An innovative model for changing the lifestyles of persons with obesity and/or type 2 diabetes mellitus

The aim of the CURIAMO project is to validate the short and long-term efficacy of a multidisciplinary model lifestyle intervention in obesity and type 2 diabetes. Research Design and Methods: Over a three year period, about 1000 adults will be enrolled: 70% with overweight or obesity and 30% with type 2 diabetes (overweight or obese). Inclusion criteria include: age between 18 and 80 years old, BMI over 27 kg/m2 and/or a diagnosis of type 2 diabetes mellitus; participants will be divided in three age groups (18-45; 45-65; 65-80 years old). Study duration will be 5 years: 1 year of intervention followed by a mean follow-up period of 4 years. In the first years, after a four month intensive lifestyle intervention, subjects will follow a maintenance program. During the maintenance program subjects will repeat every four months medical examination, nutritional and psychological counseling in total for approximately 90 minutes and will receive reinforcement for the achieved results. The intervention includes seven steps and involves the following experts: endocrinologists, sport medicine doctors or cardiologists, psychologists, dieticians, educators, nurses,exercise physiologists, and promoters of outdoor activities. Results: The primary outcome of the study is measuring 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 year and during the follow-up. Cost/utility analysis of the model will be made in participants with diabetes.