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   PDF    HTML   XML   3,980 Downloads   7,702 Views   Citations


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.

Share and Cite:

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.

Conflicts of Interest

The authors declare no conflicts of interest.


[1] D. Dunstan, S. Colagiuri, P. Zimmet, et al., “The Rising Prevalence of Diabetes and Impaired Glucose Tolerance: The Australian Diabetes, Obesity and Lifestyle Study,” Diabetes Care, Vol. 25, No. 5, 2002, pp. 829-834. doi:10.2337/diacare.25.5.829
[2] E. L. M. Barr, D. J. Magliano, P. Z. Zimmet, et al., “The Australian Diabetes, Obesity and Lifestyle Study. Tracking the Accelerating Epidemic: Its Causes and Outcomes,” International Diabetes Institute, Melbourne, 2006.
[3] S. F. Wetterhall, D. R. Olson, F. DeStefano, et al., “Trends in Diabetes and Diabetic Complications, 1980-1987,” Diabetes Care, Vol. 15, No. 8, 1992, pp. 960-967. doi:10.2337/diacare.15.8.960
[4] A. C. Powers, “Diabetes Mellitus. Harrison’s Principles of Internal Medicine,” The McGraw-Hill Companies, Inc., Ohio, 2005.
[5] S. Colagiuri, R. Colagiuri, B. Conway, et al., “DiabCo$t Australia: Assessing the Burden of Type 2 Diabetes in Australia,” Diabetes Australia, Canberra, 2003.
[6] D. L. Kasper, E. Braunwald, A. S. Fauci, et al., “Harrison’s Principles of Internal Medicine,” 16th Edition, The McGraw-Hill Companies, Inc., New York, 2005.
[7] P. Zimmet, K. G. M. M. Alberti, J. Shaw, “Global and Societal Implications of the Diabetes Epidemic,” Nature, Vol. 414, No. 6865, 2001, pp. 782-787. doi:10.1038/414782a
[8] Australian Centre for Diabetes Strategies, “National Evidence Based Guidelines for the Management of Type 2 Diabetes Mellitus. Prince of Wales Hospital,” National Health and Medical Research Council, Sydney, 2005.
[9] J. Tuomilehto and J. Lindstrom, “The Principal Trials for Prevention of Type 2 Diabetes Have Now Confirmed That Type 2 Diabetes Can Be Prevented by Life Style Changes. Prevention of Type 2 Diabetes by Life Style,” Journees Annuelles de Diabetologie de Hotel-Dieu, 2003, pp. 77-89.
[10] C. L. Gillies, K. R. Abrams, P. C. Lambert, et al., “Pharmacological and Lifestyle Interventions to Prevent or Delay Type 2 Diabetes in People with Impaired Glucose Tolerance: Systematic Review and Meta-Analysis,” (BMJ) British Medical Journal, Vol. 334, No. 7588, 2007, pp. 334-299. doi:10.1136/bmj.39063.689375.55
[11] A. Yuen, Y. Sugeng, T. J. Weiland, et al., “Lifestyle and Medication Interventions for the Prevention and Delay of Type 2 Diabetes in Pre-diabetes: A Systematic Review of Randomised Controlled Trials,” Australian and New Zealand Journal of Public Health, Vol. 34, No. 2, 2010, pp. 172-178.
[12] S. L. Norris, M. M. Engelgau and K. M. Narayan, “Effectiveness of Self-Management Training in Type 2 Diabetes: A Systematic Review of Randomized Controlled Trials,” Diabetes Care, Vol. 24, No. 3, 2001, pp. 561-587. doi:10.2337/diacare.24.3.561
[13] P. Gaede, P. Vedel, H. H. Parving, et al., “Intensified Multifactorial Intervention in Patients with Type 2 Diabetes Mellitus and Microalbuminuria: The Steno Type 2 Randomised Study,” Lancet, Vol. 353, No. 9153, 1999, pp. 617-622. doi:10.1016/S0140-6736(98)07368-1
[14] J. S. Cramer, R. F. Sibley, D. P. Bartlett, et al., “An Adaptation of the Diabetes Prevention Program for Use with High-Risk, Minority Patients with Type 2 Diabetes,” Diabetes Education, Vol. 33, No. 3, 2007, pp. 503-508. doi:10.1177/0145721707301680
[15] M. J. Davies, S. Heller, T. C. Skinner, et al., “Effectiveness of the Diabetes Education and Self Management for Ongoing and Newly Diagnosed (DESMOND) Programme for People with Newly Diagnosed Type 2 Diabetes: Cluster Randomised Controlled Trial,” (BMJ) British Medical Journal, Vol. 336, No. , 2008, pp. 491-495. doi:10.1136/bmj.39474.922025.BE
[16] T. A. Deakin, J. E. Cade, R. Williams, et al., “Structured Patient Education: The Diabetes X-PERT Programme Makes a Difference,” Diabetic Medicine, Vol. 23, No. 9, 2006, pp. 944-954. doi:10.1111/j.1464-5491.2006.01906.x
[17] S. H. Kim, S. J. Lee, E. S. Kang, et al., “Effects of Lifestyle Modification on Metabolic Parameters and Carotid Intima-Media Thickness in Patients with Type 2 Diabetes Mellitus,” Metabolism, Vol. 55, No. 8, 2006, pp. 1053-1059. doi:10.1016/j.metabol.2006.03.017
[18] C. K. Roberts and R. J. Barnard, “Effects of Exercise and Diet on Chronic Disease,” Journal of Applied Physiology, Vol. 98, No. 1, 2005, pp. 3-30. doi:10.1152/japplphysiol.00852.2004
[19] M. Trento, P. Passera, M. Bajardi, et al., “Lifestyle Intervention by Group Care Prevents Deterioration of Type II Diabetes: A 4-Year Randomized Controlled Clinical Trial,” Diabetologia, Vol. 45, No. 9, 2001, pp. 1231-1239. doi:10.1007/s00125-002-0904-8
[20] G. A. Jelinek, T. J. Weiland, G. Moore, et al., “Screening for Type 2 Diabetes with Random Finger-Prick Glucose and Bedside HbA1c in an Australian Emergency Department,” Emergency Medicine & Australasian, Vol. 22, No. 5, 2010, pp. 427-434. doi:10.1111/j.1742-6723.2010.01333.x
[21] T. J. Weiland, M. Nguyen and G. A. Jelinek, “Illness Perception and Knowledge with Regard to Prediabetes and Type 2 Diabetes: A Pilot Study of Emergency Department Patients and Staff,” European Journal of Emergency Medicine, Vol. 19, No. 6, 2011, pp. 353-358.
[22] Training in Flexible, Intensive Insulin Management to Enable Dietary Freedom in People with Type 1 Diabetes: Dose Adjustment for Normal Eating (DAFNE) Randomised Controlled Trial,” (BMJ) British Medical Journal, Vol. 325, 2002, p. 746. doi:10.1136/bmj.325.7367.746
[23] Y. Ohkubo, H. Kishikawa, E. Araki, et al., “Intensive Insulin Therapy Prevents the Progression of Diabetic Microvascular Complications in Japanese Patients with Non-Insulin-Dependent Diabetes Mellitus: A Randomized Prospective 6-Year Study,” Diabetes Research and Clinical Practice, Vol. 28, No. 2, 1995, pp. 103-117. doi:10.1016/0168-8227(95)01064-K
[24] J. P. Burke, S. M. Haffner, S. P. Gaskill, et al., “Reversion from Type 2 Diabetes to Nondiabetic Status. Influence of the 1997 American Diabetes Association Criteria,” Diabetes Care, Vol. 21, No. 8, 1998, pp. 1266-1270. doi:10.2337/diacare.21.8.1266
[25] E. Hadgkiss, G. Jelinek, T. Weiland, et al., “Health-Related Quality of Life Outcomes at 1 and 5 Years after a Residential Retreat Promoting Lifestyle Modification for People with Multiple Sclerosis,” Neurological Sciences, in press, 2012.
[26] M. P. Li, G. A. Jelinek, T. J. Weiland, et al., “Effect of a Residential Retreat Promoting Lifestyle Modifications on Health-Related Quality of Life in People with Multiple Sclerosis,” Quality in Primary Care, Vol. 18, No. 8, 2010, pp. 379-389.
[27] S. Colagiuri, D. Davies, S. Girgis, et al., “National Evidence Based Guideline for Case Detection and Diagnosis of Type 2 Diabetes,” Diabetes Australia, Canberra, 2009.
[28] W. C. Knowler, E. Barrett-Connor, S. E. Fowler, et al., “Reduction in the Incidence of Type 2 Diabetes with Lifestyle Intervention or Metformin,” New England Journal of Medicine, Vol. 346, No. 6, 2002, pp. 393-403. doi:10.1056/NEJMoa012512

Copyright © 2023 by authors and Scientific Research Publishing Inc.

Creative Commons License

This work and the related PDF file are licensed under a Creative Commons Attribution 4.0 International License.