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Multidisciplinary lifestyle management approach in patients with type 2 diabetes mellitus in real clinical practice. Results of application “Life is easy” programme in Russia

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a disease with high medical and social impact due to its wide and ever-increasing prevalence, high hospitalization and mortality rates. Despite the whole range of therapeutic options, lifestyle intervention remains as important as ever since it underlies guidelines of T2DM management. 
AIMS: To evaluate the effect of intensive lifestyle management approach on body weight reduction and on long-term maintenance of the achieved results in patients with T2DM. 
MATERIALS AND METHODS: We performed multicenter, interventional, prospective, non-randomized 12 month study. One hundred thirty overweight (obese) patients with T2DM included in the study were divided into two groups: group of lifestyle intervention (n=100) and control group (n=30). Patients in the group of lifestyle intervention participated in the intensive lifestyle modification and body weight reduction programme, which consisted of components: change in diet plan, physical exercise programme, cognitive behavioral techniques, educational and medical support. Clinical assessment and completing of patient questionnaires were performed at baseline, after 3 and 12 months. Patients in the control group did not attend programme, their clinical data were recorded during clinical visits every 3 months. 
RESULTS: Ninety patients (90%) in the group of lifestyle intervention and twenty nine patients (96.7%) in the control group completed the study and fulfilled protocol. After 12 months, patients in the group of lifestyle intervention lost 5.8% of their baseline weight and patients in the control group showed 1.2% decrease of their baseline weight. Body weight loss 5% was observed in 49.2% of patients in the group of lifestyle intervention and in 12.9% of patients in the control group (OR=6.54 [2.01; 21.33]; р=0.002). By the end of observation, delta reduction of glycated hemoglobin (HbA1c) in the intervention group was higher than in the control group (0.79% and 0.11%, respectively), the odds ratio for lowering HbA1c 0.5% from baseline between two groups was 14.10 [3.24; 61.30] (p0.001) in favor of the group of lifestyle intervention. 58.3% patients in the group of lifestyle intervention with baseline level of HbA1c 7% (n=48) achieved a HbA1c target of 7%; in the control group two patients (13.3%) out of fifteen with baseline level of HbA1c 7% achieved the target after 3 months and returned to baseline by the end of observation. 
CONCLUSIONS: Our results suggest that the programme of intensive lifestyle modification in patients with T2DM is highly efficient and safe.