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

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; p = 0.334), dietary diversity, or ANC visits. The intervention increased knowledge of iron-rich foods (coefficient 0.96; 95% CI: 0.50, 1.41; p < 0.001), consumption of promoted foods (aOR: 1.81; 95% CI: 1.08, 3.02; p = 0.023), behavior to enhance iron bioavailability (aOR: 4.41; 95% CI: 1.23, 15.83; p = 0.023), and coronavirus disease 2019 (COVID-19) knowledge (aOR: 4.06; 95% CI: 1.56, 10.54; p = 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.