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VALID Trial dataset from a randomised controlled trial in Nepal on the effect of virtual counselling on compliance with iron and folic acid supplementation

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posted on 2024-09-23, 08:54 authored by Naomi SavilleNaomi Saville
<p dir="ltr">Virtual Antenatal Intervention for improved Diet and Iron intake (VALID) was a non-blinded parallel group two-arm individually randomised superiority trial with 1:1 allocation. The primary objective was to assess whether the intervention, in addition to usual government services, increased women’s compliance to IFA supplementation, compared with access only to usual government services. As a secondary objective, we assessed impacts on dietary knowledge and practices, access to ANC, and knowledge of COVID.In the control arm women had access to routine ANC.</p><p dir="ltr">Participants were pregnant women who were married, aged 13-49 years, able to answer questions, 12-28 weeks’ gestation and living in Kapilvastu, Nepal. Women were randomised to receive routine antenatal care (ANC) (control arm), or ANC plus a virtual antenatal intervention of two problem-solving counselling sessions via video call. The primary outcome was Iron Folic Acid (IFA) tablet compliance (consumption on 12+ 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.</p><p dir="ltr">Trial registration: ISRCTN17842200 Date of registration: 13 Jan 2022. URL: <a href="https://doi.org/10.1186/ISRCTN17842200" target="_blank">https://doi.org/10.1186/ISRCTN17842200</a></p><p dir="ltr">The trial dataset contains all the variables collected in baseline and endline surveys with enrolled pregnant women. </p>

Funding

UK Medical Research Council (MRC)/ Newton Fund, grant number MR/R020485/1

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