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

TY - JOUR

T1 - 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

AU - Ruifrok, Anneloes E

AU - Rogozinska, Ewelina

AU - van Poppel, Mireille N M

AU - Rayanagoudar, Girish

AU - Kerry, Sally

AU - de Groot, Christianne J M

AU - Yeo, SeonAe

AU - Molyneaux, Emma

AU - McAuliffe, Fionnuala M

AU - Poston, Lucilla

AU - Roberts, Tracy

AU - Riley, Richard D

AU - Coomarasamy, Arri

AU - Khan, Khalid

AU - Mol, Ben Willem

AU - Thangaratinam, Shakila

AU - i-WIP (International Weight Management in Pregnancy) Collaborative Group

AU - Astrup, Arne

N1 - CURIS 2015 NEXS 335

PY - 2014/11/9

Y1 - 2014/11/9

N2 - 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.

AB - 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.

KW - Diet, Reducing

KW - Economics, Medical

KW - Female

KW - Humans

KW - Motor Activity

KW - Pregnancy

KW - Pregnancy Outcome

KW - Weight Gain

U2 - 10.1186/2046-4053-3-131

DO - 10.1186/2046-4053-3-131

M3 - Journal article

C2 - 25370505

SN - 2046-4053

VL - 3

JO - Systematic Reviews

JF - Systematic Reviews

M1 - 131

ER -