TITLE:
Difficulties in Recruitment for a Randomised Controlled Trial of Lifestyle Intervention for Type 2 Diabetes: Implications for Diabetes Management
AUTHORS:
George A. Jelinek, Emily Hadgkiss, Craig Hassed, Bernard Crimmins, Peter Schattner, Danny Liew, Rick Kausman, Warrick J. Inder, Siegfried Gutbrod, Tracey J. Weiland
KEYWORDS:
Type 2 Diabetes Mellitus; Randomised Controlled Trial; Management; Lifestyle; Risk Factors
JOURNAL NAME:
Open Journal of Endocrine and Metabolic Diseases,
Vol.2 No.4,
November
19,
2012
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.