Three Lifestyle Interventions on Endothelial Function and Cardiometabolic Risk in Obese Patients With Metabolic Syndrome

NACompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

December 31, 2008

Study Completion Date

June 30, 2009

Conditions
Metabolic SyndromeObesity
Interventions
BEHAVIORAL

hypocaloric diet

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.

BEHAVIORAL

Exercise recommendations

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

BEHAVIORAL

Pragmatic diet

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.

BEHAVIORAL

Pedometer-based fitness (10,000 steps)

Subjects were provided with pedometers and were instructed to perform at least 10,000 steps daily, diary recorded.

BEHAVIORAL

Structured assisted exercise (fitness)

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

Trial Locations (1)

90035903

Hospital de Clinicas de Porto Alegre, Porto Alegre

All Listed Sponsors
lead

Hospital de Clinicas de Porto Alegre

OTHER

NCT00943865 - Three Lifestyle Interventions on Endothelial Function and Cardiometabolic Risk in Obese Patients With Metabolic Syndrome | Biotech Hunter | Biotech Hunter