Background
Methods
Study design
Inclusion criteria for the studies and search strategy
Data collection and management
Childhood variables collected through the i-WIP-3 Collaboration
Primary outcome measures
Secondary outcome measures
Data management and statistical analyses
Subgroup analyses
Sample size
Ethical considerations
Patient and public involvement
Results
Characteristic | Total (all studies) | LIMIT | UPBEAT | ROLO | TOPd | LiP | Bogaertsc |
---|---|---|---|---|---|---|---|
Randomised to original RCTa | |||||||
- Control | 2550 | 1104 | 772 | 226 | 141 | 180 | 127 |
- Intervention | 2638 | 1108 | 783 | 205 | 284 | 180 | 78 |
- Overall | 5180 | 2212 | 1555 | 431 | 425 | 360 | 205 |
Eligible for 3–5-year follow-upb | |||||||
- Control | 2362 | 1056 | 751 | 226 | 133 | 75 | 121 |
- Intervention | 2438 | 1065 | 759 | 204 | 253 | 81 | 76 |
- Overall | 4800 | 2121 | 1510 | 430 | 386 | 156 | 197 |
Participated (children)e | |||||||
- Control | 1237 | 691 | 263 | 107 | 44 | 75 | 57 |
- Intervention | 1292 | 726 | 250 | 107 | 89 | 81 | 39 |
- Overall | 2529 | 1417 | 513 | 214 | 133 | 156 | 96 |
Participated (mothers)e | |||||||
- Control | 1159 | 626 | 260 | 107 | 42 | 67 | 57 |
- Intervention | 1224 | 663 | 251 | 107 | 88 | 76 | 39 |
- Overall | 2383 | 1289 | 511 | 214 | 130 | 143 | 96 |
Characteristic | Overall, n=2535 | Intervention, n=1297 | Control, n=1238 |
---|---|---|---|
BMI category, N (%) | |||
- 25.0–29.9 | 790 (31.16) | 389 (29.99) | 401 (32.39) |
- 30.0–34.9 | 954 (37.63) | 501 (38.63) | 453 (36.59) |
- 35.0–39.9 | 516 (20.36) | 260 (20.05) | 256 (20.68) |
- ≥40.0 | 275 (10.85) | 147 (11.33) | 128 (10.34) |
Maternal BMI (kg/m2), median (IQR) | 32.32 (28.80, 35.90) | 32.40 (29.00, 35.97) | 32.29 (28.70, 35.80) |
Maternal age (years), mean (SD) | 30.46 (5.19) | 30.39 (5.18) | 30.52 (5.19) |
Parity, N (%) | |||
- 0 | 1060 (41.81) | 558 (43.02) | 502 (40.55) |
- 1+ | 1475 (58.19) | 739 (56.98) | 736 (59.45) |
Maternal height (cm), mean (SD) | 165.28 (6.62) | 165.45 (6.61) | 165.11 (6.64) |
Maternal weight (kg), mean (SD) | 90.39 (16.66) | 90.88 (16.54) | 89.88 (16.77) |
Ethnicity, N (%) | |||
- Non-Caucasian | 278 (11.07) | 134 (10.43) | 144 (11.75) |
- Caucasian | 2233 (88.93) | 1151 (89.57) | 1082 (88.25) |
Infant sex, N (%) | |||
- Male | 1263 (49.82) | 650 (50.12) | 613 (49.52) |
- Female | 1272 (50.18) | 647 (49.88) | 625 (50.48) |
Child age (years) at follow-up, mean (SD) | 3.56 (0.83) | 3.53 (0.79) | 3.59 (0.86) |
Child anthropometric outcomes
Primary outcome
Outcome | Intervention, n=1292f | Control, n=1237f | Unadjusted estimate (95% CI) | Unadjusted p | τ unadjusted modeld | Adjusted estimate (95% CI) | Adjusted p | τ adjusted modeld |
---|---|---|---|---|---|---|---|---|
BMIz >90th percentilea | 380/1262 (30.11) | 355/1208 (29.39) | 0.84 (0.53, 1.33) | 0.449 | 0.24 | 0.97 (0.87, 1.08) | 0.610 | 0.00 |
Weight (kg)b | 16.79 (2.94) | 16.88 (3.30) | 2.80 (−4.37, 9.97) | 0.362 | 6.70 | 0.17 (−1.19, 1.52) | 0.341 | 0.00 |
Height (cm)b | 100.07 (6.81) | 100.49 (7.29) | 16.85 (−26.48, 60.19) | 0.363 | 40.56 | 1.00 (−0.93, 2.94) | 0.132 | 0.31 |
Head circumference (cm)b | 50.46 (1.78) | 50.48 (1.74) | 12.78 (−27.42, 52.99) | 0.386 | 25.02 | 0.54 (−1.04, 2.11) | 0.204 | 0.25 |
BMI (kg/m2)b | 16.66 (1.54) | 16.58 (1.50) | 2.94 (−4.38, 10.26) | 0.349 | 6.85 | 0.24 (−0.15, 0.63) | 0.136 | 0.15 |
Weight z-scorec | 0.69 (0.98) | 0.64 (1.01) | 0.19 (−0.13, 0.52) | 0.186 | 0.27 | 0.05 (−0.53, 0.63) | 0.446 | 0.00 |
Height z-scorec | 0.19 (0.99) | 0.18 (1.01) | 0.09 (−734.51, 734.69) | 0.540 | 0.00 | – | – | –e |
Head circumference z-scorec | 0.76 (1.16) | 0.74 (1.11) | 0.20 (−0.43, 0.82) | 0.370 | 0.32 | 0.04 (−0.45, 0.53) | 0.701 | 0.11 |
BMI z-scorec | 0.84 (1.04) | 0.78 (1.02) | 0.22 (−0.21, 0.64) | 0.243 | 0.37 | 0.05 (−0.55, 0.66) | 0.427 | 0.00 |
Weight for length (WFL) z-scorec | 0.84 (1.04) | 0.78 (1.03) | 0.21 (−0.28, 0.69) | 0.319 | 0.40 | 0.07 (−1.56, 1.70) | 0.425 | 0.00 |
Abdomen circumference (cm)b | 52.13 (4.04) | 52.08 (4.30) | 8.97 (−13.64, 31.57) | 0.355 | 21.15 | 0.65 (−0.41, 1.72) | 0.133 | 0.37 |
Arm circumference (cm)b | 17.22 (1.61) | 17.10 (1.60) | 5.77 (−18.40, 29.93) | 0.412 | 9.68 | 0.27 (−5.66, 6.19) | 0.311 | 0.00* |
Biceps skinfold (mm)b | 7.23 (2.70) | 7.16 (2.62) | 1.72 (−4.16, 7.61) | 0.420 | 3.64 | 0.10 (−2.55, 2.75) | 0.572 | 0.00* |
Triceps skinfold (mm)b | 11.40 (3.30) | 11.22 (3.13) | 2.01 (−3.24, 7.26) | 0.370 | 4.89 | 0.27 (−0.50, 1.04) | 0.238 | 0.12 |
Subscapular skinfold (mm)b | 6.85 (2.29) | 6.87 (2.51) | 1.12 (−1.90, 4.14) | 0.384 | 2.81 | 0.02 (−0.45, 0.48) | 0.910 | 0.17 |
Fat mass (kg)b | 3.91 (1.41) | 3.95 (1.36) | 0.95 (−1.30, 3.19) | 0.306 | 1.76 | 0.03 (−0.89, 0.95) | 0.737 | 0.00 |
Systolic blood pressure (mmHg)b | 100.05 (8.62) | 100.18 (8.52) | 17.48 (−26.55, 61.51) | 0.354 | 41.15 | 1.33 (−2.15, 4.82) | 0.180 | 0.00* |
Diastolic blood pressure (mmHg)b | 60.49 (8.60) | 59.92 (8.44) | 11.03 (−15.78, 37.84) | 0.338 | 25.04 | 1.00 (−0.95, 2.95) | 0.205 | 0.87 |
Secondary outcomes
Sensitivity analyses
Maternal anthropometric outcomes
Outcome | Intervention (n=1224)d | Control (n=1159)d | Unadjusted estimate (95% CI) | Unadjusted p | τ unadjusted modelc | Adjusted estimate (95% CI) | Adjusted p | τ adjusted modelc |
---|---|---|---|---|---|---|---|---|
Weight (kg)a | 92.63 (18.78) | 91.62 (19.30) | 16.13 (−22.71, 54.97) | 0.335 | 36.37 | 0.70 (−2.95, 4.35) | 0.389 | 0.00 |
Waist circumference (cm)a | 99.49 (14.31) | 99.47 (14.43) | 23.86 (−53.94, 101.65) | 0.401 | 48.43 | 0.82 (−3.36, 5.00) | 0.338 | 0.00* |
BMI (kg/m2)a | 33.92 (6.36) | 33.65 (6.60) | 5.89 (−8.59, 20.38) | 0.343 | 13.57 | 0.22 (−0.87, 1.32) | 0.366 | 0.00 |
Systolic blood pressure (mmHg)a | 119.83 (12.06) | 120.75 (12.94) | 28.91 (−68.27, 126.10) | 0.413 | 60.35 | 0.55 (−6.95, 8.04) | 0.599 | 0.00* |
Diastolic blood pressure (mmHg)a | 75.22 (9.40) | 76.06 (9.95) | 17.92 (−43.89, 79.73) | 0.424 | 38.38 | −0.13 (−4.51, 4.25) | 0.872 | 0.64 |
Weight changeb trial entry until follow-up | 1.23 (10.23) | 0.86 (10.17) | 0.86 (−2.51, 4.22) | 0.268 | 0.43 | 0.52 (−2.47, 3.51) | 0.424 | 0.00* |
Child diet, activity and development outcomes
Outcome | Intervention, n=1292e | Control, n=1237e | Unadjusted estimate (95% CI) | Unadjusted p | τ unadjusted modeld | Adjusted estimate (95% CI) | Adjusted p | τ adjusted modeld |
---|---|---|---|---|---|---|---|---|
Ever breastfeda | 1049/1365 (76.85) | 986/1300 (75.85) | 0.93 (0.89, 0.98) | 0.003 | 0.00 | 1.01 (0.98, 1.05) | 0.495 | 0.00 |
Breastfed ≥6monthsa | 477/1016 (46.95) | 470/968 (48.55) | 0.79 (0.58, 1.07) | 0.126 | 0.07 | 0.97 (0.93, 1.01) | 0.146 | 0.00 |
Energy (kJ)b | 4427.56 (1404.86) | 4358.04 (1354.44) | 1635.52 (−4661.88, 7932.91) | 0.380 | 2518.13 | 110.99 (−1908.35, 2130.32) | 0.394 | 0.15* |
Fat/day (g)b | 36.30 (12.38) | 35.41 (11.74) | 13.71 (−35.27, 62.69) | 0.352 | 19.57 | 1.82 (−4.39, 8.02) | 0.312 | 1.93 |
Protein/day (g)b | 43.41 (15.39) | 42.24 (14.17) | 16.17 (−43.25, 75.59) | 0.362 | 23.75 | 1.53 (−19.70, 22.76) | 0.330 | 0.00* |
Carbohydrate/day (g)b | 168.18 (71.61) | 171.28 (73.59) | 47.57 (−148.78, 243.92) | 0.407 | 78.44 | 1.32 (−80.57, 83.21) | 0.723 | 0.00* |
Fruits/dayc | 3.28 (2.07, 4.79) | 3.12 (2.00, 4.56) | 1.28 (−2.32, 4.88) | 0.340 | 2.22 | 0.22 (−1.60, 2.04) | 0.318 | 0.00* |
Vegetables/dayc | 2.79 (1.64, 4.64) | 2.93 (1.72, 4.43) | 1.10 (−2.21, 4.40) | 0.369 | 2.04 | 0.17 (−1.53, 1.86) | 0.370 | 0.00* |
Dairy/dayc | 2.57 (1.71, 3.64) | 2.43 (1.57, 3.50) | 0.90 (−1.46, 3.25) | 0.312 | 1.46 | 0.15 (−0.28, 0.59) | 0.288 | 0.15 |
Extras/dayc | 1.64 (0.93, 2.57) | 1.71 (0.93, 2.65) | 0.45 (−0.95, 1.85) | 0.381 | 0.85 | −0.05 (−1.09, 1.00) | 0.616 | 0.00* |
Physical activity, (min/week)c | 982.50 (570.00, 1650.00) | 915.00 (510.00, 1680.00) | 576.87 (−1795.95, 2949.70) | 0.405 | 946.32 | 41.55 (−1157.17, 1240.27) | 0.522 | 0.00* |
Screen time (min/week)c | 400.00 (210.00, 720.00) | 390.00 (210.00, 630.00) | 204.40 (−647.94, 1056.74) | 0.410 | 339.19 | 20.71 (−173.60, 215.02) | 0.515 | 23.55 |
Ages and stages communicationc | 55.00 (50.00, 60.00) | 55.00 (50.00, 60.00) | 13.92 (−29.36, 57.19) | 0.381 | 26.45 | 0.62 (−4.6e+07, 4.6e+07) | 0.764 | 0.00* |
Ages and stages gross motorc | 60.00 (50.00, 60.00) | 60.00 (50.00, 60.00) | 13.89 (−31.82, 59.60) | 0.404 | 27.98 | 0.84 (−5.2e+07, 5.2e+07) | 0.728 | 0.00* |
Ages and stages fine motorc | 50.00 (40.00, 60.00) | 50.00 (40.00, 60.00) | 9.53 (−32.40, 51.46) | 0.521 | 25.65 | −1.62 (−8.26, 5.03) | 0.458 | 2.95 |
Ages and stages problem solvingc | 60.00 (50.00, 60.00) | 60.00 (50.00, 60.00) | 14.00 (−30.60, 58.59) | 0.391 | 27.27 | 1.14 (−8.8e+07, 8.8e+07) | 0.707 | 0.00* |
Ages and stages personal socialc | 55.00 (50.00, 60.00) | 55.00 (50.00, 60.00) | 14.22 (−29.01, 57.46) | 0.372 | 26.44 | 1.11 (−3.26, 5.48) | 0.407 | 1.60 |
Ages and stages totalc | 270.00 (250.00, 285.00) | 270.00 (245.00, 285.00) | 64.76 (−154.29, 283.82) | 0.416 | 134.10 | 1.32 (−21.00, 23.63) | 0.786 | 5.46 |
Total sleep/night (h)c | 11.16 (1.25) | 11.16 (1.27) | 3.77 (−12.38, 19.92) | 0.421 | 6.47 | 0.18 (−2.31, 2.68) | 0.323 | 0.00* |
Maternal diet outcomes
Outcome | Intervention (n=1224)b | Control (n=1159)b | Unadjusted estimate (95% CI) | Unadjusted p | τ unadjusted modelc | Adjusted estimate (95% CI) | Adjusted p | τ adjusted modelc |
---|---|---|---|---|---|---|---|---|
Mother energy (kJ)a | 7649.98 (3232.58) | 7705.48 (2832.20) | 2490.10 (−9919.95, 14900.15) | 0.479 | 4966.20 | −111.83 (−1496.28, 1272.61) | 0.736 | 404.07 |
Mother fat (g)a | 65.87 (30.64) | 66.96 (27.88) | 20.77 (−87.10, 128.63) | 0.494 | 43.15 | −1.74 (−15.90, 12.42) | 0.626 | 4.45 |
Mother protein (g)a | 93.16 (42.61) | 92.51 (35.92) | 31.39 (−111.14, 173.91) | 0.443 | 56.98 | 1.11 (−40.42, 42.64) | 0.668 | 0.01* |
Mother carbohydrate (g)a | 221.42 (105.69) | 223.80 (94.77) | 70.96 (−293.58, 435.51) | 0.490 | 145.81 | −4.09 (−49.76, 41.59) | 0.706 | 12.95 |
Mother fruitsa | 2.07 (1.14, 3.64) | 2.00 (1.07, 3.29) | 1.14 (−2.82, 5.10) | 0.338 | 1.51 | 0.36 (−2.16, 2.88) | 0.591 | 0.86 |
Mother vegetablesa | 4.93 (2.93, 7.71) | 4.86 (3.00, 7.64) | 2.02 (−7.29, 11.33) | 0.449 | 3.68 | 0.18 (−2.81, 3.18) | 0.804 | 0.96 |
Mother dairya | 1.50 (0.86, 2.57) | 1.50 (0.93, 2.57) | 0.68 (−2.41, 3.76) | 0.444 | 1.22 | 0.02 (−1.93, 1.98) | 0.841 | 0.00 |
Mother extrasa | 1.14 (0.64, 2.00) | 1.21 (0.70, 2.21) | 0.07 (−3.68, 3.82) | 0.943 | 1.47 | −0.41 (−2.92, 2.11) | 0.555 | 0.94 |