Fig. 1

Flow diagram of subjects through the different phases of the randomized controlled trial. Computer-generated random number tables were used for randomization after the patients were assessed with respect to the inclusion/exclusion criteria. The patients were then allocated to the intervention or control arm and were matched for gender. The patients in the intervention group then proceeded to receive a 6-month lifestyle programme, and the patients in the control group received standard care. Of the 55 patients who were potentially eligible for the trial, 31 % (n = 17) were not eligible, and 1 % (n = 3) refused to participate. Of the 35 randomized patients, 83 % completed the trial (n = 29), with an attrition rate of 17 %. The data analysis was performed in accordance with the intention-to-treat analysis protocol