Journal article
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
Open Journal of Endocrine and Metabolic Diseases | Scientific Research Publishing, Inc. | Published : 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 lifestyl..
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