Healthy lifestyle behaviours mainly including a balanced diet and regular physical activity have consistently been associated with reduced risks of gestational diabetes mellitus (GDM), hypertensive disorders of pregnancy (HDP), excessive gestational weight gain (GWG), preterm birth, caesarean delivery, and adverse offspring outcomes. Despite the rapid growth of trials evaluating lifestyle interventions during pregnancy and postpartum, maternal and neonatal outcomes are inconsistently prioritised, making comparisons across studies difficult and limiting the feasibility of evidence synthesis.
Core Outcome Sets (COSs) helps to minimise selective outcome reporting, enhance comparability between studies, and facilitate evidence synthesis for healthcare decision-making. Several COSs have been developed for pregnancy-related conditions, including GDM, pre-eclampsia, cardiac disease in pregnancy and multimorbidity during pregnancy. However, no COS currently exist for evaluating lifestyle interventions across pregnancy and the postpartum period.
Moreover, most of current COS methodology generally treats all included outcomes as having equal value. In reality, GDM, HDP, GWG, preterm birth, caesarean delivery, and adverse offspring outcomes differ substantially in their consequences for maternal, neonatal and long-term health. Incorporating severity weighting into COS development may therefore provide a more clinically meaningful framework for evaluating the effectiveness of lifestyle interventions.
This study aims to develop a severity-weighted COS and associated evaluation framework for lifestyle interventions during pregnancy and postpartum through a multi-stage, stakeholder-engaged process.
We searched the COMET database and identified three potentially relevant COS: 1."Pregnancy Nutrition Core Outcome Set (PRENCOS): A core outcome set development study". This study developed COS focused on nutrition during pregnancy which including maternal and neonatal outcomes and nutritional status. While PRENCOS is limited to nutritional outcomes and does not address the broader range of lifestyle interventions (including physical activity). 2. "A core outcome set for studies of gestational diabetes mellitus prevention and treatment". This study developed COS on prevention and treatment of GDM. However, this study only focused on GDM and does not cover the full spectrum of lifestyle interventions targeting multiple pregnancy and postpartum outcomes. 3. "Core outcome set for diabetes after pregnancy prevention across the life span: international Delphi study". This study developed COS targeted diabetes prevention after a GDM pregnancy and extends into the longer postpartum period. It is relevant to postpartum lifestyle interventions but is narrowly focused on diabetes prevention rather than comprehensive evaluation of lifestyle interventions during pregnancy and the early postpartum period.
Yao Cheng1 (principal investigator), Hao Xiang2 (supervisor), Ziming Huang1 (supervisor)
1: Maternal and Child Health Hospital of Hubei Province
2: Wuhan University
Disease Category: Pregnancy & childbirth
Disease Name: maternal health
Age Range: 18 - 60
Sex: Female
Nature of Intervention: Behavioural , Diet and nutrition, Educational/self-management, Exercise
- Clinical experts
- Families
- Patient/ support group representatives
- Policy makers
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Literature review
First, a systematic review of the literature will generate a longlist of reported outcomes and their measurements, which will be supplemented by stakeholder interviews to ensure comprehensiveness. Second, an online Delphi survey will simultaneously determine core outcomes and assign severity ratings, with participants evaluating each outcomes importance for inclusion in the COS and its clinical seriousness using standardised scales. Finally, a face-to-face consensus meeting will review Delphi results, resolve discrepancies, and finalise the COS together with agreed severity weights.