BRIGHT-SAM: BRaIn development, Growth and HealTh in children with Severe Acute Malnutrition
Lead Research Organisation:
National Institute for Medical Research
Department Name: Mwanza Research Centre
Abstract
Severe acute malnutrition (SAM) remains common among young children in low-income countries. In the past few decades the introduction of ready-to-use therapeutic foods (RUTF) into community-based SAM management has revolutionised SAM treatment by broadening access, improving outcomes, reducing hospital stays, and reducing costs. However, currently used RUTF products have formulations which do not result in optimal status of essential fatty acids (EFAs) which are required for brain and cognitive development. SAM is associated with impaired cognitive development in children, even many years after their nutritional recovery. Recommendations for SAM management include provision of caregiver education in stimulating their child (psychosocial (PS) intervention) as this has been shown to improve cognitive development in children with SAM. This component of SAM management often receives little attention during hospital treatment and has not been integrated into community SAM management. Currently, tested PS interventions, which show benefit to development of children with SAM, are too intensive and costly for scaling up and PS interventions used more broadly in the community for all children have shown some, but limited benefit.
Our working hypothesis, which we later want to test in a large clinical trial, is that both RUTF with improved EFA balance and a short, focussed PS intervention delivered while children are receiving RUTF, are required for promoting cognitive development of children with SAM. In the current study we need to adapt both these interventions for use in Tanzania. An appropriate RUTF formulation for testing in a trial has been developed by Nutriset, the company which currently provides RUTF globally, but we need to determine the acceptability of this new formulation to Tanzanian children with SAM and their caregivers. We will work with local health care staff, agencies interested in child development, and caregivers of children with SAM to develop a PS intervention based on the World Health Organization recommendations and on what is currently being used locally. We will then pilot both the novel RUTF and the PS intervention developed, among 100 children with SAM, to determine EFA status at recruitment and 8 weeks after recruitment and child development and brain function at 16 weeks after recruitment. Cognitive development will be measured by the Malawi Developmental Assessment Tool (MDAT) which is well validated in Africa and has been adapted for use with Tanzanian children as well as by a novel eye-tracking tool which is simple and potentially feasible for large scale field research. We will also test 100 non-malnourished children not given RUTF or the PS intervention in order to determine local normal EFA status, child development and cognitive function. Within the pilot study we will investigate contextual factors such as family socioeconomic status and structure, urban versus rural residence, child HIV status, and maternal mental health to see how these affect the delivery of the interventions and the child's response to them.
The project has several components, in addition to development and piloting of the two interventions, which will assist in planning the future clinical trial: determination of the variability in the MDAT, eye-tracking measures of cognitive function, and blood EFA profile which will aid calculation of the number of children needed for a trial; determination of the contextual factors which need to be considered in the trial; engagement with local health care staff managing SAM and providers of child development interventions in order to ensure that our interventions are appropriate and locally owned. Local understanding, appropriateness and ownership of the interventions will also benefit scale-up of the interventions if they prove beneficial to children in the future large trial.
Our working hypothesis, which we later want to test in a large clinical trial, is that both RUTF with improved EFA balance and a short, focussed PS intervention delivered while children are receiving RUTF, are required for promoting cognitive development of children with SAM. In the current study we need to adapt both these interventions for use in Tanzania. An appropriate RUTF formulation for testing in a trial has been developed by Nutriset, the company which currently provides RUTF globally, but we need to determine the acceptability of this new formulation to Tanzanian children with SAM and their caregivers. We will work with local health care staff, agencies interested in child development, and caregivers of children with SAM to develop a PS intervention based on the World Health Organization recommendations and on what is currently being used locally. We will then pilot both the novel RUTF and the PS intervention developed, among 100 children with SAM, to determine EFA status at recruitment and 8 weeks after recruitment and child development and brain function at 16 weeks after recruitment. Cognitive development will be measured by the Malawi Developmental Assessment Tool (MDAT) which is well validated in Africa and has been adapted for use with Tanzanian children as well as by a novel eye-tracking tool which is simple and potentially feasible for large scale field research. We will also test 100 non-malnourished children not given RUTF or the PS intervention in order to determine local normal EFA status, child development and cognitive function. Within the pilot study we will investigate contextual factors such as family socioeconomic status and structure, urban versus rural residence, child HIV status, and maternal mental health to see how these affect the delivery of the interventions and the child's response to them.
The project has several components, in addition to development and piloting of the two interventions, which will assist in planning the future clinical trial: determination of the variability in the MDAT, eye-tracking measures of cognitive function, and blood EFA profile which will aid calculation of the number of children needed for a trial; determination of the contextual factors which need to be considered in the trial; engagement with local health care staff managing SAM and providers of child development interventions in order to ensure that our interventions are appropriate and locally owned. Local understanding, appropriateness and ownership of the interventions will also benefit scale-up of the interventions if they prove beneficial to children in the future large trial.
Technical Summary
The use of ready-to-use therapeutic foods (RUTF) for community-based management of children with severe acute malnutrition (SAM) is well-established and saves lives. However, current RUTF formulations result in a low ratio of n3/n6 essential fatty acids (EFAs) and other data show that low levels of the n3 EFA, docosahexaenoic acid, are associated with impaired cognitive function. An RUTF has been developed with an EFA content which should improve n3/n6 EFA ratio. We will test this for acceptability among children with SAM and their caregivers and we will assess the EFA profile and variability before and after the interventions, and compare with that of control children.
Current recommendations for SAM treatment include provision of psychosocial (PS) interventions to help caregivers improve cognitive function of their children. However, to date these have had little impact: interventions shown to be efficacious have been too intensive and costly for scale-up and those scaled-up widely for children without SAM had little benefit. A short intervention focussing on the most high-risk children may have greater benefit. We will work with caregivers, local health staff, and local organizations working to promote child development to design a short, focussed PS intervention which can be offered in parallel with RUTF for community-based SAM treatment.
Our long-term plan is to conduct a well-powered 2X2 factorial clinical trial of the novel RUTF and the PS intervention to determine their individual and any synergistic effects on cognitive development of children with SAM. The development project will aid this by: finalising the interventions, determining contextual factors influencing intervention delivery and uptake, determining variability in EFA and development outcomes to aid sample size calculations; engagement with local health care staff managing SAM and providers of child development interventions to ensure that our interventions are appropriate and locally own
Current recommendations for SAM treatment include provision of psychosocial (PS) interventions to help caregivers improve cognitive function of their children. However, to date these have had little impact: interventions shown to be efficacious have been too intensive and costly for scale-up and those scaled-up widely for children without SAM had little benefit. A short intervention focussing on the most high-risk children may have greater benefit. We will work with caregivers, local health staff, and local organizations working to promote child development to design a short, focussed PS intervention which can be offered in parallel with RUTF for community-based SAM treatment.
Our long-term plan is to conduct a well-powered 2X2 factorial clinical trial of the novel RUTF and the PS intervention to determine their individual and any synergistic effects on cognitive development of children with SAM. The development project will aid this by: finalising the interventions, determining contextual factors influencing intervention delivery and uptake, determining variability in EFA and development outcomes to aid sample size calculations; engagement with local health care staff managing SAM and providers of child development interventions to ensure that our interventions are appropriate and locally own
Planned Impact
The development project will establish the processes and pathways through which the trial that is being developed, and its scale-up if shown to be efficacious, will achieve impact.
Children with SAM, their caregivers and community involved in both the intervention development and piloting will benefit from the messages about improving child nutrition and cognitive development. If the interventions are efficacious, the child's development will improve which could provide them with lifelong cognitive, social and economic benefit. Skills gained by caregivers in promoting their child's development will also benefit other children in the family and potentially those of friends and neighbours through local communication.
Once the RUTF and PS interventions have been developed, piloted and modified based on the project findings, we plan to conduct a well-powered 2X2 factorial trial of the two interventions. This trial will provide similar benefits as above to children with SAM and their caregivers but to a much larger number. Having children achieve their cognitive development potential has long term economic and social benefits for communities by increasing the productivity and social engagement of community members, and decreasing the need for community support of those less able to care for themselves.
Representatives of Tanzanian government and NGOs interested in promoting child development will benefit from the interactions with similar organizations, and the project staff, as part of the formative research when developing the PS intervention. They will also benefit from the study results regarding factors which affect the pathway from child development intervention to outcome.
Project staff involved in the qualitative research, the intervention development and assessment, and pilot trial delivery will have indirect impacts through capacity strengthening. Project staff will benefit from training in SAM management, EFA metabolism, child development interventions and their assessment, and designing and monitoring complex interventions. These skills will be key for their employment in the intervention trial and for their future careers.
Organisations and academics working to promote child nutrition and development will be able to use the trial results to develop their own similar interventions in different contexts which will extend the information about contextual factors and their triggering of intervention mechanisms to a much broader area than Tanzania.
The health system: the PS intervention will be designed to have minimal burden on hospital staff workloads. If the revised RUTF formulation improves cognition, this can be scaled up by Nutriset with little added work or cost for the health system.
Local and international policy makers: we will work with Tanzanian government decision-makers, health workers, NGOs, and international organizations, as part of the formative research and pilot intervention. We will also engage these groups in a future trial. UNICEF has expressed strong interest in the future trial and supports the importance of the project. These ongoing links with local and international policy makers and programme implementers will facilitate scale-up locally and internationally, should the interventions prove efficacious. Even if the future trial shows no benefit of the interventions on child development, the results will increase the evidence base of how to manage development of children with SAM. While all agree on the importance of child development, as yet there is little information as to how programmes can be both effective and feasible. Our focus on a short but intense intervention for very high risk children could be cost-effective.
The development community: the project will contribute to the achievement of SDG2 and SDG4 by ensuring that children have access to nutritious food, and ensuring the quality early childhood development.
Children with SAM, their caregivers and community involved in both the intervention development and piloting will benefit from the messages about improving child nutrition and cognitive development. If the interventions are efficacious, the child's development will improve which could provide them with lifelong cognitive, social and economic benefit. Skills gained by caregivers in promoting their child's development will also benefit other children in the family and potentially those of friends and neighbours through local communication.
Once the RUTF and PS interventions have been developed, piloted and modified based on the project findings, we plan to conduct a well-powered 2X2 factorial trial of the two interventions. This trial will provide similar benefits as above to children with SAM and their caregivers but to a much larger number. Having children achieve their cognitive development potential has long term economic and social benefits for communities by increasing the productivity and social engagement of community members, and decreasing the need for community support of those less able to care for themselves.
Representatives of Tanzanian government and NGOs interested in promoting child development will benefit from the interactions with similar organizations, and the project staff, as part of the formative research when developing the PS intervention. They will also benefit from the study results regarding factors which affect the pathway from child development intervention to outcome.
Project staff involved in the qualitative research, the intervention development and assessment, and pilot trial delivery will have indirect impacts through capacity strengthening. Project staff will benefit from training in SAM management, EFA metabolism, child development interventions and their assessment, and designing and monitoring complex interventions. These skills will be key for their employment in the intervention trial and for their future careers.
Organisations and academics working to promote child nutrition and development will be able to use the trial results to develop their own similar interventions in different contexts which will extend the information about contextual factors and their triggering of intervention mechanisms to a much broader area than Tanzania.
The health system: the PS intervention will be designed to have minimal burden on hospital staff workloads. If the revised RUTF formulation improves cognition, this can be scaled up by Nutriset with little added work or cost for the health system.
Local and international policy makers: we will work with Tanzanian government decision-makers, health workers, NGOs, and international organizations, as part of the formative research and pilot intervention. We will also engage these groups in a future trial. UNICEF has expressed strong interest in the future trial and supports the importance of the project. These ongoing links with local and international policy makers and programme implementers will facilitate scale-up locally and internationally, should the interventions prove efficacious. Even if the future trial shows no benefit of the interventions on child development, the results will increase the evidence base of how to manage development of children with SAM. While all agree on the importance of child development, as yet there is little information as to how programmes can be both effective and feasible. Our focus on a short but intense intervention for very high risk children could be cost-effective.
The development community: the project will contribute to the achievement of SDG2 and SDG4 by ensuring that children have access to nutritious food, and ensuring the quality early childhood development.
| Description | Tanzania Home Economics Association (Mwanza chapter) |
| Organisation | Tanzania Home Economics Association (TAHEA) |
| Country | Tanzania, United Republic of |
| Sector | Charity/Non Profit |
| PI Contribution | From around June 2020, our research team started collaborating with the Tanzania Home Economics Association (TAHEA) in formative research on malnutrition and child development. TAHEA has grass root child development programme targeting vulnerable families in Mwanza, so our collaboration with them helped in identifying potential research participants for our formative work. More recently TAHEA have worked with us to develop a locally appropriate psycho-social intervention to improve child cognitive health which we tested as part of the BRIGHT-SAM study. As a partner, TAHEA will be involved in writing papers coming out the the research project |
| Collaborator Contribution | TAHEA has helped our research team to identify potential research participants in our study area and are working with our research team to develop a psychosocial intervention which we have used in the feasibility study. |
| Impact | 1. The collaboration has helped successful participant recruitment for our formative phase of the study. 2. The collaboration is helped to develop a locally appropriate psychosocial intervention which we have evaluated as part of the ongoing study. 3. The collaboration will help in writing dissemination materials, particularly in linking results with policies and broader societal expectations. 4. The collaboration is helping in working for further grant applications to address health problems of children with malnutrition |
| Start Year | 2020 |
| Description | Visit to a child care centre |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | Local |
| Primary Audience | Other audiences |
| Results and Impact | As part of formative research for the current study we visited one day care centre run by TAHEA where children are supported (with various educational activities) to enhance proper cognitive development. In this centre had an opportunity to speak with mothers and teachers about our project and how it could help contribute in improving cognitive development particularly among children recovering from severe acute malnutrition. As a result of the talk many mothers became interested to participate in our study. |
| Year(s) Of Engagement Activity | 2020 |