Effectiveness and cost-effectiveness of 4 supplementary foods for treating moderate acute malnutrition: results from a cluster-randomized intervention trial in Sierra Leone.

BACKGROUND: Moderate acute malnutrition (MAM) affects 33 million children annually. Investments in formulations of corn-soy blended flours and lipid-based nutrient supplements have effectively improved MAM recovery rates. Information costs and cost-effectiveness differences are still needed. OBJECTIVES: We assessed recovery and sustained recovery rates of MAM children receiving a supplementary food: ready-to-use supplementary food (RUSF), corn soy whey blend with fortified vegetable oil (CSWB w/oil), or Super Cereal Plus with amylase (SC + A) compared to Corn Soy Blend Plus with fortified vegetable oil (CSB+ w/oil). We also estimated differences in costs and cost effectiveness of each supplement. METHODS: In Sierra Leone, we randomly assigned 29 health centers to provide a supplement containing 550 kcal/d for ∼12 wk to 2691 children with MAM aged 6-59 mo. We calculated cost per enrollee, cost per child who recovered, and cost per child who sustained recovery each from 2 perspectives: program perspective and caregiver perspective, combined. RESULTS: Of 2653 MAM children (98.6%) with complete data, 1676 children (63%) recovered. There were no significant differences in the odds of recovery compared to CSB+ w/oil [0.83 (95% CI: 0.64-1.08) for CSWB w/oil, 1.01 (95% CI: 0.78-1.3) for SC + A, 1.05 (95% CI: 0.82-1.34) for RUSF]. The odds of sustaining recovery were significantly lower for RUSF (0.7; 95% CI 0.49-0.99) but not CSWB w/oil or SC + A [1.08 (95% CI: 0.73-1.6) and 0.96 (95% CI: 0.67-1.4), respectively] when compared to CSB+ w/oil. Costs per enrollee [US dollars (USD)/child] ranged from $105/child in RUSF to $112/child in SC + A and costs per recovered child (USD/child) ranged from $163/child in RUSF to $179/child in CSWB w/oil, with overlapping uncertainty ranges. Costs were highest per sustained recovery (USD/child), ranging from $214/child with the CSB+ w/oil to $226/child with the SC + A, with overlapping uncertainty ranges. CONCLUSIONS: The 4 supplements performed similarly across recovery (but not sustained recovery) and costed measures. Analyses of posttreatment outcomes are necessary to estimate the full cost of MAM treatment. This trial was registered at clinicaltrials.gov as NCT03146897.

Body Composition Changes in Children during Treatment for Moderate Acute Malnutrition: Findings from a 4-Arm Cluster-Randomized Trial in Sierra Leone.

BACKGROUND: Measures that better describe "healthy" and sustainable recovery during nutritional treatment of children with moderate acute malnutrition (MAM) are needed. OBJECTIVES: We compared changes to body composition among children receiving 1 of 4 specialized nutritious food (SNFs) during treatment of MAM and by recovery and relapse outcomes. METHODS: The study was nested within a prospective, cluster-randomized, community-based, cost-effectiveness trial assessing 4 SNFs to treat children aged 6-59 mo with MAM [midupper arm circumference (MUAC) ≥11.5 cm and <12.5 cm without bipedal edema] in Sierra Leone. Biweekly SNF rations (1 of 3 fortified-blended foods or a lipid-based nutrient supplement) were given until children recovered (MUAC ≥12.5 cm), or up to 7 rations (∼12 wk). Deuterium dilution was used to estimate fat-free mass (FFM) and fat mass (FM) at enrollment and after 4 wk of treatment to ensure similar treatment exposure among the participants. Another MUAC measurement was performed among recovered children 4 wk after program exit to determine whether recovery was sustained. ANOVA, paired t tests, and linear regression models were used to determine significant differences in changes from baseline to 4 wk. RESULTS: Among 312 analyzed participants, mean baseline weight comprised ∼80% FFM; mean weight gained after 4 wk comprised ∼82% FFM. Changes in FM and FFM among 4 SNFs were similar. Children who recovered gained more weight (241%), FFM (179%), and weight-for-height z score (0.44 compared with 0) compared with those who did not recover; sustainers gained 150% more weight. FM gains were positive among recovered children and sustainers, as well as negative among those who did not recover or sustain recovery, but not significantly different. CONCLUSIONS: Four SNFs had similar effects on body composition in children after 4 wk of treatment for MAM, showing a healthy pattern of weight gain, the majority being FFM. Differential responses to treatment underscore a need for further research to provide targets for healthy, sustainable recovery. This trial was registered at clinicaltrials.gov as NCT03146897.

Fortified blended flour supplements displace plain cereals in feeding of young children.

Lipid-based nutritional supplements (LNS) and fortified blended flours (FBF) are widely used to increase the nutrient density of children's diets and improve their health, but their effectiveness could be modified by displacement of other foods. We reanalysed data from a cost-effectiveness trial comparing impacts on anthropometry of three FBFs (Corn Soy Blend Plus [CSB+], Corn Soy Whey Blend [CSWB], SuperCereal Plus [SC+]) and one LNS (Ready-to-use Supplementary Food [RUSF]) among infants aged 7-23 months in Burkina Faso. Using dietary diversity data from a single 24-h recall period (n = 1,591 children, observed once over 18-month study period), we fit logistic regression models to estimate differences in intake of each food group making up the infant and young child minimum dietary diversity score and linear models to test for differences in dietary diversity score among children in each supplement arm. We tested for differences in breastfeeding time using the subsample for which breastfeeding was observed (n = 176). Children who consumed one of the three FBFs had lower odds of consuming household grains, roots and tubers compared with the LNS consumers (odds ratios [ORs] = 0.35-0.47; 95% confidence intervals [CIs]: 0.20-1.05). Consumption of other foods, dietary diversity and breastfeeding did not differ significantly at the 5% significance level. FBFs displaced the household's own cereals more than LNS, with no difference in the child's consumption of other more nutrient-rich family foods. Given limited stomach capacity and feeding time, providing fortified cereals may help improve children's overall diet quality in settings where children would otherwise be fed nutrient-poor root crops or cereal grains.

Effects of food supplementation on cognitive function, cerebral blood flow, and nutritional status in young children at risk of undernutrition: randomized controlled trial.

OBJECTIVE: To assess the effects of food supplementation on improving working memory and additional measures including cerebral blood flow in children at risk of undernutrition. DESIGN: Randomized controlled trial. SETTING: 10 villages in Guinea-Bissau. PARTICIPANTS: 1059 children aged 15 months to 7 years; children younger than 4 were the primary population. INTERVENTIONS: Supervised isocaloric servings (≈1300 kJ, five mornings each week, 23 weeks) of a new food supplement (NEWSUP, high in plant polyphenols and omega 3 fatty acids, within a wide variety and high fortification of micronutrients, and a high protein content), or a fortified blended food (FBF) used in nutrition programs, or a control meal (traditional rice breakfast). MAIN OUTCOME MEASUREMENTS: The primary outcome was working memory, a core executive function predicting long term academic achievement. Additional outcomes were hemoglobin concentration, growth, body composition, and index of cerebral blood flow (CBFi). In addition to an intention-to-treat analysis, a predefined per protocol analysis was conducted in children who consumed at least 75% of the supplement (820/925, 89%). The primary outcome was assessed by a multivariable Poisson model; other outcomes were assessed by multivariable linear mixed models. RESULTS: Among children younger than 4, randomization to NEWSUP increased working memory compared with the control meal (rate ratio 1.20, 95% confidence interval 1.02 to 1.41, P=0.03), with a larger effect in the per protocol population (1.25, 1.06 to 1.47, P=0.009). NEWSUP also increased hemoglobin concentration among children with anemia (adjusted mean difference 0.65 g/dL, 95% confidence interval 0.23 to 1.07, P=0.003) compared with the control meal, decreased body mass index z score gain (-0.23, -0.43 to -0.02, P=0.03), and increased lean tissue accretion (2.98 cm2, 0.04 to 5.92, P=0.046) with less fat (-5.82 cm2, -11.28 to -0.36, P=0.04) compared with FBF. Additionally, NEWSUP increased CBFi compared with the control meal and FBF in both age groups combined (1.14 mm2/s×10-8, 0.10 to 2.23, P=0.04 for both comparisons). Among children aged 4 and older, NEWSUP had no significant effect on working memory or anemia, but increased lean tissue compared with FBF (4.31 cm2, 0.34 to 8.28, P=0.03). CONCLUSIONS: Childhood undernutrition is associated with long term impairment in cognition. Contrary to current understanding, supplementary feeding for 23 weeks could improve executive function, brain health, and nutritional status in vulnerable young children living in low income countries. Further research is needed to optimize nutritional prescriptions for regenerative improvements in cognitive function, and to test effectiveness in other vulnerable groups. TRIAL REGISTRATION: ClinicalTrials.gov NCT03017209.

Impact of stakeholder perspectives on cost-effectiveness estimates of four specialized nutritious foods for preventing stunting and wasting in children 6-23 months in Burkina Faso.

BACKGROUND: Multiple specialized nutritious food options are programmed for supplementation in humanitarian and development settings. However, comparative cost-effectiveness evidence is lacking, let alone incorporation of perspectives from uncompensated stakeholders. A Burkina Faso trial evaluated the cost-effectiveness of Corn Soy Blend Plus w/ oil (CSB+ w/oil, reference arm), Corn Soy Whey Blend w/oil (CSWB w/oil), Super Cereal Plus (SC+), and Ready-to-Use Supplementary Food (RUSF) in reducing stunting and wasting among children 6-23 months old. This paper presents cost-effectiveness findings from multiple stakeholders' perspectives, including caregivers and program volunteers. METHODS: An activity-based costing with ingredients approach was used to summarize cost of the 18-month-long blanket supplementary feeding for each enrolled child (in 2018 USD). Time data were collected using self-reported and observational instruments. Cost-effectiveness relative to CSB+ w/oil assessed incremental cost per enrolled child against incremental outcomes: prevalence of stunting at 23 months of age and number of months of wasting. Two combined perspectives were compared: program (donor, implementer, and volunteer) versus program and caregiver (adding caregiver). RESULTS: A total of 6112 children were enrolled. While similar effectiveness was found in three arms (CSWB w/oil was less effective), costs differed. Product cost and caregiver time to prepare study foods were major drivers of cross-arm cost differences from the respective combined perspective. The two major drivers were used to construct uncertainty ranges of cost per enrolled child from program and caregiver perspective: $317 ($279- $355) in CSB+ w/oil, $350 ($327- $373) in CSWB w/oil, $387 ($371- $403) in RUSF, and $434 ($365- $503) in SC+. Cost from program and caregiver perspective was a substantial increase from program perspective. CSB+ w/oil was most cost-effective in reducing stunting and wasting, and this main finding was robust to changing perspectives and all corresponding sensitivity analyses when uncompensated time was valued at minimum wage ($0.36/h). The break-even point for uncompensated time valuation is >$0.84/h, where RUSF became the most cost-effective from the program and caregiver perspective. Relative cost-effectiveness rankings among the other three arms depended on choice of perspectives, and were sensitive to values assigned to product cost, international freight cost, opportunity cost of time, and outcomes of a hypothetical control. Volunteer opportunity cost did not affect arm comparisons, but lack of compensation resulted in negative financial consequences for caregivers. CONCLUSIONS: Evaluating cost-effectiveness by incorporating uncompensated stakeholders provided crucial implementation insights around nutrition products and programming. TRIAL REGISTRATION: Trial registration number: NCT02071563. Name of registry: ClinicalTrials.gov URL of registry: https://clinicaltrials.gov/ct2/show/NCT02071563?type=Intr&cond=Malnutrition&cntry=BF&draw=2&rank=9 Date of registration: February 26, 2014. Date of enrollment of first participant: July 2014.

Program changes are effective and cost-effective in increasing the amount of oil used in preparing corn soy blend porridge for treatment of moderate acute malnutrition in Malawi.

Corn Soy Blend (CSB) porridge is commonly prepared with oil for treatment of moderate acute malnutrition (MAM). A recent review recommended that 30 g of oil be used with 100 g of CSB to increase energy density and micronutrient absorption. This study assessed the effectiveness and cost-effectiveness of program changes aimed at achieving that target oil:CSB ratio in prepared porridge. Caregivers of children in MAM supplementary feeding programs were assigned to three groups: a control group received monthly rations of 1 L oil, 8 kg CSB in bulk, and social and behavior change communication (SBCC); intervention groups received 2.6 L oil, 8 kg CSB provided either in bulk (Group 1) or four 2-kg packages with printed messages (Group 2), and enhanced SBCC emphasizing the target oil:CSB ratio. Compared to the control, both intervention groups had higher mean added oil per 100 g CSB (18 g, p < 0.01, and 13 g, p= 0.04, higher in groups 1 and 2, respectively), and greater odds of meeting or exceeding the target ratio (28.4, p< 0.01, and 12.7, p= 0.02, in groups 1 and 2, respectively). Cost per caregiver reaching the target ratio was most favorable in Group 1 ($391 in Group 1, $527 in Group 2, and $1,666 in the control). Enhanced SBCC combined with increased oil ration resulted in increased use of oil in CSB porridge in a supplementary feeding program. Modified packaging did not improve effectiveness. However, both interventions were more cost-effective than standard programming.

Ready-to-use foods for management of moderate acute malnutrition: considerations for scaling up production and use in programs.

Ready-to-use foods are one of the available strategies for the treatment of moderate acute malnutrition (MAM), but challenges remain in the use of these products in programs at scale. This paper focuses on two challenges: the need for cheaper formulations using locally available ingredients that are processed in a safe, reliable, and financially sustainable local production facility; and the effective use of these products in large-scale community-based programs. Linear programming tools can be used successfully to design local compositions that are in line with international guidelines, low in cost, and acceptable, and the efficacy of these local formulations in the treatment of MAM was recently demonstrated in Malawi. The production of local formulations for programs at scale relies on the existence of a reliable and efficient local production facility. Technical assistance may be required in the development of sustainable business models at an early stage in the process, taking into account the stringent product quality and safety criteria and the required investments. The use of ready-to-use products, as of any food supplement, in programs at scale will be affected by the practice of household sharing and diversion of these products for other uses. Additional measures can be considered to account for sharing. These products designed for the treatment and prevention of MAM are to be used in community-based programs and should therefore be used in conjunction with other interventions and designed so that they do not replace the intake of other foods and breastmilk. Remaining challenges and implications for the (operations) research agenda are discussed.

Nutritional enhancement of US Title II food aid products.

BACKGROUND: Food aid provided by the United States has saved the lives of the vulnerable for many years. Recognizing the need for a thorough review of product formulations and specifications, the US Agency for International Development (USAID) commissioned a 2-year assessment of quality issues relating to Title II food aid products. This article presents findings and recommendations of that review relating to product enhancements. OBJECTIVE: The core question addressed was: Are current commodity specifications for enriched FBFs appropriate in light of evolving nutritional science and food fortification technology, or do they need to be updated? METHODS: Empirical data were derived from a number of sources, including a survey of Title II implementing partners focusing on procurement and logistics, and uses of FBFs and other foods. Input of implementing partners, civil society, and donor organizations was obtained through individual consultations, international and small group meetings. More than 400 individuals accessed the project's website. The project convened a panel of experts in food technology and science, food policy, law, industry, medicine, development and humanitarian work, and the maritime industry, and held regular joint meetings with USDA and USAID. The draft report was widely disseminated and posted on the website. RESULTS AND CONCLUSIONS: The findings of this research led to the following broad areas of improvement in US Title II food aid products: 1) Improve the formulation of existing FBF products used in Title II programming. This includes the addition of a dairy source of protein to products targeted to children 6 to 24 months of age, pregnant and lactating women, wasted children, and wasted individuals undergoing HIV/AIDS treatment. 2) Upgrade the vitamin and mineral mixes used and diversify approaches to addressing micronutrient needs. Enhance the composition of premixes used to fortify blended foods as well as milled grains and vegetable oil; facilitate shipping offortificant premix with bulk cereals for in-country fortification; and develop micronutrient powders (sachets) and other point-of-use fortification options. 3) Develop or adopt non-cereal-based (e.g., lipid-based) products for the management of nutritional deficiencies. This is an argument for more choice among appropriate tools, not for discarding products that have already shown their value over many years. It also does not reduce the need to maintain a focus on supplying high volumes of quality grains as the main staple in food aid baskets.