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一项基于网络的移动健康干预措施并辅以电话支持,以增加超重或肥胖孕妇的身体活动:可行性随机对照试验。

A Web-Based mHealth Intervention With Telephone Support to Increase Physical Activity Among Pregnant Patients With Overweight or Obesity: Feasibility Randomized Controlled Trial.

作者信息

Thomas Tainayah, Xu Fei, Sridhar Sneha, Sedgwick Tali, Nkemere Linda, Badon Sylvia E, Quesenberry Charles, Ferrara Assiamira, Mandel Sarah, Brown Susan D, Hedderson Monique

机构信息

Department of Epidemiology and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.

Division of Research, Kaiser Permanente Northern California, Oakland, CA, United States.

出版信息

JMIR Form Res. 2022 Jun 22;6(6):e33929. doi: 10.2196/33929.

Abstract

BACKGROUND

Pregnant patients with overweight or obesity are at high risk for perinatal complications. Excess gestational weight gain (GWG) further exacerbates this risk. Mobile health (mHealth) lifestyle interventions that leverage technology to facilitate self-monitoring and provide just-in-time feedback may motivate behavior change to reduce excess GWG, reduce intervention costs, and increase scalability by improving access.

OBJECTIVE

This study aimed to test the acceptability and feasibility of a pilot mHealth lifestyle intervention for pregnant patients with overweight or obesity to promote moderate intensity physical activity (PA), encourage guideline-concordant GWG, and inform the design of a larger pragmatic cluster randomized controlled trial.

METHODS

We conducted a mixed methods acceptability and feasibility randomized controlled trial among pregnant patients with a prepregnancy BMI of 25 to 40 kg/m. Patients with singletons at 8 to 15 weeks of gestation who were aged ≥21 years and had Wi-Fi access were recruited via email from 2 clinics within Kaiser Permanente Northern California and randomized to receive usual prenatal care or an mHealth lifestyle intervention. Participants in the intervention arm received wireless scales, access to an intervention website, activity trackers to receive automated feedback on weight gain and activity goals, and monthly calls from a lifestyle coach. Surveys and focus groups with intervention participants assessed intervention satisfaction and ways to improve the intervention. PA outcomes were self-assessed using the Pregnancy Physical Activity Questionnaire, and GWG was assessed using electronic health record data for both arms.

RESULTS

Overall, 33 patients were randomly assigned to the intervention arm, and 35 patients were randomly assigned to the usual care arm. All participants in the intervention arm weighed themselves at least once a week, compared with 20% (7/35) of the participants in the usual care arm. Participants in the intervention arm wore the activity tracker 6.4 days per week and weighed themselves 5.3 times per week, and 88% (29/33) of them rated the program "good to excellent." Focus groups found that participants desired more nutrition-related support to help them manage GWG and would have preferred an app instead of a website. Participants in the intervention arm had a 23.46 metabolic equivalent of task hours greater change in total PA per week and a 247.2-minute greater change in moderate intensity PA per week in unadjusted models, but these effects were attenuated in adjusted models (change in total PA: 15.55 metabolic equivalent of task hours per week; change in moderate intensity PA: 199.6 minutes per week). We found no difference in total GWG (mean difference 1.14 kg) compared with usual care.

CONCLUSIONS

The pilot mHealth lifestyle intervention was feasible, highly acceptable, and promoted self-monitoring. Refined interventions are needed to effectively affect PA and GWG among pregnant patients with overweight or obesity.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03936283; https://clinicaltrials.gov/ct2/show/NCT03936283.

摘要

背景

超重或肥胖的孕妇发生围产期并发症的风险很高。孕期体重过度增加(GWG)会进一步加剧这种风险。移动健康(mHealth)生活方式干预利用技术促进自我监测并提供即时反馈,可能会促使行为改变,以减少过度的GWG,降低干预成本,并通过改善可及性提高可扩展性。

目的

本研究旨在测试一项针对超重或肥胖孕妇的mHealth生活方式试点干预措施的可接受性和可行性,以促进中等强度身体活动(PA),鼓励符合指南的GWG,并为一项更大规模的实用整群随机对照试验的设计提供信息。

方法

我们在孕前体重指数为25至40 kg/m的孕妇中进行了一项混合方法的可接受性和可行性随机对照试验。通过电子邮件从北加利福尼亚州凯撒医疗机构的2家诊所招募了妊娠8至15周、年龄≥21岁且能使用Wi-Fi的单胎孕妇,并将她们随机分为接受常规产前护理或mHealth生活方式干预。干预组的参与者收到无线秤、干预网站的访问权限、用于接收体重增加和活动目标自动反馈的活动追踪器,以及生活方式教练每月的电话。对干预组参与者进行的调查和焦点小组讨论评估了干预满意度以及改进干预的方法。使用《孕期身体活动问卷》进行自我评估PA结果,并使用双臂的电子健康记录数据评估GWG。

结果

总体而言,33名患者被随机分配到干预组,35名患者被随机分配到常规护理组。干预组的所有参与者每周至少称一次体重,而常规护理组的参与者中这一比例为20%(7/35)。干预组的参与者每周佩戴活动追踪器6.4天,每周称体重5.3次,其中88%(29/33)的人将该项目评为“良好至优秀”。焦点小组发现,参与者希望获得更多与营养相关的支持来帮助他们控制GWG,并且更喜欢应用程序而不是网站。在未调整的模型中,干预组参与者每周的总PA代谢当量小时变化增加23.46,中等强度PA每周变化增加247.2分钟,但在调整模型中这些效果减弱(总PA变化:每周15.55代谢当量小时;中等强度PA变化:每周199.6分钟)。与常规护理相比,我们发现总GWG没有差异(平均差异1.14 kg)。

结论

mHealth生活方式试点干预是可行的、高度可接受的,并促进了自我监测。需要改进干预措施以有效影响超重或肥胖孕妇的PA和GWG。

试验注册

ClinicalTrials.gov NCT03936283;https://clinicaltrials.gov/ct2/show/NCT03936283

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/542e/9260523/4e64c51e4e36/formative_v6i6e33929_fig1.jpg

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