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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

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.

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.

Trial registration: ISRCTN17842200 Date of registration: 13 Jan 2022. URL: https://doi.org/10.1186/ISRCTN17842200

The trial dataset contains all the variables collected in baseline and endline surveys with enrolled pregnant women.

Funding

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

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