Table 4.
Study outcomes between the LMP group and the control group (ITT analysis).
| Outcomes | LMP group | Valid n† | Control group | Valid n | LMP vs. control | Crude P value | LMP vs. control | Adjusted P value | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n(%) | Mean ± SD | n(%) | Mean ± SD | Crude OR/Mean difference‡ | 95% CI | Adjusted OR/Mean difference§ | 95% CI | |||||
| Primary outcome | ||||||||||||
| GDM at 24–28 weeks | 20(25.0%) | — | 80 | 23(26.7%) | — | 86 | 0.91 | 0.46–1.83 | 0.798 | 1.00 | 0.48–2.08 | 0.993 |
| Secondary outcomes | ||||||||||||
| SGA (<10th percentile) | 12(15.6%) | — | 77 | 12(14.3%) | — | 84 | 1.11 | 0.47–2.64 | 0.817 | 1.21 | 0.48–3.01 | 0.688 |
| LGA (>90th percentile) | 8(10.4%) | — | 77 | 6(7.1%) | — | 84 | 1.51 | 0.50–4.56 | 0.468 | 1.53 | 0.48–4.87 | 0.469 |
| Macrosomia (birth weight >=4 kg) | 1(1.3%) | — | 78 | 2(2.4%) | — | 85 | 0.54 | 0.05–6.06 | 0.617 | 0.66 | 0.05–8.27 | 0.745 |
| Other maternal or delivery outcomes | ||||||||||||
| Preeclampsia | 0(0.0%) | — | 77 | 1(1.2%) | — | 84 | —¶¶¶ | — | — | — | — | — |
| Gestational hypertension | 2(2.6%) | — | 77 | 1(1.2%) | — | 84 | 2.21 | 0.20–24.91 | 0.520 | 2.59 | 0.19–35.24 | 0.475 |
| Caesarean section¶ | 24(34.8%) | — | 69 | 16(20.5%) | — | 78 | 2.07 | 0.99–4.33 | 0.054 | 2.20 | 1.00–4.84 | 0.049 |
| Preterm delivery | 3(3.8%) | — | 78 | 0(0.0%) | — | 84 | —¶¶¶ | — | — | — | — | — |
| Total gestational weight gain (kg) | — | 11.6 ± 4.0 | 76 | — | 11.8 ± 5.9 | 81 | −0.25 | −1.85–1.35 | 0.758 | −0.72 | −2.28–0.85 | 0.368 |
| Excessive gestational weight gain¶¶ | 14(18.4%) | — | 76 | 21(25.9%) | — | 81 | 0.65 | 0.30–1.39 | 0.261 | 0.65 | 0.28–1.47 | 0.297 |
| Total gestational weight gain categories¶¶ | 0.491 | 0.537 | ||||||||||
| Below recommended range | 32(42.1%) | — | 76 | 33(40.7%) | — | 81 | 1 | 1 | ||||
| Within recommended range | 30(39.5%) | — | 27(33.3%) | — | 1.15 | 0.56–2.34 | 1.13 | 0.53–2.40 | ||||
| Above recommended range | 14(18.4%) | — | 21(25.9%) | — | 0.69 | 0.30–1.58 | 0.67 | 0.28–1.64 | ||||
| Other infant outcomes | ||||||||||||
| Gestation age at birth (week) | — | 39.1 ± 1.2 | 78 | — | 39.2 ± 1.0 | 84 | −0.03 | −0.37–0.31 | 0.849 | −0.02 | −0.37–0.33 | 0.907 |
| Birth weight (g) | — | 3131 ± 441 | 78 | — | 3128 ± 361 | 85 | 3.74 | −120.55–128.03 | 0.953 | 32.08 | −95.38–159.53 | 0.620 |
| Birth weight <2500 g | 3(3.8%) | — | 78 | 2(2.4%) | — | 85 | 1.66 | 0.27–10.21 | 0.584 | 1.27 | 0.18–8.80 | 0.809 |
| Apgar score at 5 min <7 | 0(0.0%) | — | 77 | 1(1.2%) | — | 82 | —¶¶¶ | — | — | — | — | — |
| Shoulder dystocia | 0(0.0%) | — | 77 | 0(0.0%) | — | 83 | —¶¶¶ | — | — | — | — | — |
ITT – intention to treat. LMP – lifestyle modification program. SD – standard deviation. OR – odds ratio. CI – confidence interval. GDM – gestational diabetes mellitus. SGA – small for gestational age. LGA – large for gestational age. †Valid n for the particular variable and the % of the categorical variable was calculated based on the valid n. ‡Control as the reference category. §Adjusted for age (continuous), marital status (married vs. others), monthly family income (<HK$20,000 vs. >=HK$20,000) and pre-pregnant BMI (continuous). ¶Excluding those caesarean sections in private hospital due to maternal request (n = 16). ¶¶Based on US Institute of Medicine28. ¶¶¶Not applicable due to zero number of outcome variables.