Diet and physical activity in pregnancy to prevent gestational diabetes: a protocol for an individual participant data (IPD) meta-analysis on the differential effects of interventions with economic evaluation

Coomar, D. et al. (2021) Diet and physical activity in pregnancy to prevent gestational diabetes: a protocol for an individual participant data (IPD) meta-analysis on the differential effects of interventions with economic evaluation. BMJ Open, 11(6), e048119. (doi: 10.1136/bmjopen-2020-048119) (PMID:34117047) (PMCID:PMC8202105)

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Abstract

Introduction: Mothers with gestational diabetes mellitus (GDM) are at increased risk of pregnancy-related complications and developing type 2 diabetes after delivery. Diet and physical activity-based interventions may prevent GDM, but variations in populations, interventions and outcomes in primary trials have limited the translation of available evidence into practice. We plan to undertake an individual participant data (IPD) meta-analysis of randomised trials to assess the differential effects and cost-effectiveness of diet and physical activity-based interventions in preventing GDM and its complications. Methods: The International Weight Management in Pregnancy Collaborative Network database is a living repository of IPD from randomised trials on diet and physical activity in pregnancy identified through a systematic literature search. We shall update our existing search on 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 without language restriction to identify relevant trials until March 2021. Primary researchers will be invited to join the Network and share their IPD. Trials including women with GDM at baseline will be excluded. We shall perform a one and two stage random-effect meta-analysis for each intervention type (all interventions, diet-based, physical activity-based and mixed approach) to obtain summary intervention effects on GDM with 95% CIs and summary treatment–covariate interactions. Heterogeneity will be summarised using I2 and tau2 statistics with 95% prediction intervals. Publication and availability bias will be assessed by examining small study effects. Study quality of included trials will be assessed by the Cochrane Risk of Bias tool, and the Grading of Recommendations, Assessment, Development and Evaluations approach will be used to grade the evidence in the results. A model-based economic analysis will be carried out to assess the cost-effectiveness of interventions to prevent GDM and its complications compared with usual care. Ethics and dissemination: Ethics approval is not required. The study is registered on the International Prospective Register of Systematic Reviews (CRD42020212884). Results will be submitted for publication in peer-reviewed journals.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Simpson, Professor Sharon and Iliodromiti, Dr Stamatina
Authors: Coomar, D., Hazlehurst, J. M., Austin, F., Foster, C., Hitman, G. A., Heslehurst, N., Iliodromiti, S., Betran Lazaga, A. P., Moss, N., Poston, L., Nirantharakumar, K., Roberts, T., Simpson, S. A., Teede, H. J., Riley, R., Allotey, J., and Thangaratinam, S.
College/School:College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > MRC/CSO SPHSU
College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
Journal Name:BMJ Open
Publisher:BMJ Publishing Group
ISSN:2044-6055
ISSN (Online):2044-6055
Published Online:11 June 2021
Copyright Holders:Copyright © 2021 The Authors
First Published:First published in BMJ Open 11(6): e048119
Publisher Policy:Reproduced under a Creative Commons License

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
168560MRC SPHSU/GU Transfer FellowshipsLaurence MooreMedical Research Council (MRC)MC_PC_13027HW - MRC/CSO Social and Public Health Sciences Unit
727661SPHSU Core Renewal: Complexity in Health Improvement Research ProgrammeLaurence MooreMedical Research Council (MRC)MC_UU_12017/14IHW - MRC/CSO SPHU
Chief Scientist Office (CSO)SPHSU14
Complexity in healthMedical Research Council (MRC)MC_UU_00022/1HW - MRC/CSO Social and Public Health Sciences Unit