Toggle Main Menu Toggle Search

Open Access padlockePrints

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

Lookup NU author(s): Dr Nicola HeslehurstORCiD



This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).


© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.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 I 2 and tau 2 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.

Publication metadata

Author(s): Coomar D, Hazlehurst JM, Austin F, Foster C, Hitman GA, Heslehurst N, Iliodromiti S, Betran AP, Moss N, Poston L, Nirantharakumar K, Roberts T, Simpson SA, Teede HJ, Riley R, Allotey J, Thangaratinam S

Publication type: Article

Publication status: Published

Journal: BMJ Open

Year: 2021

Volume: 11

Issue: 6

Print publication date: 11/06/2021

Online publication date: 11/06/2021

Acceptance date: 16/03/2021

Date deposited: 28/06/2021

ISSN (electronic): 2044-6055

Publisher: BMJ Publishing Group


DOI: 10.1136/bmjopen-2020-048119

PubMed id: 34117047


Altmetrics provided by Altmetric


Funder referenceFunder name
NIHR Health Technology Assessment Programme (NIHR129715)