Table 2.
Physiological Outcomes in Intervention (I, n=105) and Control Group (C, n=104)
| Outcomes | Baseline | Month 3 | Month 6 | Month 9 | Month 12 |
|---|---|---|---|---|---|
| HbAlc, % (SE) | |||||
| Intervention | 8.9 (0.2) | 7.9 (0.2) | 7.7 (0.1) | 7.8 (0.1) | 7.6 (0.1) |
| Control | 8.8 (0.2) | 8.3 (0.2) | 8.3 (0.2) | 8.2 (0.1) | 8.1 (0.1) |
| Diff (I-C) | 0.1 (0.3) | −0.4 (0.2) | − 0.6 (0.2) ** | − 0.4 (0.2) * | − 0.5 (0.2) ** |
| Changes from baseline, % (SE) | |||||
| Intervention | - | − 1.0 (0.1) *** | − 1.2 (0.1) *** | − 1.1 (0.1) *** | − 1.3 (0.1) *** |
| Control | - | − 0.5 (0.1) *** | − 0.5 (0.1) *** | − 0.6 (0.1) *** | − 0.7 (0.1) *** |
| Diff (I-C) | - | − 0.5 (0.2) ** | − 0.7 (0.2) *** | − 0.6 (0.2) ** | − 0.6 (0.2) *** |
| HbA1c ≥ 0.5% reduction from baseline, n (%) | |||||
| Intervention | 64 (61.0%) | 69 (65.7%) | 66 (62.9%) | 69 (65.7%) | |
| Control | 45 (43.3%) | 40 (38.5%) | 46 (44.2%) | 50 (48.1%) | |
| Diff (I-C) | 17.7% ** | 27.2% *** | 18.7% ** | 17.6% ** | |
| Glucose, mg/dL (SE) | |||||
| Intervention | 160.1 (6.3) | 128.5 (4.5) | 127.9 (4.6) | 131.6 (4.7) | 124.8 (4.3) |
| Control group | 158.3 (5.3) | 143.5 (5.3) | 151.9 (5.2) | 148.9 (4.8) | 147.1 (4.9) |
| Diff (I-C) | 1.8 (8.2) | − 15.0 (6.8) * | − 24.0 (6.9) *** | − 17.3 (6.7) ** | − 22.3 (6.6) *** |
| Changes from baseline, mg/dL (SE) | |||||
| Intervention | - | − 31.6 (5.0) *** | − 32.1 (5.0) *** | − 28.5 (5.0) *** | − 35.2 (5.0) *** |
| Control group | - | − 14.8 (5.1) ** | −6.3 (5.1) | −9.4 (5.1) | − 11.1 (5.1) * |
| Diff (I-C) | - | − 16.8 (7.1) * | − 25.8 (7.1) *** | − 19.1 (7.1) ** | − 24.1 (7.1) ** |
| Triglyceride, mg/dL (SE) | |||||
| Intervention | 177.3 (11.2) | 159.5 ( 9.8) | 163.0 ( 9.9) | 169.4 (10.1) | 167.6 (10.3) |
| Control group | 180.6 (12.6) | 174.9 (11.4) | 178.9 (11.5) | 172.1 (11.3) | 174.7 (12.3) |
| Diff (I-C) | −3.3 (16.8) | −15.4 (15.0) | −16 (15.1) | −2.7 (15.2) | −7.1 (16.0) |
| Changes from baseline, mg/dL (SE) | |||||
| Intervention |
−
17.8 ( *
8.8) |
−14.3 ( 8.8) | −7.9 (8.8) | −9.7 ( 8.8) | |
| Control group | −5.8 ( 8.8) | −1.7 ( 8.8) | −8.5 ( 8.8) | −5.9 ( 8.8) | |
| Diff (I-C) | −12.1 (12.4) |
−12.6 (12.4) | 0.6 (12.4) | −3.8 (12.4) | |
| Total Cholesterol, mg/dL (SE) | |||||
| Intervention | 188.5 (4.2) | 178.2 (3.9) | 176.2 (3.7) | 178.5 (3.8) | 178.8 (3.7) |
| Control group | 201.1 (5.1) | 190.7 (4.1) | 190.6 (3.9) | 188.4 (4.0) | 193.6 (4.7) |
| Diff (I-C) | −12.6 (6.6) | − 12.5 (5.7) * | − 14.4 (5.4) ** | −9.9 (5.5) | − 14.8 (6.0) * |
| Changes from baseline, mg/dL (SE) | |||||
| Intervention | - | − 10.3 (3.3) *** | − 12.3 (3.3) *** | − 10.0 (3.3) ** | − 9.7 (3.3) ** |
| Control group | - | − 10.4 (3.3) *** | − 10.5 (3.3) *** | − 12.7 (3.3) *** | − 7.5 (3.3) * |
| Diff (I-C) | - | −0.1 (4.6) | −1.8 (4.6) | 2.7 (4.6) | −2.2 (4.6) |
| HDL, mg/dL (SE) | |||||
| Intervention | 49.8 (1.2) | 49.8 (1.2) | 49.6 (1.2) | 48.9 (1.2) | 49.0 (1.2) |
| Control group | 48.7 (1.1) | 49.6 (1.2) | 49.5 (1.6) | 52.1 (3.8) | 49.7 (1.2) |
| Diff (I-C) | 1.1 (1.5) | 0.2 (1.7) | 0.1 (2.0) | −3.2 (3.9) | −0.7 (1.7) |
| Changes from baseline, mg/dL (SE) | |||||
| Intervention | - | 0.0 (1.7) | −0.2 (1.7) | −0.9 (1.7) | −0.8 (1.7) |
| Control group | - | 0.9 (1.7) | 0.8 (1.7) | 3.5 (1.7) * | 1.1 (1.7) |
| Diff (I-C) | - | −0.9 (2.4) | −1.0 (2.4) | −4.4 (2.4) | −1.9 (2.4) |
| LDL, mg/dL (SE) | |||||
| Intervention | 104.6 (3.3) | 97.7 (3.0) | 94.8 (2.9) | 96.3 (3.0) | 97.6 (3.1) |
| Control group | 115.6 (4.0) | 107.4 (3.5) | 107.6 (3.3) | 105.2 (3.4) | 109.1 (3.5) |
| Diff (I-C) | − 11.0 (5.2)** | − 9.7 (4.6) * | − 12.8 (4.3) ** | − 8.9 (4.5) * | − 11.5 (4.6) * |
| Changes from baseline, mg/dL (SE) | |||||
| Intervention | - | − 6.9 (2.8) ** | − 9.8 (2.8) *** | − 8.3 (2.8) ** | − 7.0 (2.8) * |
| Control group | - | − 8.2 (2.8) ** | − 8.0 (2.8) ** | − 10.4 (2.8) *** | − 6.5 (2.8) * |
| Diff (I-C) | - | 1.3 (3.9) | −1.8 (3.9) | 2.1 (3.9) | −0.5 (3.9) |
| Systolic BP, mg/dL (SE) | |||||
| Intervention | 134.7 (1.8) | 133.1 (1.8) | 131.2 (1.8) | na | 134.3 (1.5) |
| Control group | 133.1 (2.0) | 134.4 (2.0) | 132.1 (1.7) | na | 136.2 (1.9) |
| Diff (I-C) | 1.6 (2.7) | −1.3 (2.6) | −0.9 (2.4) | - | −1.9 (2.4) |
| Diastolic BP, mg/dL (SE) | |||||
| Intervention | 78.9 (1.0) | 78.8 (1.0) | 77.5 (0.9) | na | 79.0 (0.9) |
| Control group | 78.5 (1.1) | 80.3 (1.0) | 79.5 (1.1) | na | 81.2 (0.9) |
| Diff (I-C) | 0.4 (1.5) * | −1.5 (1.4) | −2.0 (1.4) | - | −2.2 (1.2) |
| BP controlled (Systolic/Diastolic BP<130/80), n (%) | |||||
| Intervention | 37 (35.2%) | 37 (35.2%) | 40 (38.1%) | na | 31 (29.5%) |
| Control group | 38 (36.5%) | 34 (32.7%) | 38 (36.5%) | na | 25 (24.0%) |
| Diff (I-C) | −1.3% | 2.5% | 2.6% | - | 5.5% |
Note: Boldface indicates statistical significance (*p<0.05, **p<0.01, ***p<0.001). na, not measured