An evaluation of behavioural methods for cardiovascular risk reduction in general practice
| ISRCTN | ISRCTN17714180 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17714180 |
| Secondary identifying numbers | HB14 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 01/12/2010
- 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
Prof Andrew Steptoe
Scientific
Scientific
Department of Epidemiology and Public Health
UCL
Gower Street Campus
1-19 Torrington Place
London
WC1E 6BT
United Kingdom
| Phone | +44 (0)20 7679 1680 |
|---|---|
| a.steptoe@ucl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Scientific title | |
| Study objectives | Risk factors for cardiovascular disease include cigarette smoking, high blood pressure, high blood cholesterol, and being overweight. People with more than one risk factor are at even higher risk. The aim of this study was to compare changes in behaviour and risk factors in patients in general practices using a specially trained practice nurse with those in practices where nurses used their usual procedures. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular diseases |
| Intervention | The behavioural intervention was based on the 'stages of change' model developed by Prochaska and Diclemente, an approach popular with those involved in health promotion in the 1990s. The trained nurses arranged assessment followed by two or three 20 minute counselling sessions, depending on the number of risk factors. |
| Intervention type | Other |
| Primary outcome measure | Initial assessment comprised a questionnaire covering demographic data, measures of smoking, diet, and physical activity, and measures of attitude and motivation; and physical measurements including height, weight, cholesterol, and blood pressure. These measurements were repeated at 4 and 12 months. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/1994 |
| Completion date | 03/08/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 883 |
| Key inclusion criteria | Patients with at least one out of three risk factors (raised cholesterol, smoking, raised body mass index [BMI] and physical inactivity) were to be recruited from each of 10 intervention practices and 10 control practices in and near London. Recruitment was difficult and eventually there were 316 patients in the intervention group and 567 in the control group (883 patients instead of 2000). 54% of patients were women, 96% were white, mean age was 47, 77% were married, and 78% employed. Risk factors were evenly balanced between the two groups. Of 316 intervention patients 285, 230, and 176 attended the 1st, 2nd, and 3rd counselling session. 204 and 169 returned for the 4 and 12 month assessment. Comparable figures for the 567 patients in the control group were 423 and 251 for the follow-up assessments. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/1994 |
| Date of final enrolment | 03/08/1997 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Epidemiology and Public Health
London
WC1E 6BT
United Kingdom
WC1E 6BT
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
NHS Cardiovascular Disease and Stroke National Research and Development Programme (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/03/1996 | Yes | No | |
| Results article | change in behaviour results | 01/06/1998 | Yes | No | |
| Results article | promotion of health results | 01/03/1999 | Yes | No | |
| Results article | GP and nurse results | 01/04/1999 | Yes | No | |
| Results article | Behavioral counseling results | 09/10/1999 | Yes | No |
