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

DOI: 10.4236/ojemd.2012.24008    3,423 Downloads   6,616 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.

Conflicts of Interest

The authors declare no conflicts of interest.

Cite this paper

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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