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

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.

Assessing food-based strategies to address anaemia in pregnancy in rural plains Nepal: a mixed methods study.

Anaemia in pregnancy is a persistent health problem in Nepal and could be reduced through nutrition counselling and strengthened iron folic acid supplementation programmes. We analysed 24-hour diet recall data from 846 pregnant women in rural plains Nepal, using linear programming to identify the potential for optimised food-based strategies to increase iron adequacy. We then conducted qualitative research to analyse how anaemia was defined and recognised, how families used food-based strategies to address anaemia, and the acceptability of optimised food-based strategies. We did 16 interviews of recently pregnant mothers, three focus group discussions with fathers, three focus group discussions with mothers-in-law and four interviews with key informants. Dietary analyses showed optimised diets did not achieve 100 % of recommended iron intakes, but iron intakes could be doubled by increasing intakes of green leaves, egg and meat. Families sought to address anaemia through food-based strategies but were often unable to because of the perceived expense of providing an 'energy-giving' diet. Some foods were avoided because of religious or cultural taboos, or because they were low status and could evoke social consequences if eaten. There is a need for counselling to offer affordable ways for families to optimise iron adequacy. The participation of communities in tailoring advice to ensure cultural relevance and alignment with local norms is necessary to enable its effectiveness.

Comprehensive Anaemia Programme and Personalized Therapies (CAPPT): protocol for a cluster-randomised controlled trial testing the effect women's groups, home counselling and iron supplementation on haemoglobin in pregnancy in southern Nepal.

BACKGROUND: Anaemia in pregnancy remains prevalent in Nepal and causes severe adverse health outcomes. METHODS: This non-blinded cluster-randomised controlled trial in the plains of Nepal has two study arms: (1) Control: routine antenatal care (ANC); (2) Home visiting, iron supplementation, Participatory Learning and Action (PLA) groups, plus routine ANC. Participants, including women in 54 non-contiguous clusters (mean 2582; range 1299-4865 population) in Southern Kapilbastu district, are eligible if they consent to menstrual monitoring, are resident, married, aged 13-49 years and able to respond to questions. After 1-2 missed menses and a positive pregnancy test, consenting women < 20 weeks' gestation, who plan to reside locally for most of the pregnancy, enrol into trial follow-up. Interventions comprise two home-counselling visits (at 12-21 and 22-26 weeks' gestation) with iron folic acid (IFA) supplement dosage tailored to women's haemoglobin concentration, plus monthly PLA women's group meetings using a dialogical problem-solving approach to engage pregnant women and their families. Home visits and PLA meetings will be facilitated by auxiliary nurse midwives. The hypothesis is as follows: Haemoglobin of women at 30 ± 2 weeks' gestation is ≥ 0.4 g/dL higher in the intervention arm than in the control. A sample of 842 women (421 per arm, average 15.6 per cluster) will provide 88% power, assuming SD 1.2, ICC 0.09 and CV of cluster size 0.27. Outcomes are captured at 30 ± 2 weeks gestation. Primary outcome is haemoglobin concentration (g/dL). Secondary outcomes are as follows: anaemia prevalence (%), mid-upper arm circumference (cm), mean probability of micronutrient adequacy (MPA) and number of ANC visits at a health facility. Indicators to assess pathways to impact include number of IFA tablets consumed during pregnancy, intake of energy (kcal/day) and dietary iron (mg/day), a score of bioavailability-enhancing behaviours and recall of one nutrition knowledge indicator. Costs and cost-effectiveness of the intervention will be estimated from a provider perspective. Using constrained randomisation, we allocated clusters to study arms, ensuring similarity with respect to cluster size, ethnicity, religion and distance to a health facility. Analysis is by intention-to-treat at the individual level, using mixed-effects regression. DISCUSSION: Findings will inform Nepal government policy on approaches to increase adherence to IFA, improve diets and reduce anaemia in pregnancy. TRIAL REGISTRATION: ISRCTN 12272130 .

Equity implications of rice fortification: a modelling study from Nepal.

OBJECTIVE: To model the potential impact and equity impact of fortifying rice on nutritional adequacy of different subpopulations in Nepal. DESIGN: Using 24-h dietary recall data and a household consumption survey, we estimated: rice intakes; probability of adequacy (PA) of eight micronutrients commonly fortified in rice (vitamin A, niacin (B3), pyridoxine (B6), cobalamin (B12), thiamin (B1), folate (B9), Fe and Zn) plus riboflavin (B2), vitamin C and Ca and mean probability of adequacy (MPA) of these micronutrients. We modelled: no fortification; fortification of purchased rice, averaged across all households and in rice-buying households only. We compared adequacy increases between population subgroups. SETTING: (i) Dhanusha and Mahottari districts of Nepal (24-h recall) and (ii) all agro-ecological zones of Nepal (consumption data). PARTICIPANTS: (i) Pregnant women (n 128), mothers-in-law and male household heads; (ii) households (n 4360). RESULTS: Unfortified diets were especially inadequate in vitamins B12, A, B9, Zn and Fe. Fortification of purchased rice in rice-purchasing households increased PA > 0·9 for thiamin, niacin, B6, folate and Zn, but B12 and Fe remained inadequate even after fortification (PA range 0·3-0·9). Pregnant women's increases exceeded men's for thiamin, niacin, B6, folate and MPA; men had larger gains in vitamin A, B12 and Zn. Adequacy improved more in the hills (coefficient 0·08 (95 % CI 0·05, 0·10)) and mountains (coefficient 0·07 (95 % CI 0·01, 0·14)) but less in rural areas (coefficient -0·05 (95 % CI -0·09, -0·01)). CONCLUSIONS: Consumption of purchased fortified rice improves adequacy and gender equity of nutrient intake, especially in non-rice-growing areas.

Consumption of rice, acceptability and sensory qualities of fortified rice amongst consumers of social safety net rice in Nepal.

INTRODUCTION: Micronutrient deficiencies are prevalent in Nepal where starchy foods constitute a large proportion of diets and consumption of micronutrient-rich foods is inadequate. We conducted a study to determine whether rice would be an appropriate vehicle for micronutrient fortification in Nepal. MATERIALS AND METHODS: In Bajura in remote rural Nepal, we conducted a household survey to characterize rice intakes in 195 households, and a double-blinded acceptability test with 177 social safety net rice consumers ≥18 years of age. Of these, 168 tasted fortified and unfortified rice to assess whether respondents could differentiate between fortified and non-fortified rice and their sensory properties. Rice was fortified by blending hot extruded kernels containing 6 micronutrients together with non-fortified rice at a 1:99 ratio. We used binomial tests to assess whether participants could correctly differentiate fortified rice, from non-fortified rice and paired t-tests to compare scores for sensory qualities of cooked fortified and non-fortified rice. We used multiple regression to test associations between per capita consumption and age, gender, wealth and food security. RESULTS: Per capita consumption of rice (median 216g/day, IQR 144.0, 288.0) did not vary by wealth but was +52.08g, (95% CI 10.43, 93.72) higher amongst moderately to severely food insecure households compared with food secure / mildly food insecure. Most respondents could not differentiate fortified rice from non-fortified rice: 37.5% identified uncooked fortified rice and 39.3% cooked rice, which was not different from the 33% expected by chance (p = 0.22 and p = 0.09 respectively). The sensory qualities of fortified rice were acceptable (scoring 3.9 out of 5) and did not differ from non-fortified rice (p>0.05). CONCLUSION: A rice fortification programme implemented through the Nepal Food Corporation's social safety nets has potential because purchase and consumption of rice is high and fortified rice is acceptable among consumers in remote food insecure areas of Nepal.

Participatory Women's Groups with Cash Transfers Can Increase Dietary Diversity and Micronutrient Adequacy during Pregnancy, whereas Women's Groups with Food Transfers Can Increase Equity in Intrahousehold Energy Allocation.

Background: There is scarce evidence on the impacts of food transfers, cash transfers, or women's groups on food sharing, dietary intakes, or nutrition during pregnancy, when nutritional needs are elevated. Objective: This study measured the effects of 3 pregnancy-focused nutrition interventions on intrahousehold food allocation, dietary adequacy, and maternal nutritional status in Nepal. Methods: Interventions tested in a cluster-randomized controlled trial (ISRCTN 75964374) were "Participatory Learning and Action" (PLA) monthly women's groups, PLA with transfers of 10 kg fortified flour ("Super Cereal"), and PLA plus transfers of 750 Nepalese rupees (∼US$7.5) to pregnant women. Control clusters received usual government services. Primary outcomes were Relative Dietary Energy Adequacy Ratios (RDEARs) between pregnant women and male household heads and pregnant women and their mothers-in-law. Diets were measured by repeated 24-h dietary recalls. Results: Relative to control, RDEARs between pregnant women and their mothers-in-law were 12% higher in the PLA plus food arm (log-RDEAR coefficient = 0.12; 95% CI: 0.02, 0.21; P = 0.014), but 10% lower in the PLA-only arm between pregnant women and male household heads (-0.11; 95% CI: -0.19, -0.02; P = 0.020). In all interventions, pregnant women's energy intakes did not improve, but odds of pregnant women consuming iron-folate supplements were 2.5-4.6 times higher, odds of pregnant women consuming more animal-source foods than the household head were 1.7-2.4 times higher, and midupper arm circumference was higher relative to control. Dietary diversity was 0.4 food groups higher in the PLA plus cash arm than in the control arm. Conclusions: All interventions improved maternal diets and nutritional status in pregnancy. PLA women's groups with food transfers increased equity in energy allocation, whereas PLA with cash improved dietary diversity. PLA alone improved diets, but effects were mixed. Scale-up of these interventions in marginalized populations is a policy option, but researchers should find ways to increase adherence to interventions. This trial was registered at www.controlled-trials.com as ISRCTN 75964374.