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母亲日程电子监测(eMOMS):一项可行性随机对照试验中对体重指数升高的孕妇群体的招募

Electronic Monitoring Of Mom's Schedule (eMOMS): Recruitment of pregnant populations with elevated BMI in a feasibility randomized controlled trial.

作者信息

Jacobson Lisette T, Wolfe Michael, Zackula Rosey, Okut Hayrettin, Hampton Faith E, Grainger David A, Griebel-Thompson Adrianne K, Ling Kong Kai, Befort Christie

机构信息

University of Kansas School of Medicine-Wichita, Department of Population Health, 1010 North Kansas, Wichita, KS 67214, USA.

University of Kansas School of Medicine-Wichita, Department of Obstetrics and Gynecology, 1010 North Kansas, Wichita, KS 67214, USA.

出版信息

Prev Med Rep. 2023 May 29;34:102254. doi: 10.1016/j.pmedr.2023.102254. eCollection 2023 Aug.

Abstract

Underrepresentation of pregnant populations in randomized controlled trials of lifestyle change interventions is concerning due to high attrition and providers' limited clinical time. The purpose of this evaluative study was to assess intervention uptake of pregnant individuals enrolled in a three-arm feasibility randomized controlled trial, electronic Monitoring Of Mom's Schedule (eMOMS), examining lifestyle changes and lactation support alone, and in combination. Measures included: (1) participation and completion rates, and characteristics of intervention completers versus other eligible participants; and (2) provider experiences with screening and enrolling pregnant participants. Pregnant people with a pre-pregnancy body mass index ≥ 25 and < 35 kg/m were enrolled into the eMOMS trial between September 2019 - December 2020. Of the 44 consented participants, 35 were randomized, at a participation rate of 35%, and 26 completed the intervention, resulting in a completion rate of 74%. Intervention completers were slightly older and entered the study earlier in pregnancy compared to non-completers. Completers were more likely to be first-time mothers, resided in urban areas, had higher educational attainment, and were slightly more racially and ethnically diverse. A majority of providers reported willingness to participate, believed the study aligned with their organization's mission, and were satisfied with using iPads for screening. Lessons learned to guide recruitment success include use of: (1) designated research staff in combination with physician support; and (2) user-friendly technology to help mitigate time burden on physicians and their staff. Future work should focus on successful strategies to recruit/retain pregnant populations in clinical trials.

摘要

由于高损耗率和医疗服务提供者临床时间有限,孕妇群体在生活方式改变干预措施的随机对照试验中代表性不足,这令人担忧。这项评估研究的目的是评估参与一项三臂可行性随机对照试验——妈妈日程电子监测(eMOMS)的孕妇对干预措施的接受情况,该试验单独及联合考察生活方式改变和哺乳支持。测量指标包括:(1)参与率和完成率,以及干预完成者与其他符合条件参与者的特征;(2)医疗服务提供者筛查和招募孕妇参与者的经历。孕前体重指数≥25且<35kg/m²的孕妇于2019年9月至2020年12月期间纳入eMOMS试验。在44名同意参与的参与者中,35名被随机分组,参与率为35%,26名完成了干预,完成率为74%。与未完成者相比,干预完成者年龄稍大,在孕期较早进入研究。完成者更有可能是初产妇,居住在城市地区,受教育程度较高,种族和民族多样性略高。大多数医疗服务提供者表示愿意参与,认为该研究与他们所在机构的使命相符,并对使用iPad进行筛查感到满意。为指导招募成功而吸取的经验教训包括使用:(1)指定研究人员并结合医生支持;(2)用户友好型技术,以帮助减轻医生及其工作人员的时间负担。未来的工作应侧重于在临床试验中招募/留住孕妇群体的成功策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31a4/10244679/eb30f65d5bae/gr1.jpg

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