Impact of a Virtual Antenatal Intervention for Improved Diet and Iron Intake in Kapilvastu District, Nepal: VALID Randomised Controlled Trial

Background: Anaemia affects 46% of Nepalese pregnant women. Iron and folic acid (IFA) supplementation reduces anaemia but compliance is suboptimal. We hypothesised that virtual counselling would increase compliance to IFA 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 randomised superiority trial (1:1 allocation) with 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 either routine antenatal care (ANC) alone (control arm) or in combination with a virtual antenatal intervention for improved diet and iron intake (intervention arm), comprising two virtual problem-solving counselling sessions. The primary outcome was consumption of IFA on <=12 of the previous 14 days in late pregnancy. Secondary outcomes were dietary diversity, promoted food consumption, bioavailability enhancement, and knowledge of iron-rich foods. Primary logistic regression analysis was by intention-to-treat, adjusting for baseline values.Trial registration: ISRCTN 17842200. Status: closed.Findings: We enrolled 319 (161 control, 158 intervention) from 23 January to 6 May 2022 and analysed outcomes in 144 control and 127 intervention women. Baseline-endline compliance increased by 29.7 percentage points in intervention (49.0 to 78.7%) and 19.8 in control arms (53.8% to 73.6%) but we found no effect upon IFA compliance (OR 1.33 95% CI 0.75, 2.35, p=0.334), dietary diversity or ANC visits. The intervention increased recall of iron-rich foods (coefficient 0.96 (95% CI 0.50, 1 .41), p<0.001), promoted foods consumption (aOR 1.81 (95% CI 1.08, 3.02), p=0.023), behaviour to enhance bioavailability (aOR 4.41 95% CI 1.23, 15.83, p=0.023) and COVID-19 knowledge (aOR 4.06 (95% CI 1.56, 10.54, p=0.004). Interpretation: To increase IFA and ANC, antenatal counselling needs supplementing with family/community support and health system strengthening.Trial Registration: ISRCTN 17842200.Funding: This work was supported by UK Medical Research Council (MRC)/ Newton Fund, grant number MR/R020485/1.Declaration of Interest: We declare no competing interests.Ethical Approval: We obtained ethical approval from Nepal Health Research Council (570/2021) and UCL ethics committee (14301/001).