Study: NCT00943865

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: hypocaloric diet
Description: patients received individually tailored hypocaloric diet, with 20% of total calories as fat (with 7-8 % of saturated fats), 50 to 65% carbohydrates and 15% to 20% proteins. Total of calories for each patient calculated assuming the ideal body weight to fulfill a BMI of 25 kg⁄ M2. Total daily amount of calories estimated calculating 30 calories/Kg of ideal weight for each subject. Subjects were advised against consuming high fat snacks or additional fats. Alimentary plans specified the number of servings from each food group, and dairy intake was held constant.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Exercise recommendations
Description: Exercise was advised but not measured: they received recommendations to be physically active and perform 1 hour of aerobic exercise as preferred, everyday.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Pragmatic diet
Description: Patients received a portable colored handbook with evidence- based recommendations on healthy eating attitudes and pragmatic menus, with low carbohydrates and high protein and vegetables. It included controlled portions (adjusted for individual hand size) for the six meals, with low glucose aliments and whole grains, legumes, yogurt, fruits, olive oils, eggwhite and low fat milk, fiber and a handful of nuts. Portions were tailored according to individual hand size, without calories counting. Beans, farofa and white cheese bread, which are commonly present in Brazilian food, and red meat were allowed, but with portion control.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Pragmatic diet
Description: Patients received a portable colored handbook with evidence- based recommendations on healthy eating attitudes and pragmatic menus, with low carbohydrates and high protein and vegetables. It included controlled portions (adjusted for individual hand size) for the six meals, with low glucose aliments and whole grains, legumes, yogurt, fruits, olive oils, eggwhite and low fat milk, fiber and a handful of nuts. Portions were tailored according to individual hand size, without calories counting. Beans, farofa and white cheese bread, which are commonly present in Brazilian food, and red meat were allowed, but with portion control.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Pedometer-based fitness (10,000 steps)
Description: Subjects were provided with pedometers and were instructed to perform at least 10,000 steps daily, diary recorded.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Structured assisted exercise (fitness)
Description: They were scheduled for a more structured assisted exercise intervention: three bicycle ergometer sessions per week, under direct supervision of the same trained exercise physiologists in each session. Heart rate monitors were used to adjust workload to achieve the target heart rate (75% of the maximum attainable heart rate), as determined by their individual maximal treadmill exercise test. All patients were trained by the same staff, Borg scale was registered in every session and persuasive goal setting was made during exercise sessions