Aim: To describe the multidisciplinary lifestyle intervention model used in an experimental CURIAMO (Centro Universitario Ricerca Interdipartimentale Attività Motoria) project designed to validate the short- and long-term efficacy of the model in obesity and Type 2 diabetes.
Research design and methods: Over a 3-yr period, about 1000 adults (70% diabetes-free and overweight or obese; 30% with Type 2 diabetes and overweight or obese).
Inclusion criteria: Age range 18-80 yr, body mass index >27 kg/m2 with or without Type 2 diabetes mellitus; participants will be divided into three age groups (18-45, 45-65, 65-80 yr). The study duration will be from 5 to 6 yr: 1 yr of intervention followed by a mean follow-up period of 4 yr. In the first years, after a 4- month intensive lifestyle intervention, subjects will follow a maintenance programme. The intervention, which includes seven steps, involves the following experts: endocrinologists, sport medicine doctors or cardiologists, psychologists, dietitians, educators, nurses, exercise physiologists, and promoters of outdoor activities.
Results: The main endpoint of the study is to measure the efficacy of the lifestyle improvement intervention, defined as a loss of at least 7% of body weight combined with an increase of at least 10 MET/h-1·week-1 of energy expenditure by physical activity, after 1 yr and during the follow-up. A cost/utility analysis of the model will be made in participants with diabetes.
Conclusions: We expect that the CURIAMO model will be highly effective, and that the aim of the intervention will be achieved in more than 70% of cases.