Randomised controlled trial of buddy support in the reduction of cardiovascular risk related behaviour

ISRCTN	ISRCTN37146824
DOI	https://doi.org/10.1186/ISRCTN37146824
Secondary identifying numbers	REC00155

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

Jenner Health Centre
201 Stanstead Road
Forest Hill
London
SE23 1HU
United Kingdom

Phone	+44 (0)20 8690 2231

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
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	Change in Body Mass Index, serum cholesterol, diastolic and systolic blood pressure, smoking cessation, exercise and alcohol consumption.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/04/1998
Completion date	01/10/2000

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Not provided at time of registration
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

England
United Kingdom

Study participating centre

Jenner Health Centre

London
SE23 1HU
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive London, 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