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ISRCTN
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ISRCTN37146824
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial of buddy support in the reduction of cardiovascular risk related behaviour
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Scientific title
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Acronym
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N/A
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Serial number at source
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REC00155
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cardiovascular disease
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Participants - inclusion criteria
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Adults registered with participating practices, aged between 35 and 65.
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Participants - exclusion criteria
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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.
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Anticipated start date
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01/04/1998
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Anticipated end date
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01/10/2000
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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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.
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Primary outcome measure(s)
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Change in Body Mass Index, serum cholesterol, diastolic and systolic blood pressure, smoking cessation, exercise and alcohol consumption.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NHS Executive London, UK
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Trial website
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Publications
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Contact name
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Dr
Martin
Edwards
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Address
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Jenner Health Centre
201 Stanstead Road
Forest Hill
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City/town
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London
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Zip/Postcode
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SE23 1HU
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Country
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United Kingdom
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Tel
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+44 (0)20 8690 2231
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Fax
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+44 (0)20 7771 4210
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Email
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cc@martinedwards.me.uk
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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08/12/2010
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Date ISRCTN assigned
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23/01/2004
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