Methods | Quasi-randomised controlled trial, set in antenatal clinic at Wollongong Hospital, Wollongong, NSW, Australia | |
Participants | Inclusion criteria: healthy, pregnant women from the antenatal clinic at Wollongong Hospital and from 2 obstetricians in private practice. They were aged 21- 40 years, had a singleton pregnancy, were between 12 and 16 weeks’ gestation, were nonsmokers, and consumed no more than 1 alcoholic drink each day Exclusion criteria: any problem associated with glucose metabolism or insulin resistance or that interfered with the ability of the study participant to follow dietary instructions |
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Interventions | Participants were randomised to a low glycaemic diet or high glycaemic diet Low glycaemic diet (n = 32): seen by dietitian 5 times during pregnancy, received dietary recommendation for low GI diet with 33% fat, 55% CHO. The low GI diet was based on verified low-GI foods, including pasta and brand-name breads and breakfast cereals with a high fibre content High glycaemic diet (n = 30): also seen by dietitian 5 times during pregnancy, received dietary recommendation for moderate-to-high GI diet (high fibre, low sugar) with 33% fat, 55% CHO |
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Outcomes | Weight gain (from 12 weeks to 36 weeks), large-for-gestational age (>90th centile for birthweight), small-for-gestational age (< 10th centile for birthweight) | |
Notes | Age (low GI, high GI): 30.1 ± 0.7, 29.6 ± 0.7. BMI at baseline (low GI, high GI): 24.4 ± 0.7, 26.6 ± 0.9 kg/m2 The baseline visit was between 12-16 weeks’ gestation. |
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Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Alternation. |
Allocation concealment (selection bias) | High risk | Alternate allocation to study groups. |
Blinding (performance bias and detection bias) All outcomes |
Unclear risk | No information provided. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | Loss of participants to follow-up: In the low-GI diet group, 2 women withdrew due to being unwilling to follow the diet and 1 delivered before the final visit. In high-GI diet group, 1 woman was unwilling to follow the diet, 1 lost to follow-up, and 3 miscarriages Intention-to-treat analysis: data were analysed for participants according to their randomly-allocated group, not all original participants were included in the analysis |
Selective reporting (reporting bias) | Unclear risk | Could not determine. |
Other bias | Low risk | Baseline characteristics were similar. |