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
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
-
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.