Abstract
BackgroundEffective diabetes prevention strategies that can be implemented in daily practice, without huge amounts of money and a lot of personnel are needed. The Dutch Diabetes Federation developed a protocol for coaching people with impaired fasting glucose (IFG; according to WHO criteria: 6.1 to 6.9 mmol/l) to a sustainable healthy lifestyle change: ‘the road map towards diabetes prevention’ (abbreviated: Road Map: RM). This protocol is applied within a primary health care setting by a general practitioner and a practice nurse. The feasibility and (cost-) effectiveness of care provided according to the RM protocol will be evaluated.Methods/DesignA cluster randomised clinical trial is performed, with randomisation at the level of the general practices. Both opportunistic screening and active case finding took place among clients with high risk factors for diabetes. After IFG is diagnosed, motivated people in the intervention practices receive 3–4 consultations by the practice nurse within one year. During these consultations they are coached to increase the level of physical activity and healthy dietary habits. If necessary, participants are referred to a dietician, physiotherapist, lifestyle programs and/or local sports activities. The control group receives care as usual. The primary outcome measure in this study is change in Body Mass Index (BMI). Secondary outcome measures are waist circumference, physical activity, total and saturated fat intake, systolic blood pressure, blood glucose, total cholesterol, HDL cholesterol, triglycerides and behaviour determinants like risk perception, perceived knowledge and motivation. Based on a sample size calculation 120 people in each group are needed. Measurements are performed at baseline, and after one (post-intervention) and two years follow up. Anthropometrics and biochemical parameters are assessed in the practices and physical activity, food intake and their determinants by a validated questionnaire. The cost-effectiveness is estimated by using the Chronic Disease Model (CDM). Feasibility will be tested by interviews among health care professionals.DiscussionThe results of the study will provide valuable information for both health care professionals and policy makers. If this study shows the RM to be both effective and cost-effective the protocol can be implemented on a large scale.Trial registrationISRCTN41209683. Ethical approval number: NL31342.075.10.
Highlights
Effective diabetes prevention strategies that can be implemented in daily practice, without huge amounts of money and a lot of personnel are needed
If this study shows the Route map diabetes prevention (RM) to be both effective and cost-effective the protocol can be implemented on a large scale
People with impaired fasting glucose (IFG) have a high risk of developing type 2 diabetes mellitus (T2DM) on short term, and have an increased cardiovascular risk [5]
Summary
Effective diabetes prevention strategies that can be implemented in daily practice, without huge amounts of money and a lot of personnel are needed. The Dutch Diabetes Federation developed a protocol for coaching people with impaired fasting glucose (IFG; according to WHO criteria: 6.1 to 6.9 mmol/l) to a sustainable healthy lifestyle change: ‘the road map towards diabetes prevention’ (abbreviated: Road Map: RM). In 2011 the estimated prevalence in the Netherlands was 834.100 people with diabetes, of which 90% with type 2 diabetes mellitus (T2DM), with an annual estimate of newly discovered cases of 71,000 in that year [2] This number translates into approximately 5% of the total Dutch population and is expected to rise to 1,300,000 and 1,600,000 in 2025 [3]. Without changes in lifestyle and proper support, about 9% of people with IFG will develop T2DM within three years [6]
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