutch language.|
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-apr-2005|
|- planned closingdate||1-mrt-2008|
|- Target number of participants||600|
|- Interventions||Patients of the VU University Medical Centre will be randomized into two groups.|
One group will receive a six-months 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.
|- Primary outcome||To evaluate cost-effectiveness of a lifestyle intervention in patients with cardiovascular disease.
|- Secondary outcome||N/A|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. Helma IJzelenberg|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Ir. J.C. Seidell|
|- Sponsor/Initiator ||VU University Medical Center, Department of Nutrition and Health|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||14-jul-2005 - 11-dec-2006|