• Bob Mash, Naomi Levitt, Krisela Steyn, Merrick Zwarenstein, and Stephen Rollnick.
• Family Medicine and Primary Care, Stellenbosch University, Box 19063, Tygerberg 7505, South Africa. rm@sun.ac.za
• Bmc Fam Pract. 2012 Dec 24; 13: 126126.

BackgroundDiabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life.Trial DesignPragmatic cluster randomized controlled trialParticipants: Type 2 diabetic patients attending 45 public sector community health centres in Cape TownInterventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room.ObjectiveTo evaluate the effectiveness of the group diabetes education programmeOutcomes:Primary Outcomesdiabetes self-care activities, 5% weight loss, 1% reduction in HbA1c.Secondary Outcomesself-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of lifeRandomisation: Computer generated random numbersBlinding: Patients, health promoters and research assistants could not be blinded to the health centre's allocationNumbers randomized: Seventeen health centres (34 in total) will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570.DiscussionThe study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can be implemented more widely.Trial RegisterPan African Clinical Trial Registry PACTR201205000380384.

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