Activity, Lifestyle And Nutrition and Therapy study
| ISRCTN | ISRCTN69776211 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69776211 |
| Protocol serial number | NTR42 |
| Sponsor | Vrije University Medical Centre (VUMC) (The Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) |
- Submission date
- 04/08/2005
- Registration date
- 04/08/2005
- Last edited
- 04/02/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Helma IJzelenberg
Scientific
Scientific
De Boelelaan 1085
Amsterdam
1081 HV
Netherlands
| Phone | +31 (0)20 598 9951 |
|---|---|
| helma.ijzelenberg@falw.vu.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | ALANT |
| Study objectives | To evaluate cost-effectiveness of a lifestyle intervention in patients with cardiovascular disease. |
| Ethics approval(s) | Ethics approval received from the local ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Cost-effectiveness of a lifestyle intervention in patients with cardiovascular disease |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 600 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2005 |
| Date of final enrolment | 01/03/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
De Boelelaan 1085
Amsterdam
1081 HV
Netherlands
1081 HV
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 10/09/2012 | Yes | No |
