Abstract
BackgroundPregnant women who gain excess weight are at risk of complications during pregnancy and in the long term. Interventions based on diet and physical activity minimise gestational weight gain with varied effect on clinical outcomes. The effect of interventions on varied groups of women based on body mass index, age, ethnicity, socioeconomic status, parity, and underlying medical conditions is not clear. Our individual patient data (IPD) meta-analysis of randomised trials will assess the differential effect of diet- and physical activity-based interventions on maternal weight gain and pregnancy outcomes in clinically relevant subgroups of women.Methods/designRandomised trials on diet and physical activity in pregnancy will be identified by searching the following databases: MEDLINE, EMBASE, BIOSIS, LILACS, Pascal, Science Citation Index, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of s of Reviews of Effects, and Health Technology Assessment Database. Primary researchers of the identified trials are invited to join the International Weight Management in Pregnancy Collaborative Network and share their individual patient data. We will reanalyse each study separately and confirm the findings with the original authors. Then, for each intervention type and outcome, we will perform as appropriate either a one-step or a two-step IPD meta-analysis to obtain summary estimates of effects and 95% confidence intervals, for all women combined and for each subgroup of interest. The primary outcomes are gestational weight gain and composite adverse maternal and fetal outcomes. The difference in effects between subgroups will be estimated and between-study heterogeneity suitably quantified and explored. The potential for publication bias and availability bias in the IPD obtained will be investigated. We will conduct a model-based economic evaluation to assess the cost effectiveness of the interventions to manage weight gain in pregnancy and undertake a value of information analysis to inform future research.Systematic review registrationPROSPERO 2013: CRD42013003804
Highlights
Pregnant women who gain excess weight are at risk of complications during pregnancy and in the long term
The primary objective of this individual patient data (IPD) meta-analysis is to determine the differential effects of weight management interventions in pregnancy on maternal weight gain and composite adverse maternal and fetal outcomes in women according to their (i) body mass index (BMI), (ii) age, (iii) ethnicity, (iv) parity, and (v) underlying medical conditions
Sample size considerations no formal sample size requirements are necessary for the meta-analysis, we have considered the potential power of our IPD meta-analysis in comparison to single trials in this field to detect clinically important effects in each subgroup separately (Table 3)
Summary
Pregnant women who gain excess weight are at risk of complications during pregnancy and in the long term. Excessive weight gain in pregnancy is associated with maternal and fetal complications such as pre-eclampsia, gestational diabetes, caesarean section, large for gestational age babies [1,2,3,4,5,6,7,8], and postpartum weight retention [9,10] It is a risk factor for maternal and childhood obesity in the long term [5,9,11], resulting in significant burden to the health care systems globally [9,10,12,13,14,15,16,17]. We were unable to ascertain if the intervention had a differential beneficial effect on particular subgroups of women
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