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eMoms:针对孕妇和产后女性的电子介导体重干预措施。研究设计与基线特征。

eMoms: Electronically-mediated weight interventions for pregnant and postpartum women. Study design and baseline characteristics.

作者信息

Fernandez Isabel Diana, Groth Susan W, Reschke Jennifer E, Graham Meredith L, Strawderman Myla, Olson Christine M

机构信息

Department of Public Health Sciences, Division of Epidemiology, University of Rochester School of Medicine and Dentistry, 265 Crittenden Blvd., CU 420644, Rochester, NY 14642-0644, United States.

School of Nursing, University of Rochester, United States.

出版信息

Contemp Clin Trials. 2015 Jul;43:63-74. doi: 10.1016/j.cct.2015.04.013. Epub 2015 May 6.

Abstract

BACKGROUND

The influence of childbearing in the development of obesity is situated within two different but related contexts: pregnancy-related weight gain and weight gain prevention and control in young adult women. Pregnancy related weight gain contributes to long-term weight retention in childbearing women.

OBJECTIVE

To present the study design, data collection procedures, recruitment challenges, and the baseline characteristics for the eMoms of Rochester study, a randomized clinical trial testing the effect of electronically-mediated behavioral interventions to prevent excessive gestational weight gain (GWG) and postpartum weight retention among women aged 18-35 years of diverse income and racial/ethnic backgrounds in an urban setting.

DESIGN

Randomized double blind clinical trial. A total of 1722 women at or below 20 weeks of gestation were recruited primarily from obstetric practices and randomized to 3 treatment groups: control arm; intervention arm with access to intervention during pregnancy and control at postpartum (e-intervention 1); and intervention arm with access to intervention during pregnancy and postpartum (e-intervention 2). Enrollment and consent were completed via study staff or online. Data were collected via online surveys, medical charts, and measurement of postpartum weights. The primary endpoints are gaining more weight than recommended by the Institution of Medicine guidelines and weight retained at 12 months postpartum.

CONCLUSION

This study will provide evidence on the efficacy of behavioral interventions in the prevention of excessive GWG and postpartum weight retention with potential dissemination to obstetric practices and/or health insurances. ClinicalTrials.gov #NCT01331564.

摘要

背景

生育对肥胖发展的影响存在于两个不同但相关的背景中:与妊娠相关的体重增加以及年轻成年女性的体重增加预防和控制。与妊娠相关的体重增加会导致生育期女性长期体重滞留。

目的

介绍罗切斯特电子妈妈研究的研究设计、数据收集程序、招募挑战和基线特征,这是一项随机临床试验,旨在测试电子介导的行为干预对预防城市环境中18 - 35岁不同收入和种族/族裔背景女性的过度孕期体重增加(GWG)和产后体重滞留的效果。

设计

随机双盲临床试验。总共招募了1722名妊娠20周及以下的女性,主要来自产科诊所,并随机分为3个治疗组:对照组;孕期可获得干预且产后为对照的干预组(电子干预1);孕期和产后均可获得干预的干预组(电子干预2)。通过研究人员或在线方式完成入组和同意程序。通过在线调查、病历和产后体重测量收集数据。主要终点是体重增加超过医学研究所指南推荐的量以及产后12个月时的体重滞留情况。

结论

本研究将为行为干预在预防过度GWG和产后体重滞留方面的疗效提供证据,并有可能推广至产科诊所和/或医疗保险机构。ClinicalTrials.gov #NCT01331564。

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