Background
Methods
Study design, randomisation and participants
Metabolic profiling
Statistical analyses
Change in metabolic profiles across pregnancy in obese women in the control arm
Effect of the intervention on change in metabolic profiles across pregnancy
Analysis assumptions and sensitivity analyses
Indirect comparison with metabolic profiles in unselected ‘healthy’ pregnancy
Results
Participants with at least one metabolic profile analysed (analysis sample) n = 1158a | All eligible participants in the six contributing centres n = 1194a | |||
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Control n = 577 | Intervention n = 581 | Control n = 593 | Intervention n = 601 | |
BMI, n (%) | ||||
30–34.9 kg/m2 | 273 (47.3) | 287 (49.4) | 279 (47) | 296 (49.3) |
35–39.9 kg/m2 | 203 (35.2) | 177 (30.5) | 209 (35.2) | 185 (30.8) |
≥ 40 kg/m2 | 101 (17.5) | 117 (20.1) | 105 (17.7) | 120 (20) |
Ethnicity, n (%) | ||||
White | 389 (67.4) | 384 (66.1) | 396 (66.8) | 397 (66.1) |
Asian | 38 (6.6) | 43 (7.4) | 43 (7.3) | 45 (7.5) |
Black | 120 (20.8) | 127 (21.9) | 123 (20.7) | 130 (21.6) |
Other | 30 (5.2) | 27 (4.6) | 31 (5.2) | 29 (4.8) |
Parity, n (%) | ||||
Primiparous | 260 (45.1) | 257 (44.2) | 266 (44.9) | 265 (44.1) |
Multiparous | 317 (54.9) | 324 (55.8) | 327 (55.1) | 336 (55.9) |
Age, n (%) | ||||
< 25 years | 97 (16.8) | 85 (14.6) | 100 (16.9) | 90 (15) |
25–29 years | 141 (24.4) | 165 (28.4) | 147 (24.8) | 169 (28.1) |
30–34 years | 187 (32.4) | 174 (29.9) | 188 (31.7) | 182 (30.3) |
≥ 35 years | 152 (26.3) | 157 (27) | 158 (26.6) | 160 (26.6) |
Gestational diabetes, n (%) | ||||
Yes | 146 (25.3) | 137 (23.6) | 148 (25.0) | 137 (22.8) |
No | 366 (63.4) | 344 (59.2) | 370 (62.4) | 351 (58.4) |
Missing | 65 (11.3) | 100 (17.2) | 75 (12.6) | 113 (18.8) |
Centre, n (%) | ||||
Bradford | 19 (3.3) | 22 (3.8) | 25 (4.2) | 28 (4.7) |
Glasgow | 130 (22.5) | 132 (22.7) | 131 (22.1) | 134 (22.3) |
Manchester | 67 (11.6) | 67 (11.5) | 70 (11.8) | 69 (11.5) |
Newcastle | 120 (20.8) | 116 (20) | 122 (20.6) | 120 (20) |
St George’s, London | 53 (9.2) | 55 (9.5) | 54 (9.1) | 57 (9.5) |
St Thomas’s, London | 188 (32.6) | 189 (32.5) | 191 (32.2) | 193 (32.1) |
First clinic visit | ||||
n (%) | 538 (93.2) | 545 (93.8) | 593 (100.0) | 601 (100.0) |
Median (IQR) gestation, weeks | 17.0 (16.1–17.9) | 17.0 (16.1–18.0) | 17.0 (16.1–17.9) | 17.0 (16.1–18.0) |
Second clinic visit | ||||
n (%) | 500 (86.7) | 477 (82.1) | 591 (99.7) | 598 (99.5) |
Median (IQR) gestation, weeks | 27.7 (27.3–28.1) | 27.7 (27.3–28.1) | 27.7 (27.3–28.3) | 27.7 (27.3–28.1) |
Third clinic visit | ||||
n (%) | 407 (70.5) | 374 (64.4) | 524 (88.4) | 485 (80.7) |
Median (IQR) gestation, weeks | 34.7 (34.3–35.1) | 34.6 (34.3–35.1) | 34.7 (34.3–35.3) | 34.7 (34.3–35.3) |
Change in metabolic profiles in obese pregnant women
Effect of the lifestyle intervention on change in the metabolic profiles of obese pregnant women
Difference in mean rate of change in metabolic traits per 4 weeks of gestation between 16 and 36 weeks comparing women receiving intervention to control group (95% confidence intervals)b | ||
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In original units (see first column) per 4 weeks, median (IQR) | In SD units per 4 weeks,c median (IQR) | |
Extremely large VLDL | ||
Concentration of chylomicrons and extremely large VLDL particles, mol/L | – 5.430 × 10– 12 (– 8.323 × 10– 12 to – 2.537 × 10– 12) | – 0.041 (– 0.065 to – 0.018) |
Total lipids in chylomicrons and extremely large VLDL, mmol/L | – 0.001 (– 0.002 to – 5.322 × 10– 4) | – 0.041 (– 0.064 to – 0.018) |
Phospholipids in chylomicrons and extremely large VLDL, mmol/L | – 1.457 × 10– 4 (– 2.287 × 10– 4 to – 6.274 × 10– 5) | – 0.038 (– 0.061 to – 0.015) |
Total cholesterol in chylomicrons and extremely large VLDL, mmol/L | – 1.623 × 10– 4 (– 2.725 × 10– 4 to – 5.212 × 10– 5) | – 0.032 (– 0.055 to – 0.009) |
Cholesterol esters in chylomicrons and extremely large VLDL, mmol/L | – 6.952 × 10– 5 (– 1.289 × 10– 4 to – 1.015 × 10– 5) | – 0.025 (– 0.049 to – 0.002) |
Free cholesterol in chylomicrons and extremely large VLDL, mmol/L | – 9.276 × 10– 5 (– 1.468 × 10– 4 to – 3.868 × 10– 5) | – 0.037 (– 0.059 to – 0.014) |
Triglycerides in chylomicrons and extremely large VLDL, mmol/L | – 8.450 × 10– 4 (– 0.001 to – 4.077 × 10– 4) | – 0.043 (– 0.066 to – 0.020) |
Very large VLDL | ||
Concentration of very large VLDL particles, mol/L | – 2.919 × 10– 11 (– 4.656 × 10– 11 to – 1.183 × 10– 11) | – 0.033 (– 0.054 to – 0.012) |
Total lipids in very large VLDL, mmol/L | – 0.003 (– 0.005 to – 0.001) | – 0.033 (– 0.054 to – 0.012) |
Phospholipids in very large VLDL, mmol/L | – 4.618 × 10– 4 (– 7.453 × 10– 4 to – 1.782 × 10– 4) | – 0.032 (– 0.053 to – 0.011) |
Total cholesterol in very large VLDL, mmol/L | – 4.869 × 10– 4 (– 8.058 × 10– 4 to – 1.681 × 10– 4) | – 0.031 (– 0.052 to – 0.009) |
Cholesterol esters in very large VLDL, mmol/L | – 2.409 × 10– 4 (– 4.085 × 10– 4 to – 7.328 × 10– 5) | – 0.029 (– 0.051 to – 0.007) |
Free cholesterol in very large VLDL, mmol/L | – 2.459 × 10– 4 (– 3.986 × 10– 4 to – 9.316 × 10– 5) | – 0.032 (– 0.054 to – 0.010) |
Triglycerides in very large VLDL, mmol/L | – 0.002 (– 0.003 to – 7.781 × 10– 4) | – 0.034 (– 0.055 to – 0.012) |
Large VLDL | ||
Concentration of large VLDL particles, mol/L | – 1.436 × 10– 10 (– 2.419 × 10– 10 to – 4.524 × 10– 11) | – 0.028 (– 0.049 to – 0.008) |
Total lipids in large VLDL, mmol/L | – 0.008 (– 0.014 to – 0.003) | – 0.028 (– 0.049 to – 0.007) |
Phospholipids in large VLDL, mmol/L | – 0.001 (– 0.003 to – 4.202 × 10– 4) | – 0.027 (– 0.048 to – 0.006) |
Total cholesterol in large VLDL, mmol/L | – 0.002 (– 0.003 to – 3.658 × 10– 4) | – 0.025 (– 0.046 to – 0.004) |
Cholesterol esters in large VLDL, mmol/L | – 6.322 × 10– 4 (– 0.001 to – 4.684 × 10– 5) | – 0.021 (– 0.042 to 5.042 × 10– 4) |
Free cholesterol in large VLDL, mmol/L | – 9.788 × 10– 4 (– 0.002 to – 3.053 × 10– 4) | – 0.028 (– 0.049 to – 0.007) |
Triglycerides in large VLDL, mmol/L | – 0.005 (– 0.009 to – 0.002) | – 0.029 (– 0.050 to – 0.009) |
Medium VLDL | ||
Concentration of medium VLDL particles, mol/L | – 2.706 × 10– 10 (– 5.176 × 10– 10 to – 2.363 × 10– 11) | – 0.020 (– 0.041 to 4.479 × 10– 4) |
Total lipids in medium VLDL, mmol/L | – 0.009 (– 0.017 to – 5.203 × 10– 4) | – 0.020 (– 0.040 to 0.001) |
Phospholipids in medium VLDL, mmol/L | – 0.002 (– 0.003 to 2.571 × 10– 5) | – 0.018 (– 0.038 to 0.003) |
Total cholesterol in medium VLDL, mmol/L | – 0.001 (– 0.004 to 6.072 × 10– 4) | – 0.012 (– 0.034 to 0.009) |
Cholesterol esters in medium VLDL, mmol/L | – 3.934 × 10– 4 (– 0.001 to 6.747 × 10– 4) | – 0.006 (– 0.028 to 0.017) |
Free cholesterol in medium VLDL, mmol/L | – 0.001 (– 0.002 to – 5.763 × 10– 6) | – 0.018 (– 0.039 to 0.002) |
Triglycerides in medium VLDL, mmol/L | – 0.006 (– 0.010 to – 0.001) | – 0.023 (– 0.043 to – 0.002) |
Other lipids, lipoproteins affected by the intervention | ||
Triglycerides in very large HDL, mmol/L | – 2.479 × 10– 4 (– 4.714 × 10– 4 to – 2.436 × 10– 5) | – 0.024 (– 0.046 to – 0.001) |
Phospholipids in small HDL, mmol/L | – 0.002 (– 0.004 to – 1.363 × 10– 4) | – 0.022 (– 0.042 to – 0.001) |
Mean diameter for VLDL particles, nm | – 0.031 (– 0.054 to – 0.008) | – 0.027 (– 0.048 to – 0.007) |
Serum total triglycerides, mol/L | – 0.015 (– 0.031 to 8.645 × 10– 4) | – 0.017 (– 0.038 to 0.003) |
Triglycerides in VLDL, mmol/L | – 0.015 (– 0.028 to – 0.002) | – 0.022 (– 0.042 to – 0.001) |
Ratio of triglycerides to phosphoglycerides | – 0.005 (– 0.009 to – 6.198 × 10– 4) | – 0.022 (– 0.042 to – 0.001) |
Estimated degree of unsaturation | 0.001 (1.229 × 10– 4 to 0.002) | 0.027 (0.006 to 0.048) |
Ratio of 18:2 linoleic acid to total fatty acids, % | 0.069 (0.013 to 0.126) | 0.028 (0.007 to 0.049) |
Ratio of omega-6 fatty acids to total fatty acids, % | 0.077 (0.023 to 0.131) | 0.031 (0.011 to 0.051) |
Ratio of polyunsaturated fatty acids to total fatty acids, % | 0.079 (0.020 to 0.138) | 0.028 (0.009 to 0.047) |
Ratio of saturated fatty acids to total fatty acids, % | – 0.049 (– 0.083 to – 0.015) | – 0.035 (– 0.058 to – 0.012) |
Other traits affected by the intervention | ||
Lactate, mmol/L | – 0.017 (– 0.027 to – 0.006) | – 0.037 (– 0.061 to – 0.013) |
Pyruvate, mmol/L | – 0.002 (– 0.003 to – 6.028 × 10– 4) | – 0.039 (– 0.064 to – 0.014) |
Alanine, mmol/L | – 0.001 (– 0.002 to – 2.708 × 10– 5) | – 0.024 (– 0.050 to 0.002) |
Acetate, mmol/L | 3.081 × 10– 4 (7.541 × 10– 5 to 5.408 × 10– 4) | 0.035 (0.009 to 0.062) |