Abstract
BackgroundThe aim of this individual participant data meta-analysis (IPDMA) is to evaluate the effects of dietary and lifestyle interventions among pregnant women who are overweight or obese on later maternal and early childhood outcomes at ages 3–5 years.Methods/designWe will build on the established International Weight Management in Pregnancy (i-WIP) IPD Collaborative Network, having identified researchers who have conducted randomised dietary and lifestyle interventions among pregnant women who are overweight or obese, and where ongoing childhood follow-up of participants has been or is being undertaken. The primary maternal outcome is a diagnosis of maternal metabolic syndrome. The primary childhood outcome is BMI above 90%.We have identified 7 relevant trials, involving 5425 women who were overweight or obese during pregnancy, with approximately 3544 women and children with follow-up assessments available for inclusion in the meta-analysis.DiscussionThe proposed IPDMA provides an opportunity to evaluate the effect of dietary and lifestyle interventions among pregnant women who are overweight or obese on later maternal and early childhood health outcomes, including risk of obesity. This knowledge is essential to effectively translate research findings into clinical practice and public health policy.Systematic review registrationThis IPD has been prospectively registered (PROSPERO), ID number CRD42016047165.
Highlights
The aim of this individual participant data meta-analysis (IPDMA) is to evaluate the effects of dietary and lifestyle interventions among pregnant women who are overweight or obese on later maternal and early childhood outcomes at ages 3–5 years
We propose to extend this existing collaboration to evaluate the effect of dietary and lifestyle interventions among pregnant women who are overweight or obese on later maternal and early childhood health outcomes, establishing the International Weight Management in Pregnancy Collaboration: 3-year follow-up (i-WIP-3)
For the main subgroup analysis, assuming that the treatment effect in the higher Body mass index (BMI) category is approximately 1.5 times that in the lower BMI category (OR of 1.5); that the control group Odds ratio (OR) for the higher BMI category compared to the lower BMI category is approximately 1.6, and that about 70% of women have early pregnancy BMI in the higher category (≥30.0), there is greater than 80% power to detect the interaction effect (82.2%, with 95% CI 79.6–84.5%), with good coverage of 96.4%
Summary
There is an increasing recognition of the association between maternal obesity, high infant birth weight, and the subsequent development of childhood obesity. While each of the identified randomised trials are sufficiently similar in design and outcomes to allow meaningful meta-analysis to occur, the intensity of the intervention provided and social demographics of included participants is diverse with the IPD proposed enabling identification of effect modifiers through pre-specified subgroup analyses This can be achieved in a relatively efficient manner and with sufficient statistical power, avoiding the expense, duplication of effort, and inevitable time delays in undertaking another large-scale pregnancy intervention trial with a pre-specified primary outcome of later maternal or early childhood obesity. This knowledge is essential to effectively translate research findings into clinical practice and public health policy, and to maximise the return on publicly funded research investments globally
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