Development of local-ingredients-based supplementary food and evaluation of its comparability to standard corn-soy blend plus in treating moderate acute malnutrition among children aged 6 to 59 months in Wolaita, Southern Ethiopia.

Background: Acute malnutrition is a severe public health issue in Ethiopia, where the prevalence is among the highest in the world. Acute malnutrition is classified as moderate or severe. Children with moderate acute malnutrition (MAM) have an increased risk of infections and mortality. If children with MAM are not properly managed, MAM can progress to the severe form which is a life-threatening condition. MAM, on the other hand, has not received the attention it deserves and is not commonly recognized as a public health issue. In Ethiopia, children with MAM, who are living in food-insecure districts, are getting corn-soy blend plus (CSB+), which is the standard supplement. In Ethiopia, in districts not classified as chronically food insecure, there are no food supplementation programs. Optimal feeding of locally available, nutrient-dense foods could treat MAM. To our knowledge, few studies in Ethiopia have evaluated the effect of local-ingredients-based supplements (LIBS) compared to conventional supplements for treating MAM. Objective: The aim of this thesis is to develop local-ingredients-based supplementary food and evaluate if it is comparable to standard corn-soy blend plus in treating moderate acute malnutrition among children aged 6 to 59 months. Methods: We conducted a descriptive phenomenological qualitative study to assess barriers to management of MAM among children aged 6-59 months in Damot Pulassa, Wolaita, South Ethiopia (Paper I). We used six focus group discussions with mothers or caregivers of children aged 6 to 59 months, and ten in-depth interviews with health service providers, to identify the barriers toward existing management practice for MAM. Thereafter, we developed the LIBS for treating children with MAM aged 6 to 59 months. We developed the LIBS from locally available ingredients such as: pumpkin seed, peanut, amaranth grain, flaxseed and emmer wheat. Collection of ingredients, sorting, soaking, draining, drying, roasting, dehulling or shelling, milling and mixing were done (Paper II). A randomized controlled non-inferiority trial with two arms, involving 324 children with MAM, was conducted to evaluate if the LIBS is similar to CSB+ in treating children with MAM. One hundred and sixty-two children were randomized to each of the two arms. The first arm received 125.2 g of LIBS per day along with 8 ml of refined deodorized and cholesterol-free sunflower oil. The first arm received 150 g CSB+ per day along with 16 ml of refined deodorized and cholesterol-free sunflower oil. Each child was provided with a daily ration of either LIBS or CSB+ for 12 weeks (Paper III). The study protocol of Paper III was published (Paper IV). Result: In Paper I, possible reasons for MAM, identification of a child with MAM, management services for MAM, maternal-level barriers, service provider-level barriers, and measures to improve the service were identified as six themes. Maternal-level barriers to managing MAM were: lack of food and money, selling-out of self-produced foods without having sufficient reserves at home, large household size, and shame about having a child with malnutrition. Service provider-level barriers to managing MAM were: occasional house-to-house screening of children, family-initiated counseling, leaving the management responsibility of children with MAM to the family, and lack of repeated follow-up visits by service providers. Mothers or caregivers and service providers perceived as the existing management practice for MAM can be improved through focused, routine and inclusive counseling (including all mothers of children aged below five years and fathers), and the provision of supplementary food. In Paper II, LIBS1, LIBS2, LIBS3, and LIBS4 were the four food supplements that were developed. The protein content of four developed LIBSs ranged from 20.3 g to 22.5 g, the fat content from 29.3 g to 33.5 g, the kcal content from 510 kcal to 570 kcal, the fiber content from 6.0 g to 8.5 g, the moisture content from 2.8 g to 3.7 g, and the ash content from 2.1 g to 4.3 g. Calcium was 75.6 mg to 115.6 mg, potassium was 473.1 mg to 570.2 mg, sodium was 79.3 mg to 114.4 mg, zinc was 4.1 mg to 5.6 mg, iron was 8.2 mg to 10.2 mg, phosphorous was 442.6 mg to 470.4 mg, and phytate was 2.1 mg to 4.3 mg. LIBS 4 had a significantly higher level of protein, fat, energy, iron, zinc, phosphorous, and potassium compared to LIBS 1, LIBS 2, and LIBS 3. The phytate content of the four LIBS was significantly different. The lowest level of phytate was found in LIBS 4 (Paper II). LIBS was shown to be non-inferior to CSB+ in both intention-to-treat (ITT) and per-protocol (PP) analyses for recovery rate [ITT risk difference = 4.9% (95% CI: –4.70, 14.50); PP risk difference = 3.7% (95% CI: –5.91, 13.31)]; average weight gain [ITT risk difference = 0.10 g (95% CI: –0.33 g, 0.53 g); PP risk difference = 0.04 g (95% CI: –0.38 g, 0.47 g)]; recovery time [ITT risk difference = –2.64 days (95% CI: –8.40 days, 3.13 days); PP difference –2.17 days (95% CI: –7.97 days, 3.64 days]. Non-inferiority of LIBS compared with CSB+ was also shown for the MUAC gain and length/height gain (Paper III). Conclusion: We observed that maternal-level barriers and service provider-level barriers negatively affect the management of MAM among children aged 6 to 59 months. A supplementary feeding that addresses the food shortage of households, in addition to nutrition counseling, is critical in overcoming MAM. We demonstrated that the nutrients of developed LIBSs were within the recommended range of required nutrients for treating children with MAM. We showed that LIBS was similar compared to CSB+ in treating children with MAM aged 6 to 59 months. Therefore, LIBS could be used for the management of children with MAM. Trial registration: Pan-African Clinical Trial Registration number: PACTR201809662822990, registered on 12 September, 2018.Bakgrunn: Akutt underernæring er et alvorlig folkehelseproblem i Etiopia, prevalensen er blant de høyeste i verden. Akutt underernæring kan klassifiseres som moderat eller alvorlig. Barn med moderat akutt underernæring (MAM) har økt risiko for infeksjoner og dødelighet. Hvis barn med MAM ikke behandles riktig, kan det utvikle seg til den alvorlige formen som er en livstruende tilstand. MAM har ikke fått så mye oppmerksomhet og er ikke anerkjent som et folkehelseproblem. I Etiopia får barn med MAM, som bor i distrikter som ikke er matsikre et standardtilskuddet av mais-soyapblanding (CSB+). I Etiopia, i distrikter som ikke er klassifisert som kronisk matusikre, er det derimot ingen kosttilskuddsprogrammer. Tilskudd av lokalt tilgjengelig, næringsrike matvarer kan behandle MAM. Så vidt vi vet, har få studier i Etiopia evaluert effekten av lokale ingrediensbaserte tilleggskost (LIBS) sammenlignet med konvensjonelle tilleggskost for behandling av MAM. Mål: Målet med denne oppgaven var å utvikle tilleggskost basert på lokale ingredienser og vurdere om det er sammenlignbart med standard mais-soyablanding ved behandling av moderat akutt underernæring blant barn i alderen 6 til 59 måneder. Metoder: Vi gjennomførte en deskriptiv fenomenologisk kvalitativ studie for å vurdere barrierer for håndtering av MAM blant barn i alderen 6-59 måneder i Damot Pulassa, Wolaita, Sør-Etiopia (Artikkel I). Vi gjennomførte seks fokusgruppediskusjoner med mødre eller omsorgspersoner til barn i alderen 6 til 59 måneder, og ti dybdeintervjuer med helsetjenesteleverandører, for å identifisere barrierene mot eksisterende behandlingspraksis for MAM. Deretter utviklet vi LIBS for behandling av barn med MAM i alderen 6 til 59 måneder. Vi utviklet LIBS fra lokalt tilgjengelige ingredienser som: gresskarfrø, peanøtter, amarantkorn, linfrø og emmerhvete. Gjennomføringen av innsamling av ingredienser, sortering, bløtlegging, tørking, steking, avskalling, maling og blanding er beskrevet i Artikkel II. En randomisert kontrollert non-inferiority studie med to armer involverte 324 barn med MAM, ble utført for å evaluere om LIBS er lik CSB+ ved behandling av barn med MAM. Ett hundre og sekstito barn ble randomisert til hver av de to armene. Barna i den første armen mottok 125,2 g LIBS per dag sammen med 8 ml raffinert lukt- og kolesterolfri solsikkeolje. Barna i andre armen fikk 150 g CSB+ per dag sammen med 16 ml raffinert lukt- og kolesterolfri solsikkeolje. Hvert barn fikk en daglig rasjon av enten LIBS eller CSB+ i 12 uker (Artikkel III). Studieprotokollen til Artikkel III ble publisert (Artikkel IV). Resultat: I Artikkel I ble mulige årsaker til MAM, identifisering av barn med MAM, behandling for MAM, barrierer på morsnivå, barrierer på helsetjenestenivå og tiltak for å forbedre tjenesten identifisert som seks temaer. Barrierer på morsnivå for å håndtere MAM var: mangel på mat og penger, salg av egenprodusert mat uten å ha tilstrekkelige reserver hjemme, stor husholdningsstørrelse og skam over å ha et barn med underernæring. Barrierer på helsetjenestenivå for å håndtere MAM var: sporadiske hus-til-hus screening av barn, familieinitiert rådgivning, overlate behandlingsansvar for barn med MAM til familien, og mangel på gjentatte oppfølgingsbesøk fra helsetjenesten. Mødre/omsorgspersoner og helsetjenesten som oppfattes som den eksisterende behandlingspraksisen for MAM kan forbedres gjennom fokusert, rutinemessig og inkluderende rådgivning (inkludert alle foreldre til barn under fem år), og tilbud om kosttilskudd. I Artikkel II var LIBS1, LIBS2, LIBS3 og LIBS4 de fire kosttilskuddene som ble utviklet. Proteininnholdet i fire utviklede LIBS-er varierte fra 20,3 g til 22,5 g, fettinnholdet fra 29,3 g til 33,5 g, kcal-innholdet fra 510 kcal til 570 kcal, fiberinnholdet fra 6,0 g til 8,5 g, vanninholdet fra 2,8 g til 3,7 g, og askeinnholdet fra 2,1 g til 4,3 g. Kalsium var 75,6 mg til 115,6 mg, kalium var 473,1 mg til 570,2 mg, natrium var 79,3 mg til 114,4 mg, sink var 4,1 mg til 5,6 mg, jern var 8,2 mg til 10,2 mg, fosfor var 442,6 mg til 470,4 mg, og fytat var 2,1 mg til 4,3 mg. LIBS 4 hadde et betydelig høyere nivå av protein, fett, energi, jern, sink, fosfor og kalium sammenlignet med LIBS 1, LIBS 2 og LIBS 3. Fytatinnholdet i de fire LIBS var signifikant forskjellig. Det laveste nivået av fytat ble funnet i LIBS 4 (Artikkel II). LIBS ble vist å være ikke-underordnet CSB+ i både intensjon-å-behandle (ITT) og per-protokoll (PP) analyser for utvinningsgrad [ITT risikoforskjell = 4,9 % (95 % KI: –4,70, 14,50); PP risikoforskjell = 3,7 % (95 % KI: –5,91, 13,31)]; gjennomsnittlig vektøkning [ITT risikoforskjell = 0,10 g (95 % KI: –0,33 g, 0,53 g); PP-risikoforskjell = 0,04 g (95 % KI: –0,38 g, 0,47 g)]; restitusjonstid [ITT risikoforskjell = –2,64 dager (95 % KI: –8,40 dager, 3,13 dager); PP-forskjell –2,17 dager (95 % KI: –7,97 dager, 3,64 dager]. Ikke-inferioritet av LIBS sammenlignet med CSB+ ble også vist for overarmsomkrets (MUAC) og lengde/høydeøkning (Artikkel III). Konklusjon: Vi observerte at barrierer på både på nivå hos mor/omsorgsperson og hos helsetjenesten som negativt påvirket behandlingen av MAM blant barn i alderen 6 til 59 måneder. Kostbehandling som dekker husholdningenes matmangel, i tillegg til ernæring rådgivning, er avgjørende for å overvinne MAM. Vi har viste at LIBS var innenfor det anbefalte området av nødvendige næringsstoffer for å behandle barn med MAM. Vi har videre viste at LIBS var like bra som CSB+ for behandling av barn med MAM i alderen 6 til 59 måneder. Prøveregistrering: Pan-African Clinical Trial Registreringsnummer: PACTR201809662822990, registrert 12. september 2018.Doktorgradsavhandlin

A local-ingredients-based supplement is an alternative to corn-soy blends plus for treating moderate acute malnutrition among children aged 6 to 59 months: A randomized controlled non-inferiority trial in Wolaita, Southern Ethiopia

Background Globally, moderate acute malnutrition (MAM) affects approximately 5% of children below five years of age. MAM is a persistent public health problem in Ethiopia. The current approach in Ethiopia for managing MAM is a supplementary feeding program; however, this is only provided to chronically food-insecure areas. The objective of the study was to compare a local-ingredients-based supplement (LIBS) with the standard corn-soy blend plus (CSB+) in treating MAM among children aged 6 to 59 months to test the hypothesis that the recovery rate achieved with LIBS will not be more than 7% worse than that achieved with CSB+. Methods and findings We used an individual randomized controlled non-inferiority trial design with two arms, involving 324 children with MAM aged 6 to 59 months in Wolaita, Southern Ethiopia. One hundred and sixty-two children were randomly assigned to each of the two arms. In the first arm, 125.2 g of LIBS with 8 ml of refined deodorized and cholesterol-free sunflower oil/day was provided. In the second arm, 150 g of CSB+ with 16 ml of refined deodorized and cholesterol-free sunflower oil/day was provided. Each child was provided with a daily ration of either LIBS or CSB+ for 12 weeks. Both intention-to-treat (ITT) and per-protocol (PP) analyses were done. ITT and PP analyses showed non-inferiority of LIBS compared with CSB+ for recovery rate [ITT risk difference = 4.9% (95% CI: -4.70, 14.50); PP risk difference = 3.7% (95% CI: –5.91, 13.31)]; average weight gain [ITT risk difference = 0.10 g (95% CI: -0.33 g, 0.53 g); PP risk difference = 0.04 g (95% CI: -0.38 g, 0.47 g)]; and recovery time [ITT risk difference = -2.64 days (95% CI: -8.40 days, 3.13 days); PP difference -2.17 days (95% CI: -7.97 days, 3.64 days]. Non-inferiority in MUAC gain and length/height gain was also observed in the LIBS group compared with the CSB+ group. Conclusions LIBS can be used as an alternative to the standard CSB+ for the treatment of MAM. Thus, the potential of scaling up the use of LIBS should be promoted.publishedVersio

Development of local-ingredients-based supplementary food and evaluation of its comparability to standard corn-soy blend plus in treating moderate acute malnutrition among children aged 6 to 59 months in Wolaita, Southern Ethiopia.

Background: Acute malnutrition is a severe public health issue in Ethiopia, where the prevalence is among the highest in the world. Acute malnutrition is classified as moderate or severe. Children with moderate acute malnutrition (MAM) have an increased risk of infections and mortality. If children with MAM are not properly managed, MAM can progress to the severe form which is a life-threatening condition. MAM, on the other hand, has not received the attention it deserves and is not commonly recognized as a public health issue. In Ethiopia, children with MAM, who are living in food-insecure districts, are getting corn-soy blend plus (CSB+), which is the standard supplement. In Ethiopia, in districts not classified as chronically food insecure, there are no food supplementation programs. Optimal feeding of locally available, nutrient-dense foods could treat MAM. To our knowledge, few studies in Ethiopia have evaluated the effect of local-ingredients-based supplements (LIBS) compared to conventional supplements for treating MAM. Objective: The aim of this thesis is to develop local-ingredients-based supplementary food and evaluate if it is comparable to standard corn-soy blend plus in treating moderate acute malnutrition among children aged 6 to 59 months. Methods: We conducted a descriptive phenomenological qualitative study to assess barriers to management of MAM among children aged 6-59 months in Damot Pulassa, Wolaita, South Ethiopia (Paper I). We used six focus group discussions with mothers or caregivers of children aged 6 to 59 months, and ten in-depth interviews with health service providers, to identify the barriers toward existing management practice for MAM. Thereafter, we developed the LIBS for treating children with MAM aged 6 to 59 months. We developed the LIBS from locally available ingredients such as: pumpkin seed, peanut, amaranth grain, flaxseed and emmer wheat. Collection of ingredients, sorting, soaking, draining, drying, roasting, dehulling or shelling, milling and mixing were done (Paper II). A randomized controlled non-inferiority trial with two arms, involving 324 children with MAM, was conducted to evaluate if the LIBS is similar to CSB+ in treating children with MAM. One hundred and sixty-two children were randomized to each of the two arms. The first arm received 125.2 g of LIBS per day along with 8 ml of refined deodorized and cholesterol-free sunflower oil. The first arm received 150 g CSB+ per day along with 16 ml of refined deodorized and cholesterol-free sunflower oil. Each child was provided with a daily ration of either LIBS or CSB+ for 12 weeks (Paper III). The study protocol of Paper III was published (Paper IV). Result: In Paper I, possible reasons for MAM, identification of a child with MAM, management services for MAM, maternal-level barriers, service provider-level barriers, and measures to improve the service were identified as six themes. Maternal-level barriers to managing MAM were: lack of food and money, selling-out of self-produced foods without having sufficient reserves at home, large household size, and shame about having a child with malnutrition. Service provider-level barriers to managing MAM were: occasional house-to-house screening of children, family-initiated counseling, leaving the management responsibility of children with MAM to the family, and lack of repeated follow-up visits by service providers. Mothers or caregivers and service providers perceived as the existing management practice for MAM can be improved through focused, routine and inclusive counseling (including all mothers of children aged below five years and fathers), and the provision of supplementary food. In Paper II, LIBS1, LIBS2, LIBS3, and LIBS4 were the four food supplements that were developed. The protein content of four developed LIBSs ranged from 20.3 g to 22.5 g, the fat content from 29.3 g to 33.5 g, the kcal content from 510 kcal to 570 kcal, the fiber content from 6.0 g to 8.5 g, the moisture content from 2.8 g to 3.7 g, and the ash content from 2.1 g to 4.3 g. Calcium was 75.6 mg to 115.6 mg, potassium was 473.1 mg to 570.2 mg, sodium was 79.3 mg to 114.4 mg, zinc was 4.1 mg to 5.6 mg, iron was 8.2 mg to 10.2 mg, phosphorous was 442.6 mg to 470.4 mg, and phytate was 2.1 mg to 4.3 mg. LIBS 4 had a significantly higher level of protein, fat, energy, iron, zinc, phosphorous, and potassium compared to LIBS 1, LIBS 2, and LIBS 3. The phytate content of the four LIBS was significantly different. The lowest level of phytate was found in LIBS 4 (Paper II). LIBS was shown to be non-inferior to CSB+ in both intention-to-treat (ITT) and per-protocol (PP) analyses for recovery rate [ITT risk difference = 4.9% (95% CI: –4.70, 14.50); PP risk difference = 3.7% (95% CI: –5.91, 13.31)]; average weight gain [ITT risk difference = 0.10 g (95% CI: –0.33 g, 0.53 g); PP risk difference = 0.04 g (95% CI: –0.38 g, 0.47 g)]; recovery time [ITT risk difference = –2.64 days (95% CI: –8.40 days, 3.13 days); PP difference –2.17 days (95% CI: –7.97 days, 3.64 days]. Non-inferiority of LIBS compared with CSB+ was also shown for the MUAC gain and length/height gain (Paper III). Conclusion: We observed that maternal-level barriers and service provider-level barriers negatively affect the management of MAM among children aged 6 to 59 months. A supplementary feeding that addresses the food shortage of households, in addition to nutrition counseling, is critical in overcoming MAM. We demonstrated that the nutrients of developed LIBSs were within the recommended range of required nutrients for treating children with MAM. We showed that LIBS was similar compared to CSB+ in treating children with MAM aged 6 to 59 months. Therefore, LIBS could be used for the management of children with MAM. Trial registration: Pan-African Clinical Trial Registration number: PACTR201809662822990, registered on 12 September, 2018

Development and nutritional evaluation of local ingredients-based supplements to treat moderate acute malnutrition among children aged below five years: A descriptive study from rural Wolaita, Southern Ethiopia

In Ethiopia, moderate acute malnutrition (MAM) is a persistent public health problem. The current management approaches for MAM among children are counseling in food‐secure settings and food supplementation in chronically food‐insecure areas. The objective of this study was to develop a local ingredients‐based supplement (LIBS) for treating MAM among children. Collection of food ingredients (pumpkin seed, amaranth grain, flaxseed, peanut, and emmer wheat) was made. Sorting, soaking, drying, roasting, and milling of ingredients were done. Nutrient analysis was done using triplicate measurements of each nutrient. One‐way ANOVA was used to analyze differences in means with ± standard deviation of nutrient measurements among the supplements. The nutrient content of four developed LIBS ranged from 20.3 g to 22.5 g for protein, 29.3 g to 33.5 g for fat, 509.5 kcal to 570.0 for kcal, 6.0 g to 8.5 g for fiber, 2.8 g to 3.7 g for moisture, and 2.1 g to 4.3 g for ash. The mineral and antinutrient components ranged from 75.6 mg to 115.6 mg for calcium, 473.1 mg to 570.2 mg for potassium, 79.3 mg to 114.4 mg for sodium, 4.1 mg to 5.6 mg for zinc, 8.2 mg to 10.2 mg for iron, 442.6 mg to 470.4 mg for phosphorous, and 2.1 mg to 4.3 mg for phytate. The LIBS with the highest portion of pumpkin seed had significantly highest amounts of protein, fat, calories, iron, zinc, and potassium. The results found were within the recommended range of required nutrients for the treatment of children with MAM. Therefore, LIBS may be used for the management of children with MAM

A local-ingredients-based supplement is an alternative to corn-soy blends plus for treating moderate acute malnutrition among children aged 6 to 59 months: A randomized controlled non-inferiority trial in Wolaita, Southern Ethiopia

Background Globally, moderate acute malnutrition (MAM) affects approximately 5% of children below five years of age. MAM is a persistent public health problem in Ethiopia. The current approach in Ethiopia for managing MAM is a supplementary feeding program; however, this is only provided to chronically food-insecure areas. The objective of the study was to compare a local-ingredients-based supplement (LIBS) with the standard corn-soy blend plus (CSB+) in treating MAM among children aged 6 to 59 months to test the hypothesis that the recovery rate achieved with LIBS will not be more than 7% worse than that achieved with CSB+. Methods and findings We used an individual randomized controlled non-inferiority trial design with two arms, involving 324 children with MAM aged 6 to 59 months in Wolaita, Southern Ethiopia. One hundred and sixty-two children were randomly assigned to each of the two arms. In the first arm, 125.2 g of LIBS with 8 ml of refined deodorized and cholesterol-free sunflower oil/day was provided. In the second arm, 150 g of CSB+ with 16 ml of refined deodorized and cholesterol-free sunflower oil/day was provided. Each child was provided with a daily ration of either LIBS or CSB+ for 12 weeks. Both intention-to-treat (ITT) and per-protocol (PP) analyses were done. ITT and PP analyses showed non-inferiority of LIBS compared with CSB+ for recovery rate [ITT risk difference = 4.9% (95% CI: -4.70, 14.50); PP risk difference = 3.7% (95% CI: –5.91, 13.31)]; average weight gain [ITT risk difference = 0.10 g (95% CI: -0.33 g, 0.53 g); PP risk difference = 0.04 g (95% CI: -0.38 g, 0.47 g)]; and recovery time [ITT risk difference = -2.64 days (95% CI: -8.40 days, 3.13 days); PP difference -2.17 days (95% CI: -7.97 days, 3.64 days]. Non-inferiority in MUAC gain and length/height gain was also observed in the LIBS group compared with the CSB+ group. Conclusions LIBS can be used as an alternative to the standard CSB+ for the treatment of MAM. Thus, the potential of scaling up the use of LIBS should be promoted