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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16922700
Publication citations
-
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.