Methods | Randomised controlled trial, set in a hospital in Brisbane, Australia | |
Participants | 50 women randomised. Inclusion criteria: obese pregnant women were recruited at 12 weeks’ gestation, aged 18-45, BMI ≥ 30 kg/m2, pregnancy care at study hospital, willing and able to be randomised to an exercise intervention Exclusion criteria: non-English speaking, contraindication or inability to exercise, medical or obstetric contraindication to exercise including haemodynamically significant heart disease, restrictive lung disease, incompetent cervix (cerclage), multiple gestation, severe anaemia, chronic bronchitis, type 1 diabetes, orthopaedic limitations, poorly controlled seizure disorder, poorly controlled hyperthyroidism, or a heavy smoker |
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Interventions | Intervention group: the intervention group received an individualised exercise program with an energy expenditure (EE) goal of 900 kcal/ week. Advice from physiotherapist and diaries for self-monitoring Control group: routine obstetric care. |
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Outcomes | Self-report of exercise (behaviour change). | |
Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was by a random number allocation technique conducted by a 3rd party |
Allocation concealment (selection bias) | Unclear risk | Not clear but external randomisation. |
Blinding (performance bias and detection bias) All outcomes |
High risk | No blinding.The impact of the lack of blinding was not clear. The use ofself-monitoring diaries by the intervention group may have introduced recall bias |
Incomplete outcome data (attrition bias) All outcomes |
High risk | Randomised 50 women, at 36 weeks 36 were followed up (30% attrition) |
Selective reporting (reporting bias) | Unclear risk | Assessment from published study report and on-line supplement |
Other bias | Unclear risk | There were no statistically significant differences between the intervention and control groups in any baseline variable. Different monitoring techniques in the 2 groups (diaries in the intervention group) may have led to recall bias |