Study protocol for a randomised controlled trial of a virtual antenatal intervention for improved diet and iron intake in Kapilvastu district, Nepal: VALID.
Study protocol for a randomised controlled trial of a virtual antenatal intervention for improved diet and iron intake in Kapilvastu district, Nepal: VALID.
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DOI：
10.1136/bmjopen-2022-064709
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发表时间：
2023-02-16
期刊：
影响因子：
2.9
通讯作者：
中科院分区：
文献类型：
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作者：
尽管有证据表明，铁和叶酸补充剂可以改善孕妇的贫血症，但尼泊尔的吸收情况并不理想。我们假设，与产前护理（仅ANC）相比，在怀孕中期提供两次虚拟咨询，将提高COVID-19大流行期间IFA片剂的依从性。这项在尼泊尔平原进行的非盲个体随机对照试验有两个研究组：（1）对照组：常规ANC;（2）“虚拟”产前咨询加常规ANC。如果已婚、年龄13-49岁、能够回答问题、妊娠12-28周、计划在尼泊尔居住5周，则有资格入组。干预措施包括两次虚拟咨询会议，由辅助护士助产士在怀孕中期至少间隔2周提供协助。虚拟咨询采用与孕妇及其家人对话解决问题的方法。我们将150名孕妇随机分配到每组，根据初孕/多次孕和基线时IFA消耗量进行分层，假设对照组患病率为67%，失访率为10%，提供80%的把握度来检测主要结局的15%绝对差异。结果是在登记后49-70天测量的，否则直到分娩。主要结局：过去14天中至少80%的IFA消耗。次要结局：饮食多样性、促进干预食品的消费、提高生物利用度的实践方法和对富铁食品的了解。我们的混合方法过程评估探索可接受性，保真度，可行性，覆盖范围（公平性和覆盖范围），可持续性和影响途径。我们从供应商的角度估计干预的成本和成本效益。主要分析是通过意向治疗，使用逻辑回归。我们获得了尼泊尔健康研究理事会（570/2021）和伦敦大学学院伦理委员会（14301/001）的伦理批准。我们将在同行评审的期刊文章中传播研究结果，并让尼泊尔的决策者参与进来。ISRCTN17842200。
Despite evidence that iron and folic acid (IFA) supplements can improve anaemia in pregnant women, uptake in Nepal is suboptimal. We hypothesised that providing virtual counselling twice in mid-pregnancy, would increase compliance to IFA tablets during the COVID-19 pandemic compared with antenatal care (ANC alone. This non-blinded individually randomised controlled trial in the plains of Nepal has two study arms: (1) control: routine ANC; and (2) ‘Virtual’ antenatal counselling plus routine ANC. Pregnant women are eligible to enrol if they are married, aged 13–49 years, able to respond to questions, 12–28 weeks’ gestation, and plan to reside in Nepal for the next 5 weeks. The intervention comprises two virtual counselling sessions facilitated by auxiliary nurse midwives at least 2 weeks apart in mid-pregnancy. Virtual counselling uses a dialogical problem-solving approach with pregnant women and their families. We randomised 150 pregnant women to each arm, stratifying by primigravida/multigravida and IFA consumption at baseline, providing 80% power to detect a 15% absolute difference in primary outcome assuming 67% prevalence in control arm and 10% loss-to-follow-up. Outcomes are measured 49–70 days after enrolment, or up to delivery otherwise. Primary outcome: consumption of IFA on at least 80% of the previous 14 days. Secondary outcomes: dietary diversity, consumption of intervention-promoted foods, practicing ways to enhance bioavailability and knowledge of iron-rich foods. Our mixed-methods process evaluation explores acceptability, fidelity, feasibility, coverage (equity and reach), sustainability and pathways to impact. We estimate costs and cost-effectiveness of the intervention from a provider perspective. Primary analysis is by intention-to-treat, using logistic regression. We obtained ethical approval from Nepal Health Research Council (570/2021) and UCL ethics committee (14301/001). We will disseminate findings in peer-reviewed journal articles and by engaging policymakers in Nepal. ISRCTN17842200.
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影响因子：
3.4
作者：
Morrison J;Giri R;Arjyal A;Kharel C;Harris-Fry H;James P;Baral S;Saville N;Hillman S
通讯作者：
Hillman S
影响因子：
5
作者：
Harris-Fry H;Saville NM;Paudel P;Manandhar DS;Cortina-Borja M;Skordis J
通讯作者：
Skordis J
DOI：
10.1136/bmj.h1258
发表时间：
2015-03-19
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Moore GF;Audrey S;Barker M;Bond L;Bonell C;Hardeman W;Moore L;O'Cathain A;Tinati T;Wight D;Baird J
通讯作者：
Baird J
影响因子：
2.8
作者：
Girard, Amy Webb;Olude, Oluwafunke
通讯作者：
Olude, Oluwafunke
影响因子：
2.5
作者：
Saville NM;Kharel C;Morrison J;Harris-Fry H;James P;Copas A;Giri S;Arjyal A;Beard BJ;Haghparast-Bidgoli H;Skordis J;Richter A;Baral S;Hillman S
通讯作者：
Hillman S