Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
16/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Martin Edwards

ORCID ID

Contact details

Jenner Health Centre
201 Stanstead Road
Forest Hill
London
SE23 1HU
United Kingdom
+44 (0)20 8690 2231

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

REC00155

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/04/1998

Overall trial end date

01/10/2000

Reason abandoned

Eligibility

Participant inclusion criteria

Adults registered with participating practices, aged between 35 and 65.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant 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.

Recruitment start date

01/04/1998

Recruitment end date

01/10/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Jenner Health Centre
London
SE23 1HU
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive London, UK

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes