The Cost and Cost-Effectiveness of an Integrated Wasting Prevention and Screening Intervention Package in Burkina Faso and Mali.

BACKGROUND: Little is known about costs and cost effectiveness of interventions that integrate wasting prevention into screening for child wasting. OBJECTIVES: This study's objective was to estimate the cost and cost-effectiveness of an intervention that integrated behavior change communication (BCC) and small-quantity lipid-based nutrient supplements (SQ-LNS) into platforms for wasting screening in Burkina Faso (a facility-based platform, where BCC was enhanced compared with standard care) and Mali (a community-based platform, with standard BCC). METHODS: Activity-based costing was used to estimate the cost per child-contact for the intervention and the comparison group, which did not receive the intervention. Costs were ascertained from accounting records, interviews, surveys, and observations. The number of child-contacts was calculated using population size estimates and average attendance rates for each service. Costs per disability-adjusted life year (DALY) averted were estimated using a Markov model populated with data from the parent trials on impact of wasting incidence and treatment coverage. RESULTS: In the intervention group in Burkina Faso, the cost per child-contact of facility-based screening was $0.85 of enhanced BCC was $4.28, and of SQ-LNS was $8.86. In Mali, the cost per child-contact of community-based screening was $0.57, standard BCC was $0.72, and SQ-LNS was $4.14. Although no SQ-LNS costs were incurred in the comparison groups (hence lower total costs), costs per child-contact for screening and BCC were higher because coverage of these services was lower. The intervention package cost $1073 per DALY averted in Burkina Faso and $747 in Mali. CONCLUSIONS: Integration of wasting prevention into screening for child wasting led to higher total costs but lower unit costs than standard screening due to increased coverage. Greater cost-effectiveness could be achieved if BCC were strengthened and led to improved caregiver health and nutrition practices and if screening triggered appropriate use of services and higher treatment coverage.

Food Systems Interventions for Nutrition: Lessons from 6 Program Evaluations in Africa and South Asia.

Although there is growing global momentum behind food systems strategies to improve planetary and human health-including nutrition-there is limited evidence of what types of food systems interventions work. Evaluating these types of interventions is challenging due to their complex and dynamic nature and lack of fit with standard evaluation methods. In this article, we draw on a portfolio of 6 evaluations of food systems interventions in Africa and South Asia that were intended to improve nutrition. We identify key methodological challenges and formulate recommendations to improve the quality of such studies. We highlight 5 challenges: a lack of evidence base to justify the intervention, the dynamic and multifaceted nature of the interventions, addressing attribution, collecting or accessing accurate and timely data, and defining and measuring appropriate outcomes. In addition to more specific guidance, we identify 6 cross-cutting recommendations, including a need to use multiple and diverse methods and flexible designs. We also note that these evaluation challenges present opportunities to develop new methods and highlight several specific needs in this space.

Consumer Demand for Milk and the Informal Dairy Sector Amidst COVID-19 in Nairobi, Kenya.

Background: The coronavirus disease 2019 (COVID-19) pandemic has had large negative effects on countries' economies and individual well-being throughout the world, particularly in low- and middle-income countries. Pandemic-related changes in behavior and government restrictions in Kenya may have negatively affected food supply chains and household food access; however, the empirical evidence is currently limited. Objectives: The study explored changes in informal milk markets, dairy consumption, and food insecurity among low-income households in urban and periurban Nairobi, Kenya, following the start of the COVID-19 pandemic in the country. Methods: Baseline data on milk sales and consumption were collected in late 2019 from dairy vendors operating in the informal sector and their dairy customers. We conducted 2 longitudinal telephone surveys with the same study participants in July and September-October 2020, respectively. Results: At the first follow-up, the volume of milk sold by informal vendors had dropped by 30% compared with their baseline level, and the volume of milk from informal markets consumed by households decreased by 23%. By the second follow-up, the volume of milk sold and consumed had recovered somewhat but remained lower than the volume observed 1 y prior in the same season. Large reductions in the consumption of other animal-sourced products were also observed. The rate of food insecurity increased by 16 and 11 percentage points in the first and second follow-up periods, respectively, compared with baseline. Conclusions: The evidence, therefore, suggests that the timing of the pandemic and the related restrictions were associated with a decrease in the supply and consumption of milk from informal markets in Nairobi and a decrease in the food security of periurban consumers.

Preventive small-quantity lipid-based nutrient supplements reduce severe wasting and severe stunting among young children: an individual participant data meta-analysis of randomized controlled trials.

BACKGROUND: Meta-analyses show that small-quantity lipid-based nutrient supplements (SQ-LNSs) reduce child wasting and stunting. There is little information regarding effects on severe wasting or stunting. OBJECTIVES: We aimed to identify the effect of SQ-LNSs on prevalence of severe wasting (weight-for-length z score < -3) and severe stunting (length-for-age z score < -3). METHODS: We conducted a 2-stage meta-analysis of individual participant data from 14 randomized controlled trials of SQ-LNSs provided to children 6-24 mo of age. We generated study-specific and subgroup estimates of SQ-LNS compared with control and pooled the estimates using fixed-effects models. We used random-effects meta-regression to examine study-level effect modifiers. In sensitivity analyses, we examined whether results differed depending on study arm inclusion criteria and types of comparisons. RESULTS: SQ-LNS provision led to a relative reduction of 31% in severe wasting [prevalence ratio (PR): 0.69; 95% CI: 0.55, 0.86; n = 34,373] and 17% in severe stunting (PR: 0.83; 95% CI: 0.78, 0.90; n = 36,795) at endline. Results were similar in most of the sensitivity analyses but somewhat attenuated when comparisons using passive control arms were excluded (PR: 0.74; 95% CI: 0.57, 0.96; n = 26,327 for severe wasting and PR: 0.88; 95% CI: 0.81, 0.95; n = 28,742 for severe stunting). Study-level characteristics generally did not significantly modify the effects of SQ-LNSs, but results suggested greater effects of SQ-LNSs in sites with greater burdens of wasting or stunting, or with poorer water quality or sanitation. CONCLUSIONS: Including SQ-LNSs in preventive interventions to promote healthy child growth and development is likely to reduce rates of severe wasting and stunting. This meta-analysis was registered at www.crd.york.ac.uk/PROSPERO as CRD42019146592.

Strengthening causal inference from randomised controlled trials of complex interventions.

Researchers conducting randomised controlled trials (RCTs) of complex interventions face design and analytical challenges that are not fully addressed in existing guidelines. Further guidance is needed to help ensure that these trials of complex interventions are conducted to the highest scientific standards while maximising the evidence that can be extracted from each trial. The key challenge is how to manage the multiplicity of outcomes required for the trial while minimising false positive and false negative findings. To address this challenge, we formulate three principles to conduct RCTs: (1) outcomes chosen should be driven by the intent and programme theory of the intervention and should thus be linked to testable hypotheses; (2) outcomes should be adequately powered and (3) researchers must be explicit and fully transparent about all outcomes and hypotheses before the trial is started and when the results are reported. Multiplicity in trials of complex interventions should be managed through careful planning and interpretation rather than through post hoc analytical adjustment. For trials of complex interventions, the distinction between primary and secondary outcomes as defined in current guidelines does not adequately protect against false positive and negative findings. Primary outcomes should be defined as outcomes that are relevant based on the intervention intent and programme theory, declared (ie, registered), and adequately powered. The possibility of confirmatory causal inference is limited to these outcomes. All other outcomes (either undeclared and/or inadequately powered) are secondary and inference relative to these outcomes will be exploratory.

Characteristics that modify the effect of small-quantity lipid-based nutrient supplementation on child anemia and micronutrient status: an individual participant data meta-analysis of randomized controlled trials.

BACKGROUND: Small-quantity lipid-based nutrient supplements (SQ-LNSs) have been shown to reduce the prevalence of child anemia and iron deficiency, but effects on other micronutrients are less well known. Identifying subgroups who benefit most from SQ-LNSs could support improved program design. OBJECTIVES: We aimed to identify study-level and individual-level modifiers of the effect of SQ-LNSs on child hemoglobin (Hb), anemia, and inflammation-adjusted micronutrient status outcomes. METHODS: We conducted a 2-stage meta-analysis of individual participant data from 13 randomized controlled trials of SQ-LNSs provided to children 6-24 mo of age (n = 15,946). We generated study-specific and subgroup estimates of SQ-LNSs compared with control, and pooled the estimates using fixed-effects models. We used random-effects meta-regression to examine potential study-level effect modifiers. RESULTS: SQ-LNS provision decreased the prevalence of anemia (Hb < 110 g/L) by 16% (relative reduction), iron deficiency (plasma ferritin < 12 µg/L) by 56%, and iron deficiency anemia (IDA; Hb < 110 g/L and plasma ferritin <12 µg/L) by 64%. We observed positive effects of SQ-LNSs on hematological and iron status outcomes within all subgroups of the study- and individual-level effect modifiers, but effects were larger in certain subgroups. For example, effects of SQ-LNSs on anemia and iron status were greater in trials that provided SQ-LNSs for >12 mo and provided 9 (as opposed to <9) mg Fe/d, and among later-born (than among first-born) children. There was no effect of SQ-LNSs on plasma zinc or retinol, but there was a 7% increase in plasma retinol-binding protein (RBP) and a 56% reduction in vitamin A deficiency (RBP < 0.70 µmol/L), with little evidence of effect modification by individual-level characteristics. CONCLUSIONS: SQ-LNSs can substantially reduce the prevalence of anemia, iron deficiency, and IDA among children across a range of individual, population, and study design characteristics. Policy-makers and program planners should consider SQ-LNSs within intervention packages to prevent anemia and iron deficiency.This trial was registered at www.crd.york.ac.uk/PROSPERO as CRD42020156663.

Social Assistance Programs and Birth Outcomes: A Systematic Review and Assessment of Nutrition and Health Pathways.

BACKGROUND: Poor birth outcomes are an important global public health problem. Social assistance programs that provide cash or in-kind transfers, such as food or vouchers, hold potential to improve birth outcomes but the evidence on their effectiveness has not been reviewed. OBJECTIVES: We systematically reviewed studies that used experimental or quasi-experimental methods to evaluate the impacts of social assistance programs on outcomes in low- and middle-income countries. METHODS: The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system was used to assess the certainty of the evidence for birth weight and neonatal mortality (most common outcomes reported). We summarized the evidence on hypothesized nutrition and health pathways of impact. RESULTS: We included 6 evaluations of 4 different cash transfer programs and 1 evaluation of a community-based participatory learning and action program that provided food and cash transfers. The 4 studies that assessed birth weight impacts found significant (P < 0.05) effects ranging from 31 to 578 g. Out of 3 studies that assessed neonatal mortality impacts, 2 found significant effects ranging from 0.6 to 3.1 deaths/1000 live births. The certainty of the evidence for both outcomes was rated as very low due to several methodological limitations. In terms of potential pathways, some studies documented positive effects on maternal diet, antenatal care (ANC) utilization, and delivery in a health facility. CONCLUSIONS: Better-designed evaluations are needed to strengthen the evidence base on these programs. Evaluation studies should elucidate underlying mechanisms of impact by including outcomes related to maternal diet, ANC seeking, use of skilled delivery, and women's empowerment in nutrition and health domains. Studies should also assess potential unintended negative consequences of social assistance, such as reduced birth spacing and excess pregnancy weight gain.

Characteristics that modify the effect of small-quantity lipid-based nutrient supplementation on child growth: an individual participant data meta-analysis of randomized controlled trials.

BACKGROUND: Meta-analyses show that small-quantity lipid-based nutrient supplements (SQ-LNSs) reduce child stunting and wasting. Identification of subgroups who benefit most from SQ-LNSs may facilitate program design. OBJECTIVES: We aimed to identify study-level and individual-level modifiers of the effect of SQ-LNSs on child growth outcomes. METHODS: We conducted a 2-stage meta-analysis of individual participant data from 14 randomized controlled trials of SQ-LNSs provided to children 6-24 mo of age (n = 37,066). We generated study-specific and subgroup estimates of SQ-LNS compared with control and pooled the estimates using fixed-effects models. We used random-effects meta-regression to examine study-level effect modifiers. In sensitivity analyses, we examined whether results differed depending on study arm inclusion criteria and types of comparisons. RESULTS: SQ-LNS provision decreased stunting (length-for-age z score < -2) by 12% (relative reduction), wasting [weight-for-length (WLZ) z score < -2] by 14%, low midupper arm circumference (MUAC) (<125 mm or MUAC-for-age z score < -2) by 18%, acute malnutrition (WLZ < -2 or MUAC < 125 mm) by 14%, underweight (weight-for-age z score < -2) by 13%, and small head size (head circumference-for-age z score < -2) by 9%. Effects of SQ-LNSs generally did not differ by study-level characteristics including region, stunting burden, malaria prevalence, sanitation, water quality, duration of supplementation, frequency of contact, or average compliance with SQ-LNS. Effects of SQ-LNSs on stunting, wasting, low MUAC, and small head size were greater among girls than among boys; effects on stunting, underweight, and low MUAC were greater among later-born (than among firstborn) children; and effects on wasting and acute malnutrition were greater among children in households with improved (as opposed to unimproved) sanitation. CONCLUSIONS: The positive impact of SQ-LNSs on growth is apparent across a variety of study-level contexts. Policy-makers and program planners should consider including SQ-LNSs in packages of interventions to prevent both stunting and wasting.This trial was registered at www.crd.york.ac.uk/PROSPERO as CRD42019146592.

Tubaramure, a Food-Assisted Integrated Health and Nutrition Program, Reduces Child Wasting in Burundi: A Cluster-Randomized Controlled Intervention Trial.

BACKGROUND: Little is known about the impact of food-assisted maternal and child health programs (FA-MCHN) on child wasting. OBJECTIVES: We assessed the impact of Tubaramure, a FA-MCHN program in Burundi, on child (0 to 24 months) wasting and the differential impacts by socio-economic characteristics and age. The program targeted women and their children during the first 1000 days and included 1) food rations, 2) strengthening and promotion of use of health services, and 3) behavior change communication (BCC). METHODS: We conducted a 4-arm, cluster-randomized, controlled trial (2010-2012). Clusters were defined as "collines" (communities). Impact was estimated using repeated cross-sectional data (n = ∼2620 children in each round). Treatment arms received household and individual (mother or child in the first 1000 days) food rations (corn-soy blend and micronutrient-fortified vegetable oil) from pregnancy to 24 months (T24 arm), from pregnancy to 18 months (T18), or from birth to 24 months (TNFP). All beneficiaries received the same BCC for the first 1000 days. The control arm received no rations or BCC. RESULTS: Wasting (weight-for-length Z-score <2 SD) increased from baseline to follow-up in the control group (from 6.5% to 8%), but Tubaramure had a significant (P < 0.05) protective effect on wasting [treatment arms combined, -3.3 percentage points (pp); T18, -4.5 pp] and on the weight-for-length z-score (treatment arms combined, +0.15; T24, +0.20; T18, +0.17). The effects were limited to children whose mother and household head had no education, and who lived in the poorest households. The largest effect was found in children 6 to 12 months of age: the group with the highest wasting prevalence. CONCLUSIONS: FA-MCHN programs in highly food-insecure regions can protect the most disadvantaged children from wasting. These findings are particularly relevant in the context of the economic crisis due to the coronavirus disease 2019 pandemic, which is expected to dramatically increase child wasting.

Incidence Correction Factors for Moderate and Severe Acute Child Malnutrition From 2 Longitudinal Cohorts in Mali and Burkina Faso.

Child acute malnutrition (AM) is an important cause of child mortality. Accurately estimating its burden requires cumulative incidence data from longitudinal studies, which are rarely available in low-income settings. In the absence of such data, the AM burden is approximated using prevalence estimates from cross-sectional surveys and the incidence correction factor $K$, obtained from the few available cohorts that measured AM. We estimated $K$ factors for severe acute malnutrition (SAM) and moderate acute malnutrition (MAM) from AM incidence and prevalence using representative cross-sectional baseline and longitudinal data from 2 cluster-randomized controlled trials (Innovative Approaches for the Prevention of Childhood Malnutrition-PROMIS) conducted between 2014 and 2017 in Burkina Faso and Mali. We compared K estimates using complete (weight-for-length z score, mid-upper arm circumference (MUAC), and edema) and partial (MUAC, edema) definitions of SAM and MAM. $K$ estimates for SAM were 9.4 and 5.7 in Burkina Faso and in Mali, respectively; K estimates for MAM were 4.7 in Burkina Faso and 5.1 in Mali. The MUAC and edema-based definition of AM did not lead to different $K$ estimates. Our results suggest that $K$ can be reliably estimated when only MUAC and edema-based data are available. Additional studies, however, are required to confirm this finding in different settings.

Can Children Catch up from the Consequences of Undernourishment? Evidence from Child Linear Growth, Developmental Epigenetics, and Brain and Neurocognitive Development.

Recovery from nutritionally induced height deficits continues to garner attention. The current literature on catch-up growth, however, has 2 important limitations: wide-ranging definitions of catch-up growth are used, and it remains unclear whether children can recover from the broader consequences of undernutrition. We addressed these shortcomings by reviewing the literature on the criteria for catch-up in linear growth and on the potential to recover from undernutrition early in life in 3 domains: linear growth, developmental epigenetics, and child brain and neurocognitive development. Four criteria must be met to demonstrate catch-up growth in height: after a period in which a growth-inhibiting condition (criterion 1) causes a reduction in linear growth velocity (criterion 2), alleviation of the inhibiting condition (criterion 3) leads to higher-than-normal velocity (criterion 4). Accordingly, studies that are observational, do not use absolute height, or have no alleviation of an inhibiting condition cannot be used to establish catch-up growth. Adoption and foster care, which provide dramatic improvements in children's living conditions not typically attained in nutrition interventions, led to some (but incomplete) recovery in linear growth and brain and neurocognitive development. Maternal nutrition around the time of conception was shown to have long-term (potentially permanent) effects on DNA methylation in the offspring. Undernourishment early in life may thus have profound irreversible effects. Scientific, program, and policy efforts should focus on preventing maternal and child undernutrition rather than on correcting its consequences or attempting to prove they can be corrected.

Randomized controlled trials of multi-sectoral programs: Lessons from development research.

Development is a multi-faceted process; achieving development goals thus requires a multi-sectoral approach. For over two decades, our research group of economists and nutritionists has designed and implemented randomized trials to assess the effectiveness of multisectoral programs in improving nutrition, food security, and other measures of well-being, largely at the request of developing country governments, development partners, and non-governmental organizations. Our approach addresses three perceived pitfalls of RCTs: the "black box" nature of RCTs, limited external validity, and challenges in translation of results to impacts at scale. We address these concerns by identifying and assessing programmatic pathways to impact with quantitative and qualitative methods; studying similar programs implemented by different organizations across various settings; and working closely with implementing partners in the design, research, and dissemination processes to inform adaptation and scale-up of programs and policies.

The cost of improving nutritional outcomes through food-assisted maternal and child health and nutrition programmes in Burundi and Guatemala.

Evidence on the cost-effectiveness of multisectoral maternal and child health and nutrition programmes is scarce. We conducted a prospective costing study of two food-assisted maternal and child health and nutrition programmes targeted to pregnant women and children during the first 1,000 days (pregnancy to 2 years). Each was paired with a cluster-randomized controlled trial to evaluate impact and compare the optimal quantity and composition of food rations (Guatemala, five treatment arms) and their optimal timing and duration (Burundi, three treatment arms). We calculated the total and per beneficiary cost, conducted cost consequence analyses, and estimated the cost savings from extending the programme for 2 years. In Guatemala, the programme model with the lowest cost per percentage point reduction in stunting provided the full-size family ration with an individual ration of corn-soy blend or micronutrient powder. Reducing family ration size lowered costs but failed to reduce stunting. In Burundi, providing food assistance for the full 1,000 days led to the lowest cost per percentage point reduction in stunting. Reducing the duration of ration eligibility reduced per beneficiary costs but was less effective. A 2-year extension could have saved 11% per beneficiary in Guatemala and 18% in Burundi. We found that investments in multisectoral nutrition programmes do not scale linearly. Programmes providing smaller rations or rations for shorter durations, although less expensive per beneficiary, may not provide the necessary dose to improve (biological) outcomes. Lastly, delivering effective programmes for longer periods can generate cost savings by dispersing start-up costs and lengthening peak operating capacity.

Tubaramure, a Food-Assisted Maternal and Child Health and Nutrition Program in Burundi, Increased Household Food Security and Energy and Micronutrient Consumption, and Maternal and Child Dietary Diversity: A Cluster-Randomized Controlled Trial.

BACKGROUND: Food-assisted maternal and child health and nutrition programs are a widely used approach to address undernutrition. Little is known about the effects of these programs' combined household and individual food rations on household and individual food consumption. Tubaramure in Burundi targeted women and children during the first 1000 d of life, and included: 1) food rations (corn-soy blend and micronutrient-fortified vegetable oil); 2) health services strengthening and promotion of their use; and 3) behavior change communication on nutrition, hygiene, and health practices. OBJECTIVES: The objectives were: 1) to assess Tubaramure's impact on household food consumption and food security, maternal dietary diversity, and infant and young child feeding practices; 2) to explore the role of the food rations; and 3) assess 6-8 mo impacts around 8 mo after the end of the program. METHODS: We used a 4-arm cluster-randomized controlled repeated cross-sectional design (11,906 observations). The treatment arms received the same food ration but differed in the ration timing and duration: 1) the first 1000 d; 2) from pregnancy through 17.9 mo of age; or 3) from birth through 23.9 mo of age. RESULTS: Tubaramure significantly (P < 0.05) improved the percentage of food secure households [from 4.5 to 7.3 percentage points (pp)], and increased household energy consumption (from 17% to 20%) and micronutrient consumption. The program had a positive effect on maternal dietary diversity (+0.4 food groups, P < 0.05) and increased the proportion of children aged 6-23.9 mo consuming ≥4 food groups (from 8.0 to 9.6 pp, P < 0.05). The effects on many outcomes were attributable to the food rations. Postprogram effects (P < 0.05) were found on household food security, maternal dietary diversity, and younger sibling's complementary feeding practices. CONCLUSIONS: Programs such as Tubaramure have the potential to improve food security and household and individual energy and micronutrient consumption in severely resource-constrained populations, as seen in rural Burundi. This trial was registered at clinicaltrials.gov as NCT01072279.

Impact on child acute malnutrition of integrating a preventive nutrition package into facility-based screening for acute malnutrition during well-baby consultation: A cluster-randomized controlled trial in Burkina Faso.

BACKGROUND: Community management of acute malnutrition (CMAM) is a highly efficacious approach for treating acute malnutrition (AM) in children who would otherwise be at significantly increased risk of mortality. In program settings, however, CMAM's effectiveness is limited because of low screening coverage of AM, in part because of the lack of perceived benefits for caregivers. In Burkina Faso, monthly screening for AM of children <2 years of age is conducted during well-baby consultations (consultation du nourrisson sain [CNS]) at health centers. We hypothesized that the integration of a preventive package including age-appropriate behavior change communication (BCC) on nutrition, health, and hygiene practices and a monthly supply of small-quantity lipid-based nutrient supplements (SQ-LNSs) to the monthly screening would increase AM screening and treatment coverage and decrease the incidence and prevalence of AM. METHODS AND FINDINGS: We used a cluster-randomized controlled trial and allocated 16 health centers to the intervention group and 16 to a comparison group. Both groups had access to standard CMAM and CNS services; caregivers in the intervention group also received age-appropriate monthly BCC and SQ-LNS for children >6 months of age. We used two study designs: (1) a repeated cross-sectional study of children 0-17 months old (n = 2,318 and 2,317 at baseline and endline 2 years later) to assess impacts on AM screening coverage, treatment coverage, and prevalence; (2) a longitudinal study of 2,113 children enrolled soon after birth and followed up monthly for 18 months to assess impacts on AM screening coverage, treatment coverage, and incidence. Data were analyzed as intent to treat. Level of significance for primary outcomes was α = 0.016 after adjustment for multiple testing. Children's average age was 8.8 ± 4.9 months in the intervention group and 8.9 ± 5.0 months in the comparison group at baseline and, respectively, 0.66 ± 0.32 and 0.67 ± 0.33 months at enrollment in the longitudinal study. Relative to the comparison group, the intervention group had significantly higher monthly AM screening coverage (cross-sectional study: +18 percentage points [pp], 95% CI 10-26, P < 0.001; longitudinal study: +23 pp, 95% CI 17-29, P < 0.001). There were no impacts on either AM treatment coverage (cross-sectional study: +8.0 pp, 95% CI 0.09-16, P = 0.047; longitudinal study: +7.7 pp, 95% CI -1.2 to 17, P = 0.090), AM incidence (longitudinal study: incidence rate ratio = 0.98, 95% CI 0.75-1.3, P = 0.88), or AM prevalence (cross-sectional study: -0.46 pp, 95% CI -4.4 to 3.5, P = 0.82). A study limitation is the referral of AM cases (for ethical reasons) by study enumerators as part of the monthly measurement in the longitudinal study that may have attenuated the detectable impact on AM treatment coverage. CONCLUSIONS: Adding a preventive package to CMAM delivered at health facilities in Burkina Faso increased participation in monthly AM screening, thus overcoming a major impediment to CMAM effectiveness. The lack of impact on AM treatment coverage and on AM prevalence and incidence calls for research to address the remaining barriers to uptake of preventive and treatment services at the health center and to identify and test complementary approaches to bring integrated preventive and CMAM services closer to the community while ensuring high-quality implementation and service delivery. TRIAL REGISTRATION: ClinicalTrials.gov NCT02245152.

Impact on child acute malnutrition of integrating small-quantity lipid-based nutrient supplements into community-level screening for acute malnutrition: A cluster-randomized controlled trial in Mali.

BACKGROUND: Community-based management of acute malnutrition (CMAM) has been widely adopted to treat childhood acute malnutrition (AM), but its effectiveness in program settings is often limited by implementation constraints, low screening coverage, and poor treatment uptake and adherence. This study addresses the problem of low screening coverage by testing the impact of distributing small-quantity lipid-based nutrient supplements (SQ-LNSs) at monthly screenings held by community health volunteers (CHVs). Screening sessions included behavior change communication (BCC) on nutrition, health, and hygiene practices (both study arms) and SQ-LNSs (one study arm). Impact was assessed on AM screening and treatment coverage and on AM incidence and prevalence. METHODS AND FINDINGS: A two-arm cluster-randomized controlled trial in 48 health center catchment areas in the Bla and San health districts in Mali was conducted from February 2015 to April 2017. In both arms, CHVs led monthly AM screenings in children 6-23 months of age and provided BCC to caregivers. The intervention arm also received a monthly supply of SQ-LNSs to stimulate caregivers' participation and supplement children's diet. We used two study designs: i) a repeated cross-sectional study (n = approximately 2,300) with baseline and endline surveys to examine impacts on AM screening and treatment coverage and prevalence (primary study outcomes) and ii) a longitudinal study of children enrolled at 6 months of age (n = 1,132) and followed monthly for 18 months to assess impact on AM screening and treatment coverage and incidence (primary study outcomes). All analyses were done by intent to treat. The intervention significantly increased AM screening coverage (cross-sectional study: +40 percentage points [pp], 95% confidence interval [CI]: 32, 49, p < 0.001; longitudinal study: +28 pp, 95% CI: 23, 33, p < 0.001). No impact on treatment coverage or AM prevalence was found. Children in the intervention arm, however, were 29% (95% CI: 8, 46; p = 0.017) less likely to develop a first AM episode (incidence) and, compared to children in comparison arm, their overall risk of AM (longitudinal prevalence) was 30% (95% CI: 12, 44; p = 0.002) lower. The intervention lowered CMAM enrollment by 10 pp (95% CI: 1.9, 18; p = 0.016), an unintended negative impact likely due to CHVs handing out preventive SQ-LNSs to caregivers of AM children instead of referring them to the CMAM program. Study limitations were i) the referral of AM cases by our research team (for ethical reasons) during monthly measurements in the longitudinal study might have interfered with usual CMAM activities and ii) the outcomes presented by child age also reflect seasonal variations because of the closed cohort design. CONCLUSIONS: Incorporating SQ-LNSs into monthly community-level AM screenings and BCC sessions was highly effective at improving screening coverage and reducing AM incidence, but it did not improve AM prevalence or treatment coverage. Future evaluation and implementation research on CMAM should carefully assess and tackle the remaining barriers that prevent AM cases from being correctly diagnosed, referred, and adequately treated. TRIAL REGISTRATION: ClinicalTrials.gov NCT02323815.

PROCOMIDA, a Food-Assisted Maternal and Child Health and Nutrition Program, Contributes to Postpartum Weight Retention in Guatemala: A Cluster-Randomized Controlled Intervention Trial.

BACKGROUND: Food-assisted maternal and child health and nutrition (FA-MCHN) programs are widely used to reduce household food insecurity and maternal and child undernutrition in low- and middle-income countries. These programs, however, may unintentionally lead to excessive energy intake and unhealthy weight gain, especially in food-secure populations. OBJECTIVE: We evaluated the impact of an FA-MCHN program implemented in Guatemala on maternal weight from pregnancy to 24 mo postpartum. The program was earlier shown to reduce stunting. METHODS: We used a longitudinal, cluster-randomized controlled trial with arms varying in family ration size [full (FFR), reduced (RFR), none (NFR)] and individual maternal ration type [corn-soy blend (CSB), lipid-based nutrient supplement (LNS), micronutrient powder (MNP)]: A: FFR + CSB; B: RFR + CSB; C: NFR + CSB; D: FFR + LNS; E: FFR + MNP; F: control. Weight was measured during pregnancy and at 1, 4, 6, 9, 12, 18, and 24 mo postpartum. We used linear mixed models controlling for pregnancy weight with random cluster and mother effects. Data on 3535 women were analyzed. RESULTS: Significant (P < 0.05) or marginally significant (P < 0.10) effects of 0.50-0.65 kg were found at all time points (except 9 mo) in arm A. Similar-sized effects were found in arms B (1, 4, 6, and 12 mo) and C (1 and 12 mo). Marginally significant effects (0.51-0.66 kg) were found in arm D (1, 6, 9, and 12 mo); in arm E, marginally significant effects (0.48-0.75 kg) were found from 6 to 24 mo. CONCLUSIONS: The effect on maternal postpartum weight is of concern because of the high existing prevalence of overweight. Programs need to include "double-duty" objectives and actions, to ensure that addressing child undernutrition does not exacerbate the problem of unhealthy weight gain. This trial was registered at clinicaltrials.gov as NCT01072279.

A Multisectoral Food-Assisted Maternal and Child Health and Nutrition Program Targeted to Women and Children in the First 1000 Days Increases Attainment of Language and Motor Milestones among Young Burundian Children.

BACKGROUND: Child development is affected by multiple factors throughout pregnancy and childhood. Multisectoral programs addressing these factors may improve children's development. OBJECTIVE: We evaluated the impact of a food-assisted multisectoral nutrition program (Tubaramure) on children's (4-41.9 mo) motor and language development. Tubaramure was targeted to Burundian women and children in the first 1000 d and provided micronutrient-fortified food rations; nutrition, health, and hygiene behavior change communication; and health system-strengthening activities. METHODS: Program impact was assessed using a cluster-randomized controlled trial with repeated cross-sections: 2010 (baseline, children 4-41.9 mo), 2012 (follow-up during implementation, children 4-23.9 mo), and 2014 (follow-up postimplementation, children 24-41.9 mo). Sixty villages were randomly assigned to 4 groups with varying timing and duration of food rations: pregnancy-24 mo; pregnancy-18 mo; 0-24 mo; and control, no direct Tubaramure benefits. Treatment groups were pooled and compared with control using difference-in-difference estimates. We examined impact pathways by assessing program impacts on intermediary variables and their associations with development outcomes. RESULTS: At first follow-up, Tubaramure positively affected language (0.4 milestones, P < 0.05) but not motor development among children aged 4-23.9 mo. Among the 12-23.9 mo age subgroup, the program positively affected language (0.7 milestones, P < 0.01) and motor (0.6 milestones, P = 0.08) development. At second follow-up, among children aged 24-41.9 mo, Tubaramure marginally affected motor development (0.4 milestones, P = 0.09). In age subgroup analyses, program impacts were limited to children aged 24-29.9 mo [0.4 motor (P = 0.09) and 1.0 language (P < 0.01) milestones]. Pathway analyses revealed significant positive impacts on diet, health, and nutritional indicators of children aged 12-23.9 mo and health and nutritional indicators of children aged 24-29.9 mo, supporting the plausibility of program impacts on child development. CONCLUSIONS: Tubaramure had small positive impacts on children's motor and language development through multiple pathways, demonstrating the role multisectoral nutrition programs can play in improving children's development. This trial was registered at clinicaltrials.gov as NCT01072279.