Comparing two simplified questionnaire-based methods with 24-h recalls for estimating fortifiable wheat flour and oil consumption in Mandaluyong City, Philippines.

Information on fortifiable food consumption is essential to design, monitor and evaluate fortification programmes, yet detailed methods like 24-h recalls (24HRs) that provide such data are rarely conducted. Simplified questionnaire-based methods exist but their validity compared with 24HRs has not been shown. We compared two simplified methods (i.e., a household food acquisition and purchase questionnaire [FAPQ] and a 7-day semiquantitative food frequency questionnaire [SQ-FFQ]) against 24HRs for estimating fortifiable food consumption. We assessed the consumption of fortifiable wheat flour and oil using a FAPQ and, for wheat flour only, a 7-day SQ-FFQ and compared the results against 24HRs. The participants included children 12-18 months (n = 123) and their mothers 18-49 years selected for a study assessing child vitamin A intake and status in Mandaluyong City, Philippines. For fortifiable wheat flour, the FAPQ estimated considerably lower mean intakes compared to 24HRs for children and mothers (2.2 vs. 14.1 g/day and 5.1 vs. 42.3 g/day, respectively), while the SQ-FFQ estimated slightly higher mean intakes (15.7 vs. 14.1 g/day and 51.5 vs. 42.3 g/day, respectively). For fortifiable oil, the FAPQ estimated considerably higher mean intakes compared to 24HRs for children and mothers (4.6 vs. 1.8 g/day and 12.5 vs. 6.1 g/day, respectively). The SQ-FFQ, but not the FAPQ, generated useful information on fortifiable food consumption that can inform fortification programme design and monitoring decisions in the absence of more detailed individual-level data. Potential adaptations to improve the FAPQ, such as additional questions on foods prepared away from home and usage patterns, merit further research.

Bioaccessibility and bioavailability of biofortified food and food products: Current evidence.

Biofortification increases micronutrient content in staple crops through conventional breeding, agronomic methods, or genetic engineering. Bioaccessibility is a prerequisite for a nutrient to fulfill a biological function, e.g., to be bioavailable. The objective of this systematic review is to examine the bioavailability (and bioaccessibility as a proxy via in vitro and animal models) of the target micronutrients enriched in conventionally biofortified crops that have undergone post-harvest storage and/or processing, which has not been systematically reviewed previously, to our knowledge. We searched for articles indexed in MEDLINE, Agricola, AgEcon, and Center for Agriculture and Biosciences International databases, organizational websites, and hand-searched studies' reference lists to identify 18 studies reporting on bioaccessibility and 58 studies on bioavailability. Conventionally bred biofortified crops overall had higher bioaccessibility and bioavailability than their conventional counterparts, which generally provide more absorbed micronutrient on a fixed ration basis. However, these estimates depended on exact cultivar, processing method, context (crop measured alone or as part of a composite meal), and experimental method used. Measuring bioaccessibility and bioavailability of target micronutrients in biofortified and conventional foods is critical to optimize nutrient availability and absorption, ultimately to improve programs targeting micronutrient deficiency.

Making programmes worth their salt: Assessing the context, fidelity and outcomes of implementation of the double fortified salt programme in Uttar Pradesh, India.

Double fortified salt (DFS) has proven efficacy in addressing iron deficiency and anaemia, thus improving maternal and child nutrition outcomes. However, DFS delivery in large-scale settings is less understood, with limited documentation of its fidelity of implementation (FOI). We assessed the FOI of the DFS intervention in Uttar Pradesh, India, to improve the design and implementation of such programmes that aim to reduce the anaemia burden, especially in women of reproductive age (WRA). We conducted in-depth interviews with DFS programme staff (n = 25) and end-user WRAs (23), guided by a programme impact pathway. We transcribed and thematically analysed the interviews and used an adapted analytic framework to document FOI across four domains-objects of intervention, implementation staff, implementation context and target of implementation. DFS utilisation remained low due to a combination of factors including poor product quality, distribution challenges, ineffective promotion and low awareness amongst end-user WRAs. Motivation levels were higher amongst district-level staff compared to frontline staff, who lacked supervisory support and effective incentives to promote DFS. Three typologies of DFS users emerged-'believers', 'thrifters' and 'naysayers'-who indicated differing reasons for DFS purchase and its use or nonuse. The implementation of the DFS programme varied significantly from its theorised programme impact pathway. The adapted analytic framework helped document FOI and assess the programme's readiness for impact assessments and subsequent scale-up. The programme needs product quality improvements, incentivised distribution and stronger promotion to effectively deliver and improve the realisation of its potential as an anaemia prevention strategy.

Mortality, Human Immunodeficiency Virus (HIV) Transmission, and Growth in Children Exposed to HIV in Rural Zimbabwe.

BACKGROUND: Clinical outcomes of children who are human immunodeficiency virus (HIV)-exposed in sub-Saharan Africa remain uncertain. METHODS: The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial evaluated improved infant and young child feeding (IYCF) and/or improved water, sanitation, and hygiene in 2 rural Zimbabwean districts with 15% antenatal HIV prevalence and > 80% prevention of mother-to-child transmission (PMTCT) coverage. Children born between February 2013 and December 2015 had longitudinal HIV testing and anthropometry. We compared mortality and growth between children who were HIV-exposed and HIV-unexposed through 18 months. Children receiving IYCF were excluded from growth analyses. RESULTS: Fifty-one of 738 (7%) children who were HIV-exposed and 198 of 3989 (5%) children who were HIV-unexposed (CHU) died (hazard ratio, 1.41 [95% confidence interval {CI}, 1.02-1.93]). Twenty-five (3%) children who were HIV-exposed tested HIV positive, 596 (81%) were HIV-exposed uninfected (CHEU), and 117 (16%) had unknown HIV status by 18 months; overall transmission estimates were 4.3%-7.7%. Mean length-for-age z score at 18 months was 0.38 (95% CI, .24-.51) standard deviations lower among CHEU compared to CHU. Among 367 children exposed to HIV in non-IYCF arms, 147 (40%) were alive, HIV-free, and nonstunted at 18 months, compared to 1169 of 1956 (60%) CHU (absolute difference, 20% [95% CI, 15%-26%]). CONCLUSIONS: In rural Zimbabwe, mortality remains 40% higher among children exposed to HIV, vertical transmission exceeds elimination targets, and half of CHEU are stunted. We propose the composite outcome of "alive, HIV free, and thriving" as the long-term goal of PMTCT programs. CLINICAL TRIALS REGISTRATION: NCT01824940.

Can Double Fortification of Salt with Iron and Iodine Reduce Anemia, Iron Deficiency Anemia, Iron Deficiency, Iodine Deficiency, and Functional Outcomes? Evidence of Efficacy, Effectiveness, and Safety.

BACKGROUND: Anemia, iron deficiency, and iodine deficiency are problems of important public health concern in many parts of the world, with consequences for the health, development, and work capacity of populations. Several countries are beginning to implement double fortified salt (DFS) programs to simultaneously address iodine and iron deficiencies. OBJECTIVE: Our objective was to summarize the evidence for efficacy and effectiveness of DFS on the full range of status and functional outcomes and across different implementation and evaluation designs essential to successful interventions. METHODS: We conducted a systematic review and meta-analysis of published and gray literature examining the effects of DFS on nutritional status, cognition, work productivity, development, and morbidity of all population groups. We searched for articles in Medline, Embase, CINAHL, Cochrane Central Register, and ProQuest for randomized trials, quasi-randomized trials, and program effectiveness evaluations. RESULTS: A total of 22 studies (N individuals = 52,758) were included. Efficacy studies indicated a significant overall positive effect on hemoglobin concentration [standardized mean difference (95% CI): 0.33 (0.18, 0.48)], ferritin [0.42 (0.08, 0.76)], anemia [risk ratio (95% CI): 0.80 (0.70, 0.92)], and iron deficiency anemia [0.36 (0.24, 0.55)]. Effects on urinary iodine concentration were not significantly different between DFS and iodized salt. The impact on functional outcomes was mixed. Only 2 effectiveness studies were identified. They reported programmatic challenges including low coverage, suboptimal DFS quality, and storage constraints. CONCLUSIONS: Given the biological benefits of DFS across several populations in efficacy research, additional evaluations of robust DFS programs delivered at scale, which consider effective implementation and measure appropriate biomarkers, are needed.

Maternal Capabilities Are Associated with Child Caregiving Behaviors Among Women in Rural Zimbabwe.

BACKGROUND: Young children require high-quality care for healthy growth and development. We defined "maternal capabilities" as factors that influence mothers' caregiving ability (physical and mental health, social support, time, decision-making autonomy, gender norm attitudes, and mothering self-efficacy), and developed survey tools to assess them. OBJECTIVES: We hypothesized that mothers with stronger capabilities during pregnancy would be more likely to practice improved care behaviors after their child was born. METHODS: We assessed maternal capabilities among 4667 pregnant women newly enrolled in the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial. Several improved child-care practices were promoted until 18 mo postpartum, the trial endpoint. Care practices were assessed by survey, direct observation, or transcription from health records during postpartum research visits. We used logistic regression to determine the predictive association between maternal capabilities during pregnancy and child-care practices. RESULTS: Mothers with more egalitarian gender norm attitudes were more likely to have an institutional delivery [adjusted OR (AOR), 2.06; 95% CI, 1.57-2.69], initiate breastfeeding within 1 h of delivery (AOR, 1.38; 95% CI, 1.03-1.84), exclusively breastfeed (EBF) from birth to 3 mo (AOR, 2.55; 95% CI, 1.95-3.35) and 3-6 mo (AOR, 1.75; 95% CI, 1.36-2.25), and, among households randomized to receive extra modules on sanitation and hygiene, have soap and water at a handwashing station (AOR, 1.76; 95% CI, 1.29-2.39). Mothers experiencing time stress were less likely to EBF from birth to 3 mo (AOR, 0.79; 95% CI, 0.66-0.93). Greater social support was associated with institutional delivery (AOR, 1.53; 95% CI, 1.37-1.98) and, among mothers randomized to receive extra complementary feeding modules, feeding children a minimally diverse diet (AOR, 1.18; 95% CI, 1.01-1.37). Depressed mothers were 37% and 33%, respectively, less likely to have an institutional delivery (AOR, 0.63; 95% CI, 0.44-0.88) and a fully immunized child (AOR, 0.67; 95% CI, 0.50-0.90). CONCLUSIONS: Interventions to reduce maternal depression, time stress, inadequate social support, and inequitable gender norms may improve maternal child caregiving.

Understanding drivers of private-sector compliance to large-scale food fortification: A case study on edible oil value chains in Bangladesh.

Micronutrient deficiency is a pertinent global challenge that affects billions of people and has deleterious health effects. Large-scale food fortification (LSFF) is a cost- effective way to tackle micronutrient deficiency and improve health outcomes, particularly in low- and middle-income countries (LMICs). However, the success of LSFF in LMICs is often hampered by limited compliance with fortification mandates by the private sector, who supply fortified foods. In this paper, we use a case study of the edible oil produced in Bangladesh to analyze the factors facilitating and impeding this compliance by for-profit actors. We identified four bottlenecks that disincentivize private sector actors' decision to comply. First, fortified and non-fortified products co-exist in the market, disincentivizing producers to invest in fortification. Second, the lack of traceability reduces the risk for large-scale producers' non-compliance with the regulation. Third, small-scale producers face economic pressures that prevent them from adequately fortifying oil products. Lastly, law enforcement is currently inconsistent, allowing the supply of under-fortified oil in the market. Given the evidence, we recommend to strengthen the control of bulk item fortification through more frequent and rigorous surveillance at the production level. This will ensure that resource constrained consumers who also have the greatest potential to benefit from added nutrients, remain able to access affordable and nutrient-enriched food.

Firm's compliance behaviour towards food fortification regulations: Evidence from oil and salt producers in Bangladesh.

Impact of national food fortification programs is contingent on the extent to which there is compliance with national standards. However, this compliance is often sub-optimal and is not consistently measured. One of the challenges to more regular measurement is an over-reliance on quantitative assessments of micronutrient levels for compliance, which are costly. In resource constrained environments, this contributes to weaknesses in regulatory monitoring. We offer an alternative, systems-based approach to determine compliance, presenting a unique score that can capture firms' compliance behaviour, based on whether and how firms actually carry out stages of the fortification process. The key utility of such a measure being its use to monitor fortification propensity and assess changes in response to interventions. Further, we present an empirical application of this measure, providing novel evidence on firms' compliance towards food fortification regulations in Bangladesh, investigating the institutional and firm-level factors that correlate with compliance behaviour towards food fortification regulations among edible oil and salt producers.

Maternal caregiving capabilities are associated with child linear growth in rural Zimbabwe.

Between birth and 2 years, children's well-being depends on the quality of care they receive from caregivers, primarily their mothers. We developed a quantitative survey instrument to assess seven psychosocial characteristics of women that determine their caregiving ability ('maternal capabilities': physical health, mental health, decision-making autonomy, social support, mothering self-efficacy, workload and time stress, and gender norm attitudes). We measured maternal capabilities in 4,025 mothers and growth in their 4,073 children participating in the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial in rural Zimbabwe. We used generalized estimating equation models with exchangeable correlation structure to test the association between each maternal capability during pregnancy, and infant length-for-age Z (LAZ) at 18 months, accounting only for within-cluster correlation and intervention arms in unadjusted analyses and for potential confounders in adjusted analyses to examine the association between each capability, assessed during pregnancy, with child LAZ at 18 months of age. In adjusted models, each unit increase in gender norm attitudes score (reflecting more equitable gender norm attitudes) was associated with +0.09 LAZ (95% CI: 0.02, 0.16) and a decreased odds of stunting (adjusted odds ratio [AOR]: 0.86; 95% CI: 0.74, 1.01); each unit increase in social support score was associated with +0.11 LAZ (95% CI: 0.05, 0.17, p < 0.010) and decreased odds of stunting (AOR: 0.83; 95% CI: 0.73, 0.96). Each unit increase in decision-making autonomy was associated with a 6% reduced odds of stunting (AOR: 0.94; 95% CI: 0.89, 0.996, p = 0.04). Interventions and social programming that strengthen these maternal capabilities may improve child nutritional status.

Fortified Foods Are Major Contributors to Apparent Intakes of Vitamin A and Iodine, but Not Iron, in Diets of Women of Reproductive Age in 4 African Countries.

BACKGROUND: Food fortification is implemented to increase intakes of specific nutrients in the diet, but contributions of fortified foods to nutrient intakes are rarely quantified. OBJECTIVES: We quantified iron, vitamin A, and iodine intakes from fortified staple foods and condiments among women of reproductive age (WRA). METHODS: In subnational (Nigeria, South Africa) and national (Tanzania, Uganda) cross-sectional, clustered household surveys, we assessed fortifiable food consumption. We estimated daily nutrient intakes from fortified foods among WRA by multiplying the daily apparent fortifiable food consumption (by adult male equivalent method) by a fortification content for the food. Two fortification contents were used: measured, based on the median amount quantified from individual food samples collected from households; and potential, based on the targeted amount in national fortification standards. Results for both approaches are reported as percentages of the estimated average requirement (EAR) and recommended nutrient intake (RNI). RESULTS: Fortified foods made modest contributions to measured iron intakes (0%-13% RNI); potential intakes if standards are met were generally higher (0%-65% RNI). Fortified foods contributed substantially to measured vitamin A and iodine intakes (20%-125% and 88%-253% EAR, respectively); potential intakes were higher (53%-655% and 115%-377% EAR, respectively) and would exceed the tolerable upper intake level among 18%-56% of WRA for vitamin A in Nigeria and 1%-8% of WRA for iodine in Nigeria, Tanzania, and Uganda. CONCLUSIONS: Fortified foods are major contributors to apparent intakes of vitamin A and iodine, but not iron, among WRA. Contributions to vitamin A and iodine are observed despite fortification standards not consistently being met and, if constraints to meeting standards are addressed, there is risk of excessive intakes in some countries. For all programs assessed, nutrient intakes from all dietary sources and fortification standards should be reviewed to inform adjustments where needed to avoid risk of low or excessive intakes.

Independent and combined effects of improved water, sanitation, and hygiene (WASH) and improved complementary feeding on early neurodevelopment among children born to HIV-negative mothers in rural Zimbabwe: Substudy of a cluster-randomized trial.

BACKGROUND: Globally, nearly 250 million children (43% of all children under 5 years of age) are at risk of compromised neurodevelopment due to poverty, stunting, and lack of stimulation. We tested the independent and combined effects of improved water, sanitation, and hygiene (WASH) and improved infant and young child feeding (IYCF) on early child development (ECD) among children enrolled in the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial in rural Zimbabwe. METHODS AND FINDINGS: SHINE was a cluster-randomized community-based 2×2 factorial trial. A total of 5,280 pregnant women were enrolled from 211 clusters (defined as the catchment area of 1-4 village health workers [VHWs] employed by the Zimbabwean Ministry of Health and Child Care). Clusters were randomly allocated to standard of care, IYCF (20 g of small-quantity lipid-based nutrient supplement per day from age 6 to 18 months plus complementary feeding counseling), WASH (ventilated improved pit latrine, handwashing stations, chlorine, liquid soap, and play yard), and WASH + IYCF. Primary outcomes were child length-for-age Z-score and hemoglobin concentration at 18 months of age. Children who completed the 18-month visit and turned 2 years (102-112 weeks) between March 1, 2016, and April 30, 2017, were eligible for the ECD substudy. We prespecified that primary inferences would be drawn from findings of children born to HIV-negative mothers; these results are presented in this paper. A total of 1,655 HIV-unexposed children (64% of those eligible) were recruited into the ECD substudy from 206 clusters and evaluated for ECD at 2 years of age using the Malawi Developmental Assessment Tool (MDAT) to assess gross motor, fine motor, language, and social skills; the MacArthur-Bates Communicative Development Inventories (CDI) to assess vocabulary and grammar; the A-not-B test to assess object permanence; and a self-control task. Outcomes were analyzed in the intention-to-treat population. For all ECD outcomes, there was not a statistical interaction between the IYCF and WASH interventions, so we estimated the effects of the interventions by comparing the 2 IYCF groups with the 2 non-IYCF groups and the 2 WASH groups with the 2 non-WASH groups. The mean (95% CI) total MDAT score was modestly higher in the IYCF groups compared to the non-IYCF groups in unadjusted analysis: 1.35 (0.24, 2.46; p = 0.017); this difference did not persist in adjusted analysis: 0.79 (-0.22, 1.68; p = 0.057). There was no evidence of impact of the IYCF intervention on the CDI, A-not-B, or self-control tests. Among children in the WASH groups compared to those in the non-WASH groups, mean scores were not different for the MDAT, A-not-B, or self-control tests; mean CDI score was not different in unadjusted analysis (0.99 [95% CI -1.18, 3.17]) but was higher in children in the WASH groups in adjusted analysis (1.81 [0.01, 3.61]). The main limitation of the study was the specific time window for substudy recruitment, meaning not all children from the main trial were enrolled. CONCLUSIONS: We found little evidence that the IYCF and WASH interventions implemented in SHINE caused clinically important improvements in child development at 2 years of age. Interventions that directly target neurodevelopment (e.g., early stimulation) or that more comprehensively address the multifactorial nature of neurodevelopment may be required to support healthy development of vulnerable children. TRIAL REGISTRATION: ClinicalTrials.gov NCT01824940.

Bottlenecks and predictors of coverage and adherence outcomes for a micronutrient powder program in Ethiopia.

A theory-driven evaluation was conducted to assess performance of a trial to deliver micronutrient powder (MNP) through the Ethiopian Ministry of Health. We adapted an approach to coverage assessment, originally developed to identify bottlenecks in health service delivery, to examine sequential program outcomes and their correlates using cross-sectional survey data of caregivers of children 6-23 months (N = 1915). Separate multivariable Poisson regression models were used to estimate adjusted risk ratios of conceptually relevant determinants of coverage and adherence. Caregivers of children >11 months were more likely to have received MNP than caregivers of younger infants, yet children 12-17 months were 32% (P < 0.001) and children 18-23 months 38% (P < 0.001) less likely to have been fed MNP in the 14 days preceding the survey than children 6-11 months. Among caregivers who initiated feeding MNP, the most frequently reported reasons for discontinuing use were not obtaining additional supply (36.1%) and perceived child rejection of food with MNP (22.9%). For each additional time a caregiver met with frontline workers in the 3 months preceding the survey, they were 13% more likely to have recently fed MNP (P < 0.001). Caregivers' perception that MNP produced positive changes in children was associated with a 14% increase in the likelihood of having recently fed it (P < 0.001). These results emphasize the importance of counselling for MNP and infant and young child feeding for initial use and the importance of multiple contacts with frontline workers for continued use.

Preventing environmental enteric dysfunction through improved water, sanitation and hygiene: an opportunity for stunting reduction in developing countries.

In 2011, one in every four (26%) children under 5 years of age worldwide was stunted. The realization that most stunting cannot be explained by poor diet or by diarrhoea, nor completely reversed by optimized diet and reduced diarrhoea has led to the hypothesis that a primary underlying cause of stunting is subclinical gut disease. Essentially, ingested microbes set in motion two overlapping and interacting pathways that result in linear growth impairment. Firstly, partial villous atrophy results in a reduced absorptive surface area and loss of digestive enzymes. This in turn results in maldigestion and malabsorption of much needed nutrients. Secondly, microbes and their products make the gut leaky, allowing luminal contents to translocate into systemic circulation. This creates a condition of chronic immune activation, which (i) diverts nutrient resources towards the metabolically expensive business of infection fighting rather than growth; (ii) suppresses the growth hormone-IGF axis and inhibits bone growth, leading to growth impairment; and (iii) causes further damage to the intestinal mucosa thereby exacerbating the problem. As such, the unhygienic environments in which infants and young children live and grow must contribute to, if not be the overriding cause of, this environmental enteric dysfunction. We suggest that a package of baby-WASH interventions (sanitation and water improvement, handwashing with soap, ensuring a clean play and infant feeding environment and food hygiene) that interrupt specific pathways through which feco-oral transmission occurs in the first two years of a child's life may be central to global stunting reduction efforts.

Assessing Maternal Capabilities in the SHINE Trial: Highlighting a Hidden Link in the Causal Pathway to Child Health.

A potential bottleneck for increasing the adoption of child health interventions has been limited attention to designing actions that are built on the essential role that caregivers play in determining their effectiveness. In the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial, we utilize the concept of maternal capabilities to examine participants' skills and attributes that affect their ability to provide appropriate care for their young child, fully engage with trial interventions, and influence the response to these interventions at the household level. We hypothesize that the impact of SHINE interventions on child stunting and anemia will be modified by these maternal capabilities. Drawing upon multiple theories, we identify and define critical maternal capabilities domains, and describe how they are measured in the trial. Description of maternal capabilities and their role as potential modifiers on impact will increase understanding of the impact of SHINE interventions, and the generalizability of our findings.

Assessment of Environmental Enteric Dysfunction in the SHINE Trial: Methods and Challenges.

Environmental enteric dysfunction (EED) is a virtually ubiquitous, but poorly defined, disorder of the small intestine among people living in conditions of poverty, which begins early in infancy and persists. EED is characterized by altered gut structure and function, leading to reduced absorptive surface area and impaired intestinal barrier function. It is hypothesized that recurrent exposure to fecal pathogens and changes in the composition of the intestinal microbiota initiate this process, which leads to a self-perpetuating cycle of pathology. We view EED as a primary gut disorder that drives chronic systemic inflammation, leading to growth hormone resistance and impaired linear growth. There is currently no accepted case definition or gold-standard biomarker of EED, making field studies challenging. The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial in Zimbabwe is evaluating the independent and combined effects of a package of infant feeding and/or water, sanitation, and hygiene interventions on stunting and anemia. SHINE therefore provides an opportunity to longitudinally evaluate EED in a well-characterized cohort of infants, using a panel of biomarkers along the hypothesized causal pathway. Our aims are to describe the evolution of EED during infancy, ascertain its contribution to stunting, and investigate the impact of the randomized interventions on the EED pathway. In this article, we describe current concepts of EED, challenges in defining the condition, and our approach to evaluating EED in the SHINE trial.

The Potential Role of Mycotoxins as a Contributor to Stunting in the SHINE Trial.

Children in developing countries experience multiple exposures that are harmful to their growth and development. An emerging concern is frequent exposure to mycotoxins that contaminate a wide range of staple foods, including maize and groundnuts. Three mycotoxins are suspected to contribute to poor child health and development: aflatoxin, fumonisin, and deoxynivalenol. We summarize the evidence that mycotoxin exposure is associated with stunting, and propose that the causal pathway may be through environmental enteric dysfunction (EED) and disturbance of the insulin-like growth factor 1 (IGF-1) axis. The objectives of this substudy are to assess the relationship between agricultural and harvest practices and mycotoxin exposure; to evaluate associations between mycotoxin exposure and child stunting; and to investigate EED as a potential pathway linking mycotoxin exposure to child stunting, to inform potential areas for intervention.

Theory-Driven Process Evaluation of the SHINE Trial Using a Program Impact Pathway Approach.

Two reasons for the lack of success of programs or interventions are poor alignment of interventions with the causes of the problem targeted by the intervention, leading to poor efficacy (theory failure), and failure to implement interventions as designed (program failure). These failures are important for both public health programs and randomized trials. In the Sanitation Hygiene and Infant Nutrition Efficacy (SHINE) Trial, we utilize the program impact pathway (PIP) approach to track intervention implementation and behavior uptake. In this article, we present the SHINE PIP including definitions and measurements of key mediating domains, and discuss the implications of this approach for randomized trials. Operationally, the PIP can be used for monitoring and strengthening intervention delivery, facilitating course-correction at various stages of implementation. Analytically, the PIP can facilitate a richer understanding of the mediating and modifying determinants of intervention impact than would be possible from an intention-to-treat analysis alone.

The SHINE Trial Infant Feeding Intervention: Pilot Study of Effects on Maternal Learning and Infant Diet Quality in Rural Zimbabwe.

The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial is designed to measure the independent and combined effects of improved water, sanitation, and hygiene and improved infant feeding on child stunting and anemia in Zimbabwe. We developed and pilot-tested the infant feeding intervention delivered by 9 village health workers to 19 mothers of infants aged 7-12 months. Between September 2010 and January 2011, maternal knowledge was assessed using mixed methods, and infant nutrient intakes were assessed by 24-hour recall. We observed positive shifts in mothers' knowledge. At baseline, 63% of infants met their energy requirement and most did not receive enough folate, zinc, or calcium; none met their iron requirement. Postintervention, all infants received sufficient fat and vitamin A, and most consumed enough daily energy (79%), protein (95%), calcium (89%), zinc (89%), folate (68%), and iron (68%). The SHINE trial infant feeding intervention led to significant short-term improvements in maternal learning and infant nutrient intakes.

Design of an Intervention to Minimize Ingestion of Fecal Microbes by Young Children in Rural Zimbabwe.

We sought to develop a water, sanitation, and hygiene (WASH) intervention to minimize fecal-oral transmission among children aged 0-18 months in the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial. We undertook 4 phases of formative research, comprising in-depth interviews, focus group discussions, behavior trials, and a combination of observations and microbiological sampling methods. The resulting WASH intervention comprises material inputs and behavior change communication to promote stool disposal, handwashing with soap, water treatment, protected exploratory play, and hygienic infant feeding. Nurture and disgust were found to be key motivators, and are used as emotional triggers. The concept of a safe play space for young children was particularly novel, and families were eager to implement this after learning about the risks of unprotected exploratory play. An iterative process of formative research was essential to create a sequenced and integrated longitudinal intervention for a SHINE household as it expects (during pregnancy) and then cares for a new child.

Using Geographic Information Systems and Spatial Analysis Methods to Assess Household Water Access and Sanitation Coverage in the SHINE Trial.

Access to water and sanitation are important determinants of behavioral responses to hygiene and sanitation interventions. We estimated cluster-specific water access and sanitation coverage to inform a constrained randomization technique in the SHINE trial. Technicians and engineers inspected all public access water sources to ascertain seasonality, function, and geospatial coordinates. Households and water sources were mapped using open-source geospatial software. The distance from each household to the nearest perennial, functional, protected water source was calculated, and for each cluster, the median distance and the proportion of households within <500 m and >1500 m of such a water source. Cluster-specific sanitation coverage was ascertained using a random sample of 13 households per cluster. These parameters were included as covariates in randomization to optimize balance in water and sanitation access across treatment arms at the start of the trial. The observed high variability between clusters in both parameters suggests that constraining on these factors was needed to reduce risk of bias.