Difficulties in Recruitment for a Randomised Controlled Trial of Lifestyle Intervention for Type 2 Diabetes: Implications for Diabetes Management

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DOI: 10.4236/ojemd.2012.24008    4,020 Downloads   7,830 Views  Citations

ABSTRACT

Objective: To report our experience of attempting a randomised controlled trial of an intensive lifestyle intervention for early type 2 diabetes delivered in a residential setting. Methods: We established a trial requiring 84 participants (46 standard care and 38 intervention) to detect a 1% difference in HbA1c between intervention and control groups at 12 months, allowing for attrition. Ethics approval was obtained from Monash University. Results: The study was abandoned after five months of consistent promotion due to recruitment failure (four subjects recruited). Conclusion: It appears to be difficult for patients with diabetes to commit to a live-in period of education regarding lifestyle modification as a means of treating the illness. We recommend better education of patients and their doctors about the potential health benefits of lifestyle change to manage type 2 diabetes, and further research into novel methods of delivering lifestyle advice which are both effective and sustainable.

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G. A. Jelinek, E. Hadgkiss, C. Hassed, B. Crimmins, P. Schattner, D. Liew, R. Kausman, W. J. Inder, S. Gutbrod and T. J. Weiland, "Difficulties in Recruitment for a Randomised Controlled Trial of Lifestyle Intervention for Type 2 Diabetes: Implications for Diabetes Management," Open Journal of Endocrine and Metabolic Diseases, Vol. 2 No. 4, 2012, pp. 53-57. doi: 10.4236/ojemd.2012.24008.

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