Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
09/07/2009
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

Ms Janet Cade

ORCID ID

Contact details

71-75 Clarendon Road
Leeds
Leeds
LS2 9PL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0626133451

Study information

Scientific title

Acronym

Study hypothesis

To assess the impact of a peer educator in promoting healthy eating in people with diabetes.

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

Quality of life

Patient information sheet

Condition

Nutritional, Metabolic, Endocrine: Diabetes

Intervention

The study will carry out a randomised controlled trial of peer education for healthy eating in people with diabetes living in Burnley and Bradford. These are areas with large ethnic minority population and a high level of low income families. The peer education will involve training 'expert patients' who will then pass on their knowledge to groups of other people with diabetes from their locality. The control group will receive standard care. This will involve an individual 15 minute appointment with a dietitian and GP/practice nurse. Follow up of both groups will be conducted at three months post education and at 12 months. Differences between groups in terms of food and nutrient intake, weight and measures of diabetic control will be compared.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Differences in food/nutrient intake patterns between the group receiving peer education and the standard education package - specifically: changes in fat, saturated fat, energy, fibre, and fruit and vegetable intakes.
2. Assessment of the sustainability of any changes over a one year period.
3. Assessment of the ability of the peer educator to promote improvement in diabetic control over 3 months and 12 months as compared with the standard educational package alone.
4. Development of a culturally acceptable, health promotion intervention.
5. Difference in continued motivation to change between groups.
6. Difference in cost of intervention between the groups.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2002

Overall trial end date

31/08/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Adults with type 2 diabetes (defined as onset over 30 years, not on insulin within the first year).
Registered with GP practices selected from socially deprived catchment groups (using Jarman scores) and with a high percentage of people of South Asian origin.
135 subjects will be needed in each group (270 total). This number will be split between Bradford and Burnley.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

270

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/09/2002

Recruitment end date

31/08/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

71-75 Clarendon Road
Leeds
LS2 9PL
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Bradford South and West Primary Care Trust (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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16922700

Publication citations

  1. Results

    Deakin TA, Cade JE, Williams R, Greenwood DC, Structured patient education: the diabetes X-PERT Programme makes a difference., Diabet. Med., 2006, 23, 9, 944-954, doi: 10.1111/j.1464-5491.2006.01906.x.

Additional files

Editorial Notes