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尼泊尔卡皮拉瓦斯图地区虚拟产前干预对改善饮食和铁摄入量的影响——VALID随机对照试验

Impact of a virtual antenatal intervention for improved diet and iron intake in Kapilvastu district, Nepal - the VALID randomized controlled trial.

作者信息

Saville Naomi M, Bhattarai Sanju, Giri Santosh, Sapkota Suprich, Morrison Joanna, Thapaliya Bibhu, Bhattarai Basudev, Yadav Samata, Arjyal Abriti, Copas Andrew, Haghparast-Bidgoli Hassan, Harris-Fry Helen, Piya Reecha, Baral Sushil C, Hillman Sara L

机构信息

Institute for Global Health, University College London (UCL), London, United Kingdom.

HERD International, Lalitpur, Nepal.

出版信息

Front Nutr. 2024 Nov 7;11:1464967. doi: 10.3389/fnut.2024.1464967. eCollection 2024.

Abstract

INTRODUCTION

Counseling, together with iron and folic acid supplements, can improve hemoglobin levels in pregnant women, but few interventions have tested a virtual method of delivering counseling. We hypothesized that a virtual counseling intervention delivered via a mobile device (mHealth) would prevent and treat anemia, compared with routine antenatal care (ANC).

METHODS

Virtual antenatal intervention for improved diet and iron intake (VALID) was a non-blinded parallel group two-arm, individually randomized superiority trial (1:1 allocation). Participants were pregnant women who were married, aged 13-49 years, able to answer questions, 12-28 weeks' gestation and living in Kapilvastu district, Nepal. Women were randomized to receive routine ANC (control arm), or ANC plus a virtual antenatal intervention of two problem-solving counseling sessions via video call. The primary outcome was iron folic acid (IFA) tablet compliance (consumption on 12 or more days of the previous 14 days). Secondary outcomes were dietary diversity, promoted food consumption, iron bioavailability enhancement, and knowledge of iron-rich foods. Primary logistic regression analysis was by intention-to-treat, adjusting for baseline values.

RESULTS

We enrolled 319 pregnant women (161 control, 158 intervention) from 23 January 2022 to 6 May 2022 and analyzed outcomes in 144 control and 127 intervention women. Compliance with IFA increased in both arms. In the intervention arm, compliance increased by 29.7 percentage points (pp) (49.0-78.7%) and 19.8 pp. in the control arm (53.8-73.6%). Despite the more significant increase in the intervention arm, we found no intervention effect upon IFA compliance (adjusted odds ratio [aOR] 1.33; 95% confidence interval [CI]: 0.75, 2.35;  = 0.334), dietary diversity, or ANC visits. The intervention increased knowledge of iron-rich foods (coefficient 0.96; 95% CI: 0.50, 1.41;  < 0.001), consumption of promoted foods (aOR: 1.81; 95% CI: 1.08, 3.02;  = 0.023), behavior to enhance iron bioavailability (aOR: 4.41; 95% CI: 1.23, 15.83;  = 0.023), and coronavirus disease 2019 (COVID-19) knowledge (aOR: 4.06; 95% CI: 1.56, 10.54;  = 0.004). The total intervention cost was US$35,193, and the cost per pregnant woman receiving two virtual counseling sessions was US$277.

CONCLUSION

Virtual counseling can improve antenatal health behaviors, such as the consumption of promoted foods and methods to enhance bioavailability. Improved IFA consumption and ANC attendance may require additional family/community support.

CLINICAL TRIAL REGISTRATION

https://www.isrctn.com/ISRCTN17842200, identifier ISRCTN17842200.

摘要

引言

咨询服务与铁剂和叶酸补充剂相结合,可提高孕妇的血红蛋白水平,但很少有干预措施测试过虚拟咨询服务的提供方式。我们假设,与常规产前护理(ANC)相比,通过移动设备提供的虚拟咨询干预(移动健康,mHealth)可以预防和治疗贫血。

方法

改善饮食和铁摄入的虚拟产前干预(VALID)是一项非盲法平行组双臂、个体随机优效性试验(1:1分配)。参与者为已婚孕妇,年龄在13至49岁之间,能够回答问题,孕周为12至28周,居住在尼泊尔卡皮拉瓦斯图区。女性被随机分为接受常规ANC(对照组),或ANC加上通过视频通话进行的两次解决问题咨询的虚拟产前干预。主要结局是铁叶酸(IFA)片剂依从性(在前14天中的12天或更多天服用)。次要结局包括饮食多样性、推荐食物的摄入量、铁生物利用度的提高以及对富含铁食物的了解。主要逻辑回归分析采用意向性分析,并对基线值进行调整。

结果

我们从2022年1月23日至2022年5月6日招募了319名孕妇(161名对照组,158名干预组),并分析了144名对照组和127名干预组女性的结局。两组的IFA依从性均有所提高。在干预组中,依从性提高了29.7个百分点(pp)(从49.0%提高到78.7%),对照组提高了19.8 pp(从53.8%提高到73.6%)。尽管干预组的提高更为显著,但我们发现对IFA依从性(调整后的优势比[aOR]为1.33;95%置信区间[CI]:0.75,2.35;P = 0.334)、饮食多样性或ANC就诊次数没有干预效果。该干预提高了对富含铁食物的了解(系数为0.96;95% CI:0.50,1.41;P < 0.001)、推荐食物的摄入量(aOR:1.81;95% CI:1.08,3.02;P = 0.023)、提高铁生物利用度的行为(aOR:4.41;95% CI:1.23,15.83;P = 0.023)以及2019冠状病毒病(COVID-19)知识(aOR:4.06;95% CI:1.56,10.54;P = 0.004)。总干预成本为35,193美元,接受两次虚拟咨询的每名孕妇的成本为277美元。

结论

虚拟咨询可以改善产前健康行为,如推荐食物的摄入量和提高生物利用度的方法。提高IFA摄入量和ANC就诊率可能需要额外的家庭/社区支持。

临床试验注册

https://www.isrctn.com/ISRCTN17842200,标识符ISRCTN17842200

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/83ee/11580260/c7ba32f9c3aa/fnut-11-1464967-g001.jpg

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