Dataset Information

Study protocol for a randomised controlled trial of a virtual antenatal intervention for improved diet and iron intake in Kapilvastu district, Nepal: VALID.

ABSTRACT:

Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

ISRCTN17842200.

SUBMITTER: Saville NM

PROVIDER: S-EPMC9936277 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Publications

Study protocol for a randomised controlled trial of a virtual antenatal intervention for improved diet and iron intake in Kapilvastu district, Nepal: VALID.

Saville Naomi M NM Bhattarai Sanju S Harris-Fry Helen H Giri Santosh S Manandhar Shraddha S Morrison Joanna J Copas Andrew A Thapaliya Bibhu B Arjyal Abriti A Haghparast-Bidgoli Hassan H Baral Sushil C SC Hillman Sara S

BMJ open 20230216 2

<h4>Introduction</h4>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.<h4>Methods and analysis</h4>This non-blinded individually randomised controlled trial in the plains of Nepal has two study arms: (1) control: routine ANC; and (2) ...[more]

PMID: 36797013

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Project description:IntroductionCounseling, 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).MethodsVirtual 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.ResultsWe 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.ConclusionVirtual 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 registrationhttps://www.isrctn.com/ISRCTN17842200, identifier ISRCTN17842200.

Project description:BackgroundCoverage of iron-folic acid (IFA) supplementation is a key indicator for tracking programmatic progress within and across countries. However, the validity of maternal report of this information during household surveys has yet to be determined.ObjectivesThis study aimed to examine the validity of maternal recall of receipt of IFA supplementation during antenatal care (ANC) and factors associated with accuracy of maternal recall.MethodsA longitudinal cohort design was employed. The direct observation of the IFA received during all ANC visits at the 5 study health posts served as the "gold standard" to the maternal report of IFA received during the postpartum interview. Individual-level validity was assessed by calculating indicator sensitivity, specificity, and AUC. The inflation factor (IF) measured population-level bias. A multivariable log-binomial model was used to assess factors associated with accurate recall.ResultsThe majority (95.8%) of women were observed receiving IFA during pregnancy. Women overreported the number of IFA tablets received compared with what was observed during ANC visits (mean difference: 45 tablets). Maternal report of any IFA receipt was moderate (AUC = 0.60; 95% CI: 0.50, 0.71), and population bias was low (IF = 1.01). However, the individual-level validity was poor across the 7 IFA tablet count categories; the AUC for categories ranged from misleading to moderate. Driven by the trend of maternal overreport, the IF indicated that maternal report drastically underestimated the coverage of lower tablet categories and overestimated the coverage of higher tablet counts. Accuracy of maternal report was not associated with months since last ANC observation nor any maternal characteristics.ConclusionsMaternal report of the amount of IFA supplementation received during pregnancy produced extremely biased population coverage and performed poorly to moderately for individual-level validity. It is imperative to improve this indicator because it is used in global frameworks and national program planning.

Project description:BackgroundInfant birthweight is an important public health indicator that is a proxy of maternal and baby's health. Earthquakes can cause acute distress, but can also contribute to chronic stress through long-term disruptions to social, economic and domestic circumstances. The aims of this study were to examine the direct effect of earthquake experiences on the birthweight of infants of women who experienced the 2015 Nepal Earthquakes during pregnancy and whether mental health mediated this relationship.MethodsThis is a prospective, population-based cohort study. Pregnant women in Bhaktapur District, Nepal who had experienced the 2015 earthquakes after conception were recruited. Baseline data were collected in structured individual interviews. Follow up was a short telephone interview two weeks after the baby's birth. Infant birthweight recorded on the hospital-issued birth certificate. The direct effect of earthquake experiences on birthweight and the indirect effect via antenatal common mental disorders (CMDs) were tested using Sobel tests simultaneously.ResultsIn total 497/498 women contributed baseline data and 469 (94.4%) women also provided the birth weight of their infants. In total 6% of infants had low birth weight (< 2.5 kg). The earthquake experiences did not have a significant direct effect on birthweight (p = 0.116). However, the effect of earthquake experiences had a significant indirect effect on infant birthweight via CMDs. When 15 covariates were controlled, women who had moderate to severe earthquake experiences had an increase of 1.58 scores of antenatal CMD symptoms that resulted in their babies being 20.50 g lighter than those who had low earthquake experiences (p = 0.026).ConclusionsThe findings from this study indicate that the relationship is mediated by the mental health of women during pregnancy. Data demonstrate that the mental health of women who are pregnant should be prioritised in post-disaster management not only because of the burden experienced by women but also because of the risk for the growth and development of their babies.

Project description:BackgroundThe WHO seeks to control trachoma as a public health problem in endemic areas. Achham District in western Nepal was found to have TF (trachoma follicular) above 20% in a 2006 government survey, triggering 3 annual mass drug administrations finishing in 2010. Here we assess the level of control that has been achieved using surveillance for clinical disease, ocular chlamydia trachomatis infection, and serology for antibodies against chlamydia trachomatis protein antigens.MethodsWe conducted a cross-sectional survey of children aged 1-9 years in communities in Achham District in early 2014 including clinical examination validated with photographs, conjunctival samples for Chlamydia trachomatis (Amplicor PCR), and serological testing for antibodies against chlamydia trachomatis protein antigens pgp3 and CT694 using the Luminex platform.FindingsIn 24 randomly selected communities, the prevalence of trachoma (TF and/or TI) in 1-9 year olds was 3/1124 (0.3%, 95% CI 0.1 to 0.8%), and the prevalence of ocular chlamydia trachomatis infection was 0/1124 (0%, 95% CI 0 to 0.3%). In 18 communities selected because they had the highest prevalence of trachoma in a previous survey, the prevalence of TF and/or TI was 7/716 (1.0%, 95% CI 0.4 to 2.0%) and the prevalence of ocular chlamydia trachomatis infection was 0/716 (0%, 95% CI 0 to 0.5%). In 3 communities selected for serological testing, the prevalence of trachoma was 0/68 (0%, 95% CI 0 to 5.3%), the prevalence of ocular chlamydia trachomatis infection was 0/68 (0%, 95% CI 0 to 0.5%), the prevalence of antibodies against chlamydia trachomatis protein antigen pgp3 was 1/68 (1.5%, 95% CI 0.04% to 7.9%), and the prevalence of antibodies against chlamydia trachomatis protein antigen CT694 was 0/68 (0%, 95% CI 0 to 5.3%).Conclusion/significanceThis previously highly endemic district in Nepal has little evidence of recent clinical disease, chlamydia trachomatis infection, or serological evidence of trachoma, suggesting that epidemiological control has been achieved.

Dataset Information

Study protocol for a randomised controlled trial of a virtual antenatal intervention for improved diet and iron intake in Kapilvastu district, Nepal: VALID.

Introduction

Methods and analysis

Primary outcome

Secondary outcomes

Ethics and dissemination

Trial registration number

Publications

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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