A pilot randomised trial in primary care to investigate and improve knowledge, awareness and self-management among South Asians with diabetes in Manchester
| ISRCTN | ISRCTN52142474 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52142474 |
| Secondary identifying numbers | WE16 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 30/11/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Kennedy Cruickshank
Scientific
Scientific
Clinical Epidemiology Unit
University of Manchester
Oxford Road
Manchester
M13 9PT
United Kingdom
| Phone | +44 (0)161 275 5211 |
|---|---|
| clinep@man.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/05/1994 |
| Completion date | 01/11/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 547 |
| Key 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. |
| Key exclusion criteria | Mental health illness that would preclude compliance |
| Date of first enrolment | 01/05/1994 |
| Date of final enrolment | 01/11/1997 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clinical Epidemiology Unit
Manchester
M13 9PT
United Kingdom
M13 9PT
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Diabetes (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2003 | Yes | No |
