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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
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 t...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2013
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4219396/ https://www.ncbi.nlm.nih.gov/pubmed/24295397 http://dx.doi.org/10.1186/1471-2296-14-184 |
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author | Hesselink, Arlette E Bilo, Henk JG Jonkers, Ruud Martens, Marloes de Weerdt, Inge Rutten, Guy EH |
author_facet | Hesselink, Arlette E Bilo, Henk JG Jonkers, Ruud Martens, Marloes de Weerdt, Inge Rutten, Guy EH |
author_sort | Hesselink, Arlette E |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-4219396 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-42193962014-11-05 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, Arlette E Bilo, Henk JG Jonkers, Ruud Martens, Marloes de Weerdt, Inge Rutten, Guy EH BMC Fam Pract Study Protocol 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. BioMed Central 2013-12-02 /pmc/articles/PMC4219396/ /pubmed/24295397 http://dx.doi.org/10.1186/1471-2296-14-184 Text en Copyright © 2013 Hesselink et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Hesselink, Arlette E Bilo, Henk JG Jonkers, Ruud Martens, Marloes de Weerdt, Inge Rutten, Guy EH 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4219396/ https://www.ncbi.nlm.nih.gov/pubmed/24295397 http://dx.doi.org/10.1186/1471-2296-14-184 |
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