| Process Outcome Measures Intra-group comparison; baseline vs follow-ups Inter-group comparison; final control vs final intervention [Mean ± SD] | FC vs FI (p-values) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Process Outcomes | Control Arm | Â | Intervention Arm | Â | |||||||
Baseline, n = 121 | Follow up Every 3 Months | p-values | Baseline, n = 123 | Follow up Every 3 Months | p-values | ||||||
1st, n = 121 | 2nd, n = 121 | 3rd, n = 52 | 1st, n = 123 | 2nd, n = 105 | 3rd, n = 83 | ||||||
Weight [Kg] | 78.2 ± 14.4 | 78.4 ± 15.1 | 78.8 ± 14.9 | 76.3 ± 14.8 | 0.915 | 77.5 ± 17.6 | 75.9 ± 16.9 | 74.6 ± 16.2 | 73.7 ± 16.6 | 0.258 | 0.35 |
Waist [cm] | 110 ± 16.6 | 109 ± 16.1 | 110 ± 16.2 | 106 ± 14.3 | 0.567 | 109 ± 16.5 | 107 ± 15.9 | 105 ± 15.3 | 103 ± 13.6 | 0.042* | 0.28 |
BMI [Kg/m2] | 30.6 ± 4.9 | 30.6 ± 5.1 | 30.8 ± 5.1 | 30.7 ± 5.6 | 0.986 | 30.7 ± 6.4 | 30.2 ± 6.2 | 29.4 ± 5.9 | 28.9 ± 5.9 | 0.131 | 0.06 |
HbA1c (%) | 10.7 ± 1.7 | 10.6 ± 2.1 | 10.2 ± 1.9 | 9.7 ± 1.3 | 0.001** | 11 ± 1.7 | 9.5 ± 1.6 | 8.4 ± 1.1 | 7.7 ± 0.9 | 0.0001** | 0.0001** |
eABG [mg/dL] | 261 ± 49.8 | 257 ± 58.9 | 246 ± 54.7 | 232 ± 38 | 0.0036* | 268 ± 50.2 | 227 ± 44.8 | 194 ± 32.1 | 174 ± 25.6 | < 0.0001** | 0.025* |
SBP [mm/Hg] | 133 ± 15.4 | 132 ± 13.4 | 134 ± 13.2 | 137 ± 7.1 | 0.082 | 145 ± 20.9 | 133 ± 14.2 | 127 ± 10.6 | 124 ± 9.9 | < 0.0001** | 0.0001** |
DBP [mm/Hg] | 85 ± 10.4 | 85 ± 7.9 | 86 ± 9.8 | 89 ± 4.2 | 0.03* | 94 ± 10.7 | 89 ± 7.1 | 88 ± 6.1 | 87 ± 5.4 | < 0.0001** | 0.0001** |
Cholesterol [mg/dL] | 231 ± 55.7 | 229 ± 49.6 | 223 ± 43.7 | 221 ± 53.2 | 0.3 | 223 ± 51.3 | 187 ± 36.6 | 169 ± 28.1 | 153 ± 25.9 | < 0.0001** | 0.0001** |
TG [mg/dL] | 191 ± 79.8 | 186 ± 67.7 | 175 ± 53.1 | 172 ± 48.7 | 0.1 | 272 ± 112.1 | 195 ± 53.9 | 164 ± 39.9 | 143 ± 31.6 | < 0.0001** | 0.0001** |
HDL-C [mg/dL] | 48 ± 12.5 | 46 ± 10.9 | 47 ± 12.3 | 49 ± 13.9 | 0.437 | 49 ± 18.2 | 50 ± 11.4 | 49 ± 9.7 | 49 ± 7.9 | 0.975 | 0.794 |
LDL-C [mg/dL] | 145 ± 48.5 | 146 ± 43.1 | 141 ± 39.4 | 82 ± 77.9 | < 0.0001** | 119 ± 50.3 | 99 ± 34.4 | 87 ± 26.1 | 76 ± 21.7 | < 0.0001*** | 0.0001** |
VLDL-C [mg/dL] | 38 ± 15.9 | 37 ± 13.5 | 35 ± 10.6 | 20 ± 18.5 | < 0.0001** | 54 ± 22.4 | 39 ± 10.8 | 33 ± 8 | 29 ± 6.3 | < 0.0001** | 0.0001** |
S Cr [mg/dL] | 1.0 ± 0.3 | 1 ± 0.2 | 1.0 ± 0.2 | 1 ± 0.1 | 0.8 | 1.1 ± 0.4 | 0.9 ± 0.2 | 0.9 ± 0.2 | 0.8 ± 0.1 | < 0.0001** | 0.0001** |
eGFR [ml/min/1.73m2] | 77 ± 18.1 | 77 ± 15.8 | 76 ± 16.2 | 76 ± 14.2 | 0.5 | 70 ± 2 | 80 ± 18.6 | 87 ± 18.3 | 94 ± 15.2 | < 0.001** | 0.0001** |