Table 3. Estimated effects of intervention compared with control on primary and secondary outcomes, with continuous outcomes.
| Raw data, mean (SD) | Effects based on primary model* | |||||
|---|---|---|---|---|---|---|
| Control | Intervention | Difference (95% CI) | P value | |||
| HbA1c (%) | ||||||
| Baseline | 7.83 | (1.91) | 7.89 | (1.93) | - | - |
| EOS | 7.82 | (1.93) | 7.55 | (1.79) | - | - |
| Change | −0.01 | (1.78) | −0.33 | (1.75) | −0.30 (−0.38, −0.21) | <0.001 |
| FBG (mmol/L) | ||||||
| Baseline | 8.57 | (3.38) | 8.71 | (3.49) | - | |
| EOS | 8.50 | (3.51) | 8.08 | (3.14) | - | |
| Change | −0.06 | (3.44) | −0.63 | (3.49) | −0.47 (−0.62, −0.32) | <0.001 |
| SBP (mm Hg) | ||||||
| Baseline | 137.1 | (21.2) | 136.9 | (20.8) | - | - |
| EOS | 135.6 | (20.1) | 134.4 | (19.7) | - | - |
| Change | −1.6 | (19.4) | −2.4 | (19.3) | −1.0 (−2.0, 0.0) | 0.052 |
| DBP (mm Hg) | ||||||
| Baseline | 79.7 | (12.2) | 79.8 | (12.1) | - | - |
| EOS | 79.3 | (11.6) | 78.7 | (11.3) | - | - |
| Change | −0.4 | (11.1) | −1.0 | (11.1) | −0.6 (−1.1, −0.1) | 0.032 |
| LDL-C (mmol/L) | ||||||
| Baseline | 2.83 | (0.91) | 2.84 | (0.91) | - | - |
| EOS | 2.74 | (0.88) | 2.74 | (0.88) | - | - |
| Change | −0.09 | (0.83) | −0.10 | (0.84) | −0.01 (−0.06, 0.04) | 0.808 |
| Weight (kg) | ||||||
| Baseline | 64.8 | (11.4) | 64.9 | (11.3) | - | - |
| EOS | 64.5 | (11.5) | 64.6 | (11.2) | - | - |
| Change | −0.2 | (4.5) | −0.2 | (4.3) | 0.0 (−0.2, 0.2) | 0.916 |
* Primary model: linear regression with GEE accounting for clustering and with adjustment of baseline value of the analyzed outcome.
CI, confidence interval; DBP, diastolic blood pressure; EOS, end of study; FBG, fasting blood glucose; GEE, generalized estimating equation; HbA1c, glycated hemoglobin; LDL-C, low-density lipoprotein cholesterol; SBP, systolic blood pressure.