An Intensive Lifestyle Intervention Is an Effective Treatment of Morbid Obesity: The TRAMOMTANA Study—A Two-Year Randomized Controlled Clinical Trial
Table 3
Changes in outcome variables at the 30th month.
Variable
ILI ()
COT ()
SOG ()
value overall
value
ILI versus COT
ILI versus SOG
COT versus SOG
Weight loss†
114.5 ± 19.9
103.7 ± 20.8
129.6 ± 18
125.1 ± 19
133.5 ± 27
92.5 ± 23.6
<0.0001
0.23
<0.0001
<0.0001
−9.6 ± 7.8
−3.3 ± 7.3
−30.3 ± 12.6
Body-mass index†
43.9 ± 4.2
39.6 ± 5.1
47.8 ± 5.2
46.4 ± 5.1
49.5 ± 7
34.1 ± 6.4
<0.0001
0.15
<0.0001
<0.0001
−9.9 ± 7.8
−2.5 ± 9.2
−30.5 ± 12.6
Systolic blood pressure†
125.9 ± 22.6
126.1 ± 17.5
139.2 ± 15.5
134.4 ± 18.1
128.7 ± 13.9
129.3 ± 16
0.5377
0.98
1
1
2.2 ± 16.8
−2.9 ± 12.9
1.3 ± 14.5
Diastolic blood pressure†
83.1 ± 13.8
84.2 ± 10.2
84.6 ± 12.3
81.6 ± 10.7
78 ± 7.5
73.8 ± 11.6
0.4656
1
0.66
1
3.1 ± 16.6
−2.1 ± 17.2
−4.3 ± 18.7
Heart rate†
78.07 ± 7.7
72.36 ± 5.73
88.95 ± 12.59
82.84 ± 14.45
77.22 ± 6.36
79.3 ± 6.51
0.0079
1
0.039
0.017
−6.5 ± 12.1
−6.7 ± 9.6
3.3 ± 12
Glucose†
135 ± 50.8
104.2 ± 22.5
126.4 ± 56.4
118.8 ± 43.1
106.8 ± 20.5
92.4 ± 12.9
0.1517
0.19
1
0.5
−16.4 ± 22.4
−1 ± 28.1
−11 ± 18.4
Glycated hemoglobin†
6.2 ± 0.9 ()
6.6 ± 0.8 ()
7.7 ± 1.9 ()
6.9 ± 1.9 ()
6.1 ± 0.5 ()
5.7 ± 0.8 ()
0.0965
0.12
0.32
1
7.47 ± 6.02
−9.41 ± 18.8
−7.36 ± 11.1
Total cholesterol†
212.4 ± 45.4
210.9 ± 34.2
187.1 ± 24.3
178.3 ± 25.8
177.3 ± 37.3
145.5 ± 32.7
0.0179
1
0.022
0.142
1.6 ± 17
−4.1 ± 11.7
−15.5 ± 22.5
High-density lipoprotein†
50.4 ± 12.5
51.8 ± 13.6
44.7 ± 11.9
45 ± 10.1
40.5 ± 7.8
44.4 ± 14.1
0.5462
1
1
1
3.25 ± 12.67
3.56 ± 17.77
10.4 ± 30.78
High-density lipoprotein men†
39.8 ± 11.8 ()
37.8 ± 7.7 ()
33.4 ± 10.3 ()
37 ± 9 ()
34.8 ± 7.4 ()
34.9 ± 8.3 ()
0.5637
0.93
1
1
−2.5 ± 14.2
14.5 ± 22.2
3.5 ± 28.2
High-density lipoprotein women†
54.6 ± 10.4 ()
57.4 ± 11.2 ()
48.7 ± 9.8 ()
47.9 ± 9 ()
43.5 ± 6.2 ()
49.4 ± 14.1 ()
0.2477
1
1
0.3
5.55 ± 12
−0.34 ± 14.96
14.09 ± 32.42
Low-density lipoprotein†
128.6 ± 35.2
137.7 ± 34.5
115.7 ± 21.2
108.7 ± 20.8
115.8 ± 27.3
79.2 ± 25.6
<0.0001
0.1342
<0.0001
0.0006
10.2 ± 23.3
−4.6 ± 15.2
−29.9 ± 22.3
Triglycerides†
168.8 ± 66.2
155.6 ± 55.6
135.6 ± 44.6
124.5 ± 38.4
141.5 ± 71.1
103.5 ± 39.4
0.098
1
0.2
0.21
−3.4 ± 30.9
−5.1 ± 23.6
−20.9 ± 28.8
values for overall comparisons within groups 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 follow-up in international units. The second row indicates the mean percentage change (%) ± standard deviation (%) by calculation according to unit paired patient from baseline to follow-up. International units: weight loss 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 %.
