Between-group differences in change in anthropometry and safety outcomes from birth/baseline to ages 6 and 12 months
| 6 months | 12 months | |||||
| Control | Intervention | Difference (95% CI) Intervention versus control | Control | Intervention | Difference (95% CI) Intervention versus control | |
| Primary outcome | ||||||
| Change in weight SDS from birth | 0.05 (1.0) | −0.05 (0.91) | −0.06 (−0.19 to 0.06) | 0.35 (1.05) | 0.28 (0.96) | −0.04 (−0.17 to 0.10) |
| Secondary outcomes | ||||||
| Rapid weight gain ≥+0.67 SDS (%) | 94 (28.6%) | 74 (21.8%) | OR: 0.74 (0.51 to 1.07) | 151 (45.9%) | 137 (40.3%) | OR: 0.84 (0.59 to 1.17) |
| Change in weight SDS from baseline | 0.42 (0.53) | 0.32 (0.65) | −0.08 (−0.17 to −0.004) | 0.70 (0.70) | 0.65 (0.72) | −0.04 (−0.14 to 0.07) |
| Change in BMI SDS from baseline | 0.34 (0.69) | 0.27 (0.73) | −0.07 (−0.17 to 0.04) | 0.69 (0.89) | 0.68 (0.86) | −0.01 (−0.14 to 0.12) |
| Change in abdominal circumference SDS from baseline | 3.96 (2.8) | 3.59 (2.8) | −0.33 (−0.70 to 0.05) | 5.95 (3.1) | 5.68 (3.1) | −0.27 (−0.70 to 0.16) |
| Sum of skinfold thickness (mm) | 16.4 (3.1) | 16.5 (3.0) | 0.10 (−0.42 to 0.61) | |||
| Abdominal ultrasound subcutaneous fat thickness (cm) | 0.46 (0.12) | 0.46 (0.12) | 0.00 (−0.02 to 0.03) | |||
| Abdominal ultrasound visceral fat thickness (cm) | 2.5 (0.5) | 2.6 (0.5) | 0.07 (−0.02 to 0.16) | |||
| Change in mother’s weight from baseline (kg) | −1.34 (3.7) | −1.25 (3.4) | 0.03 (−0.62 to 0.68) | −2.99 (5.2) | −2.82 (5.6) | 0.12 (−0.83 to 1.08) |
| Change in mother’s BMI from baseline (kg/m2) | −0.50 (1.3) | −0.46 (1.9) | −0.00 (−0.23 to 0.24) | −1.10 (1.9) | −1.04 (2.1) | 0.02 (−0.33 to 0.37) |
| Safety outcomes | ||||||
| Drop in one centile band <0.67 SDS (%) | 7 (2.1%) | 7 (2.1%) | OR: 1.08 (0.36 to 3.22) | 7 (2.1%) | 8 (2.4%) | OR: 1.20 (0.42 to 3.44) |
| Change in length (cm) from baseline | 8.97 (2.7) | 8.71 (2.7) | −0.22 (−0.53 to 0.09) | 17.38 (2.3) | 17.19 (3) | −0.17 (−0.56 to 0.21) |
| Change in head circumference SDS from baseline | 0.19 (0.49) | 0.13 (0.50) | −0.06 (−0.14 to 0.02) | 0.24 (0.60) | 0.18 (0.64) | −0.06 (−0.15 to 0.04) |
| Maternal safety outcomes* | ||||||
| Change in SF-8 mental health score from baseline | 1.0 (8.3) | 0.4 (8.2) | −0.60 (−1.77 to 0.58) | 1.2 (8.0) | −1.1 (9.7) | −2.29 (−3.60 to −0.99) |
| Change in SF-8 physical health score from baseline | 2.4 (8.8) | 3.1 (9.0) | 0.07 (−1.05 to 1.19) | 2.6 (8.3) | 2.9 (9.7) | −0.11 (−1.26 to 1.05) |
| Change in health VAS score from baseline | 1.7 (14.4) | 2.3 (16.2) | −0.64 (−2.8 to 1.57) | 0.8 (15.3) | 0.5 (19.6) | −1.03 (−3.68 to 1.62) |
| Change in anxiety score from baseline | −1.5 (9.1) | 0.5 (11.5) | 1.32 (−0.22 to 2.85) | |||
Mean (SD) for continuous variables, number (%) for categorical variables; SDS calculated using WHO 2006 growth charts. Differences are adjusted for value of outcome at birth/baseline if this was measured. Values displayed in bold font are statistically significant (P<0.05).
*Mother’s quality of life was assessed using the SF-8 and EuroQoL VAS. Maternal anxiety was measured using Spiegelberger Short State Anxiety Inventory.
BMI, body mass index; SDS, SD score; SF, Standard Form; VAS, visual analogue scale.