Background
Methods
Ethics
Study design
Inclusion and exclusion criteria
Trial entry
Randomisation, masking and group allocation
Nested randomised trial
Treatment schedules
Lifestyle Advice group
Walking group (nested randomised controlled trial)
Standard Care group
Study endpoints: maternal diet
Study endpoints: maternal physical activity
Analysis and reporting of results
Sample size
Results
Characteristic | Lifestyle advice (n = 974) | Standard care (n = 950) | Total (n = 1924) |
---|---|---|---|
Maternal age, yearsa
| 29.4 ± 5.4 | 29.6 ± 5.4 | 29.5 ± 5.4 |
Gestational age at entry, weeksb
| 14.3 (12.0 to 17.0) | 14.3 (12.0 to 17.1) | 14.3 (12.0 to 17.1) |
Body mass index category, n (%) | |||
25.0 to 29.9 | 410 (42.1) | 421 (44.3) | 831 (43.2) |
30.0 to 34.9 | 282 (29.0) | 268 (28.2) | 550 (28.6) |
35.0 to 39.9 | 180 (18.5) | 155 (16.3) | 335 (17.4) |
≥40.0 | 102 (10.5) | 106 (11.2) | 208 (10.8) |
Public patient, n (%) | 954 (97.9) | 927 (97.6) | 1881 (97.8) |
Caucasian, n (%) | 883 (90.7) | 866 (91.2) | 1749 (90.9) |
Smoker, n (%) | 124 (12.7) | 97 (10.2) | 221 (11.5) |
Nulliparous, n (%) | 410 (42.1) | 385 (40.5) | 795 (41.3) |
Index of Socio-economic Disadvantage, n(%)c
| |||
Unknown | 2 (0.2) | 1 (0.1) | 3 (0.2) |
Quintile 1 (most disadvantaged) | 296 (30.4) | 274 (28.8) | 570 (29.6) |
Quintile 2 | 231 (23.7) | 236 (24.8) | 467 (24.3) |
Quintile 3 | 157 (16.1) | 143 (15.1) | 300 (15.6) |
Quintile 4 | 138 (14.2) | 151 (15.9) | 289 (15.0) |
Quintile 5 (least disadvantaged) | 150 (15.4) | 145 (15.3) | 295 (15.3) |
Macronutrient consumption and food groups
Outcome | Time point | Lifestyle advice (n = 945)b
| Standard care (n = 928)b
| Adjusted treatment × time interactionP-valuec
| Adjusted treatment effect | |
---|---|---|---|---|---|---|
P
| 95% CI | |||||
Total energy, kJd
| Trial entry | 8678.89 (2690.39) | 8501.40 (2565.19) | 0.99 | 0.09 | 178.60 (-26.56 to 383.77) |
28 weeks | 8772.33 (2545.60) | 8675.26 (2792.00) | ||||
36 weeks | 8667.72 (2585.28) | 8568.86 (2751.49) | ||||
4 months | 8763.08 (2694.71) | 8628.89 (2686.06) | ||||
Breads and cereals, servings/dayd
| Trial entry | 2.63 (1.45) | 2.61 (1.43) | 0.82 | 0.27 | 0.06 (-0.04 to 0.16) |
28 weeks | 2.65 (1.34) | 2.59 (1.42) | ||||
36 weeks | 2.66 (1.33) | 2.59 (1.42) | ||||
4 months | 2.58 (1.39) | 2.51 (1.37) | ||||
Dairy, servings/day | Trial entry | 2.05 (1.34) | 2.21 (1.52) | 0.002 | 0.02 | -0.17 (-0.30 to -0.03) |
28 weeks | 2.30 (1.24) | 2.24 (1.39) | 0.09 | 0.12 (-0.02 to 0.25) | ||
36 weeks | 2.42 (1.42) | 2.33 (1.40) | 0.24 | 0.09 (-0.06 to 0.24) | ||
4 months | 2.28 (1.36) | 2.24 (1.42) | 0.56 | 0.05 (-0.11 to 0.21) | ||
Fruit, servings/dayd
| Trial entry | 2.67 (2.07) | 2.48 (1.63) | 0.44 | 0.002 | 0.21 (0.08 to 0.35) |
28 weeks | 2.70 (1.62) | 2.43 (1.74) | ||||
36 weeks | 2.56 (1.47) | 2.34 (1.67) | ||||
4 months | 2.24 (1.64) | 2.11 (1.56) | ||||
Meat and legumes, servings/dayd
| Trial entry | 2.14 (1.03) | 2.10 (0.94) | 0.67 | 0.14 | 0.06 (-0.02 to 0.14) |
28 weeks | 2.17 (1.08) | 2.10 (0.97) | ||||
36 weeks | 2.14 (0.91) | 2.08 (1.05) | ||||
4 months | 2.30 (0.95) | 2.29 (1.08) | ||||
Vegetables, servings/day | Trial entry | 4.96 (2.64) | 4.82 (2.57) | 0.03 | 0.30 | 0.13 (-0.12 to 0.38) |
28 weeks | 5.16 (2.68) | 4.71 (2.37) | 0.0002 | 0.47 (0.22 to 0.72) | ||
36 weeks | 4.87 (2.54) | 4.51 (2.65) | 0.003 | 0.40 (0.13 to 0.67) | ||
4 months | 5.63 (3.12) | 5.24 (2.62) | 0.003 | 0.50 (0.17 to 0.82) | ||
Non-core group foods, servings/day | Trial entry | 7.51 (3.81) | 7.27 (3.61) | 0.01 | 0.10 | 0.29 (-0.06 to 0.65) |
28 weeks | 6.84 (3.24) | 7.14 (3.41) | 0.17 | -0.24 (-0.58 to 0.10) | ||
36 weeks | 6.86 (3.54) | 6.96 (3.24) | 0.72 | -0.06 (-0.41 to 0.28) | ||
4 months | 8.15 (3.69) | 7.95 (3.76) | 0.41 | 0.17 (-0.24 to 0.59) | ||
Alcohol, gd
| Trial entry | 2.25 (5.21) | 2.48 (6.47) | 0.59 | 0.20 | 0.07 (-0.03 to 0.17) |
28 weeks | 0.34 (1.35) | 0.25 (0.86) | ||||
36 weeks | 0.31 (1.42) | 0.27 (1.06) | ||||
4 months | 2.27 (4.04) | 2.18 (4.92) | ||||
Dietary fibre, gd
| Trial entry | 32.39 (12.91) | 31.64 (12.43) | 0.16 | 0.002 | 1.55 (0.55 to 2.56) |
28 weeks | 33.75 (12.39) | 31.88 (12.42) | ||||
36 weeks | 32.78 (11.80) | 30.93 (12.89) | ||||
4 months | 34.09 (13.61) | 32.50 (12.68) | ||||
Carbohydrates, gd
| Trial entry | 255.27 (90.54) | 246.38 (83.50) | 0.69 | 0.06 | 6.55 (-0.19 to 13.29) |
28 weeks | 258.11 (82.97) | 255.89 (93.44) | ||||
36 weeks | 253.61 (85.76) | 251.43 (90.66) | ||||
4 months | 247.86 (89.54) | 243.25 (88.71) | ||||
Percentage energy from carbohydratesd
| Trial entry | 46.85 (5.97) | 46.22 (5.59) | 0.23 | 0.39 | 0.19 (-0.24 to 0.62) |
28 weeks | 46.96 (5.33) | 46.89 (5.30) | ||||
36 weeks | 46.61 (5.44) | 46.68 (5.81) | ||||
4 months | 44.89 (5.91) | 44.76 (6.18) | ||||
Protein, gd
| Trial entry | 97.59 (30.65) | 97.80 (30.58) | 0.07 | 0.14 | 1.82 (-0.57 to 4.22) |
28 weeks | 100.07 (32.16) | 97.56 (30.59) | ||||
36 weeks | 100.13 (30.22) | 97.10 (32.18) | ||||
4 months | 102.67 (31.15) | 101.24 (30.08) | ||||
Percentage energy from protein | Trial entry | 22.72 (3.83) | 23.22 (3.88) | 0.0001 | 0.008 | -0.49 (-0.86 to -0.13) |
28 weeks | 22.98 (3.74) | 22.82 (3.66) | 0.11 | 0.31 (-0.07 to 0.68) | ||
36 weeks | 23.35 (3.85) | 22.98 (4.04) | 0.11 | 0.33 - 0.08 to 0.75) | ||
4 months | 23.80 (4.25) | 23.87 (4.26) | 0.80 | -0.06 (-0.55 to 0.42) | ||
Total Fat, gd
| Trial entry | 65.28 (23.60) | 64.33 (22.27) | 0.83 | 0.48 | 0.64 (-1.14 to 2.41) |
28 weeks | 66.54 (22.50) | 66.70 (23.62) | ||||
36 weeks | 65.98 (22.14) | 66.24 (23.70) | ||||
4 months | 68.16 (23.68) | 67.72 (23.99) | ||||
Percentage energy from total fatd
| Trial entry | 27.77 (4.51) | 27.97 (4.20) | 0.42 | 0.06 | -0.31 (-0.64 to 0.02) |
28 weeks | 28.02 (4.19) | 28.45 (4.19) | ||||
36 weeks | 28.13 (4.23) | 28.59 (4.36) | ||||
4 months | 28.76 (4.31) | 29.00 (4.39) | ||||
Saturated fat, gd
| Trial entry | 26.47 (10.98) | 26.08 (10.01) | 0.50 | 0.71 | 0.15 (-0.64 to 0.94) |
28 weeks | 26.98 (9.87) | 27.37 (10.30) | ||||
36 weeks | 27.10 (10.20) | 27.48 (10.62) | ||||
4 months | 27.49 (10.51) | 27.25 (10.29) | ||||
Percentage energy from saturated fatd
| Trial entry | 11.23 (2.50) | 11.34 (2.38) | 0.09 | 0.04 | -0.20 (-0.38 to -0.01) |
28 weeks | 11.37 (2.33) | 11.70 (2.41) | ||||
36 weeks | 11.52 (2.41) | 11.85 (2.47) | ||||
4 months | 11.59 (2.43) | 11.68 (2.47) | ||||
Monounsaturated fat, gd
| Trial entry | 22.60 (8.56) | 22.28 (8.13) | 0.75 | 0.62 | 0.16 (-0.48 to 0.81) |
28 weeks | 22.99 (8.27) | 23.12 (8.70) | ||||
36 weeks | 22.72 (7.96) | 22.81 (8.72) | ||||
4 months | 23.69 (8.72) | 23.65 (9.12) | ||||
Polyunsaturated fat, gd
| Trial entry | 9.09 (3.50) | 8.95 (3.59) | 0.90 | 0.23 | 0.17 (-0.11 to 0.45) |
28 weeks | 9.31 (3.67) | 9.13 (3.81) | ||||
36 weeks | 9.06 (3.33) | 8.89 (3.71) | ||||
4 months | 9.48 (3.71) | 9.43 (4.16) |
Micronutrient consumption
Outcome | Time point | Lifestyle advice (n = 945)b
| Standard care (n = 928)b
| Adjusted treatment × time interactionP-valuec
| Adjusted treatment effect | |
---|---|---|---|---|---|---|
P
| 95% CI | |||||
Caffeine, mgd
| Trial entry | 142.59 (156.88) | 136.59 (156.36) | 0.57 | 0.57 | 3.68 (-8.90 to 16.26) |
28 weeks | 134.63 (147.21) | 132.76 (147.04) | ||||
36 weeks | 129.61 (141.89) | 128.55 (140.66) | ||||
4 months | 202.78 (191.12) | 191.83 (185.43) | ||||
Sodium, mgd
| Trial entry | 2713.21 (1080.73) | 2644.16 (1102.75) | 0.86 | 0.10 | 70.55 (-13.71 to 154.81) |
28 weeks | 2684.04 (1038.11) | 2651.08 (1048.43) | ||||
36 weeks | 2704.91 (1059.82) | 2620.33 (1045.35) | ||||
4 months | 2822.92 (1164.27) | 2759.30 (1092.84) | ||||
Calcium, mg | Trial entry | 930.81 (388.80) | 963.43 (429.48) | 0.007 | 0.11 | -32.10 (-71.25 to 7.04) |
28 weeks | 1009.34 (366.54) | 984.56 (400.48) | 0.04 | 40.73 (1.57 to 79.88) | ||
36 weeks | 1031.14 (421.66) | 1003.76 (404.85) | 0.15 | 31.99 (-11.04 to 75.02) | ||
4 months | 1007.13 (415.11) | 990.64 (416.75) | 0.37 | 21.26 (-25.14 to 67.67) | ||
Iron, mgd
| Trial entry | 13.79 (4.79) | 13.57 (4.61) | 0.83 | 0.08 | 0.33 (-0.04 to 0.70) |
28 weeks | 14.21 (4.56) | 13.94 (4.92) | ||||
36 weeks | 14.03 (4.48) | 13.69 (5.04) | ||||
4 months | 14.51 (4.79) | 14.08 (4.77) | ||||
Zinc, mgd
| Trial entry | 11.71 (3.69) | 11.71 (3.56) | 0.08 | 0.11 | 0.23 (-0.06 to 0.52) |
28 weeks | 12.14 (3.70) | 11.82 (3.70) | ||||
36 weeks | 12.12 (3.68) | 11.75 (3.90) | ||||
4 months | 12.36 (3.74) | 12.12 (3.62) | ||||
Magnesium, mgd
| Trial entry | 344.03 (116.89) | 342.67 (116.44) | 0.11 | 0.06 | 9.07 (-0.20 to 18.33) |
28 weeks | 356.11 (110.62) | 344.98 (119.15) | ||||
36 weeks | 353.11 (112.18) | 340.31 (117.27) | ||||
4 months | 364.02 (119.85) | 354.13 (118.78) | ||||
Phosphorus, mgd
| Trial entry | 1586.85 (497.80) | 1595.95 (515.48) | 0.08 | 0.16 | 28.14 (-11.27 to 67.56) |
28 weeks | 1657.50 (493.47) | 1618.65 (509.91) | ||||
36 weeks | 1671.51 (516.33) | 1626.25 (518.62) | ||||
4 months | 1689.35 (528.98) | 1655.95 (514.58) | ||||
Potassium, mg | Trial entry | 3591.78 (1220.73) | 3570.31 (1169.87) | 0.05 | 0.69 | 23.15 (-90.33 to 136.63) |
28 weeks | 3723.05 (1129.40) | 3586.57 (1223.47) | 0.004 | 173.10 (54.97 to 291.23) | ||
36 weeks | 3674.33 (1131.83) | 3541.08 (1185.20) | 0.01 | 158.03 (38.14 to 277.92) | ||
4 months | 3781.35 (1271.44) | 3657.89 (1165.91) | 0.06 | 127.88 (-4.96 to 260.72) | ||
Iodine, μgd
| Trial entry | 204.05 (108.94) | 205.81 (105.00) | 0.37 | 0.38 | 3.54 (-4.36 to 11.44) |
28 weeks | 210.93 (97.92) | 206.26 (96.36) | ||||
36 weeks | 215.94 (101.27) | 209.86 (99.91) | ||||
4 months | 214.81 (109.29) | 212.34 (102.24) | ||||
Vitamin A Active Equivalent, μgd
| Trial entry | 1475.35 (974.00) | 1404.15 (752.52) | 0.16 | 0.003 | 110.40 (36.48 to 184.32) |
28 weeks | 1605.54 (1323.79) | 1424.89 (890.08) | ||||
36 weeks | 1462.83 (821.57) | 1363.63 (877.70) | ||||
4 months | 1658.00 (1077.44) | 1539.68 (852.02) | ||||
Retinol, μgd
| Trial entry | 366.23 (558.09) | 336.37 (311.97) | 0.34 | 0.33 | 18.56 (-18.64 to 55.75) |
28 weeks | 422.55 (1087.70) | 372.54 (607.22) | ||||
36 weeks | 349.30 (400.65) | 369.78 (508.35) | ||||
4 months | 376.11 (626.42) | 371.01 (464.27) | ||||
Vitamin B1 (thiamine), mgd
| Trial entry | 1.55 (0.57) | 1.52 (0.56) | 0.50 | 0.07 | 0.04 (-0.00 to 0.08) |
28 weeks | 1.61 (0.55) | 1.57 (0.61) | ||||
36 weeks | 1.62 (0.55) | 1.56 (0.62) | ||||
4 months | 1.58 (0.57) | 1.54 (0.56) | ||||
Vitamin B2 (riboflavin), mg | Trial entry | 2.14 (0.84) | 2.19 (0.87) | 0.02 | 0.22 | -0.05 (-0.13 to 0.03) |
28 weeks | 2.33 (0.79) | 2.28 (0.89) | 0.05 | 0.08 (-0.00 to 0.17) | ||
36 weeks | 2.37 (0.86) | 2.33 (0.87) | 0.23 | 0.06 (-0.03 to 0.15) | ||
4 months | 2.34 (0.87) | 2.29 (0.85) | 0.24 | 0.06 (-0.04 to 0.15) | ||
Niacin, mgd
| Trial entry | 22.60 (7.43) | 22.49 (7.24) | 0.32 | 0.09 | 0.49 (-0.08 to 1.07) |
28 weeks | 23.02 (7.61) | 22.57 (7.47) | ||||
36 weeks | 23.04 (7.05) | 22.35 (7.75) | ||||
4 months | 23.89 (7.47) | 23.25 (7.08) | ||||
Vitamin C, mgd
| Trial entry | 165.11 (117.86) | 152.24 (90.04) | 0.50 | 0.02 | 8.87 (1.40 to 16.34) |
28 weeks | 158.26 (91.27) | 147.34 (100.64) | ||||
36 weeks | 149.35 (87.94) | 142.60 (99.13) | ||||
4 months | 139.11 (89.17) | 133.80 (77.94) | ||||
Vitamin E, mgd
| Trial entry | 7.37 (2.90) | 7.35 (2.91) | 0.71 | 0.17 | 0.16 (-0.07 to 0.38) |
28 weeks | 7.58 (2.77) | 7.39 (2.97) | ||||
36 weeks | 7.40 (2.71) | 7.23 (2.85) | ||||
4 months | 7.94 (3.10) | 7.74 (3.14) | ||||
Folate, μgd
| Trial entry | 529.62 (206.87) | 520.74 (210.02) | 0.49 | 0.03 | 17.49 (1.26 to 33.71) |
28 weeks | 545.59 (203.52) | 528.35 (212.15) | ||||
36 weeks | 540.67 (196.49) | 522.05 (213.62) | ||||
4 months | 544.99 (206.99) | 528.74 (201.97) | ||||
Folate food, μgd
| Trial entry | 401.20 (161.35) | 395.15 (160.90) | 0.24 | 0.02 | 15.13 (2.14 to 28.12) |
28 weeks | 410.82 (161.38) | 394.97 (161.04) | ||||
36 weeks | 402.80 (150.79) | 388.02 (161.70) | ||||
4 months | 420.96 (164.11) | 406.71 (156.54) |
Healthy Eating Index
Outcome | Time point | Lifestyle advice (n = 945)b
| Standard care (n = 928)b
| Adjusted treatment × time interactionP-valuec
| Adjusted treatment effect | |
---|---|---|---|---|---|---|
P
| 95% CI | |||||
HEI, range 0 to 100 | Trial entry | 72.11 (7.71) | 72.80 (7.07) | <0.0001 | 0.06 | -0.67 (-1.37 to 0.03) |
28 weeks | 73.35 (6.62) | 71.86 (7.01) | <0.0001 | 1.58 (0.89 to 2.27) | ||
36 weeks | 72.95 (6.82) | 71.17 (7.69) | <0.0001 | 1.77 (1.01 to 2.53) | ||
4 months | 72.83 (7.56) | 72.15 (7.47) | 0.41 | 0.35 (-0.48 to 1.18) | ||
Total fruit, range 0 to 5 | Trial entry | 4.50 (1.02) | 4.48 (1.03) | 0.003 | 0.567 | 0.03 (-0.07 to 0.13) |
28 weeks | 4.63 (0.89) | 4.42 (1.11) | 0.0001 | 0.20 (0.10 to 0.30) | ||
36 weeks | 4.58 (0.97) | 4.34 (1.18) | <0.0001 | 0.24 (0.13 to 0.35) | ||
4 months | 4.27 (1.23) | 4.11 (1.33) | 0.07 | 0.14 (-0.01 to 0.28) | ||
Whole fruit, range 0 to 5 | Trial entry | 4.56 (1.09) | 4.57 (1.05) | 0.0002 | 0.77 | -0.01 (-0.12 to 0.09) |
28 weeks | 4.68 (0.94) | 4.50 (1.15) | 0.0003 | 0.19 (0.09 to 0.30) | ||
36 weeks | 4.64 (1.03) | 4.42 (1.24) | <0.0001 | 0.24 (0.12 to 0.35) | ||
4 months | 4.43 (1.18) | 4.35 (1.24) | 0.30 | 0.07 (-0.06 to 0.21) | ||
Total vegetables, range 0 to 5d
| Trial entry | 4.86 (0.58) | 4.88 (0.50) | 0.06 | 0.12 | 0.03 (-0.01 to 0.06) |
28 weeks | 4.91 (0.44) | 4.88 (0.48) | ||||
36 weeks | 4.88 (0.49) | 4.81 (0.62) | ||||
4 months | 4.94 (0.31) | 4.89 (0.45) | ||||
Dark-green and orange Vegetables and legumes, range 0 to 5d
| Trial entry | 4.76 (0.76) | 4.72 (0.84) | 0.12 | 0.0006 | 0.10 (0.04 to 0.16) |
28 weeks | 4.82 (0.64) | 4.73 (0.78) | ||||
36 weeks | 4.76 (0.77) | 4.64 (0.93) | ||||
4 months | 4.89 (0.46) | 4.78 (0.75) | ||||
Total grains, range 0 to 5d
| Trial entry | 3.88 (0.93) | 3.89 (0.91) | 0.24 | 0.55 | -0.02 (-0.09 to 0.05) |
28 weeks | 3.88 (0.91) | 3.95 (0.88) | ||||
36 weeks | 3.93 (0.91) | 3.92 (0.93) | ||||
4 months | 3.80 (1.00) | 3.78 (1.04) | ||||
Whole grains, range 0 to 5d
| Trial entry | 0.71 (0.88) | 0.71 (0.83) | 0.23 | 0.14 | 0.05 (-0.02 to 0.11) |
28 weeks | 0.74 (0.86) | 0.67 (0.83) | ||||
36 weeks | 0.82 (0.90) | 0.71 (0.91) | ||||
4 months | 0.81 (0.87) | 0.78 (0.88) | ||||
Milk, range 0 to 10 | Trial entry | 6.54 (2.80) | 6.98 (2.82) | <0.0001 | 0.002 | -0.42 (-0.69 to -0.16) |
28 weeks | 7.37 (2.61) | 7.15 (2.70) | 0.04 | 0.29 (0.01 to 0.56) | ||
36 weeks | 7.48 (2.49) | 7.34 (2.69) | 0.45 | 0.10 (-0.17 to 0.38) | ||
4 months | 7.23 (2.70) | 7.01 (2.69) | 0.28 | 0.17 (-0.14 to 0.48) | ||
Meat and beans, range 0 to 10d
| Trial entry | 9.59 (1.20) | 9.61 (1.07) | 0.24 | 0.67 | 0.02 (-0.06 to 0.10) |
28 weeks | 9.59 (1.16) | 9.55 (1.16) | ||||
36 weeks | 9.60 (1.13) | 9.46 (1.26) | ||||
4 months | 9.74 (0.96) | 9.74 (0.99) | ||||
Oils, range 0 to 10d
| Trial entry | 5.48 (3.19) | 5.45 (3.25) | 0.24 | 0.15 | 0.18 (-0.07 to 0.42) |
28 weeks | 5.50 (3.17) | 5.27 (3.18) | ||||
36 weeks | 5.42 (3.27) | 4.99 (3.25) | ||||
4 months | 5.69 (3.18) | 5.46 (3.26) | ||||
Saturated fat, range 0 to 10d
| Trial entry | 5.48 (3.00) | 5.36 (2.96) | 0.08 | 0.07 | 0.21 (-0.02 to 0.44) |
28 weeks | 5.31 (2.88) | 4.91 (2.90) | ||||
36 weeks | 5.04 (3.04) | 4.70 (3.02) | ||||
4 months | 5.01 (3.02) | 4.97 (3.00) | ||||
Sodium, range 0 to 10d
| Trial entry | 6.10 (2.43) | 6.22 (2.43) | 0.77 | 0.34 | -0.09 (-0.27 to 0.10) |
28 weeks | 6.28 (2.42) | 6.27 (2.32) | ||||
36 weeks | 6.10 (2.44) | 6.28 (2.38) | ||||
4 months | 5.80 (2.63) | 5.91 (2.46) | ||||
Calories from solid fats, alcohol and added sugar (SoFAAS), range 0 to 20d
| Trial entry | 15.64 (3.79) | 15.94 (3.60) | 0.150 | 0.56 | -0.08 (-0.33 to 0.18) |
28 weeks | 15.63 (3.24) | 15.55 (3.45) | ||||
36 weeks | 15.69 (3.20) | 15.57 (3.51) | ||||
4 months | 16.21 (3.33) | 16.37 (3.22) |
Glycaemic index and glycaemic load
Outcome | Time point | Lifestyle advice (n = 945)b
| Standard care (n = 928)b
| Adjusted treatment × time interactionP-valuec
| Adjusted treatment effect | |
---|---|---|---|---|---|---|
P
| 95% CI | |||||
Glycaemic load | Trial entry | 129.46 (47.84) | 124.92 (45.07) | 0.45 | 0.15 | 2.62 (-0.94 to 6.18) |
28 weeks | 130.10 (44.55) | 129.86 (50.67) | ||||
36 weeks | 126.96 (44.90) | 127.12 (48.60) | ||||
4 months | 123.56 (47.92) | 121.86 (47.71) | ||||
Glycaemic index | Trial entry | 50.57 (3.65) | 50.51 (3.59) | 0.17 | 0.10 | -0.22 (-0.48 to 0.04) |
28 weeks | 50.19 (3.36) | 50.48 (3.45) | ||||
36 weeks | 49.90 (3.47) | 50.32 (3.65) | ||||
4 months | 49.55 (3.92) | 49.71 (4.17) |
Physical activity
Outcome | Time point | Lifestyle advice (n = 974)b
| Standard care (n = 950)b
| Adjusted treatment × time interactionP-valuec
| Adjusted treatment effect | |
---|---|---|---|---|---|---|
P
| 95% CI | |||||
Commuting activityd
| Trial entry | 286.15 (386.14) | 245.40 (277.01) | 0.56 | 0.55 | 11.83 (-26.75 to 50.42) |
28 weeks | 234.95 (234.09) | 219.74 (226.69) | ||||
36 weeks | 212.05 (257.66) | 228.88 (314.25) | ||||
4 months | 309.87 (331.10) | 330.50 (422.89) | ||||
Leisure activity | Trial entry | 1081.25 (1423.50) | 1022.28 (1282.32) | 0.22 | 0.06 | 79.33 (-2.09 to 160.75) |
28 weeks | 1016.04 (1310.73) | 862.28 (1092.86) | ||||
36 weeks | 788.66 (961.96) | 777.53 (900.00) | ||||
4 months | 1281.07 (1303.30) | 1163.67 (1249.04) | ||||
Household activity | Trial entry | 3290.48 (3139.01) | 3148.30 (3093.46) | 0.59 | 0.01 | 265.60 (61.36 to 469.84) |
28 weeks | 3229.92 (3066.10) | 2988.91 (2961.08) | ||||
36 weeks | 3158.49 (2954.16) | 2813.98 (2934.20) | ||||
4 months | 4756.43 (3831.12) | 4677.16 (3881.09) | ||||
Work activityd
| Trial entry | 4697.83 (3093.41) | 4405.76 (2818.43) | 0.40 | 0.52 | 80.85 (-163.12 to 324.83) |
28 weeks | 4326.30 (2707.53) | 4279.65 (2660.85) | ||||
36 weeks | 4032.73 (2484.61) | 4059.23 (2593.77) | ||||
4 months | 3041.02 (2505.86) | 3204.85 (2706.89) | ||||
Total activity | Trial entry | 7587.63 (4573.52) | 7259.93 (4145.34) | 0.99 | 0.01 | 359.76 (74.87 to 644.65) |
28 Weeks | 7010.32 (3950.39) | 6742.48 (3836.85) | ||||
36 Weeks | 5819.82 (3954.63) | 5518.10 (3844.79) | ||||
4 Months | 6530.19 (4336.80) | 6317.00 (4498.15) |
Nested randomised trial
Outcome | Time point | Walking group (n = 257)b
| Information only (n = 269)b
| Adjusted treatment × time interactionP-valuec
| Adjusted treatment effect | |
---|---|---|---|---|---|---|
P
| 95% CI | |||||
Commuting activityd
| Trial entry | 227.30 (281.27) | 240.47 (243.97) | 0.24 | 0.63 | 17.41 (-54.57 to 89.39) |
28 weeks | 218.05 (176.55) | 200.32 (287.47) | ||||
36 weeks | 292.52 (366.32) | 185.01 (178.98) | ||||
4 months | 248.44 (263.20) | 390.00 (512.82) | ||||
Leisure activitye
| Trial entry | 1048.02 (1311.53) | 877.42 (1146.34) | 0.04 | 0.11 | 174.72 (-41.93 to 391.38) |
28 weeks | 1048.30 (1248.43) | 911.11 (1212.73) | 0.36 | 108.50 (-125.45 to 342.44) | ||
36 weeks | 796.16 (1011.25) | 727.39 (810.12) | 0.67 | 52.10 (-188.17 to 292.38) | ||
4 months | 1178.16 (1071.98) | 1374.64 (1411.67) | 0.08 | -236.04 (-503.44 to 31.37) | ||
Household activity | Trial entry | 3437.45 (3353.79) | 2961.20 (2924.20) | 0.19 | 0.16 | 294.44 (-114.88 to 703.76) |
28 weeks | 3441.23 (3085.54) | 2697.92 (2732.72) | ||||
36 weeks | 3208.16 (3005.22) | 2951.82 (3111.69) | ||||
4 months | 4862.53 (4204.93) | 4672.32 (3766.02) | ||||
Work-related activityd
| Trial entry | 4440.89 (2743.25) | 4888.99 (3130.39) | 0.19 | 0.26 | -259.57 (-710.22 to 191.08) |
28 weeks | 4121.12 (2359.13) | 4409.20 (2735.41) | ||||
36 weeks | 3512.04 (1852.27) | 4035.94 (2274.21) | ||||
4 months | 3454.71 (2619.25) | 3144.64 (2212.72) | ||||
Total activity | Trial entry | 7524.07 (4657.16) | 7311.45 (4318.89) | 0.75 | 0.40 | 247.31 (-332.35 to 826.98) |
28 weeks | 7169.05 (3823.28) | 6564.51 (3898.19) | ||||
36 weeks | 5888.77 (3688.15) | 5479.91 (4066.69) | ||||
4 months | 6526.84 (4637.30) | 6641.77 (4494.63) |