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

George A. Jelinek, Emily Hadgkiss, Craig Hassed, Bernard Crimmins, Peter Schattner, Danny Liew, Rick Kausman, Warrick J. Inder, Siegfried Gutbrod, Tracey J. Weiland

Department of General Practice, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, Australia.
Department of Medicine, Faculty of Medicine and Health Sciences, The University of Melbourne, Royal Melbourne Hospital, Melbourne, Australia.
East Bentleigh General Practice, Melbourne, Australia.
Emergency Practice Innovation Centre, St Vincent’s Hospital, Melbourne, Australia.
Formerly Department of Endocrinology, St Vincent’s Hospital, Melbourne, Australia.
Manningham General Practice, Melbourne, Australia.
The Butterfly Foundation, Malvern, Australia.
The Gawler Foundation, Yarra Junction, Australia.

DOI: 10.4236/ojemd.2012.24008                

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.

Keywords

Type 2 Diabetes Mellitus; Randomised Controlled Trial; Management; Lifestyle; Risk Factors

Conflicts of Interest

The authors declare no conflicts of interest.

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