Study protocol: Differential effects of diet and physical activity based interventions in pregnancy on maternal and fetal outcomes - individual patient data (IPD) meta-analysis and health economic evaluation
Ruifrok, Anneloes E2; Rogozinska, Ewelina3; van Poppel, Mireille N M4; Rayanagoudar, Girish3; Kerry, Sally5; de Groot, Christianne J M6; Yeo, SeonAe7; Molyneaux, Emma8; McAuliffe, Fionnuala M9; Poston, Lucilla10; Roberts, Tracy11; Riley, Richard D12; Coomarasamy, Arri13; Khan, Khalid3; Mol, Ben Willem14; Thangaratinam, Shakila3; Astrup, Arne17
1 Obesity Research, Department of Nutrition, Exercise and Sports, Faculty of Science, Københavns Universitet2 Department of Obstetrics and Gynecology, Academic Medical Centre, Amsterdam3 Women’s Health Research Unit, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London4 Department of Public and Occupational Health, EMGO + Institute for Health and Care Research, VU University Medical Center, Amsterdam5 Multidisciplinary Evidence Synthesis Hub (mEsh), Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London6 Department of Obstetrics and Gynaecology, Faculty of Medicine, VU University Medical Center, Amsterdam7 School of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, NC8 Section of Women’s Mental Health, Health Service and Population Research Department, Institute of Psychiatry, King’s College London, London9 School of Medicine & Medical Science, UCD Institute of Food and Health, Dublin10 Division of Women’s Health, Women’s Health Academic Centre, King’s College London, St. Thomas’ Hospital, London11 Health Economics Unit, School of Health and Population Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham12 School of Health and Population Sciences, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham13 School of Clinical and Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham14 School of Paediatrics and Reproductive Health, Robinson Institute, University of Adelaide, Adelaide15 unknown16 Department of Nutrition, Exercise and Sports, Department of Nutrition, Exercise and Sports, Faculty of Science, Københavns Universitet17 Department of Nutrition, Exercise and Sports, Department of Nutrition, Exercise and Sports, Faculty of Science, Københavns Universitet
differential effects of diet and physical activity based interventions in pregnancy on maternal and fetal outcomes-individual patient data (IPD) meta-analysis and health economic evaluation
BACKGROUND: Pregnant 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/DESIGN: Randomised 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 Abstracts 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 REGISTRATION: PROSPERO 2013: CRD42013003804.
Systematic Reviews, 2014, Vol 3
Diet, Reducing; Economics, Medical; Female; Humans; Motor Activity; Pregnancy; Pregnancy Outcome; Weight Gain