Condition category
Not Applicable
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
16/01/2014
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

Prof Christopher Drinkwater

ORCID ID

Contact details

Primary Care Development Centre
University of Northumbria at Newcastle
Newcastle General Hospital
Westgate Road
Newcastle upon Tyne
NE4 6BE
United Kingdom
+44 (0)191 256 3838
c.k.drinkwater@pcdc.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HB32

Study information

Scientific title

Acronym

Study hypothesis

Physical activity is a protective factor in the origins of heart disease, stroke, obesity, diabetes, and osteoporosis. It may also play a role in the promotion of mental health. Inactivity is a risk factor for coronary heart disease.

The aim of this study was to assess the effectiveness of four methods of increasing the level of physical activity in middle aged people.

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

Not Specified

Patient information sheet

Condition

Exercise and health

Intervention

The five interventions were:
1. Information pack and 5 minute interview (control group)
2. Pack plus one 40 minute motivational interview
3. As group 2 plus 30 vouchers giving free access to local leisure facilities
4. Pack plus six motivational interviews over 12 weeks
5. As group 4 plus vouchers.

At the initial interview information was collected about demography, physical activity score, knowledge about benefits of physical activity and barriers to undertaking it, smoking, alcohol consumption, diet, and general health. Physical assessment included height, weight, waist and hip circumference, blood pressure, and respiratory and cardiovascular function tests.

The 12 weeks questionnaire collected self-reported information, and the 12 month assessment covered the full range of measurements.

The participants received a postal questionnaire after 12 weeks, and were interviewed and re-assessed at 12 months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/1994

Overall trial end date

30/07/1997

Reason abandoned

Eligibility

Participant inclusion criteria

1308 patients aged between age 40 and 64 were approached opportunistically when they attended at a health centre in Newcastle upon Tyne. A further 1666 patients of the practice were invited to participate by post.

217 men and 306 women eventually took part. 81% responded to the 12-week postal enquiry, and 84% to the 12-month interview.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

523

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/1994

Recruitment end date

30/07/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Care Development Centre
Newcastle upon Tyne
NE4 6BE
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

1999 results in: http://www.ncbi.nlm.nih.gov/pubmed/10496829

Publication citations

  1. Results

    Harland J, White M, Drinkwater C, Chinn D, Farr L, Howel D, The Newcastle exercise project: a randomised controlled trial of methods to promote physical activity in primary care., BMJ, 1999, 319, 7213, 828-832.

Additional files

Editorial Notes