Clinical Study

An Intensive Lifestyle Intervention Is an Effective Treatment of Morbid Obesity: The TRAMOMTANA Study—A Two-Year Randomized Controlled Clinical Trial

Table 2

Changes at 24 months.

VariableILI ()COT ()SOG () value overall value
ILI versus COTILI versus SOGCOT versus SOG

Weight loss123.3 ± 27.2109.5 ± 26.7127.1 ± 18.3125.1 ± 20.2133.6 ± 2793.2 ± 22.7<0.00010.0044<0.0001<0.0001
−11.3 ± 8.7−1.6 ± 7−29.6 ± 13.1

Body-mass index45.8 ± 5.540.6 ± 6.947.2 ± 5.346.2 ± 5.449.5 ± 734.4 ± 6.1<0.00010.0041<0.0001<0.0001
−11.6 ± 8.7−1.8 ± 7−29.7 ± 13.1

Systolic blood pressure126.6 ± 20.3129.4 ± 15.7137.8 ± 12.7138 ± 21128.7 ± 13.9130.4 ± 18.10.698111
4.2 ± 17.60.5 ± 14.91.6 ± 12.3

Diastolic blood pressure84.6 ± 12.984 ± 12.386.4 ± 11.184 ± 11.978 ± 7.577 ± 9.60.7969111
0.4 ± 14−2.2 ± 11.7−0.6 ± 14.3

Heart rate80.3 ± 11.870.6 ± 1290.5 ± 12.880.8 ± 12.877.2 ± 6.478.1 ± 10.60.00210.00650.0064
−11.6 ± 11.8−10.1 ± 11.81.9 ± 16.2

Glucose135.6 ± 45.2112.3 ± 37.3119.3 ± 47.3124 ± 63.2106.8 ± 20.592.1 ± 14.50.03660.0910.091
−12.7 ± 24.24.3 ± 30.8−11.5 ± 18.1

Glycated hemoglobin6.4 ± 0.9 ()6.5 ± 1.2 ()7.7 ± 1.8 ()7.5 ± 2.5 ()6.1 ± 0.5 ()5.6 ± 0.7 ()0.612410.981
0.4 ± 9−3.1 ± 20.5−8.4 ± 9.8

Total cholesterol209.4 ± 40.6207.9 ± 32193.8 ± 24.5188.8 ± 27.5177.3 ± 37.3149.8 ± 29.30.006110.0110.027
0.9 ± 15.3−2.1 ± 11.1−13.5 ± 18.9

High-density lipoprotein49.6 ± 11.352.6 ± 11.344.1 ± 10.244.2 ± 9.740.5 ± 7.843.5 ± 13.30.5572110.92
6.9 ± 12.12.2 ± 19.48.3 ± 28.2

High-density lipoprotein men41.8 ± 11.2 ()43.8 ± 11.9 ()35.4 ± 8.5 ()37.8 ± 6.2 ()34.8 ± 7.4 ()38.1 ± 13.4 ()0.9113111
5.2 ± 10.511.7 ± 31.8−11.9 ± 34.9

High-density lipoprotein women52.5 ± 10.3 ()56 ± 9.5 ()47.5 ± 8.9 ()46.7 ± 9.8 ()43.5 ± 6.2 ()46.3 ± 12.8 ()0.23660.4110.54
7.6 ± 13−1.4 ± 11.16.4 ± 25

Low-density lipoprotein126.7 ± 31130.2 ± 30.3120.7 ± 19.9117.9 ± 24.1115.8 ± 27.381.7 ± 24.1<0.00010.79<0.0001<0.0001
5.2 ± 22.2−1.5 ± 16.4−27.7 ± 21.4

Triglycerides177.6 ± 73.8150.6 ± 46142.4 ± 49.7138.1 ± 42.6141.5 ± 71.1114.7 ± 66.20.12350.8810.13
−8.7 ± 27.2−0.1 ± 21.6−15.7 ± 32.7

values for the overall comparisons were calculated with the use of analysis of variance. values for the comparisons between each pair of groups were calculated with the use of the Bonferroni method in post hoc analyses. values were normalized; data were obtained from each patient percentage unitary variation (change between initial time and end time); it must be noted that this transformation does unitary variation positioning the patient on the same output level in each of the patients.
ILI: Intensive Lifestyle Intervention, COT: Conventional Obesity Therapy, and SOG: Surgical Obesity Group.
The first row indicates the mean and ± standard deviation baseline measurement, and the mean and ± standard deviation measurement at two years in international units. The second row indicates the mean percentage change (%) ± standard deviation (%) by calculation according to unit paired patient from baseline to two years.
International units: weight Kg, body-mass index Kg/m2, systolic blood pressure & diastolic blood pressure mm/Hg, heart rate bpm, glucose & total cholesterol & high-density lipoprotein & low-density lipoprotein & triglycerides mg/dL, and glycated hemoglobin %.