饮食和身体活动干预在妊娠中预防妊娠糖尿病和减少体重增加的差异效应，按母体肥胖程度分层：一项随机对照试验的个体患者数据（IPD）荟萃分析方案。

Differential effects of diet and physical activity interventions in pregnancy to prevent gestational diabetes mellitus and reduce gestational weight gain by level of maternal adiposity: a protocol for an individual patient data (IPD) meta-analysis of randomised controlled trials.

机构信息

Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK

Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.

出版信息

BMJ Open. 2023 Mar 20;13(3):e065335. doi: 10.1136/bmjopen-2022-065335.

DOI:10.1136/bmjopen-2022-065335

PMID:36940942

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10030495/

Abstract

INTRODUCTION

Women and their infants are at increased risk of complications if gestational diabetes mellitus (GDM) or excessive gestational weight gain (GWG) occurs in pregnancy. Weight management interventions in pregnancy, consisting of diet and physical activity components are targeted based on maternal body mass index (BMI). However, the relative effectiveness of interventions targeted based on alternative measures of adiposity to BMI is unclear. This individual patient data (IPD) meta-analysis aims to explore whether interventions are more effective at preventing GDM and reducing GWG in women according to their level of adiposity.

METHODS

The International Weight Management in Pregnancy Collaborative Network has a living database of IPD from randomised trials of diet and/or physical activity interventions in pregnancy. This IPD meta-analysis will use IPD from trials identified from systematic literature searches up until March 2021, where maternal adiposity measures (eg, waist circumference) were collected prior to 20 weeks' gestation. A two-stage random effects IPD meta-analysis approach will be taken for each outcome (GDM and GWG) to understand the effect of early pregnancy adiposity measures on the effect of weight management interventions for GDM prevention and GWG reduction. Summary intervention effects with 95% CIs) will be derived along with treatment covariate interactions. Between-study heterogeneity will be summarised by I and tau statistics. Potential sources of bias will be evaluated, and the nature of any missing data will be explored and appropriate imputation methods adopted.

ETHICS AND DISSEMINATION

Ethics approval is not required. The study is registered on the International Prospective Register of Systematic Reviews (CRD42021282036). Results will be submitted to peer-reviewed journals.

PROSPERO REGISTRATION NUMBER

CRD42021282036.

摘要

简介

如果妊娠期间发生妊娠期糖尿病（GDM）或妊娠体重过度增加（GWG），女性及其婴儿患并发症的风险会增加。妊娠期间的体重管理干预措施包括饮食和身体活动两部分，其干预目标是基于母体体重指数（BMI）。然而，基于 BMI 以外的肥胖指标进行干预的相对有效性尚不清楚。本项个体患者数据（IPD）荟萃分析旨在探讨根据女性的肥胖程度，干预措施在预防 GDM 和减少 GWG 方面是否更有效。

方法

国际妊娠体重管理合作网络拥有一个包含随机试验 IPD 的活数据库，这些试验针对妊娠期间的饮食和/或身体活动干预措施。本项 IPD 荟萃分析将使用从系统文献检索中确定的试验的 IPD，这些试验的系统文献检索截至 2021 年 3 月，其中在妊娠 20 周之前收集了母体肥胖指标（例如腰围）。将采用两阶段随机效应 IPD 荟萃分析方法来评估每个结局（GDM 和 GWG），以了解妊娠早期肥胖指标对体重管理干预预防 GDM 和减少 GWG 的效果的影响。将得出具有 95%置信区间的汇总干预效果（并附有治疗协变量交互作用）。通过 I 和 tau 统计量来总结研究间的异质性。将评估潜在的偏倚来源，并探讨缺失数据的性质并采用适当的插补方法。