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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
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 base...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4228083/ https://www.ncbi.nlm.nih.gov/pubmed/25370505 http://dx.doi.org/10.1186/2046-4053-3-131 |
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author | Ruifrok, Anneloes E Rogozinska, Ewelina van Poppel, Mireille NM Rayanagoudar, Girish Kerry, Sally de Groot, Christianne JM Yeo, SeonAe Molyneaux, Emma McAuliffe, Fionnuala M Poston, Lucilla Roberts, Tracy Riley, Richard D Coomarasamy, Arri Khan, Khalid Mol, Ben Willem Thangaratinam, Shakila |
author_facet | Ruifrok, Anneloes E Rogozinska, Ewelina van Poppel, Mireille NM Rayanagoudar, Girish Kerry, Sally de Groot, Christianne JM Yeo, SeonAe Molyneaux, Emma McAuliffe, Fionnuala M Poston, Lucilla Roberts, Tracy Riley, Richard D Coomarasamy, Arri Khan, Khalid Mol, Ben Willem Thangaratinam, Shakila |
author_sort | Ruifrok, Anneloes E |
collection | PubMed |
description | 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 |
format | Online Article Text |
id | pubmed-4228083 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-42280832014-11-12 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 E Rogozinska, Ewelina van Poppel, Mireille NM Rayanagoudar, Girish Kerry, Sally de Groot, Christianne JM Yeo, SeonAe Molyneaux, Emma McAuliffe, Fionnuala M Poston, Lucilla Roberts, Tracy Riley, Richard D Coomarasamy, Arri Khan, Khalid Mol, Ben Willem Thangaratinam, Shakila Syst Rev Protocol 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 BioMed Central 2014-11-04 /pmc/articles/PMC4228083/ /pubmed/25370505 http://dx.doi.org/10.1186/2046-4053-3-131 Text en Copyright © 2014 Ruifrok et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/4.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Protocol Ruifrok, Anneloes E Rogozinska, Ewelina van Poppel, Mireille NM Rayanagoudar, Girish Kerry, Sally de Groot, Christianne JM Yeo, SeonAe Molyneaux, Emma McAuliffe, Fionnuala M Poston, Lucilla Roberts, Tracy Riley, Richard D Coomarasamy, Arri Khan, Khalid Mol, Ben Willem Thangaratinam, Shakila 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4228083/ https://www.ncbi.nlm.nih.gov/pubmed/25370505 http://dx.doi.org/10.1186/2046-4053-3-131 |
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