Targeting strategies for balanced energy and protein (BEP) supplementation in pregnancy: study protocol for the TARGET-BEP cluster-randomized controlled trial in rural Bangladesh.

BACKGROUND: The World Health Organization (WHO) recommends balanced energy and protein (BEP) supplementation be provided to all pregnant women living in undernourished populations, usually defined as having a prevalence > 20% of underweight women, to reduce the risk of stillbirths and small-for-gestational-age neonates. Few geographies meet this threshold, however, and a large proportion of undernourished women and those with inadequate gestational weight gain could miss benefiting from BEP. This study compares the effectiveness of individual targeting approaches for supplementation with micronutrient-fortified BEP vs. multiple micronutrient supplements (MMS) alone as control in pregnancy in improving birth outcomes. METHODS: The TARGET-BEP study is a four-arm, cluster-randomized controlled trial conducted in rural northwestern Bangladesh. Eligible participants are married women aged 15-35 years old identified early in pregnancy using a community-wide, monthly, urine-test-based pregnancy detection system. Beginning at 12-14 weeks of gestation, women in the study area comprising 240 predefined sectors are randomly assigned to one of four intervention arms, with sector serving as the unit of randomization. The interventions involving daily supplementation through end of pregnancy are as follows: (1) MMS (control); (2) BEP; (3) targeted BEP for those with pre-pregnancy body mass index (BMI) < 18.5 kg/m2 and MMS for others; (4) targeted BEP for those with pre-pregnancy BMI < 18.5 kg/m2, MMS for others, and women with inadequate gestational weight gain switched from MMS to BEP until the end of pregnancy. Primary outcomes include birth weight, low birth weight (< 2500 g), and small for gestational age, defined using the 10th percentile of the INTERGROWTH-21st reference, for live-born infants measured within 72 h of birth. Project-hired local female staff visit pregnant women monthly to deliver the assigned supplements, monitor adherence biweekly, and assess weight regularly during pregnancy. Trained data collectors conduct pregnancy outcome assessment and measure newborn anthropometry in the facility or home depending on the place of birth. DISCUSSION: This study will assess the effectiveness of targeted balanced energy and protein supplementation to improve birth outcomes among pregnant women in rural Bangladesh and similar settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT05576207. Registered on October 5th, 2022.

Assessing implementation outcomes for launching balanced energy protein supplementation: A formative study in rural Bangladesh.

Balanced energy protein (BEP) supplementation is an efficacious intervention in pregnancy for improving birthweight and is recommended by World Health Organization (WHO) in countries with high maternal undernutrition. Few countries have implemented BEP programmes due in part to high cost, lack of data on acceptability and feasibility, and complexity of delivery. We sought to address implementation gaps in BEP interventions through a formative study designed to understand implementation outcomes. We conducted 52 in-depth interviews and 8 focus-group discussions with married women of reproductive age, family members, health care providers and pharmacists in three unions of the Gaibandha district in rural Bangladesh. Interviews were translated and transcribed in English and analysed using an analytic framework for implementation science in nutrition. BEP was viewed as an acceptable and appropriate intervention to combat undernutrition in this setting. There was a lack of clarity on who should or could be responsible for providing/distributing BEP in a way convenient to mothers. Many participants preferred door-to-door delivery and thought this approach could address social and gender inequities, but providers mentioned already being overworked and worried about adding new tasks. Participants were concerned about the affordability of BEP and opportunity costs associated with travel to proposed distribution sites such as ANC or pharmacies. Women in these communities do not always have the agency to travel without supervision or make purchasing decisions. BEP supplementation is a complex intervention; future trials seek to assess ways to overcome these implementation challenges and inform a long-term systems-owned BEP intervention.

Acceptability of a balanced energy protein (BEP) supplement for pregnant women in Bangladesh.

Balanced energy protein (BEP) supplementation in pregnancy is recommended in the context of undernutrition for the reduction of small-for-gestational age neonates and stillbirths. To inform an effectiveness trial, we evaluated the acceptability of a packaged, ready-to-eat fortified BEP product among women of reproductive age and their health care providers (HCPs) in rural Bangladesh and explored the feasibility of adhering to daily supplementation. We implemented a formative study using focus groups discussions with women (n = 29) and HCPs (n = 17) to introduce the product and investigate components of acceptability. A "trials of improved practice" activity was conducted in subset of women (n = 16) to evaluate adherence to BEP over a 2-week period, followed by focus group discussions to identify challenges with adherence and strategies employed. Contributors to BEP acceptability included the product's sensory attributes, such as taste, smell and texture; the attractive packaging and informative labelling; and the perceived benefits of use. Participants also identified household and community level factors influencing the adoption of BEP, such as trust in the provider, cultural beliefs on supplement use in pregnancy, and family member tasting and approval. Over the 2-week period, women consumed over 80% of the supplements provided to them and identified strategies for adherence, including visual aids and reminders from family members or providers. HCPs recommended targeted communication messages for mothers-in-law to foster a supportive home environment. Findings informed changes to the BEP product to improve acceptability and shaped the content of communication messages to optimise adherence in a forthcoming effectiveness trial.

Supplementation with fortified balanced energy-protein during pregnancy and lactation and its effects on birth outcomes and infant growth in southern Nepal: protocol of a 2×2 factorial randomised trial.

INTRODUCTION: Many women in low and middle-income countries enter pregnancy with low nutritional reserves with increased risk of fetal growth restriction and poor birth outcomes, including small-for-gestational-age (SGA) and preterm birth. Balanced energy-protein (BEP) supplements have shown reductions in risk of stillbirth and SGA, yet variations in intervention format and composition and limited evidence on the impact of BEP during lactation on growth outcomes warrant further study. This paper describes the protocol of the Maternal Infant Nutrition Trial (MINT) Study, which aims to evaluate the impact of a fortified BEP supplement during pregnancy and lactation on birth outcomes and infant growth in rural Nepal. METHODS AND ANALYSIS: MINT is a 2×2 factorial, household randomised, unblinded, efficacy trial conducted in a subarea of Sarlahi District, Nepal. The study area covers six rural municipalities with about 27 000 households and a population of approximately 100 000. Married women (15-30 years) who become pregnant are eligible for participation in the trial and are randomly assigned at enrolment to supplementation with fortified BEP or not and at birth to fortified BEP supplementation or not until 6 months post partum. The primary pregnancy outcome is incidence of SGA, using the INTERGROWTH-21st standard, among live born infants with birth weight measured within 72 hours of delivery. The primary infant growth outcome is mean length-for-age z-score at 6 months using the WHO international growth reference. ETHICS AND DISSEMINATION: The study was approved by the Institutional Review Board (IRB) at Johns Hopkins Bloomberg School of Public Health, Baltimore, USA (IRB00009714), the Committee on Human Research IRB at The George Washington University, Washington, DC, USA (081739), and the Ethical Review Board of the Nepal Health Research Council, Kathmandu, Nepal (174/2018). TRIAL REGISTRATION NUMBER: NCT03668977.

Trends and determinants of anemia in children 6-59 months and women of reproductive age in Chad from 2016 to 2021.

BACKGROUND: Hemoglobin assessments in children and women have been conducted annually in Chad since 2016 through the Standardized Monitoring and Assessment of Relief and Transitions (SMART) cross-sectional surveys. This analysis aims to characterize national and sub-national trends in anemia among children under five and women of reproductive age from 2016 to 2021 and to compare risk factors for anemia before and during the COVID-19 pandemic. METHODS: Hemoglobin concentrations were measured in approximately half of the 12,000 to 15,000 included households each year, except for 2020 when hemoglobin tests were omitted. For children 6 to 59 months of age, anemia was defined as hemoglobin less than 11.0 g/dL. Anemia was defined as hemoglobin less than 11.0 g/dL and 12.0 g/dL for pregnant women and non-pregnant women, respectively. Trends were stratified by agroecological zone, and tests of proportions were used to assess statistical significance. Simple and multivariate logistic regression models were conducted for 2019 and 2021 to identify risk factors for anemia. RESULTS: Reductions in anemia over the 6-year period were significant among women (47.6-30.8%, p = 0.000) and children (68.6-59.6%, p = 0.000). The Sudanian zone had consistently higher rates, particularly in children, compared to the Sahelian and Saharan zones. Significant declines in women's anemia were observed in all zones from 2019 to 2021, but this global decline was not observed among children, where rates in the Saharan zone significantly increased. In 2019, only minimum dietary diversity significantly reduced the odds of anemia in children (AOR: 0.65, 95%CI: 0.46-0.92), whereas in 2021, improvements in all diet indicators were associated with lower odds of anemia. Improved household socio-economic factors, including head of household literacy, were associated with lower odds of anemia in children (2019 AOR: 0.76, 95%CI: 0.67, 0.88) and women (2019 AOR: 0.75, 95%CI: 0.65, 0.87; 2021 AOR: 0.81, 95%CI: 0.70, 0.93). CONCLUSIONS: Anemia declined significantly in Chad among women of reproductive age and children from 2016 to 2021, but the national prevalence of 60% among children remains unacceptably high. Sub-national differences in anemia rates underline the need to identify and address regional causes of anemia while strengthening national level programs.

Trends and Determinants of Children's Wasting and Women's Thinness in Chad, 2015 to 2021.

BACKGROUND: Cross-sectional surveys using the Standardized Monitoring and Assessment of Relief and Transitions methodology have been conducted annually in Chad since 2015 to evaluate population-level nutritional status. OBJECTIVE: This analysis characterizes national and subnational trends in child wasting and women's thinness from 2015 to 2021 in Chad and identifies risk factors during the COVID-19 pandemic. METHODS: Annual survey data with 12,000 to 15,000 households were included. Wasting was estimated for children 6 to 59 months using the WHO child growth standards, and among women 15 to 49 years, thinness was defined as mid-upper arm circumference <23 cm. Trends were stratified by agroecological zone, and chi-square tests used to assess statistical significance. Simple and multivariate logistic regression models were conducted for 2020 and 2021 to identify risk factors of wasting and thinness. RESULTS: About 11,958 to 17,897 children and 9883 to 15,535 women contributed values each year. National wasting and thinness rates did not significantly decrease over the 7-year period (wasting: 14.1% to 12.1%, P = .43; thinness: 15.2% to 13.4%, P = .51) and wasting rose from 2020 to 2021. The Saharan and Sahelian zones had consistently higher rates compared to the Sudanian zone. Younger age, male sex, inadequate infant and young child feeding practices, and poorer household socio-economic factors were associated with greater odds of child wasting. For women, younger age, lack of nutrition knowledge, and poorer household socio-economic factors increased the odds of thinness. CONCLUSIONS: Undernutrition in Chad has not improved since 2015, and the COVID-19 pandemic likely exacerbated the crisis among children nationally and among women subnationally. Multisectoral approaches and regional targeting of interventions are recommended.

Sources of COVID-19 Vaccine Promotion for Pregnant and Lactating Women in Bangladesh.

COVID-19 vaccines are an effective public health intervention to reduce COVID-19-related morbidity and mortality. Given that pregnant and lactating women have a higher risk of severe COVID-19 complications, it is paramount to understand the factors that inform vaccine decision-making among this population. In this study, we sought to identify facilitators and barriers to COVID-19 vaccine acceptance and vaccine promotion in pregnant and lactating women in Bangladesh. We conducted 40 in-depth interviews with 12 pregnant women, 12 lactating women, and 16 health workers from one urban and four rural communities in Bangladesh. We used a grounded theory approach to identify emerging themes. Our results suggest that health workers and religious leaders played key roles in promoting COVID-19 vaccines in this population. Further, we found that the culture of trust in public health authorities and the existing vaccine infrastructure facilitated vaccine promotion. However, changes in vaccine eligibility and myths and rumors acted as both facilitators and barriers to vaccine promotion within our study. It is crucial that maternal immunization vaccine promotion efforts push pregnant and lactating women toward vaccine acceptance to protect the health of mothers and their babies. Additionally, as new maternal vaccines are developed and licensed, understanding how to best promote vaccines within this group is paramount.

COVID-19 vaccine eligibility of pregnant and lactating women in Bangladesh: Gap between policy and policy interpretation among policymakers and healthcare workers.

SARS-CoV-2 infection in pregnancy is associated with a greater risk of maternal and newborn morbidity and maternal death. Bangladesh confirmed its first COVID-19 case in March of 2020, and vaccination rollout started in January of 2021. In Bangladesh, pregnant women are allowed to receive COVID-19 vaccines during pregnancy with qualifications while lactating women are permitted to receive COVID-19 vaccines with no qualifications as of October 2021. There is limited evidence on how vaccine policies are disseminated, interpreted, and implemented from the national level to the community level in Bangladesh. We conducted in-depth interviews from April-August 2022 with policymakers and healthcare workers in Bangladesh to understand how different stakeholders understood and implemented COVID-19 vaccination policies related to pregnant and lactating women. We interviewed policymakers at three levels: national, divisional, and district, and interviewed healthcare workers from one one urban and three rural communities within one division. We found a gap between policies related to COVID-19 vaccination for pregnant and lactating women and policy interpretation among policymakers and healthcare workers. Policymakers and healthcare workers' perceptions differed related to policy dissemination, attitudes toward policies related to pregnant and lactating women, and eligibility of pregnant and lactating women. Our findings indicate the need for effective dissemination of and understanding of policies. Within the context of vaccine uptake and vaccine acceptance, policymakers play a critical role as they are charged with developing and disseminating policy related to vaccine eligibility. Healthcare workers rely on timely and accurate communication related to vaccine eligibility, including populations, timing, and locations. Efforts are needed to narrow the policy and policy implementation gap as doing so is crucial to controlling vaccine preventable disease.

COVID-19 vaccine decision-making among pregnant and lactating women in Bangladesh.

Pregnant and lactating women's vaccine decision-making process is influenced by many factors. Pregnant women were at increased risk for severe disease and poor health outcomes from COVID-19 at various time points during the pandemic. COVID-19 vaccines have been found to be safe and protective during pregnancy and while breastfeeding. In this study, we sought to examine key factors that informed the decision-making process among pregnant and lactating women in Bangladesh. We conducted 24 in-depth interviews, with 12 pregnant and 12 lactating women. These women were from three communities in Bangladesh: one urban community, and two rural communities. We used a grounded theory approach to identify emerging themes and organized emerging themes using a socio-ecological model. The socio-ecological model suggests that individuals are influenced by many levels, including individual-level influences, interpersonal-level influences, health care system-level influences, and policy-level influences. We found key factors at each socio-ecological level that influenced the decision-making process of pregnant and lactating women, including perceived benefits of vaccines and vaccine safety (individual-level), the influence of husbands and peers (interpersonal-level), health care provider recommendations and vaccine eligibility (health care system-level), and vaccine mandates (policy-level). As vaccination can reduce the effect of COVID-19 disease in mothers, infants, and unborn children, targeting critical factors that inform the decision-making process is paramount for improving vaccine acceptance. We hope the results of this study will inform vaccine acceptance efforts to ensure that pregnant and lactating women take advantage of this life-saving intervention.

Pregnancy Interventions to Improve Birth Outcomes: What Are the Effects on Maternal Outcomes? A Scoping Review.

Objectives: Interventions in pregnancy are commonly evaluated for their effects on birth outcomes because maternal infection and poor nutrition are the primary contributors to adverse pregnancy outcomes, especially in low- and middle-income countries (LMICs). However, the extent to which such interventions directly impact maternal health and nutrition has not been succinctly characterized. Methods: We conducted a scoping review of systematic reviews and meta-analyses of 27 pregnancy interventions to summarize the evidence of impact on maternal outcomes. Results: Overall, these were reported incompletely, and we failed to find any evidence for eight interventions. Influenza vaccination, insecticide-treated bed nets, intermittent preventive treatment for malaria, anthelmintic therapy, and treatment of bacterial vaginosis, asymptomatic bacteriuria, and periodontal disease during pregnancy provided direct benefit to women, with reductions in infection risk. Nutritional interventions such as micronutrient supplementation and balanced energy and protein improved outcomes of maternal anemia and gestational weight gain, particularly in deficient populations. Calcium and low dose aspirin significantly reduced the risk of pre-eclampsia. Conclusion: These findings highlight antenatal interventions benefitting maternal health and provide insights into pathways for impacting birth and infant outcomes.

A socio-ecological exploration to identify factors influencing the COVID-19 vaccine decision-making process among pregnant and lactating women: Findings from Kenya.

The vaccine decision-making process of pregnant and lactating women is complex. Regarding COVID-19, pregnant women are at increased risk for severe disease and poor health outcomes. While pregnant and lactating women were excluded from COVID-19 vaccine trials, available evidence suggests that COVID-19 vaccines are safe and protective during pregnancy. In this study, we used a socio-ecological approach to explore factors influencing the decision-making process for COVID-19 vaccines in pregnant and lactating women in Kenya, for the purpose of informing demand generation strategies. As pregnant and lactating women are influenced by many factors, we conducted 84 in-depth interviews with a variety of stakeholders, including 31 pregnant or lactating women, 20 healthcare workers such as nurses, midwives, doctors, and frontline workers, 25 male family members of pregnant or lactating women, and 8 gatekeepers such as community leaders and faith-based leaders. These individuals were recruited from six communities in Kenya: three urban, and three rural. We applied a grounded theory approach to identify emerging themes and organized emerging themes using the SAGE Vaccine Hesitancy model, which includes three categories of determinants of vaccine acceptance, including contextual influences, individual and group influences, and vaccine and vaccination specific issues. Myths, interpersonal norms, and religion emerged as themes related to contextual influences. Safety, risk perception, and the role of the healthcare worker emerged as themes related to individual and group influences. For vaccine and vaccination specific issues, emerging themes included availability, accessibility, and eligibility. While maternal immunization can substantially reduce the effect of infectious diseases in mothers and infants, vaccine acceptance is critical. However, vaccines do not save lives; vaccination does. We hope the results of this study can be used to tailor communication efforts to increase vaccine demand among pregnant and lactating women.

Clinical trials and pregnancy.

Traditionally, there has been a reluctance to involve pregnant people in clinical trials due to complex ethical issues surrounding the risk to unborn babies. However it is crucial that new interventions are safe and effective for all patients and ensuring this can be difficult to achieve in the absence of clinical trials.

Lack of clear national policy guidance on COVID-19 vaccines influences behaviors in pregnant and lactating women in Kenya.

SARS-CoV-2 infection in pregnancy is associated with a greater risk of maternal and newborn morbidity and maternal death. In Kenya, pregnant and lactating women (PLW) were ineligible to receive COVID-19 vaccines until August 2021. How shifts in policy influence vaccine behaviors, such as health worker recommendations and vaccine uptake, is not well documented. We conducted qualitative interviews with PLW, health workers, and policymakers in Kenya to understand how different stakeholders' perceptions of national policy regarding COVID-19 vaccination in pregnancy shaped vaccine behaviors and decision-making. Policymakers and health workers described pervasive uncertainty and lack of communication about the national policy, cited vaccine safety as their primary concern for administering COVID-19 vaccines to PLW, and expressed that PLW were inadequately prioritized in the COVID-19 vaccine program. PLW perceived the restrictive policy as indicative of a safety risk, resulting in vaccine hesitancy and potentially exacerbated inequities in vaccine access. These findings support the need for the development and dissemination of effective vaccine communication guidelines and the prioritization of PLW in COVID-19 vaccination policies and campaigns. To ensure PLW do not face the same inequities in future epidemics, data on infectious disease burdens and vaccine uptake should be collected systematically among pregnant women, and PLW should be included in future vaccine trials.

Conceptualizing the COVID-19 Pandemic: Perspectives of Pregnant and Lactating Women, Male Community Members, and Health Workers in Kenya.

Pregnant women are at greater risk of adverse outcomes from SARS-CoV-2 infection. There are several factors which can influence the ways in which pregnant women perceive COVID-19 disease and behaviorally respond to the pandemic. This study seeks to understand how three key audiences-pregnant and lactating women (PLW), male community members, and health workers-in Kenya conceptualize COVID-19 to better understand determinants of COVID-19 related behaviors. This study used qualitative methods to conduct 84 in-depth interviews in three counties in Kenya. Data were analyzed using a grounded theory approach. Emerging themes were organized based on common behavioral constructs thought to influence COVID-19 related behaviors and included myths, risk perception, economic implications, stigma, and self-efficacy. Results suggest that risk perception and behavioral attitudes substantially influence the experiences of PLW, male community members, and health workers in Kenya during the COVID-19 pandemic. Public health prevention and communication responses targeting these groups should address potential barriers to preventive health behaviors, such as the spread of misinformation, financial constraints, and fear of social ostracization.

Global disparities in public health guidance for the use of COVID-19 vaccines in pregnancy.

INTRODUCTION: Gaps in information about the safety and efficacy of COVID-19 vaccines in pregnancy have led to substantial global variation in public health guidance regarding the use of COVID-19 vaccines in pregnancy over the course of the pandemic. METHODS: We conducted systematic screenings of public health authorities' websites across 224 countries and territories every 3 weeks to track the development of policies on COVID-19 vaccine use in pregnancy. Policies were categorised using a 1-5 permissiveness scale, with 1 indicating policies that recommended use, and 5 indicating policies that recommended against use. RESULTS: As of 30 September 2021, 176 countries/territories had issued explicit guidance on COVID-19 vaccine use in pregnancy, with 38% recommending use, 28% permitting use, 15% permitting use with qualifications, 2% not recommending but with exceptions, and 17% not recommending use whatsoever. This represented a significant shift from May 2021, when only 6% of countries/territories with such policies recommended the use of COVID-19 vaccines in pregnancy (p<0.001). However, no policy positions could be found for 21% of all countries and territories, the vast majority being low and middle income. Policy positions also varied widely by vaccine product, with Pfizer/BioNTech and Moderna vaccines being most commonly recommended or permitted. CONCLUSION: Our study highlights the evolution of policies regarding COVID-19 vaccine use in pregnancy over a 5-month period in 2021, the role of pregnancy-specific data in shaping these policies and how inequities in access for pregnant people persist, both within countries and globally.

COVID-19 vaccine acceptance among Bangladeshi adults: Understanding predictors of vaccine intention to inform vaccine policy.

OBJECTIVES: The purpose of this study was to identify predictors of COVID-19 vaccine intention among Bangladeshi adults. METHODS: Secondary data from the COVID-19 Beliefs, Behaviors & Norms Survey conducted by the Massachusetts Institute of Technology (MIT) and Facebook were analyzed. Data were collected from 2,669 adult Facebook users in Bangladesh and was collected between February 15 and February 28, 2021. Binomial logistic regression examined the relationship between COVID-19 vaccination intent and demographic variables, risk perception, preventive behaviors, COVID-19 knowledge, and likelihood of future actions. RESULTS: Seventy-nine percent of respondents reported intent to get the COVID-19 vaccine when it becomes available. Intent to get vaccinated was highest among females, adults aged 71-80, individuals with college or graduate-level degrees, city dwellers, and individuals who perceived that they were in excellent health. Results of the binomial logistic regression indicated that predictors of vaccination intent include age (OR = 1.39), high risk perception of COVID-19 (OR = 1.47), and intent to practice social distancing (OR = 1.22). DISCUSSION: Findings suggest that age, perceived COVID-19 risk, and non-pharmaceutical COVID-19 interventions may predict COVID-19 vaccination intent among Bangladeshi adults. Findings can be used to create targeted messaging to increase demand for and uptake of COVID-19 vaccines in Bangladesh.

Leveraging water, sanitation and hygiene for nutrition in low- and middle-income countries: A conceptual framework.

In low- and middle-income countries (LMICs), access to water, sanitation and hygiene (WASH) is associated with nutritional status including stunting, which affects 144 million children under 5 globally. Despite the consistent epidemiological association between WASH indicators and nutritional status, the provision of WASH interventions alone has not been found to improve child growth in recent randomized control trials. We conducted a literature review to develop a new conceptual framework that highlights what is known about the WASH to nutrition pathways, the limitations of certain interventions and how future WASH could be leveraged to benefit nutritional status in populations. This new conceptual framework will provide policy makers, program implementors and researchers with a visual tool to bring into perspective multiple levels of WASH and how it may effectively influence nutrition while identifying existing gaps in implementation and research.