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基于计步器的肥胖孕妇体力活动干预(Fit MUM 研究):随机可行性研究。

A Pedometer-Guided Physical Activity Intervention for Obese Pregnant Women (the Fit MUM Study): Randomized Feasibility Study.

机构信息

Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Australia.

Centre for Integrated Critical Care, University of Melbourne, Melbourne, Australia.

出版信息

JMIR Mhealth Uhealth. 2020 May 26;8(5):e15112. doi: 10.2196/15112.

Abstract

BACKGROUND

Obesity in pregnancy is a growing problem worldwide, with excessive gestational weight gain (GWG) occurring in the majority of pregnancies. This significantly increases risks to both mother and child. A major contributor to both prepregnancy obesity and excessive GWG is physical inactivity; however, past interventions targeting maternal weight gain and activity levels during the antenatal period have been ineffective in women who are already overweight. Pedometer-guided activity may offer a novel solution for increasing activity levels in this population.

OBJECTIVE

This initial feasibility randomized controlled trial aimed to test a pedometer-based intervention to increase activity and reduce excessive GWG in pregnant women.

METHODS

We supplied 30 pregnant women with obesity a Fitbit Zip pedometer and randomized them into 1 of 3 groups: control (pedometer only), app (pedometer synced to patients' personal smartphone, with self-monitoring of activity), or app-coach (addition of a health coach-delivered behavioral change program). Feasibility outcomes included participant compliance with wearing pedometers (days with missing pedometer data), data syncing, and data integrity. Activity outcomes (step counts and active minutes) were analyzed using linear mixed models and generalized estimating equations.

RESULTS

A total of 30 participants were recruited within a 10-week period, with a dropout rate of 10% (3/30; 2 withdrawals and 1 stillbirth); 27 participants thus completed the study. Mean BMI in all groups was ≥35 kg/m. Mean (SD) percentage of missing data days were 23.4% (20.6%), 39.5% (32.4%), and 21.1% (16.0%) in control, app group, and app-coach group patients, respectively. Estimated mean baseline activity levels were 14.5 active min/day and 5455 steps/day, with no significant differences found in activity levels between groups, with mean daily step counts in all groups remaining in the sedentary (5000 steps/day) or low activity (5000-7499 steps/day) categories for the entire study duration. There was a mean decrease of 7.8 steps/day for each increase in gestation day over the study period (95% CI 2.91 to 12.69, P=.002).

CONCLUSIONS

Activity data syncing with a personal smartphone is feasible in a cohort of pregnant women with obesity. However, our results do not support a future definitive study in its present form. Recruitment and retention rates were adequate, as was activity data syncing to participants' smartphones. A follow-up interventional trial seeking to reduce GWG and improve activity in this population must focus on improving compliance with activity data recording and behavioral interventions delivered.

TRIAL REGISTRATION

Australian and New Zealand Clinical Trials Registry ACTRN12617000038392; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370884.

摘要

背景

肥胖症是全球范围内日益严重的问题,大多数孕妇都存在妊娠体重过度增加的情况。这大大增加了母婴双方的风险。导致孕前肥胖和妊娠体重过度增加的一个主要因素是身体活动不足;然而,过去针对产前期间母婴体重增加和活动水平的干预措施,对已经超重的女性无效。计步器引导的活动可能为增加该人群的活动水平提供一种新的解决方案。

目的

这项初步可行性随机对照试验旨在测试基于计步器的干预措施,以增加肥胖孕妇的活动量并减少妊娠体重过度增加。

方法

我们为 30 名肥胖孕妇提供了 Fitbit Zip 计步器,并将他们随机分为 3 组之一:对照组(仅计步器)、应用组(计步器与患者的个人智能手机同步,自我监测活动)或应用教练组(增加健康教练提供的行为改变计划)。可行性结果包括参与者佩戴计步器的依从性(计步器数据缺失天数)、数据同步和数据完整性。使用线性混合模型和广义估计方程分析活动结果(步数和活跃分钟数)。

结果

在 10 周的时间内共招募了 30 名参与者,其中 10%(3/30;2 名退出和 1 名死产)的参与者脱落;因此,27 名参与者完成了研究。所有组的平均 BMI 均≥35kg/m2。对照组、应用组和应用教练组患者分别有 23.4%(20.6%)、39.5%(32.4%)和 21.1%(16.0%)的缺失数据天数。估计的平均基线活动水平为 14.5 分钟/天和 5455 步/天,组间活动水平无显著差异,整个研究期间所有组的平均每日步数仍保持在久坐(5000 步/天)或低活动(5000-7499 步/天)类别。在整个研究期间,随着妊娠天数的增加,每天的步数平均减少了 7.8 步(95%CI 2.91 至 12.69,P=.002)。

结论

在肥胖孕妇队列中,使用个人智能手机同步活动数据是可行的。然而,我们的结果并不支持以目前的形式进行未来的确定性研究。招募和保留率以及参与者智能手机的数据同步都足够。必须进行后续干预试验,以降低该人群的妊娠体重过度增加并提高其活动水平,重点是提高活动数据记录和行为干预措施的依从性。

试验注册

澳大利亚和新西兰临床试验注册中心 ACTRN12617000038392;https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370884。

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