Effectiveness of Simplified Approach for the Management of Wasting Among Children (6-59 Months) Compared To Standard Approach in Ethiopia: A Non-Inferiority Randomized Controlled Trial

Abstract

Chapter One This section presents the definition, prevalence, and history of managing Severe Acute Malnutrition (SAM) and Moderate Acute Malnutrition (MAM) globally and in Ethiopia, as well as the significance and objectives of the study. Wasting is a type of acute malnutrition characterized by a mid-upper arm circumference (MUAC) of less than 12.5 cm or a weight-for-length/height z-score below -2 standard deviations (SD) in children aged 6 to 59 months. Approximately 45 million children are affected by wasting globally; among these, over 95% of all children with wasting live in Asia and Africa. Children with severe acute malnutrition (SAM) are nine times more likely to die than well nourished children. In Sub-Saharan and Southeast Asian countries, it accounts for nearly one million deaths each year, partly due to increased susceptibility to infections. In 2023, more than 4 million children under the age of five are estimated to be suffering from wasting in Ethiopia, representing 11% of the total under-five population. Consequently, Ethiopia is seeing a rising trend in severe acute malnutrition admissions to treatment centers from 2019 to 2023. However, the number of children receiving treatment is only about 56% of the target. Ethiopia has over two decades of experience implementing community-based management of acute malnutrition. The Therapeutic Feeding Program for treating severe acute malnutrition (SAM) in Ethiopia started in 2000 with a pilot implementation and, by 2020, had expanded to over 20,000 health facilities providing services throughout the country. The Disaster Risk Management Food Security Sector (DRMFSS) handled the management of moderate acute malnutrition separately. In 2019, guidelines for managing acute malnutrition in Ethiopia were finalized, establishing protocols for addressing SAM and moderate acute malnutrition (MAM) through the health system. Additionally, MAM and uncomplicated SAM are addressed in different programs using two distinct food products (RUTF for uncomplicated SAM and CSB++/RUSF for MAM). There are still coverage gaps for treatments of SAM, and MAM treatment is not routinely implemented in all districts. Therefore, simplification of acute malnutrition treatment is required to ensure continuity of care, increase coverage, and minimize costs. The evidence related to combining different simplifications is quite recent, and a context-specific approach has been promoted. Trials recommend that simplified approaches need to be country-specific, along with evidence generation based on each country for a combination of simplifications. Given the simplified approach, studies were conducted in settings that differ from the Ethiopian context. It is important to test and adapt these simplifications and combinations in Ethiopia; thus far, no study has addressed this issue. Therefore, the research objective was to assess the effectiveness of a simplified approach for treating wasting among children aged 6 to 59 months in comparison to the standard protocol. Chapter Two The outlines of methods and materials clarify a cluster randomized controlled non inferiority trial conducted in three woredas in the Oromia, SNNPR, and Amhara regions. Health posts served as clusters. The study subjects were children aged 6 to 59 months with uncomplicated severe xvi or moderate acute malnutrition. The sample size was estimated to detect a non-inferiority margin of 15% for recovery using the simplified protocol compared to the standard protocol. A total of 58 health posts (clusters) were estimated, with a sample size of 1,052 children (430 with SAM and 622 with MAM). However, data were collected from 55 health posts and 1,032 children. The intervention for the simplified group involved a modified dosage and a single type of ready-to-use therapeutic food (RUTF) to treat both severe acute malnutrition (SAM) and moderate acute malnutrition (MAM). Specifically, two sachets of RUTF were administered daily for SAM, while one sachet of Ready to Use Therapeutic Food (RUTF) for MAM. In contrast, for the standard group (control), weight based RUTF was given to children with SAM, meaning the amount of RUTF increased with the child’s weight, while RUSF was administered at one sachet per day for children with MAM. This trial was registered with the Pan African Clinical Trial under the unique identification number PACTR202202496481398. The effect of a simplified approach on the recovery of children 6–59 months with wasting was described in Chapter Three, This emphasizes the key finding of the simplified approach to the standard protocol for treating acute malnutrition during recovery. In the Per Protocol analysis, the recovery rate of children with wasting in the simplified group (97.8%) was non-inferior to that of the standard protocol group (97.7%), P= 0.399. The cost of RUTF per treatment for a child with SAM was $56.55 for the standard approach compared to $42.78 for the simplified one. In conclusion, the simplified method is non-inferior to the standard protocol regarding the recovery rate from wasting. Furthermore, a simplified approach (modified dosage) for managing SAM and MAM is cost effective, allowing for the treatment of more children given the limited resources available. Comparing Time to Recovery in Wasting Treatment on Simplified Approach vs. Standard Protocol was described in Chapter Four. For SAM cases, the average length of stay was 8.86 (±3.91) weeks for the simplified protocol and 8.26 (±4.18) weeks for the standard protocol (P=0.13). For MAM cases, the average length of stay was 8.18 (±2.96) weeks for the simplified approach and 8.32 (±3.55) weeks for the standard (P=0.61). No significant difference (P=0.502) was observed between the simplified protocol, 8 weeks (IQR: 7.06, 8.94), and the standard protocol, 9 weeks (IQR: 8.17, 9.83), among children with SAM regarding the median time to cure. Similarly, there was no significant difference (P=0.502) in the time to cure between the simplified approach, 8 weeks (IQR: 7.53 - 8.47), and the standard protocol, 8 weeks (IQR: 7.66, 8.34), among children with MAM. The survival curves displayed similarity, with the log-rank test showing no significance (P>0.5), indicating the non-inferiority of the simplified approach for cure time. The effect of a simplified approach on Weight and MUAC gain in the management of wasting compared to the standard protocol was presented in Chapter Five. The overall weight gain of children with wasting was 1.001 (+0.762) kg and 1.075 (+0.750) kg for the standard protocol and simplified approach, respectively (P=0.634). The overall MUAC gain of children with wasting was 1.207 (+0.667) cm and 1.320 (+0.706) cm for the standard protocol and simplified approach, respectively (P=0.326). The overall weekly weight gain of children with wasting was 0.106 (+0.105) kg and 0.108 (+0.104) kg for the standard protocol and simplified approach, respectively (P=0.799). The overall weekly MUAC gain of children with xvii wasting was 0.173 (+0.134) cm and 0.177 (+0.119) cm for the standard protocol and simplified approach, respectively (P=0.601). The mean weight gain in grams per kg per day for children with uncomplicated SAM was 3.80 (+3.17) from the standard group and 3.52 (+2.94) from the simplified group (P=0.359). Similarly, the mean weight gain in grams per kg per day for children with MAM was 2.11 (+2.26) from the standard group and 2.30 (+2.35) from the simplified group (P=0.329). The mean MUAC gain in mm per day for children with uncomplicated SAM was 0.35 (+0.22) from the standard group and 0.33 (+0.17) from the simplified group (P=0.510). The mean MUAC gain in mm per day for children with MAM was 0.21 (+0.11) from the standard group and 0.21 (+0.14) from the simplified group (P=0.520). The results indicated that the simplified approach used in this study for treating acute malnutrition (both MAM and SAM) is non-inferior to the standard treatment in terms of weight gain and MUAC gain. Future research should examine the analysis of micronutrient levels in the bodies of both SAM and MAM children. Comparing the effect of the simplified approach with standard protocol in terms of treatment outcomes in the younger age group 6-12 month s was described in Chapter Six. Complete data were collected from 480 children aged 6 to 12 months with wasting. In the intention-to-treat (ITT) analysis, the recovery (cure) rate for children with wasting in the standard group was 94.6%, compared to 93.4% in the simplified group (P=0.732). In the per-protocol (PP) analysis, the recovery rates were similar for both groups, at 97.2% (P=0.629). The average length of stay for children in the standard group was 9.44 weeks, while it was 9.02 weeks for the simplified group. Additionally, the median length of stay was 9 weeks for the standard group and 8 weeks for the simplified group (P=0.172). The average daily weight gain of children with wasting was 16.3 (+10.77) grams in the standard protocol and 17.2 (+13.10) grams in the simplified approach (P=0.457). The overall daily MUAC gain of children with wasting was 0.256 (+0.165) mm in the standard protocol and 0.274 (+0.151) mm in the simplified approach, respectively (P=0.264). The overall daily weight gain in grams per kilogram for children with wasting was 2.7 (+1.94) grams in the standard protocol and 2.9 (+2.55) grams in the simplified approach, respectively (P=0.238). Chapter Seven discusses the broader implications of its findings on the continuum of care for managing acute malnutrition, the coverage of acute malnutrition treatment, the cost and sustainability of such treatments, and the overall policy and programmatic consequences related to managing wasting. Additionally, it outlines future research perspectives, conclusions, and recommendations. In conclusion, this PhD research provides evidence for the effectiveness of a simplified approach. It demonstrates that the simplified treatment protocol does not significantly differ from the standard protocol in terms of recovery, weight, and MUAC gains in the treatment of wasting among children aged 6 to 59 months. The findings indicated that the simplified and standard protocols exhibited no significant differences in terms of the average length of stay and time needed for recovery. The study findings have practical implications and offer an opportunity to review the policies and programs, including those addressing vulnerable segments of the population.