Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
30/11/2009
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 Kennedy Cruickshank

ORCID ID

Contact details

Clinical Epidemiology Unit
University of Manchester
Oxford Road
Manchester
M13 9PT
United Kingdom
+44 (0)161 275 5211
clinep@man.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WE16

Study information

Scientific title

Acronym

Study hypothesis

Vascular disease and diabetes are major causes of morbidity and mortality in Manchester, especially among those of Afro-Caribbean and Indian sub-continent descent.
The aims of this study, which is part of a larger project, were to determine prevalence rates of some risk factors; to assess how such factors were detected and controlled in primary care; and to pilot an appropriate intervention programme to reduce obesity and high blood pressure.

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

Peripheral arterial disease; Diabetes

Intervention

1. Advice on diet and exercise were given at the start, and reinforced at days 30 and 60
2. No advice

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

In the observational part of the study blood pressure, height, weight, and hip and waist measurements were taken by a trained observer. Subjects were asked about their knowledge of their blood pressure, whether they knew if they had diabetes, about their smoking (ever, current, number of cigarettes daily), their alcohol consumption (>12 units in a year), and details of their diet.
In the interventional study weight was recorded on Days 1, 30, 60, and 90, and blood pressure was recorded on Day 1 and Day 90. Information on the 18 foods making up 95% of energy and fat in the diets was obtained at day 1 and 90 for the AfC people in the sample.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/1994

Overall trial end date

01/11/1997

Reason abandoned

Eligibility

Participant inclusion criteria

The research was undertaken in 7 general practices, in a part of Manchester with a high proportion of ethnic minority groups in their catchment areas.
Subjects aged 25-79 were selected from age-sex registers. Ethnicity was defined from grandparental origins. The final sample comprised 547 people of White European (WE) origin, 479 of African-Caribbean (AfC) origin, and 100 of Pakistani Muslim (PM) origin.
Of the initial sample 27% were no longer at the recorded address, and 16% were no longer in the practice. During the 4 years of the study 42% of people in the final sample changed address.
The random sample in the intervention study comprised 61 people of AfC origin. However 25 declined to take part, and 22 had moved or could not be contacted. The final sample was 8 in the intervention group and 6 in the control group.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

547

Participant exclusion criteria

Mental health illness that would preclude compliance

Recruitment start date

01/05/1994

Recruitment end date

01/11/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Epidemiology Unit
Manchester
M13 9PT
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

Diabetes (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

2003 results in http://www.ncbi.nlm.nih.gov/pubmed/14632704

Publication citations

  1. Results

    Vyas A, Haidery AZ, Wiles PG, Gill S, Roberts C, Cruickshank JK, A pilot randomized trial in primary care to investigate and improve knowledge, awareness and self-management among South Asians with diabetes in Manchester., Diabet. Med., 2003, 20, 12, 1022-1026.

Additional files

Editorial Notes