Developing a complex intervention for diet and activity behaviour change in obese pregnant women (the UPBEAT trial); assessment of behavioural change and process evaluation in a pilot randomised controlled trial

Table 5 Maternal and neonatal primary outcomes

	Control	Intervention	Comparison	Treatment effect	P value
Maternal	n = 75	n = 79		(95% CI)
GDM	24 (32%)	22 (28%)	Risk difference	−4% (−19 to 13)	0.574
			Risk ratio	0.87 (0.54 to 1.41)
Neonatal	n = 84	n = 86
LGA	7 (8%)	7 (8%)	Risk difference	0% (−8 to 8)	0.982
			Risk ratio	0.99 (0.36 to 2.7)
>4 Kg	16 (19%)	13 (15%)	Risk difference	−4% (−15 to 8)	0.518

Abbreviations: GDM Gestational Diabetes Mellitus by IADPSG criteria, LGA Large for Gestational Age Delivery defined as ≥ 90th customized birthweight centile [26]. Customized centiles are adjusted for maternal age, height, weight, ethnic group, gestational age and gender. Weight adjustment for women with BMI ≥ 30 Kg/m² (all women in study) is based on a notional weight corresponding to a BMI of 29.9 Kg/m².
Continuous variables are given as mean (SD) with Mean Difference & 950025 CI. Binary outcomes are n (%), with Risk Difference and risk ratio.

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