Randomised controlled trial of buddy support in the reduction of cardiovascular risk related behaviour
| ISRCTN | ISRCTN37146824 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37146824 |
| Protocol serial number | REC00155 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive London, UK |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 16/12/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Martin Edwards
Scientific
Scientific
Jenner Health Centre
201 Stanstead Road
Forest Hill
London
SE23 1HU
United Kingdom
| Phone | +44 (0)20 8690 2231 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | The study will test the hypothesis that buddy support significantly enhances the effect of lifestyle advice from a practice nurse. 700 adults aged 35-65 will receive advice and instruction in lifestyle modification designed to minimise cardiovascular risk factors. Participants will be randomly allocated to one of two conditions: solo or buddy. Buddy subjects will be allocated a buddy, a same-sex individual also from the buddy condition. Buddy pairs will be encouraged to maintain contact for six months in order to encourage each other to maintain lifestyle modifications. Solo participants (controls) will receive lifestyle advice from the nurse, but without peer support. Evaluation after six months will compare successful lifestyle modification (smoking, exercise, alcohol consumption, diet, body mass index, blood pressure) between solo and buddy groups. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular disease |
| Intervention | i. Buddy - allocated of a buddy, a same-sex individual also from the buddy condition. Buddy pairs will be encouraged to maintain contact for six months in order to encourage each other to maintain lifestyle modifications. ii. Solo (controls) will receive lifestyle advice from the nurse, but with no peer support. |
| Intervention type | Other |
| Primary outcome measure(s) |
Change in Body Mass Index, serum cholesterol, diastolic and systolic blood pressure, smoking cessation, exercise and alcohol consumption. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/10/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Key inclusion criteria | Adults registered with participating practices, aged between 35 and 65. |
| Key exclusion criteria | Patients with a history of use of psychotropic medication including antidepressants and benzodiazepines within the previous six months; a current or past history of psychotic illness, alcohol or drug abuse, or personality disorder; or with insufficient command of English for buddying to be practical. |
| Date of first enrolment | 01/04/1998 |
| Date of final enrolment | 01/10/2000 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Jenner Health Centre
London
SE23 1HU
United Kingdom
SE23 1HU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
