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A cluster-randomized controlled trial to study the effectiveness of a protocol-based lifestyle program to prevent type 2 diabetes in people with impaired fasting glucose.

Hesselink AE, Bilo HJ, Jonkers R, Martens M, de Weerdt I, Rutten GE - BMC Fam Pract (2013)

Bottom Line: The cost-effectiveness is estimated by using the Chronic Disease Model (CDM).If this study shows the RM to be both effective and cost-effective the protocol can be implemented on a large scale.ISRCTN41209683.

View Article: PubMed Central - HTML - PubMed

Affiliation: ResCon, Research & Consultancy, Haarlem, Netherlands. A.Hesselink@rescon.nl.

ABSTRACT

Background: 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). 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/design: A 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.

Discussion: The 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 registration: ISRCTN41209683. Ethical approval number: NL31342.075.10.

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Related in: MedlinePlus

Study design.
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Figure 1: Study design.

Mentions: A clustered randomized controlled trial is carried out to study the feasibility and (cost-)effectiveness of the RM. Randomization takes place at the level of the general practices. The subjects in the intervention group are treated according to the RM. Persons in the control group receive care as usual, including one consultation each year, according to the T2DM guideline of the Dutch College of General Practitioners [7]. A baseline measurement takes place just after the diagnosis of IFG and just before the start of the intervention. Outcome measurements are performed one year after the diagnosis (t1, 1-year follow-up) and two years after the diagnosis (t2, 2-year follow up) (FigureĀ 1).


A cluster-randomized controlled trial to study the effectiveness of a protocol-based lifestyle program to prevent type 2 diabetes in people with impaired fasting glucose.

Hesselink AE, Bilo HJ, Jonkers R, Martens M, de Weerdt I, Rutten GE - BMC Fam Pract (2013)

Study design.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4219396&req=5

Figure 1: Study design.
Mentions: A clustered randomized controlled trial is carried out to study the feasibility and (cost-)effectiveness of the RM. Randomization takes place at the level of the general practices. The subjects in the intervention group are treated according to the RM. Persons in the control group receive care as usual, including one consultation each year, according to the T2DM guideline of the Dutch College of General Practitioners [7]. A baseline measurement takes place just after the diagnosis of IFG and just before the start of the intervention. Outcome measurements are performed one year after the diagnosis (t1, 1-year follow-up) and two years after the diagnosis (t2, 2-year follow up) (FigureĀ 1).

Bottom Line: The cost-effectiveness is estimated by using the Chronic Disease Model (CDM).If this study shows the RM to be both effective and cost-effective the protocol can be implemented on a large scale.ISRCTN41209683.

View Article: PubMed Central - HTML - PubMed

Affiliation: ResCon, Research & Consultancy, Haarlem, Netherlands. A.Hesselink@rescon.nl.

ABSTRACT

Background: 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). 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/design: A 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.

Discussion: The 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 registration: ISRCTN41209683. Ethical approval number: NL31342.075.10.

Show MeSH
Related in: MedlinePlus