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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific title
Study objectivesThe 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) studiedCardiovascular disease
Interventioni. 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 typeOther
Primary outcome measureChange in Body Mass Index, serum cholesterol, diastolic and systolic blood pressure, smoking cessation, exercise and alcohol consumption.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/1998
Completion date01/10/2000

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteriaAdults registered with participating practices, aged between 35 and 65.
Key exclusion criteriaPatients 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 enrolment01/04/1998
Date of final enrolment01/10/2000

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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan