Methods | Randomised controlled trial (pilot study), set in Beth Israel Deaconess Medical Center, Boston, MA, and Children’s Hospital Boston, Boston, MA, USA | |
Participants | Inclusion criteria: pregnant women with prepregnancy or 1st trimester BMI equal to or greater than 25 kg/m2 and less than 45 kg/m2, singleton pregnancy, willing to consume the diets for duration of pregnancy, participant to be at week 28 or less of pregnancy at baseline visit Exclusion criteria: smoking during pregnancy, major medical illness (e.g., diabetes mellitus, hypertension, thyroid disease), taking prescription medication known to affect body weight, alcohol consumption during pregnancy, intention to deliver infants in the environment outside of Beth Israel Deaconess MedicalCenter, Boston, high level of physical activity |
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Interventions | Intervention group 1: nutrition education, dietary counselling, and a low-GL diet Intervention group 2: nutrition education, dietary counselling, and a low-fat diet |
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Outcomes | Maternal outcome: weight change Infant outcome: macrosomia, large-for-gestational age, caesarean delivery |
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Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomly “permuted blocks of 2 and 4 preventing anticipation of future assignments |
Allocation concealment (selection bias) | Low risk | Separate random assignment envelopes for each stratum. Random assignment envelopes were prepared by the hospital clinical trials unit |
Blinding (performance bias and detection bias) All outcomes |
Low risk | The following staff were blinded to group assignment: obstetricians who provided clinical care to subjects; nurses who measured maternal body weight and blood pressure, collected and processed maternal blood samples, and analysed urinalyses; labour and delivery room nurses who obtained birthweight; laboratory staff who analysed maternal blood; and staff who performed data entry. Staff who performed maternal body composition analysis, 24-h dietary recalls, and infant anthropometric measurements “were predominantly, but not always”, blinded due to logistical considerations. Formal blinding of subjects was not possible, although subjects were not informed of their group assignments |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk | 46 women were randomised and infant outcomes were available for 45. There was some loss to follow-up among women with outcome data at 36 weeks available for 38. Reasons for loss were explained and loss was reasonably balanced across groups. It was stated that analysis was by randomisation group irrespective of whether or not women received the intended intervention |
Selective reporting (reporting bias) | Unclear risk | Assessment from published study report. |
Other bias | Low risk | Baseline characteristics of subjects did not differ between intervention groups |