Controlled Trial In Rural Bangladesh Research Articles

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

BackgroundThe 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.MethodsThe 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.DiscussionThis 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 registrationClinicalTrials.gov NCT05576207. Registered on October 5th, 2022.

Comparing delivery channels to promote nutrition-sensitive agriculture: A cluster-randomized controlled trial in Bangladesh

We use a randomized controlled trial in rural Bangladesh to compare two models of delivering nutrition content jointly to husbands and wives: deploying female nutrition workers versus mostly male agriculture extension workers. Both approaches increased nutrition knowledge of men and women, household and individual diet quality, and women’s empowerment. Intervention effects on agriculture and nutrition knowledge, agricultural production diversity, dietary diversity, women’s empowerment, and gender parity do not significantly differ between models where nutrition workers versus agriculture extension workers provide the training. The exception is in an attitudes score, where results indicate same-sex agents may affect scores differently than opposite-sex agents. Our results suggest opposite-sex agents may not necessarily be less effective in providing training. In South Asia, where agricultural extension systems and the pipeline to those systems are male-dominated, training men to deliver nutrition messages may offer a temporary solution to the shortage of female extension workers and offer opportunities to scale and promote nutrition-sensitive agriculture. However, in both models, we find evidence that the presence of mothers-in-law within households modifies the programs’ effectiveness on some nutrition, empowerment, and attitude measures, suggesting that accounting for other influential household members is a potential area for future programming.

Assessing sustained uptake of latrine and child feces management interventions: Extended follow-up of a cluster-randomized controlled trial in rural Bangladesh 1-3.5 years after intervention initiation.

Sanitation interventions typically result in modest increases in latrine access, and any gains in latrine access and use are often not sustained over time. Sanitation programs also rarely include child-focused interventions such as potties. We aimed to assess the sustained effect of a multi-component sanitation intervention on access to and use of latrines and child feces management tools in rural Bangladesh. We conducted a longitudinal substudy nested within the WASH Benefits randomized controlled trial. The trial provided latrine upgrades, child potties and sani-scoops for feces removal, along with behavior change promotion to encourage use of the delivered hardware. Promotion visits to intervention recipients were frequent during the first 2 years after intervention initiation, decreased in frequency between years 2-3, and ceased after 3 years. We enrolled a random subset of 720 households from the sanitation and control arms of the trial in a substudy and visited them quarterly between 1 and 3.5 years after intervention initiation. At each visit, field staff recorded sanitation-related behaviors through spot-check observations and structured questionnaires. We assessed intervention effects on observed indicators of hygienic latrine access, potty use and sani-scoop use and investigated whether these effects were modified by duration of follow-up, ongoing behavior change promotion and household characteristics. The intervention increased hygienic latrine access from 37% among controls to 94% in the sanitation arm (p<0.001). Access among intervention recipients remained high 3.5 years after intervention initiation, including periods with no active promotion. Gains in access were higher among households with less education, less wealth and larger number of residents. The intervention increased availability of child potties from 29% among controls to 98% in the sanitation arm (p<0.001). However, fewer than 25% of intervention households reported exclusive child defecation in a potty or had observed indicators of potty and sani-scoop use, and gains in potty use declined over the follow-up period, even with ongoing promotion. Our findings from an intervention that provided free products and intensive initial behavior change promotion suggest a sustained increase in hygienic latrine access up to 3.5 years after intervention initiation but infrequent use of child feces management tools. Studies should investigate strategies to ensure sustained adoption of safe child feces management practices.

Evaluation of an on-site sanitation intervention against childhood diarrhea and acute respiratory infection 1 to 3.5 years after implementation: Extended follow-up of a cluster-randomized controlled trial in rural Bangladesh.

Diarrhea and acute respiratory infection (ARI) are leading causes of death in children. The WASH Benefits Bangladesh trial implemented a multicomponent sanitation intervention that led to a 39% reduction in the prevalence of diarrhea among children and a 25% reduction for ARI, measured 1 to 2 years after intervention implementation. We measured longer-term intervention effects on these outcomes between 1 to 3.5 years after intervention implementation, including periods with differing intensity of behavioral promotion. WASH Benefits Bangladesh was a cluster-randomized controlled trial of water, sanitation, hygiene, and nutrition interventions (NCT01590095). The sanitation intervention included provision of or upgrades to improved latrines, sani-scoops for feces removal, children's potties, and in-person behavioral promotion. Promotion was intensive up to 2 years after intervention initiation, decreased in intensity between years 2 to 3, and stopped after 3 years. Access to and reported use of latrines was high in both arms, and latrine quality was significantly improved by the intervention, while use of child feces management tools was low. We enrolled a random subset of households from the sanitation and control arms into a longitudinal substudy, which measured child health with quarterly visits between 1 to 3.5 years after intervention implementation. The study period therefore included approximately 1 year of high-intensity promotion, 1 year of low-intensity promotion, and 6 months with no promotion. We assessed intervention effects on diarrhea and ARI prevalence among children <5 years through intention-to-treat analysis using generalized linear models with robust standard errors. Masking was not possible during data collection, but data analysis was masked. We enrolled 720 households (360 per arm) from the parent trial and made 9,800 child observations between June 2014 and December 2016. Over the entire study period, diarrheal prevalence was lower among children in the sanitation arm (11.9%) compared to the control arm (14.5%) (prevalence ratio [PR] = 0.81, 95% CI 0.66, 1.00, p = 0.05; prevalence difference [PD] = -0.027, 95% CI -0.053, 0, p = 0.05). ARI prevalence did not differ between sanitation (21.3%) and control (22.7%) arms (PR = 0.93, 95% CI 0.82, 1.05, p = 0.23; PD = -0.016, 95% CI -0.043, 0.010, p = 0.23). There were no significant differences in intervention effects between periods with high-intensity versus low-intensity/no promotion. Study limitations include use of caregiver-reported symptoms to define health outcomes and limited data collected after promotion ceased. The observed effect of the WASH Benefits Bangladesh sanitation intervention on diarrhea in children appeared to be sustained for at least 3.5 years after implementation, including 1.5 years after heavy promotion ceased. Existing latrine access was high in the study setting, suggesting that improving on-site latrine quality can deliver health benefits when latrine use practices are in place. Further work is needed to understand how latrine adoption can be achieved and sustained in settings with low existing access and how sanitation programs can adopt transformative approaches of excreta management, including safe disposal of child and animal feces, to generate a hygienic home environment. ClinicalTrials.gov; NCT01590095; https://clinicaltrials.gov/ct2/show/NCT01590095.

Effect of nutrition counselling with a digital job aid on child dietary diversity: Analysis of secondary outcomes from a cluster randomised controlled trial in rural Bangladesh.

Adequate dietary diversity among infants is often suboptimal in developing countries. We assessed the impact of nutrition counselling using a digital job aid on dietary diversity of children aged 6–23 months using data from a cluster randomised controlled trial in Bangladesh. The trial had five arms, each with 25 clusters. The four intervention arms provided counselling using a digital job aid and different prenatal and post‐natal combinations of lipid‐based supplements and the comparison arm with usual practice. We enrolled 1500 pregnant women and followed them until the children reached their second birthday. We developed a tablet‐based system for intervention delivery, data collection and project supervision. We combined the four intervention arms (n = 855), in which community health workers (CHWs) provided age‐appropriate complementary feeding counselling, to compare against the comparison arm (n = 403). We calculated the outcome indicators from the children's 24‐h dietary recalls. Overall, the intervention increased the mean dietary diversity score by 0.09 (95% confidence interval [CI]: 0.2–0.16) and odds of minimum dietary diversity by 18% (95% CI: 0.99–1.40). However, there was a significant interaction on the effect of the intervention on dietary diversity by age. The mean dietary diversity score was 0.24 (95% CI: 0.11–0.37) higher in the intervention than in the comparison arm at 9 months and 0.14 (95% CI: 0.01–27) at 12 months of age. The intervention effect was non‐significant at an older age. Overall, consumption of flesh food was 1.32 times higher in the intervention arm (odds ratio [OR] 1.32, 95% CI: 1.11–1.57) in 6–23 months of age. The intervention significantly improved child dietary diversity score in households with mild and moderate food insecurity by 0.27 (95% CI: 0.06–0.49) and 0.16 (0.05–27), respectively, but not with food‐secure and severely food‐insecure households. Although the study did not evaluate the impact of digital job aid alone, the findings indicate the utility of nutrition counselling by CHWs using a digital job aid to improve child feeding practices in broader programmes.

Achieving equitable uptake of handwashing and sanitation by addressing both supply and demand-based constraints: findings from a randomized controlled trial in rural Bangladesh

BackgroundSupply driven programs that are not closely connected to community demand and demand-driven programs that fail to ensure supply both risk worsening inequity. Understanding patterns of uptake of behaviors among the poorest under ideal experimental conditions, such as those of an efficacy trial, can help identify strategies that could be strengthened in routine programmatic conditions for more equitable uptake. WASH Benefits Bangladesh was a randomized controlled efficacy trial that provided free-of cost WASH hardware along with behavior change promotion. The current paper aimed to determine the impact of the removal of supply and demand constraints on the uptake of handwashing and sanitation behaviors across wealth and education levels.MethodsThe current analysis selected 4 indicators from the WASH Benefits trial— presence of water and soap in household handwashing stations, observed mother’s hand cleanliness, observed visible feces on latrine slab or floor and reported last child defecation in potty or toilet. A baseline assessment was conducted immediately after enrolment and endline assessment was conducted approximately 2 years later. We compared change in uptake of these indicators including wealth quintiles (Q) between intervention and control groups from baseline to endline.ResultsFor hand cleanliness, the poorest mothers improved more [Q1 difference in difference, DID: 16% (7, 25%)] than the wealthiest mothers [Q5 DID: 7% (− 4, 17%)]. The poorest households had largest improvements for observed presence of water and soap in handwashing station [Q1 DID: 82% (75, 90%)] compared to the wealthiest households [Q5 DID: 39% (30, 50%)]. Similarly, poorer household demonstrated greater reductions in visible feces on latrine slab or floor [Q1DID, − 25% (− 35, − 15) Q2: − 34% (− 44, − 23%)] than the wealthiest household [Q5 DID: − 1% (− 11, 8%). For reported last child defecation in potty or toilet, the poorest mothers showed greater improvement [Q1–4 DID: 50–54% (44, 60%)] than the wealthier mothers [Q5 DID: 39% (31, 46%).ConclusionBy simultaneously addressing supply and demand-constraints among the poorest, we observed substantial overall improvements in equity. Within scaled-up programs, a separate targeted strategy that relaxes constraints for the poorest can improve the equity of a program.Trial registrationWASH Benefits Bangladesh: ClinicalTrials.gov, identifier: NCT01590095. Date of registration: April 30, 2012 ‘Retrospectively registered’.

Effect of water, sanitation, handwashing and nutrition interventions on enteropathogens in children 14 months old: a cluster-randomized controlled trial in rural Bangladesh.

We evaluated the impact of low-cost water, sanitation, handwashing (WSH) and child nutrition interventions on enteropathogen carriage in the WASH Benefits cluster-randomized controlled trial in rural Bangladesh. We analyzed 1411 routine fecal samples from children 14±2 months old in the WSH (n = 369), nutrition counseling plus lipid-based nutrient supplement (n = 353), nutrition plus WSH (n = 360), and control (n = 329) arms for 34 enteropathogens using quantitative PCR. Outcomes included the number of co-occurring pathogens; cumulative quantity of four stunting-associated pathogens; and prevalence and quantity of individual pathogens. Masked analysis was by intention-to-treat. 326 (99.1%) control children had one or more enteropathogens detected (mean 3.8±1.8). Children receiving WSH interventions had lower prevalence and quantity of individual viruses than controls (prevalence difference for norovirus: -11% [95% confidence interval [CI], -5 to -17%]; sapovirus: -9% [95%CI, -3 to -15%]; and adenovirus 40/41: -9% [95%CI, -2 to - 15%]). There was no difference in bacteria, parasites, or cumulative quantity of stunting-associated pathogens between controls and any intervention arm. WSH interventions were associated with fewer enteric viruses in children aged 14 months. Different strategies are needed to reduce enteric bacteria and parasites at this critical young age.

Can visual nudges reduce smoking tobacco expenditure? Evidence from a clustered randomized controlled trial in rural Bangladesh

AbstractIntroductionA household-level constant visual deterrent advocacy campaign to reduce tobacco intake was conducted in rural Bangladesh.AimsTo evaluate smoking tobacco expenditure by campaign components.MethodsWe conducted a single-blind clustered randomized controlled trial on 630 adult male household heads from 16 chars (riverine islands) in rural northern Bangladesh, between November 2018 and January 2019. Intervention allotment was randomized at the char level to minimize spillovers, with 8 chars in treatment and control groups each. The intervention provided households in treatment chars (n = 323) with two visual warning posters, detailing the health effects of tobacco on oneself and external actors, to be hung inside the household for 4 weeks. Households in control chars (n = 307) received nothing. Reported daily smoking (log) tobacco expenditure values were the primary outcome of interest.ResultsFinal analysis was conducted using 251 and 210 smokers in treatment and control chars respectively. The intervention reduced relative smoking tobacco expenditure by 12.8% (95% CI −31.45 to 5.81) but was not statistically significant (P-value = 0.163). Weak to moderate emotional reactions to the posters was identified as a reason for the statistical insignificance.ConclusionFor a visual anti-tobacco intervention to have a substantial impact, it must induce strong emotional responses.

Maternal and Infant Iron Status Are Related to Mother-Infant Interactions (P10-094-19)

ObjectivesTo examine the association between iron status and mother-infant interactions in dyads from rural Bangladesh. MethodsMaternal-infant interactions were assessed in dyads from a substudy nested within a randomized controlled trial in rural Bangladesh. Recorded interactions (10 minutes free-play; 2 minutes diapering) at baseline (BL) (infant age 6–18 mo; n = 116), midline (ML) (+ 3 mo; n = 324), and endline (EL) (+ 6 mo; n = 336) were coded per the Emotional Availability Scales (EAS; 4 maternal scales: sensitivity, structuring, non-intrusiveness, non-hostility; 2 child scales: responsiveness, involvement). Ferritin (Ft), transferrin receptor (TfR), and hemoglobin (Hb; in infants only) concentrations were measured at BL and EL. Group differences (categorized by iron status irrespective of intervention group) were assessed via ANCOVA (covariates: socioeconomic status, mean upper arm circumference, weight-for-age Z-score, child sex and age and maternal depressive symptoms (Center for Epidemiologic Studies Depression Scale) and reasoning abilities (Raven’s Progressive Matrices)). Stepwise regressions were run to determine predictors of the EAS scores. ResultsPrevalence of iron deficiency (ID; Ft < 23.7 mg/L) in infants dropped from 55% to 38% and of ID anemia (IDA; Hb < 110 g/L) from 53% to 32%, respectively. Only 12% of mothers were ID (Ft < 15.0 μg/L). Dyads of iron sufficient (IS) infants had higher involvement scores at BL and ML (both P ≤ 0.04), and higher sensitivity and structuring but lower non-intrusiveness scores (all P < 0.01) at ML vs dyads of ID infants. In the regressions, iron status of the mother and/or child was significantly predictive of maternal behaviors for most of the EA scales at all time points with better iron status predicting better behavioral scores except for non-intrusiveness. At BL (but not EL), child BL TfR was negatively related to involvement and responsiveness. No other iron status variables were associated with child behavior at any time point. ConclusionsAn association exists between maternal and infant iron status and dyadic interaction. Adequate iron status appears to benefit the dyadic relationship. Funding SourcesUSAID through the Johns Hopkins Global Research Activity Cooperative Agreement.

Effects of water, sanitation, handwashing and nutritional interventions on soil-transmitted helminth infections in young children: A cluster-randomized controlled trial in rural Bangladesh.

BackgroundSoil transmitted helminths (STH) infect >1.5 billion people. Mass drug administration (MDA) effectively reduces infection; however, there is evidence for rapid reinfection and risk of potential drug resistance. We conducted a randomized controlled trial in Bangladesh (WASH Benefits, NCT01590095) to assess whether water, sanitation, hygiene and nutrition interventions, alone and combined, reduce STH in a setting with ongoing MDA.Methodology/Principal findingsIn 2012–2013, we randomized 720 clusters of 5551 pregnant women into water treatment, sanitation, handwashing, combined water+sanitation+handwashing (WSH), nutrition, nutrition+WSH (N+WSH) or control arms. In 2015–2016, we enrolled 7795 children, aged 2–12 years, of 4102 available women for STH follow-up and collected stool from 7187. We enumerated STH infections with Kato-Katz. We estimated intention-to-treat intervention effects on infection prevalence and intensity. Participants and field staff were not blinded; laboratory technicians and data analysts were blinded.Prevalence among controls was 36.8% for A. lumbricoides, 9.2% for hookworm and 7.5% for T. trichiura. Most infections were low-intensity. Compared to controls, the water intervention reduced hookworm by 31% (prevalence ratio [PR] = 0.69 (0.50,0.95), prevalence difference [PD] = -2.83 (-5.16,-0.50)) but did not affect other STH. Sanitation improvements reduced T. trichiura by 29% (PR = 0.71 (0.52,0.98), PD = -2.17 (-4.03,-0.38)), had a similar borderline effect on hookworm and no effect on A. lumbricoides. Handwashing and nutrition interventions did not reduce any STH. WSH and N+WSH reduced hookworm prevalence by 29–33% (WSH: PR = 0.71 (0.52,0.99), PD = -2.63 (-4.95,-0.31); N+WSH: PR = 0.67 (0.50,0.91), PD = -3.00 (-5.14,-0.85)) and marginally reduced A. lumbricoides. Effects on infection intensity were similar.Conclusions/SignificanceIn a low-intensity infection setting with MDA, we found modest but sustained hookworm reduction from water treatment and combined WSH interventions. Impacts were more pronounced on STH species with short vs. long-term environmental survival. Our findings suggest possible waterborne transmission for hookworm. Water treatment and sanitation improvements can augment MDA to interrupt STH transmission.Trial registrationNCT01590095.

Complementary feeding practices among rural Bangladeshi mothers: Results from WASH Benefits study.

Inappropriate complementary feeding contributes to linear growth faltering in early childhood. Behaviour change interventions have been effective at improving practice, but few studies have investigated the effects of multicomponent integrated interventions. We conducted a cluster‐randomized controlled trial in rural Bangladesh in which geographic clusters were randomized into seven arms: water treatment (W), sanitation (S), handwashing (H), water, sanitation, and handwashing (WSH), improved nutrition with infant and young child feeding messages and lipid‐based nutrient supplementation for 6‐ to 24‐month olds (N), N+WSH, and control. The objective of this paper was to examine the independent and combined effects of interventions on indicators of complementary feeding. Approximately 1 and 2 years after initiation of the intervention, research assistants surveyed mothers about infant feeding practices. Complementary feeding was examined using the World Health Organization indicators of infant and young child feeding practices. We used Poisson regression models to estimate prevalence ratios and linear regression models for prevalence differences with clustered sandwich estimators to adjust for clustering. A total of 4,718 households from 720 clusters were surveyed at year 1 and 4,667 at year 2. The children in the nutrition arms had a higher prevalence of meeting the minimum dietary diversity score compared with controls (year 1: N: 66.4%; N+WSH: 65.0% vs. C:32.4%; year 2: N: 91.5%; N+WSH: 91.6% vs. C:77.7%). Children in the nutrition arms received diverse food earlier than the children in control arm. In addition, the average consumption of lipid‐based nutrient supplementation was >90% in each follow‐up. Nutrition‐specific interventions could be integrated with nutrition‐sensitive interventions such as WSH without compromising the uptake of the nutrition intervention.

A community-based cluster randomised controlled trial in rural Bangladesh to evaluate the impact of the use of iron-folic acid supplements early in pregnancy on the risk of neonatal mortality: the Shonjibon trial

BackgroundIron-deficiency is the most common nutritional deficiency globally. Due to the high iron requirements for pregnancy, it is highly prevalent and severe in pregnant women. There is strong evidence that maternal iron deficiency anaemia increases the risk of adverse perinatal outcomes. However, most of the evidence is from observational epidemiological studies except for a very few randomised controlled trials. IFA supplements have also been found to reduce the preterm delivery rate and neonatal mortality attributable to prematurity and birth asphyxia. These results combined indicate that IFA supplements in populations of iron-deficient pregnant women could lead to a decrease in the number of neonatal deaths mediated by reduced rates of preterm delivery. In this paper, we describe the protocol of a community-based cluster randomised controlled trial that aims to evaluate the impact of maternal antenatal IFA supplements on perinatal outcomes.Methods/designThe effect of the early use of iron-folic acid supplements on neonatal mortality will be examined using a community based, cluster randomised controlled trial in five districts with 30,000 live births. In intervention clusters trained BRAC village volunteers will identify pregnant women & provide iron-folic acid supplements. Groundwater iron levels will be measured in all study households using a validated test kit. The analysis will follow the intention to treat principle. We will compare neonatal mortality rates & their 95% confidence intervals adjusted for clustering between treatment groups in each groundwater iron-level group. Cox proportional hazards mixed models will be used for mortality outcomes & will include groundwater iron level as an interaction term in the mortality model.DiscussionThis paper aims to describe the study protocol of a community based randomised controlled trial evaluating the impact of the use of iron-folic acid supplements early in pregnancy on the risk of neonatal mortality. This study is critical because it will determine if antenatal IFA supplements commenced in the first trimester of pregnancy, rather than later, will significantly reduce neonatal deaths in the first month of life, and if this approach is cost-effective.Trial registrationThis trial has been registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) on 31 May 2012. The registration ID is ACTRN12612000588897.

Effects of water, sanitation, handwashing, and nutritional interventions on telomere length among children in a cluster-randomized controlled trial in rural Bangladesh.

Shorter childhood telomere length (TL) and more rapid TL attrition are widely regarded as manifestations of stress. However, the potential effects of health interventions on child TL are unknown. We hypothesized that a water, sanitation, handwashing (WSH), and nutritional intervention would slow TL attrition during the first two years of life. In a trial in rural Bangladesh, we randomized geographical clusters of pregnant women into individual water treatment, sanitation, handwashing, nutrition, combined WSH, combined nutrition plus WSH (N + WSH), or control arms. We conducted a substudy enrolling children from the control arm and the N + WSH intervention arm. Participants and outcome assessors were not masked; analyses were masked. Relative TL was measured at 1 and 2 years after intervention, and the change in relative TL was reported. Analysis was intention-to-treat. Between May 2012 and July 2013, in the overall trial, we randomized 720 geographical clusters of 5551 pregnant women to a control or an intervention arm. In this substudy, after 1 year of intervention, we assessed a total of 662 children (341 intervention and 321 control) and 713 children after 2 years of intervention (383 intervention and 330 control). Children in the intervention arm had significantly shorter relative TL compared with controls after 1 year of intervention (difference −163 base pairs (bp), p=0.001). Between years 1 and 2, TL increased in the intervention arm (+76 bp) and decreased in the controls (−23 bp) (p=0.050). After 2 years, there was no difference between the arms (p=0.305). Our unexpected finding of increased telomere attrition during the first year of life in the intervention group suggests that rapid telomere attrition during this critical period could reflect the improved growth in the intervention group, rather than accumulated stress. Funded by The Bill and Melinda Gates Foundation. NCT01590095.

Making a balanced plate for pregnant women to improve birthweight of infants: a study protocol for a cluster randomised controlled trial in rural Bangladesh

ObjectivesLow birthweight significantly contributes to neonatal mortality, morbidities and psychosocial debilities throughout the course of life. A large proportion of infants (36–55%) in Bangladesh is born with low birthweight. Nutritional...

Effect of complementary food supplementation on breastfeeding and home diet in rural Bangladeshi children

Background: Complementary food supplements (CFSs) can enhance growth where stunting is common, but substitution for the usual diet may reduce observed benefits.Objective: We aimed to characterize dietary diversity from home foods in a CFS efficacy trial and determine whether supplementation reduced breastfeeding frequency or displaced home foods.Design: In a cluster-randomized controlled trial in rural Bangladesh, children (n = 5499) received, for 1 y starting at age 6 mo, periodic child feeding counseling for mothers (control) or counseling plus 1 of 4 CFSs fed as a daily snack. Breastfeeding status and past 24-h diet were assessed at enrollment and every 3 mo thereafter until 18 mo of age. A 7–food group dietary diversity score (DDS) was calculated from home foods only, and a DDS ≥4 constituted minimum dietary diversity (MDD).Results: Most children (97%) were breastfed through 18 mo of age, and 24-h breastfeeding frequency did not differ by supplementation group. Child dietary diversity was low; only 51% of children met the MDD by 18 mo. Rice, potatoes, and biscuits (cookies) were the most frequently consumed foods, whereas the legumes, dairy, eggs, and vitamin A–rich fruit and vegetable food groups were each consumed by <50% of children. The odds of meeting the MDD through the consumption of home foods were equal or greater in the supplemented groups compared with the control group at all ages. High socioeconomic status and any maternal education were associated with increased odds of MDD at age 18 mo, whereas child sex and household food security were not associated with MDD.Conclusions: In a setting where daily complementary food supplementation improved linear growth, there was no evidence that supplementation displaced breastfeeding or home foods, and the supplementation may have improved dietary diversity. Pathways by which supplementation with fortified foods may enhance dietary diversity, such as an improved appetite and increased body size, need elucidation. This trial was registered at clinicaltrials.gov as NCT01562379.

A home calendar and recall method of last menstrual period for estimating gestational age in rural Bangladesh: a validation study.

BackgroundThe best method of gestational age assessment is by ultrasound in the first trimester; however, this method is impractical in large field trials in rural areas. Our objective was to assess the validity of gestational age estimated from prospectively collected date of last menstrual period (LMP) using crown-rump length (CRL) measured in early pregnancy by ultrasound.MethodsAs part of a large, cluster-randomized, controlled trial in rural Bangladesh, we collected dates of LMP by recall and as marked on a calendar every 5 weeks in women likely to become pregnant. Among those with a urine-test confirmed pregnancy, a subset with gestational age of <15 weeks (n = 353) were enrolled for ultrasound follow-up to measure CRL. We compared interview-assessed LMP with CRL gestational age estimates and classification of preterm, term, and post-term births.ResultsLMP-based gestational age was higher than CRL by a mean (SD) of 2.8 (10.7) days; differences varied by maternal education and preterm birth (P < 0.05). Lin’s concordance correlation coefficient was good at ultrasound [0.63 (95 % CI 0.56, 0.69)] and at birth [0.77 (95 % CI 0.73, 0.81)]. Validity of classifying preterm birth was high but post-term was lower, with specificity of 96 and 89 % and sensitivity of 86 and 67 %, respectively. Results were similar by parity.ConclusionsProspectively collected LMP provided a valid estimate of gestational age and preterm birth in a rural, low-income setting and may be a suitable alternative to ultrasound in programmatic settings and large field trials.Trial registrationClinicalTrials.gov NCT00860470 Electronic supplementary materialThe online version of this article (doi:10.1186/s41043-016-0072-y) contains supplementary material, which is available to authorized users.

Impact of a randomized controlled trial in arsenic risk communication on household water-source choices in Bangladesh

We conducted a randomized controlled trial in rural Bangladesh to examine how household drinking-water choices were affected by two different messages about risk from naturally occurring groundwater arsenic. Households in both randomized treatment arms were informed about the arsenic level in their well and whether that level was above or below the Bangladesh standard for arsenic. Households in one group of villages were encouraged to seek water from wells below the national standard. Households in the second group of villages received additional information explaining that lower-arsenic well water is always safer and these households were encouraged to seek water from wells with lower levels of arsenic, irrespective of the national standard. A simple model of household drinking-water choice indicates that the effect of the emphasis message is theoretically ambiguous. Empirically, we find that the richer message had a negative, but insignificant, effect on well-switching rates, but the estimates are sufficiently precise that we can rule out large positive effects. The main policy implication of this finding is that a one-time oral message conveying richer information on arsenic risks, while inexpensive and easily scalable, is unlikely to be successful in reducing exposure relative to the status-quo policy.

Maternal vitamin A and β-carotene supplementation and risk of bacterial vaginosis: a randomized controlled trial in rural Bangladesh

Bacterial vaginosis (BV) in pregnancy is linked to preterm birth, but its risk factors are not well understood. Micronutrient deficiencies may be associated with an increased risk of this condition. We assessed the effect of weekly vitamin A or β-carotene supplementation during pregnancy until 3 mo postpartum on BV risk in rural northeastern Bangladesh. In this cluster-randomized, placebo-controlled trial, 33 clusters (n = 33) were randomly assigned to 3 groups. Women (n = 1812) were examined for BV by using self-administered swabs and the Nugent scoring method in early pregnancy, at 32 wk of gestation, and at 3 mo postpartum. The prevalence of BV in early pregnancy, before supplementation, was 7.6% (95% CI: 6.3%, 9.1%) overall. Neither the prevalence nor the incidence of BV in the third trimester differed by supplement group. However, the prevalence (OR: 0.71; 95% CI: 0.52, 0.98) and incidence (RR: 0.58; 95% CI: 0.41, 0.81) of BV at 3 mo postpartum was lower among women in the vitamin A group (9.1% and 6.7%, respectively) than in the placebo group (12.4% and 11.8%, respectively), but not in the β-carotene group. Both vitamin A and β-carotene reduced the prevalence and incidence of BV at both time points (ie, third trimester and 3 mo postpartum) by 30-40% compared with placebo (all P < 0.05). Weekly vitamin A supplementation reduced the risk of maternal BV in this rural Bangladeshi population. Enhancement of vitamin A status before and during pregnancy may reduce the risk of BV in areas with vitamin A deficiency. This trial is registered at clinicaltrials.gov as NCT00198822.

Bright Lines, Risk Beliefs, and Risk Avoidance: Evidence from a Randomized Intervention in Bangladesh

We conducted a randomized controlled trial in rural Bangladesh to examine how household drinking water choices were aected by dierent methods of communication about risk from naturally occurring groundwater arsenic. Households in a first group of villages received information about arsenic in tubewell water in a bright-lines format that emphasizes that arsenic levels above the Bangladesh national standard is unsafe. In the remaining villages, we added a gradient message that emphasized how risks from exposure increase with arsenic levels. Unexpectedly, households receiving the gradient message were 9 percentage points less likely to take mitigating action by switching sources. This average masks significant heterogeneity in treatment eects across the arsenic distribution that does not appear to be explained by heterogeneity in households’ observed characteristics. The gradient message led to 52% more switching of water sources when the arsenic level was moderately unsafe, but 38% less switching at high arsenic levels, although only the latter dierence is significant at the five percent level. The dierences in behavior are at least partially explained by discrepancies in risk perception that