TY - JOUR
T1 - Study protocol
T2 - 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 W.
AU - Thangaratinam, Shakila
AU - van Poppel, Mireille
AU - Carballo, Ruben Barakat
AU - Bogaerts, Annick
AU - Cecatti, Jose G.
AU - Lopez, Beth
AU - Dodd, Jodie
AU - Beltagy, Nermeen El
AU - Devlieger, Roland
AU - Haakstad, Lene
AU - Shen, Gary
AU - Shub, Alexis
AU - Motaharim, Narges
AU - Khoury, Janette
AU - Luoto, Riitta
AU - Guelfi, Kym
AU - Van Poppel, Mireille
AU - Facchinetti, Fabio
AU - Phelan, Suzanne
AU - Poston, Lucilla
AU - Prevedel, Tânia T Scudeller
AU - Rauh, Kathrin
AU - Renault, Kristina
AU - Sagedal, Linda Reme
AU - Stafne, Signe Nilssen
AU - Mørkved, Siv
AU - Vesco, Kimberly
AU - Vinter, Christina
AU - Vitolo., null
AU - McAuliffe, Fionnuala M.
AU - Astrup, Arne
AU - Yeo, Seonae
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 and physical activity
KW - Individual patient data meta-analysis
KW - Pregnancy
KW - Weight gain
UR - http://www.scopus.com/inward/record.url?scp=84928045737&partnerID=8YFLogxK
U2 - 10.1186/2046-4053-3-131
DO - 10.1186/2046-4053-3-131
M3 - Article
AN - SCOPUS:84928045737
SN - 2046-4053
VL - 3
JO - Systematic Reviews
JF - Systematic Reviews
IS - 1
M1 - 131
ER -