scholarly journals Comparative Effectiveness of Four Specialized Nutritious Food Products for Treatment of Moderate Acute Malnutrition in Sierra Leone (P10-140-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Breanne Langlois ◽  
Stacy Griswold ◽  
Devika Suri ◽  
Ye Shen ◽  
Kenneth Chui ◽  
...  

Abstract Objectives This study compared the effectiveness of 4 specialized nutritious foods (SNFs) used for the treatment of moderate acute malnutrition (MAM) in children <5 years of age in Pujehun District, Sierra Leone. Methods This was a cluster-randomized trial operating through a supplementary feeding program (SFP) providing SNFs for treatment of MAM. Three study foods were fortified blended foods – Super Cereal Plus w/amylase (SC + A), Corn-soy Blend Plus w/oil (CSB + w/oil), and Corn-soy-whey Blend w/oil (CSWB w/oil) – and one was a lipid-based Ready to Use Supplementary Food (RUSF). From 4/2017 to 11/2018, children with MAM, defined as mid-upper arm circumference (MUAC) ≥11.5 cm and <12.5 cm without bipedal edema, were enrolled at participating health clinics and received rations bi-weekly until they reached an outcome or for up to 12 weeks. A stratified randomization technique was used to select 28 sites and randomize them into 7 per arm based on pre-determined criteria. During the study, an 8th site was added to the CSWB w/oil arm due to low enrollment. The primary outcome was graduation from SFP defined as MUAC ≥12.5 cm within the 12-week treatment period. Mixed-effect regression assessed whether there were differences in graduation rates among children treated with one of the 4 SNFs. Results A total of 2683 children were enrolled out of a planned sample size of ∼5000. Overall: 63% graduated from MAM, 19% developed severe acute malnutrition (SAM), 7% defaulted (missed 3 visits in a row), 1% died, and 10% reached no outcome within 12 weeks. Twenty-five % were transferred into the study from SAM treatment. By study arm, graduation rates were: 62% in CSWB w/oil, 65% in SC + A, 64% in CSB + w/oil, 62% in RUSF. In an unadjusted model, statistically significant differences in graduation rates between the arms were not detected. Data analysis is ongoing to determine if this finding is maintained in adjusted models. Conclusions The 4 foods performed comparably in treating MAM in unadjusted analysis. Decision-making by donors, governments, and programmers on which food to program should also be based on cost-effectiveness analysis. Funding Sources Supported by the Office of Food for Peace, Bureau for Democracy, Conflict, and Humanitarian Assistance, U.S. Agency for International Development.

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Akriti Singh ◽  
Isabel Potani ◽  
Stacy Griswold ◽  
Devika Suri ◽  
Breanne Langlois ◽  
...  

Abstract Objectives The objective of the study was to examine whether EED at enrollment modifies the effect of specialized nutritious foods (SNFs) on graduation from a moderate acute malnutrition (MAM) treatment program. Methods This sub-study was nested within a cluster randomized trial of MAM children 6–59 months of age supplemented with one of four SNFs: Super Cereal Plus w/amylase (SC + A), Corn Soy Blend Plus w/oil (CSB + w/oil - referent), Corn Soy Whey Blend w/oil (CSWB w/oil), and Ready to Use Supplementary Food (RUSF). Children with mid-upper arm circumference (MUAC) ≥11.5 cm and <12.5 cm with no clinical complications were enrolled. Children received the study food until they reached MUAC ≥12.5 cm or up to 12 weeks. EED was assessed at enrollment using the lactulose: mannitol (L: M) test. Samples from 387 participants were analyzed. Logistic regression was used to test for effect modification by L: M ratio (LM), L: M excretion ratio (LMER), and % lactulose excreted (%L). Results At enrollment, the mean ± SD age of sub-study participants was 14.5 ± 9.12 months, 57% were female, and 24% previously had severe acute malnutrition (SAM). The median LM was 0.49 (interquartile range, IQR = 0.42), LMER was 0.10 (IQR = 0.08), and %L was 0.34 (IQR = 0.42). The overall graduation rate was 66% (range: 60% to 74% by food). LMER, LM, and %L did not modify the effect of the study foods in unadjusted models (P = 0.116, P = 0.116, P = 0.176), and models adjusted for age, gender, and previous SAM (P = 0.057, P = 0.057, P = 0.337). Analysis excluding children with watery stool after L: M dosing (N = 16), but not before as reported by the caregiver, showed statistically significant effect modification by LMER (P = 0.03; SC + A vs. CSB + : β = 12.69, P = 0.013) and L: M ratio (P = 0.03, SC + A vs. CSB + : β = 2.55, P = 0.013). Conclusions In this study we did not find EED (L: M test) at enrollment to modify the effect of SNFs on likelihood of graduation from a MAM treatment program. This may be because EED did not affect graduation from the program, or because EED severity changes over the course of treatment. Watery stool post L: M dosing should be systematically recorded and its effect assessed in analysis. Funding Sources This work was supported by the Office of Food for Peace, Bureau for Democracy, Conflict, and Humanitarian Assistance, U.S. Agency for International Development.


2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Ye Shen ◽  
Stacy Griswold ◽  
Breanne Langlois ◽  
Devika Suri ◽  
Stephen Vosti ◽  
...  

Abstract Objectives To estimate cost-effectiveness of 4 specialized nutritious foods (SNF) for Moderate Acute Malnutrition (MAM) treatment in children under five in Pujehun District, Sierra Leone Methods In a cluster randomized trial, a mobile supplementary feeding program was set up at 29 peripheral health units to treat children with MAM (mid-upper arm circumference (MUAC) ≥11.5 cm and <12.5 cm without bipedal edema) with 1 of 4 iso-caloric rations: Corn Soy Blend Plus w/oil (CSB + w/oil, reference), Corn Soy Whey Blend w/oil (CSWB w/oil), Super Cereal Plus w/amylase (SC + A), or Ready to Use Supplementary Food (RUSF). All foods were procured from U.S. except locally produced RUSF. Unlike RUSF and oil provided in commonly programmed specifications, CSB + , CSWB, and SC + A were produced in experimental package size or formulation at small scale. Caregivers picked up rations bi-weekly until children reached an outcome or up to 12 weeks. Collected from accounting records and study instruments using activity-based costing with ingredients, data on 10 components from implementer perspective (start-up, supply chain, and programming) were summarized into cost per enrolled child in 2018 USD for each arm. Other stakeholders’ costing perspectives will also be analyzed. To assess cost-effectiveness by arm, cost per recovered child = cost per enrolled child/graduation rate. Predicted means of crude graduation rate (% of children reaching MUAC ≥12.5 cm in 12 weeks) with 95% confidence intervals were estimated from unadjusted mixed-effect model to construct crude cost-effectiveness ranges. Future analyses will be based on adjusted modeling and realistically estimated product costs at scaled production. Results Children (N = 2681) received similar number of bi-weekly rations by arm. Product and international freight were top drivers of cost differences across arms. Crude graduation rate was not statistically different by arm. Cost per enrolled child ranged from $86 in RUSF to $94 in SC + A. Cost per recovered child was $137 ($130 - 145) in RUSF, $142 ($134 - 151) in CSB + w/oil, $146 ($138 - 155) in SC + A, and $149 ($140 - 160) in CSWB w/oil. Conclusions Crude cost-effectiveness to treat MAM considering only implementer cost was similar across 4 SNFs. Funding Sources Office of Food for Peace, Bureau for Democracy, Conflict, and Humanitarian Assistance, U.S. Agency for International Development.


2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 857-857
Author(s):  
Breanne Langlois ◽  
Stacy Griswold ◽  
Ilana Cliffer ◽  
Devika Suri ◽  
Ye Shen ◽  
...  

Abstract Objectives This analysis describes differences in household-level use of four specialized nutritious foods (SNFs) for treatment of moderate acute malnutrition (MAM) in children 6–59 months of age in Sierra Leone and explores whether these behaviors influenced recovery. Methods From 4/2017 to 11/2018, sub-samples of caregivers whose children were enrolled in a supplemental feeding program (SFP) for a MAM treatment study were randomly selected for in-depth interviews and in-home observations. This was a cluster-randomized trial of 2653 children with MAM in Sierra Leone evaluating cost-effectiveness of 4 SNFs: Super Cereal Plus w/amylase (SC + A), Corn-soy Blend Plus w/oil (CSB + w/oil), Corn-soy-whey Blend w/oil (CSWB w/oil), and Ready-to-Use Supplementary Food (RUSF). Caregivers received bi-weekly isocaloric distributions of 1 of the 4 SNFs until recovery or up to 12 weeks. The purpose of the in-depth interviews was to understand caregivers’ experiences with the SFP and the SNF which they received. In-home observations gathered information about observed behaviors related to SNF use over 5 consecutive days. Descriptive statistics were calculated and stratified by study arm and by outcome to explore: consumption of the SNF by the target child, sharing and selling, and diversion of other household foods. Results A total of n = 949 caregivers completed an in-depth interview. Of these, n = 323 also had an in-home observation. Observed consumption of the SNF was high in all study arms (&gt;60%), with no discernible differences among arms. Consumption of the study food by anyone other than the beneficiary child (i.e., sharing) was similar across arms (9–12% reported, 19–27% observed), with the lowest reported and highest observed in RUSF. Very few reported giving the SNF away or selling it to others (&lt;1%). Sharing and displacement did not differ by recovery status, but children who recovered were observed consuming the SNF more often than those who failed (82% vs. 46%). Conclusions Sharing of the SNF was common among all arms but did not affect likelihood of recovery. Ensuring adequate consumption of the SNF by the beneficiary child is critical for effectiveness. Qualitative data can expand on these findings. Funding Sources Office of Food for Peace, United States Agency for International Development.


Author(s):  
Akriti Singh ◽  
Isabel Potani ◽  
Stacy P. Griswold ◽  
Devika Suri ◽  
Breanne Langlois ◽  
...  

Examining the role of environmental enteric dysfunction (EED) in child growth requires noninvasive, field-appropriate biomarkers. Alternatives to the traditionally used lactulose:mannitol (L:M) test have been explored, but few studies have compared the L:M test to host fecal mRNA transcripts. The objectives of this study were to examine whether 1) host fecal mRNA transcripts could predict presence and severity of EED, measured using the L:M test, and 2) EED modifies the effect of specialized nutritious foods (SNFs) on recovery from moderate acute malnutrition (MAM). This substudy was nested within a cluster randomized trial comparing four SNFs in the treatment of MAM among children 6 to 59 months in Sierra Leone. EED was assessed at enrollment using the L:M test and 15 host fecal mRNA transcripts on 522 children. Recovery from MAM was defined as achieving mid-upper arm circumference ≥ 12.5 cm within 12 weeks of supplementation. Random forest classification models were used to examine prediction of presence and severity of EED by host fecal mRNA transcripts. Logistic regression was used to test for effect modification by L:M test variables including % lactulose excreted (%L). Eight host fecal mRNA transcripts (AQP9, REG3A, IFI30, DECR1, BIRC3, SELL, PIK3AP1, DEFA6) identified EED (%L ≥ 0.2) and severe EED (%L ≥ 0.45) with high sensitivity and specificity. The L:M test variables did not modify the effect of SNFs on recovery from MAM. In this study, we found host fecal mRNA transcripts that could be biomarkers of EED but did not find EED to modify the effect of SNFs on MAM treatment.


2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Stacy Griswold ◽  
Breanne Langlois ◽  
Devika Suri ◽  
Ye Shen ◽  
Shelley Walton ◽  
...  

Abstract Objectives Fortified blended flours (FBFs) require preparation with boiling water, sometimes with fortified vegetable oil (FVO), using prescribed quantities and ratios. Lipid-based nutrient supplements (LNS) are ready-to-eat, individually packaged, and prescribed for consumption without adding other ingredients/foods. This study assessed compliance with recipe and ration instructions and whether this influenced treatment effectiveness for moderate acute malnutrition (MAM). Methods A cluster-randomized clinical-effectiveness trial in Sierra Leone compared four isocaloric foods in treating children 6–59 mos with uncomplicated MAM: Corn-Soy Blend Plus with FVO (CSB +), Corn-Soy Whey Blend with FVO (CSWB), Super Cereal Plus with amylase (SC + A), or ready-to-use-supplementary food (RUSF). Caregivers were advised bi-weekly by trained nurses on ingredients, quantities, and daily rations. A random sub-sample participated in in-depth interviews on ingredients used at the last preparation. Respondents were categorized in two ways: (for FBFs) using too little, the correct amount or too much or (for RUSF) correct if eaten without other food; or using the recommended ratios of ingredients. Unadjusted logistic regression evaluated the relationship between compliance and graduation from treatment. Results Graduation rates among 958 respondents: 70% CSB + , 67% CSWB, 66% SC + , and 66% RUSF. Reported use of correct ingredients was: 99% of CSB +, 97% of CSWB, and 99% of SC + A and 86% RUSF reported eating without mixing. Reported use of correct amount of flour: 34% in CSB + , 27% in CSWB, and 43% in SC + A of those, 95% in CSB + and 96% in CSWB also used the correct amount of oil. Among all caregivers, 86% in CSB + and 92% in CSWB used the correct amount of oil. In unadjusted models, the relationships between compliance behaviors and graduation were not statistically significant. Conclusions Reported use of correct ingredients was high for all study foods; among FBFs, amount of flour was often different from the recommendation while amount of oil was often correct. Further research may explain apparent low importance of emphasizing ration guidance when designing information, education, and communication for MAM treatment programs. Funding Sources Office of Food for Peace, Bureau for Democracy, Conflict, and Humanitarian Assistance, U.S. Agency for International Development.


2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1081-1081
Author(s):  
Akriti Singh ◽  
Honorine Ward ◽  
Shibani Ghosh ◽  
Beatrice Rogers ◽  
Irwin Rosenberg

Abstract Objectives The objectives of the study were to 1) develop an EED score using fecal host mRNA transcripts, 2) compare three EED biomarkers, and 3) examine associations between EED biomarkers and growth outcomes and recovery from MAM. Methods In a study nested within a supplementary feeding program for children 6–59 months of age with MAM in Sierra Leone, EED was assessed in all children enrolled using: 1) lactulose: mannitol (L: M) test (n = 422), 2) fifteen host fecal mRNA transcripts (n = 441), and 3) host fecal proteins [alpha-1-anti trypsin (AAT), myeloperoxidase (MPO), neopterin (NEO)] (n = 200). Data were also collected on anthropometry and z scores computed for length-for-age (LAZ), and weight-for-length (WLZ). Length and weight gain were assessed over 2 weeks and recovery from MAM was defined as mid-upper arm circumference ≥12.5 cm. Factor analysis was used to identify EED scores using the mRNA transcripts and mixed effects regression was conducted to test for associations. Results The fifteen host fecal mRNA transcripts clustered into three scores using factor analysis (Eigen value &gt;1). These were termed the Gut Inflammation (GI) score (Eigen value = 5.55), Gut Structure (GS) score (Eigen value = 2.48), and Gut Defense (GD) score (Eigen value = 2.22). We found agreement between the GI score and MPO (P &lt; 0.001), the GS score and AAT (P = 0.001), and between AAT and L: M excretion ratio (P = 0.036). The GD score was negatively associated with %L (P &lt; 0.001). A lower LAZ was associated with higher inflammation (GI score, P = 0.014). A lower length gain was associated with higher permeability (AAT, P = 0.001). A lower WLZ was associated with higher inflammation (GI score, P = 0.021) and higher permeability (GS score, P = 0.002). A lower weight gain was associated with lower gut defense (GD score, P = 0.044) and higher inflammation (MPO, P = 0.002). High gut defense (GD score, P = 0.011) and low permeability (AAT, P = 0.007) predicted recovery from MAM. Conclusions Fifteen mRNA transcripts clustered into three scores with clusters reflecting inflammation, permeability and gut defense. These were variably correlated with the L: M test and host fecal proteins but seemed to measure the same characteristics of EED. Markers of inflammation, permeability, and gut defense were associated with growth outcomes, and predicted recovery from MAM. Funding Sources U.S. Agency for International Development (USAID).


2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Devika Suri ◽  
Isabel Potani ◽  
Akriti Singh ◽  
Stacy Griswold ◽  
William Wong ◽  
...  

Abstract Objectives To determine differential changes in children's body composition—fat-free mass (FFM) and fat mass (FM)—after 4 weeks of treatment for moderate acute malnutrition (MAM) with one of 4 four specialized nutritious foods (SNFs). Methods This sub-study was nested within a larger cluster-randomized trial comparing the cost-effectiveness of 4 isocaloric SNFs in treating MAM among children 6–59 months in Pujehun District, Sierra Leone: Corn-Soy Blend Plus w/oil (CSB + w/oil), Super Cereal Plus w/amylase (SC + A), Corn-Soy-Whey Blend w/oil (CSWB w/oil) and Ready-to-use-Supplementary Food (RUSF). Children with mid-upper arm circumference (MUAC) ≥11.5 cm and <12.5 cm with no clinical complications were enrolled and received an SNF ration bi-weekly until they reached MUAC ≥12.5 cm or up to 12 weeks. Body composition was assessed using the deuterium dilution technique at program enrollment and after 4 weeks of treatment. Changes in weight, FM, FFM and %FFM overall and by study arm were calculated; statistical significance was determined using t-tests and ANOVA (unadjusted). Results Among 336 subjects at enrollment, mean ± SD age was 11.8 ± 6.5 mos, weight was 6.5 ± 0.9 kg, FM was 1.3 ± 0.5 kg, FFM was 5.2 ± 0.9 kg, and %FFM was 80.4 ± 7.3. After 4 weeks of treatment, mean ± SD change in weight was 0.44 ± 0.39 kg (P < 0.001), FM was 0.09 ± 0.60 kg (P = 0.005), FFM was 0.35 ± 0.56 (P < 0.001), and %FFM was 0.003 ± 8.5 (NS). Overall, weight gain consisted on average of 20.9% FM and 79.8% FFM. By study arm, mean ± SD changes in FM and FFM respectively, were: 0.12 ± 0.53 kg and 0.32 ± 0.49 kg in CSB + w/oil; 0.13 ± 0.67 kg and 0.34 ± 0.64 kg in SC + A; 0.08 ± 0.65 kg and 0.36 ± 0.57 kg in CSWB w/oil; 0.02 ± 0.49 kg and 0.39 ± 0.5 kg in RUSF. These changes were not significantly different across study arms. Conclusions Over 4 weeks of treatment for MAM, children gained roughly 80% lean mass relative to 20% fat mass. This body composition is consistent with predicted sustainability of recovery from MAM and healthier long-term disease risk. Differential effects on body composition by type of SNF were not detected after 4 weeks of treatment in this study. Funding Sources The Office of Food for Peace, Bureau for Democracy, Conflict, and Humanitarian Assistance, U.S. Agency for International Development.


2020 ◽  
Vol 189 (12) ◽  
pp. 1623-1627
Author(s):  
Francisco M Barba ◽  
Lieven Huybregts ◽  
Jef L Leroy

Abstract 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.


2016 ◽  
Vol 38 (1) ◽  
pp. 27-36 ◽  
Author(s):  
Cecile Cames ◽  
Marie Varloteaux ◽  
Ndeye Ngone Have ◽  
Alhadji Bassine Diom ◽  
Philippe Msellati ◽  
...  

Objectives: To assess the acceptability of ready-to-use food (RUF)-based outpatient protocols in HIV-infected children and adolescents with severe acute malnutrition (SAM) and moderate acute malnutrition (MAM). Methods: Plumpy Nut and Plumpy Sup were supplied every 2 weeks and prescribed by weight to SAM and MAM children, respectively. Forty-three children, 24 MAM and 19 SAM, were enrolled. Organoleptic appreciation, feeding modalities, and perceptions surrounding RUF were recorded at week 2. Sachets were counted to measure adherence throughout the study. Results: Median age was 12.2 years (interquartile range: 9.3-14.8), and 91% were on antiretroviral treatment. Overall, 80%, 76%, 68%, and 68% of children initially rated RUF color, taste, smell, and mouth feeling as good. However, feelings of disgust, refusal to eat, fragmentation of intake, self-stigma, and sharing within the household were commonly reported. Eighteen MAM and 7 SAM experienced weight recovery. Recovery duration was 54 days (31-90) in MAM versus 114 days (69-151) in SAM children ( P = .02). Their rate of RUF consumption compared to amount prescribed was approximately 50% from week 2 to week 10. Nine failed to gain weight or consume RUF and were discontinued for clinical management, and 9 dropped out due to distance to the clinic. Conclusion: Initial RUF acceptability was satisfactory. More than half the children had successful weight recovery, although adherence to RUF prescription was suboptimal. However, further research is needed to propose therapeutic foods with improved palatability, alternative and simpler intervention design, and procedures for continuous and tailored psychosocial support in this vulnerable population. Trial registration: NCT01771562 (Current Controlled Trials).


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