Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
01/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.dh.gov.uk/en/Aboutus/Researchanddevelopment/AtoZ/Cardiovasculardiseaseandstroke/DH_4001724

Contact information

Type

Scientific

Primary contact

Prof Andrew Steptoe

ORCID ID

Contact details

Department of Epidemiology and Public Health
UCL
Gower Street Campus
1-19 Torrington Place
London
WC1E 6BT
United Kingdom
+44 (0)20 7679 1680
a.steptoe@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HB14

Study information

Scientific title

Acronym

Study hypothesis

Risk factors for cardiovascular disease include cigarette smoking, high blood pressure, high blood cholesterol, and being overweight. People with more than one risk factor are at even higher risk.
The aim of this study was to compare changes in behaviour and risk factors in patients in general practices using a specially trained practice nurse with those in practices where nurses used their usual procedures.

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

GP practices

Trial type

Prevention

Patient information sheet

Condition

Cardiovascular diseases

Intervention

The behavioural intervention was based on the 'stages of change' model developed by Prochaska and Diclemente, an approach popular with those involved in health promotion in the 1990s. The trained nurses arranged assessment followed by two or three 20 minute counselling sessions, depending on the number of risk factors.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Initial assessment comprised a questionnaire covering demographic data, measures of smoking, diet, and physical activity, and measures of attitude and motivation; and physical measurements including height, weight, cholesterol, and blood pressure.
These measurements were repeated at 4 and 12 months.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/1994

Overall trial end date

03/08/1997

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with at least one out of three risk factors (raised cholesterol, smoking, raised body mass index [BMI] and physical inactivity) were to be recruited from each of 10 intervention practices and 10 control practices in and near London. Recruitment was difficult and eventually there were 316 patients in the intervention group and 567 in the control group (883 patients instead of 2000).
54% of patients were women, 96% were white, mean age was 47, 77% were married, and 78% employed. Risk factors were evenly balanced between the two groups.
Of 316 intervention patients 285, 230, and 176 attended the 1st, 2nd, and 3rd counselling session. 204 and 169 returned for the 4 and 12 month assessment. Comparable figures for the 567 patients in the control group were 423 and 251 for the follow-up assessments.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

883

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/1994

Recruitment end date

03/08/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Epidemiology and Public Health
London
WC1E 6BT
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

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

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Cardiovascular Disease and Stroke National Research and Development Programme (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

1. 1996 results in http://hej.sagepub.com/content/55/1/108.abstract
2. 1997 results in: Doherty S, Steptoe A. The behavioural management of cardiovascular risk factors. Risk 1997; 5:21-27
3. 1998 change in behaviour results in http://www.ncbi.nlm.nih.gov/pubmed/10201550
4. 1999 promotion of health results in http://hej.sagepub.com/content/58/1/3.abstract
5. 1999 Behavioral counseling results in http://www.ncbi.nlm.nih.gov/pubmed/10514155
6. 1999 GP and nurse results in http://www.ncbi.nlm.nih.gov/pubmed/10381023

Publication citations

  1. Change in behaviour results

    Doherty SC, Steptoe A, Rink E, Kendrick T, Hilton S, Readiness to change health behaviours among patients at high risk of cardiovascular disease., J Cardiovasc Risk, 1998, 5, 3, 147-153.

  2. Behavioral counseling results

    Steptoe A, Doherty S, Rink E, Kerry S, Kendrick T, Hilton S, Behavioural counselling in general practice for the promotion of healthy behaviour among adults at increased risk of coronary heart disease: randomised trial., BMJ, 1999, 319, 7215, 943-7; discussion 947-8.

  3. GP and nurse results

    Steptoe A, Doherty S, Kendrick T, Rink E, Hilton S, Attitudes to cardiovascular health promotion among GPs and practice nurses., Fam Pract, 1999, 16, 2, 158-163.

Additional files

Editorial Notes