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

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Study Justification:
– The study aimed to assess the impact of Tubaramure, a food-assisted maternal and child health program, on child wasting in Burundi.
– This is important because little is known about the impact of such programs on child wasting, especially in highly food-insecure regions like Burundi.
– The study aimed to provide evidence on the effectiveness of Tubaramure in reducing child wasting and improving child nutrition.
Highlights:
– The study found that Tubaramure had a significant protective effect on child wasting, reducing the prevalence of wasting by 3.3 percentage points.
– The program also had a positive impact on the weight-for-length z-score, indicating improved nutritional status.
– The effects of Tubaramure were most pronounced in children aged 6 to 12 months, who had the highest prevalence of wasting.
– The program was particularly effective for children from households with no education and living in the poorest households.
Recommendations for Lay Reader:
– Tubaramure, a food-assisted integrated health and nutrition program, has been shown to reduce child wasting in Burundi.
– The program provides food rations, promotes the use of health services, and encourages behavior change related to health, hygiene, and nutrition.
– The program is especially beneficial for children aged 6 to 12 months and those from disadvantaged households.
– These findings highlight the importance of implementing similar programs in highly food-insecure regions to protect vulnerable children from wasting.
Recommendations for Policy Maker:
– Based on the study findings, it is recommended to scale up Tubaramure or similar food-assisted integrated health and nutrition programs in Burundi and other food-insecure regions.
– The program should target pregnant women and children during the first 1000 days, as this is a critical period for child development.
– Emphasis should be placed on reaching households with no education and those living in poverty, as they are the most vulnerable to child wasting.
– Collaboration between government agencies, non-governmental organizations, and international donors is crucial for the successful implementation of such programs.
Key Role Players:
– Government agencies responsible for health and nutrition policies and programs
– Non-governmental organizations with expertise in food assistance, maternal and child health, and behavior change communication
– International donors providing funding and technical support
Cost Items for Planning Recommendations:
– Food rations: Budget for providing monthly family and individual rations of corn-soy blend and micronutrient-fortified vegetable oil.
– Strengthening and promotion of health services: Budget for improving the provision of preventive health services and increasing their utilization by pregnant women and children.
– Behavior change communication: Budget for implementing behavior change communication strategies to promote adequate health, hygiene, and nutrition behaviors and practices.
– Program staff and health promoters: Budget for hiring and training program staff and locally hired health promoters.
– Monitoring and evaluation: Budget for monitoring and evaluating the program’s impact and effectiveness.
– Administrative and logistical support: Budget for administrative and logistical support, including office space, equipment, and transportation.
Please note that the cost items provided are general categories and not actual cost estimates. Actual budget planning should be based on detailed program design and implementation considerations.

The strength of evidence for this abstract is 8 out of 10.
The evidence in the abstract is strong, as it is based on a cluster-randomized controlled trial with a large sample size. The study design and methodology are clearly described, and the results show a significant protective effect of the Tubaramure program on child wasting. However, to improve the evidence, it would be helpful to provide more details on the statistical analysis, such as the specific regression model used and any adjustments made for confounding variables. Additionally, including information on the generalizability of the findings and potential limitations of the study would further strengthen the evidence.

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 1 health center each. A cluster design was used since individual randomization of the Tubaramure program components was not feasible. Prior to randomization, 210 collines meeting the study criteria were grouped into strata based on population size. The number of strata in each province (5 in Cankuzo, 10 in Ruyigi) reflected the relative population size. Each stratum had 13 or 14 collines in Cankuzo and 14 or 15 collines in Ruyigi. Using random numbers with a fixed random number seed (Stata version 11, StataCorp 2009) (20), 4 collines were randomly drawn from each stratum, for a total of 60 collines. At a public lottery event with representatives from both provinces, the 4 collines in each stratum were randomly assigned to the 4 different study arms: 3 treatment arms and 1 control arm. The study included 3 treatment arms to assess the differential effects of varying the timing (starting during pregnancy or at birth) and duration (full 1000 days or shorter) of receiving food rations. The rationale for studying these was that providing food rations for the full 1000 days period is expensive; if a similar impact is obtained when providing rations for a shorter time period, more beneficiaries can be covered with the same resources. Beneficiaries in the T24 arm received the standard program: that is, all program benefits during pregnancy and up to the age of 23.9 months for the child. Beneficiaries in the T18 arm received the same benefits, but food rations ended at the age of 17.9 months for the child. In the TNFP arm (no food during pregnancy), food rations started only at birth and were provided to the mother for the first 6 months and to the child between 6 and 23.9 months of age. Collines assigned to the control arm did not receive any Tubaramure benefits, but had access to the standard health-care services provided by the Ministry of Health. Since health centers were used by various collines, the health service intervention component was not limited to the treatment arms. We conducted 3 repeated cross-sectional surveys: a baseline survey in 2010 (before the program started) and 2 follow-up surveys in 2012 and 2014 (Table 1). Each follow-up survey was conducted to assess a specific set of outcomes. Outcomes such as anemia and wasting were best measured when children were still eligible to receive program benefits: that is, when they were between 0 to 23.9 months of age. Thus, these outcomes were assessed using data from the baseline surveys (conducted before the program started) and the 2012 follow-up survey (when children 0 to 23.9 months of age were eligible to participate in the ongoing program). The full effect on child linear growth—the main outcome of the study—was expected in children who had been exposed to Tubaramure from early pregnancy to when they reached 23.9 months of age. Impacts on child linear growth were therefore assessed among children 24 months and older, using data from the baseline survey and the 2014 follow-up survey (when the program had ended and children were between 24 and 41.9 months of age) (14). The first follow-up thus included households with children 0 to 23.9 months of age, the second follow-up included households with children 24 to 41.9 months of age, and the baseline survey included both types of households. Survey waves and Tubaramure program implementation The 2010 and 2012 data on children 0 to 23.9 months of age were used in the analyses presented in this manuscript. Shortly after the baseline survey was completed, eligible families were invited to enroll in Tubaramure, and beneficiaries started receiving program benefits. The study in children 0 to 23.9 months of age was powered to detect a program effect (difference between treatment and control) on child anemia (1 of the study’s primary outcomes) in children of 11 percentage points (pp) in the T24 and TNFP groups and of 8.25 pp in the T18 group using a Type 1 error (α) of 0.05 (1-sided), a power of 0.90, an intracluster correlation coefficient of 0.006, and 15 clusters per treatment arm (13). The differences in expected effect size thus resulted in different sample sizes across arms. Using the same parameters and a baseline prevalence of wasting of 7%, we calculated that the study’s sample size allowed us to detect a reduction in the prevalence of wasting of 4 pp and a change in the mean of weight-for-length z-score (WLZ) of 0.24 when comparing the T24 or TNFP arm to the control group. For the T18 to control comparison, the detectable differences for wasting and WLZ were 4 pp and 0.21, respectively. Since all statistical models controlled for covariates, the actual minimum detectable differences were smaller. The International Food Policy Research Institute’s Institutional Review Board and the Ministry of Health of Burundi approved the study. Written informed consent for participation in the study was obtained before the start of each interview. This trial was registered at clinicaltrials.gov as {“type”:”clinical-trial”,”attrs”:{“text”:”NCT01072279″,”term_id”:”NCT01072279″}}NCT01072279. At the start of the 2010 and 2012 surveys, a household census was conducted in all 60 research collines to generate a complete list of households with a child aged 0 to 23.9 months. Using a probability proportional to size approach, we calculated the target sample size for each colline. Colline-specific lists of randomly ordered households to be surveyed were then generated. Households were visited in the order listed until the required sample size in each colline was reached. As our objective was to estimate the intent-to-treat effect, inclusion in the survey was solely based on having a child in the appropriate age group and not on actual program participation. If there was more than 1 child in this age group, 1 “index child” was randomly chosen using the alphabetic order of the children’s first names. A total of 2625 and 2612 households with a child aged 0 to 23.9 months were surveyed at baseline and follow-up, respectively (Figure 1). Trial flow chart. Abbreviations: T18, treatment arm from pregnancy to 18 months; T24, treatment arm from pregnancy to 24 months; TNFP, treatment arm from birth to 24 months. The survey team was trained extensively, which included classroom teaching, field exercises, and repeated testing to assess skill acquisition. Each field team was composed of 4 enumerators, 2 anthropometrists, and 1 team controller. The enumerators used a household questionnaire to collect data on a wide range of variables, including socio-demographic characteristics (such as education, literacy, and household asset ownership) and program participation. Nurses were trained [and standardized (21)] to collect anthropometric data. Length and height were collected using Shorr boards (Weight and Measure). Measurements were taken twice, and were taken a third time if the difference between the first 2 measurements exceeded 6 mm. The 2 closest measurements were used in the analyses. Weight data were collected using a Seca 874 digital scale (Seca), which allowed the weight of the child to be taken when the mother held the child. WLZ was calculated using the WHO 2006 growth standard (22). Wasting was defined as WLZ <2SD. In line with the CONSORT 2010 guidelines, no formal comparison of baseline means between the treatment and intervention arm was conducted (23). The impact of Tubaramure was estimated using a double-difference colline–fixed effect model, which estimates changes over time in the treatment group relative to the control group. This model was used: Here, Tj is time (baseline or follow-up), Si is the assigned study arm (T24, T18, TNFP, or control), and C is a vector representing the colline-level fixed effects. The coefficient β3 represents the estimated treatment effect. Colline-level fixed effects were used to control for unobserved time-invariant colline characteristics at baseline and follow-up. To reduce residual noise and thus maximize power, covariates (Xi) were added to the model. These included maternal and child age, child sex, maternal height, whether the primary caregiver was the biological mother (and the interaction between this variable and maternal height), the education levels of the mother and the head of household, dependency ratio, and household assets. In line with statistical theory, we used 1-sided tests given the a priori hypothesis that the program would lead to improvements in nutritional status (24). In previous analyses, we found that the impact of the program on linear growth faltering was limited to children growing up in wealthier households, to children with literate mothers, and to children with better-schooled parents. These differences were not due to differences in program enrollment or participation in program activities (14). To assess whether the impact on wasting varied by socio-economic characteristics, we estimated the impact models separately by level of maternal education (none vs. some), maternal literacy (illiterate vs. literate), education of the head of household (none vs. some), and household asset ownership (below or above median number of assets, a proxy for socio-economic status). A similar approach was used to evaluate whether the impact differed by child age: separate models were estimated for children 0 to 5.9 months, 6 to 11.9 months, 12 to 17.9 months, and 18 to 23.9 months of age. All treatment arms were pooled in the subgroup analyses. The SEs of all estimated parameters were adjusted for colline-level clustering by using a clustered (Huber-White) sandwich estimator. A P value of 0.05 was considered significant. Analyses were conducted using Stata 16 (StataCorp, version 16) (20). All analyses pertain to the individual level. No clusters were dropped from the analyses. Fewer than 3% of individual observations were excluded from the analysis because of missing or incomplete data (Figure 1).

The Tubaramure program in Burundi implemented several innovations to improve access to maternal health. These innovations include:

1. Food Rations: The program provided monthly food rations to pregnant women and women with children up to 24 months of age. The rations included corn-soy blend and micronutrient-fortified vegetable oil to improve maternal and child nutrition.

2. Strengthening and Promotion of Health Services: Tubaramure focused on improving the provision of preventive health services and increasing their utilization by pregnant and lactating women, as well as children aged 0 to 23.9 months. This component aimed to enhance access to essential maternal and child health services.

3. Behavior Change Communication (BCC): The program implemented a comprehensive BCC strategy to promote adequate health, hygiene, and nutrition behaviors and practices. BCC sessions were conducted by program staff, locally hired health promoters, and leader mothers who were selected as teachers by their fellow beneficiary mothers.

These innovations were designed to address the specific challenges faced by the population in Burundi, such as food insecurity, low levels of formal education, and high rates of anemia and stunting among children. By combining food assistance, improved health services, and behavior change communication, Tubaramure aimed to protect the most disadvantaged children from wasting and improve maternal and child health outcomes.

It’s important to note that the effectiveness of these innovations was evaluated through a cluster-randomized controlled trial, which provided evidence of the program’s impact on reducing child wasting and improving weight-for-length z-scores. The program’s effects were particularly significant for children whose mothers and household heads had no education and who lived in the poorest households. The largest effect was observed in children aged 6 to 12 months, who had the highest prevalence of wasting.

Overall, Tubaramure demonstrated that food-assisted integrated health and nutrition programs can be effective in improving access to maternal health and reducing child wasting in highly food-insecure regions like Burundi. These findings have important implications, especially in the context of the economic crisis caused by the COVID-19 pandemic, which is expected to increase child wasting rates.
AI Innovations Description
The recommendation based on the study “Tubaramure, a Food-Assisted Integrated Health and Nutrition Program, Reduces Child Wasting in Burundi: A Cluster-Randomized Controlled Intervention Trial” to improve access to maternal health is to implement similar food-assisted maternal and child health programs (FA-MCHN) in highly food-insecure regions. These programs should include the following components:

1. Food Rations: Provide monthly food rations to pregnant women and children during the first 1000 days. The rations should include nutrient-rich foods such as corn-soy blend and micronutrient-fortified vegetable oil to improve maternal and child nutrition.

2. Strengthening and Promotion of Health Services: Improve the provision of preventive health services and increase the utilization of these services by pregnant and lactating women and children aged 0 to 23.9 months. This can be achieved through training health workers, improving infrastructure, and ensuring the availability of essential medicines and supplies.

3. Behavior Change Communication (BCC): Implement a comprehensive BCC strategy to promote adequate health, hygiene, and nutrition behaviors and practices among beneficiaries. This can be done through educational sessions conducted by program staff, locally hired health promoters, and leader mothers.

It is important to note that the impact of these programs on child wasting was found to be significant in children whose mothers and household heads had no education and who lived in the poorest households. Therefore, special attention should be given to reaching and supporting the most disadvantaged populations.

Implementing FA-MCHN programs in highly food-insecure regions can help protect vulnerable children from wasting and improve maternal and child health outcomes. These programs can be particularly beneficial in contexts of economic crisis, such as the current COVID-19 pandemic, which is expected to increase child wasting.
AI Innovations Methodology
The Tubaramure program in Burundi aimed to improve access to maternal and child health services and reduce child wasting through a food-assisted integrated health and nutrition approach. The program included three core components: 1) food rations, 2) strengthening and promotion of health services, and 3) behavior change communication (BCC). The program targeted women and their children during the first 1000 days, providing food rations (corn-soy blend and micronutrient-fortified vegetable oil) from pregnancy to 24 months (T24 arm), pregnancy to 18 months (T18 arm), or birth to 24 months (TNFP arm). All beneficiaries received the same BCC for the first 1000 days.

To simulate the impact of these recommendations on improving access to maternal health, a cluster-randomized controlled trial was conducted from 2010 to 2012. The study included 60 collines (communities) in Burundi’s eastern provinces of Cankuzo and Ruyigi. The collines were randomly assigned to four study arms: T24, T18, TNFP, and a control arm. Repeated cross-sectional surveys were conducted at baseline, 2012 follow-up, and 2014 follow-up to assess various outcomes.

The impact of Tubaramure on child wasting was estimated using a double-difference colline-fixed effect model. This model compared changes over time in the treatment groups (T24, T18, TNFP) to the control group. Colline-level fixed effects were used to control for unobserved time-invariant colline characteristics. Covariates such as maternal and child age, child sex, maternal height, caregiver status, maternal and household education levels, dependency ratio, and household assets were included in the model.

The impact of Tubaramure on wasting was found to be significant, with a protective effect observed in the treatment arms compared to the control group. The effects were particularly pronounced in children aged 6 to 12 months, who had the highest prevalence of wasting. The program’s impact on wasting varied by socio-economic characteristics, with the largest effect seen in children from households with no education and living in the poorest households.

In summary, the Tubaramure program in Burundi successfully improved access to maternal health and reduced child wasting through a food-assisted integrated health and nutrition approach. The impact was assessed using a cluster-randomized controlled trial and a double-difference colline-fixed effect model. The findings highlight the importance of targeting the most disadvantaged populations in highly food-insecure regions to address maternal and child health challenges.

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