Ignite Creation Date:
2024-05-06 @ 7:32 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06045104
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-13
First Post:
2023-09-13
Brief Title:
Alternative Feeding Regimen on Recovery of Children Aged 6-59 Months With Moderate Acute Malnutrition in Bangladesh
Sponsor:
International Centre for Diarrhoeal Disease Research Bangladesh
Organization:
International Centre for Diarrhoeal Disease Research Bangladesh
Study Overview
Official Title:
Effectiveness of Context-adapted Alternative Feeding Regimen on Recovery of Children Aged 6-59 Months From Moderate Acute Malnutrition and Uncomplicated Severe Acute Malnutrition in Bangladesh A Cluster Randomized Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In spite of the large burden of acute malnutrition in the country the Community-based Management of Acute Malnutrition CMAM protocol approved in Bangladesh highly deviates from the WHO normative guidance in that it does not support the use of any currently existing nutritional products for Moderate Acute Malnutrition MAM cases it relies solely on nutrition counselling On another hand some non-governmental organizations NGOs are implementing programs making a standard use of specialized nutritional products such as nutritional supplements like Wheat Soy Blend WSB to manage MAM cases in children of Forcibly Displaced Myanmar Nationals FDMNs in the refugee camps situated at the south-eastern region of the country and in some crisis-affected districts as well
The no-food CMAM policy for MAM is decreasing the cost of treatment yet this may undermine effectiveness and impact In this context policy makers need evidence regarding context specific effective and scalable interventions for CMAM
This cluster randomized control trial cRCT will be conducted in the host communities in Teknaf and Ukhiya sub-districts of Coxs Bazar district of Bangladesh among children aged 6-59 months suffering from MAM who will be assigned to receive either of the 2 different treatment packages for a period of 4 months 120 days Then followed up for 6 months 180 days post treatment completion Each arm will consist of 280 children with MAM Both the arms will receive nutrition counselling along with the study intervention as follows
In the first arm the treatment packages for children with MAM will include a standard use of specialized nutritional products developed to address the nutritional needs of these children in acute crisisemergency settings and widely used internationally children with MAM will receive WSB with nutrition counselling for a period of 4 months 120 days
In the second arm children with MAM will receive 15 MNP with improved nutrition counselling for a period of 4 months 120 days
A cluster sampling technique will be used to enroll participants Each Community Clinic and Union Health Family Welfare Centers will serve as unit of cluster for the randomization
Primary outcome variables are 1 Daily weight gain gkgd between enrolment and end of the treatment period 2 Recovery rate at the end of the treatment period
The no-food CMAM policy for MAM is decreasing the cost of treatment yet this may undermine effectiveness and impact In this context policy makers need evidence regarding context specific effective and scalable interventions for CMAM
This cluster randomized control trial cRCT will be conducted in the host communities in Teknaf and Ukhiya sub-districts of Coxs Bazar district of Bangladesh among children aged 6-59 months suffering from MAM who will be assigned to receive either of the 2 different treatment packages for a period of 4 months 120 days Then followed up for 6 months 180 days post treatment completion Each arm will consist of 280 children with MAM Both the arms will receive nutrition counselling along with the study intervention as follows
In the first arm the treatment packages for children with MAM will include a standard use of specialized nutritional products developed to address the nutritional needs of these children in acute crisisemergency settings and widely used internationally children with MAM will receive WSB with nutrition counselling for a period of 4 months 120 days
In the second arm children with MAM will receive 15 MNP with improved nutrition counselling for a period of 4 months 120 days
A cluster sampling technique will be used to enroll participants Each Community Clinic and Union Health Family Welfare Centers will serve as unit of cluster for the randomization
Primary outcome variables are 1 Daily weight gain gkgd between enrolment and end of the treatment period 2 Recovery rate at the end of the treatment period
Detailed Description:
Background
Burden
Acute Malnutrition AM which is also known as wasting in children under five years of age is a major and significant global health problem It has two forms i Severe Acute Malnutrition SAM defined as weight-for-heightlength z-score WHZWLZ less than -3 standard deviations SDs from the median of reference population and or Mid-Upper Arm Circumference MUAC 115mm and or presence of bipedal edema and ii Moderate Acute Malnutrition MAM defined as WHZWLZ between -3SDs and -2SDs and or MUAC 115mm to 125mm It is estimated that more than half of all under five deaths are associated with undernutrition Both MAM and SAM pose serious consequences leading to increased morbidity and mortality impaired intellectual development increased risk of non-communicable diseases NCDs in adulthood and suboptimal adult work capacity Children with SAM have approximately nine times and children with MAM have approximately three times higher risk of mortality due to common communicable diseases than if they were well-nourished A MAM child is additionally at higher risk of developing SAM if their health and nutritional condition is not monitored The recent Lancet analysis estimated that in 2020 the COVID19 pandemic exacerbated the problem of AM with an additional 67 million children - equivalent to a 143 increase in the number of children with wasting More than half 39 million of these children would be from South Asia alone Although prevalence of AM in many countries have reduced still these are far from Sustainable Development Goals SDGs target
Despite Bangladesh already progressed in reduction of AM by more than half between 2007 and 2017 still it has one of the highest prevalence of AM in the world According to Bangladesh Demographic and Health Survey BDHS 2017 prevalence of AM under-5 children was 84 while the multiple indicator cluster survey MICS which included a larger sample found a slight increase from 96 in 2013 to 98 15 million in 2019 Of the total AM 75 11-12 million were MAM It depicts that currently in terms of reducing the prevalence of wasting among children under five to 5 Bangladesh has to go far away to achieve the SDG target 22 by 2025 It was observed that despite having recovery rate above the minimum standards of 75 post-discharge relapse rates of AM were very high 78 for MAM 69 while 9 for SAM in Bangladesh and Southern Ethiopia 721 375 for MAM and 346 for SAM Chang et al 2013 found 27 17 for MAM and 10 for SAM relapse cases in Malawi Therefore after recovery and discharge a child should be followed up to assess the maintenance of the nutritional status because it is likely that children who recovered from AM may recur as AM after returning to the same environment
Knowledge gap
Based on the current consensus children with MAM should also be managed at homecommunity Essential nutrition activities such as breastfeeding promotion and support education and nutrition counselling for caregivers should be an integral part of management of children aged 6-59 months with MAM or uncomplicated SAM WHO 19 Technical Group and Community Management of Acute Malnutrition CMAM Forum 2014 recommended nutritional supplements and nutrition counselling for children with MAM However the latest WHO recommendation on MAM management is that it should not provide nutritional supplements routinely unless the context is highly food insecure WHO 2017
In Bangladesh children with MAM receive basic medical treatment and motherscaregivers are provided with counselling on the use of high energynutrient dense local foods fortified with micronutrients in the outpatient care Community outreach activities are given priority in promotion and support of appropriate infant and young child feeding IYCF practices identification care referral and follow up of children with AM
Relevance
In spite of the large burden of acute malnutrition in the country the CMAM protocol approved in Bangladesh highly deviates from the WHO normative guidance in that it does not support the use of any currently existing nutritional products for MAM cases it relies solely on nutrition counselling On another hand some non-governmental organizations NGOs are implementing programs making a standard use of specialized nutritional supplements like Wheat Soy Blend WSB to manage MAM cases in children of Forcibly Displaced Myanmar Nationals FDMNs in the refugee camps situated at the south-eastern region of the country and in some crisis-affected districts as well
The no-food CMAM policy for MAM is decreasing the cost of treatment yet this may undermine effectiveness and impact In this context policy makers need evidence regarding context specific effective and scalable interventions for CMAM
Hypothesis
The study hypothesizes that improved nutrition counselling provided together with 15 MNP is equally effective recovery rate as super cereal WSB in treating children aged 6-59 months with MAM for a period of 4 months 120 days
Objectives
Primary Objectives
1 To assess the daily weight gain and recovery rate among MAM children aged 6-59 months provided with 15 MNP with improved nutrition counselling and WSB with nutrition counselling provided for a period of 4 months 120 days
2 To identify the predictors for the not recoverednon-responder to the treatments and regression to SAM among MAM children at the end of 4 months 120 days
Secondary objectives
1 To evaluate the effects of nutrition counselling combined with 15 MNP and WSB on relapse of MAM children during a period of 6 months 180 days post treatment long term
2 To evaluate the effects of nutrition counselling combined with 15 MNP and WSB provided solely on body composition lean and fat mass of MAM children at the end of 4 months 120 days and 6 months 180 days post treatment long term
3 To evaluate the effects of nutrition counselling combined with 15 MNP and WSB on cognitive development of MAM children at the end of 4 months 120 days and 6 months 180 days post treatment long term
4 To identify concurrent illness and gut microbiota in a sub-sample at baseline and end of intervention period
5 To evaluate the cost-effectiveness of community management of MAM children aged 6-59 months provided with nutrition counselling combined with 15 MNP and WSB
6 To define challenges and opportunities in scaling up the tested interventions if proven to be effective alone or cost effective as well
Methods
Study site
The study will be conducted in the host communities in Teknaf and Ukhiya sub-districts of Coxs Bazar district of Bangladesh
Study Population
This trial will be conducted in children aged 6-59 months with MAM residing in Teknaf and Ukhiya sub-districts of Coxs Bazar district of Bangladesh
Inclusion criteria
The inclusion criteria for enrolment in the study will include
i Children of either sex aged between 6-59 months having MUAC 125 mm andor WHZWLZ -2 SD ii Absence of edema or morbidities that necessitate hospitalization iii Children with appetite iv Motherscaregivers sign the consent form v Willing to bring the child to the study site every two weeks for MAM and have a plan to stay in the community for at least next 9-10 months
vi Accept the intervention package and home visits for data collection and morbidity follow up
Exclusion criteria
The study will not include children with- i Bipedal edema ii MAM with clinically severe anemia suspected tuberculosis other chronic diseases or any congenital disorder or deformity an ongoing episode of diarrhea a history of persistent diarrhea in the past month
iii Complicated SAM cases
Study plan In this cluster randomized-controlled trial cRCT 560 eligible MAM children will be enrolled treated for 4 months 120 days and then followed up for 6 months 180 days post treatment completion
Study design
This cluster randomized control trial cRCT will include children aged 6-59 months suffering from MAM who will be assigned to receive either of the 2 different treatment packages for a period of 4 months 120 days Then followed up for 6 months 180 days post treatment completion Each arm will consist of 280 children with MAM Both the arms will receive nutrition counselling along with the study intervention as follows
In the first arm the treatment packages for children with MAM will include a standard use of specialized nutritional products developed to address the nutritional needs of these children in acute crisisemergency settings and widely used internationally children with MAM will receive WSB with nutrition counselling for a period of 4 months 120 days
In the second arm children with MAM will receive 15 MNP with improved nutrition counselling for a period of 4 months 120 days
Sampling technique A cluster sampling technique will be used to enroll participants Each Community Clinic and Union Health Family Welfare Centers will serve as unit of cluster for the randomization
Field implementation of the interventions
The intervention will take place in 28 community clinics CCs and 6 Union Health Family Welfare Centers UHFWCs in the host communities in Teknaf and Ukhiya sub-districts of Coxs Bazar district of Bangladesh As per the national CMAM guidelines all the participating CCUHFWC provides the standard care and nutrition counselling for children with MAM or uncomplicated SAM Children with MAM from catchment areas of the selected 10 CCs UHFWCs will take part in each arm Research team Community Health Care Providers CHCPs Health Assistants HAs Family Welfare Assistants FWAs and local NGOs field workers will work to conduct this study All participating children would be receiving standard health and nutrition counselling at each occasion they attend the CCsUHFWC
Outcome measuresvariables
Primary effectiveness outcomes
1 Daily weight gain gkgd between enrolment and end of the treatment period for 4 months or 120 days If recovery was reached before the full duration of the treatment daily weight gain will be calculated between enrolment and recovery without stopping the treatment
2 Recovery rate at the end of the treatment period 4 months or 120 days
3 Proportion of children free from acute malnutrition at the end of the treatment period 4 months or 120 days
Secondary effectiveness outcomes
1 Proportion of non-response death defaulter and regression of MAM to SAM among MAM children at the end of treatment period 4 months or 120 days
2 Incidence of relapse during a period of 6 months 180 days post-treatment
3 Change in lean and fat mass between enrollment and end of the treatment period 4 months or 120 days and 6 months post-treatment
4 Prevalence of concurrent infections at the end of the treatment period 4 months or 120 days and 6 months post-treatment
5 Motor language and personal-social development at the end of the treatment period 4 months or 120 days and 6 months post-treatment
6 Cost-effectiveness analysis
7 Challenges and opportunities in scaling up the tested interventions
8 Feasibility and acceptability of the interventions
9 Knowledge attitudes and practices regarding nutritional and social care of MAM
Safety outcomes
- Incidence of diarrhea pneumonia malaria etc among children during study period 9-10 months
Burden
Acute Malnutrition AM which is also known as wasting in children under five years of age is a major and significant global health problem It has two forms i Severe Acute Malnutrition SAM defined as weight-for-heightlength z-score WHZWLZ less than -3 standard deviations SDs from the median of reference population and or Mid-Upper Arm Circumference MUAC 115mm and or presence of bipedal edema and ii Moderate Acute Malnutrition MAM defined as WHZWLZ between -3SDs and -2SDs and or MUAC 115mm to 125mm It is estimated that more than half of all under five deaths are associated with undernutrition Both MAM and SAM pose serious consequences leading to increased morbidity and mortality impaired intellectual development increased risk of non-communicable diseases NCDs in adulthood and suboptimal adult work capacity Children with SAM have approximately nine times and children with MAM have approximately three times higher risk of mortality due to common communicable diseases than if they were well-nourished A MAM child is additionally at higher risk of developing SAM if their health and nutritional condition is not monitored The recent Lancet analysis estimated that in 2020 the COVID19 pandemic exacerbated the problem of AM with an additional 67 million children - equivalent to a 143 increase in the number of children with wasting More than half 39 million of these children would be from South Asia alone Although prevalence of AM in many countries have reduced still these are far from Sustainable Development Goals SDGs target
Despite Bangladesh already progressed in reduction of AM by more than half between 2007 and 2017 still it has one of the highest prevalence of AM in the world According to Bangladesh Demographic and Health Survey BDHS 2017 prevalence of AM under-5 children was 84 while the multiple indicator cluster survey MICS which included a larger sample found a slight increase from 96 in 2013 to 98 15 million in 2019 Of the total AM 75 11-12 million were MAM It depicts that currently in terms of reducing the prevalence of wasting among children under five to 5 Bangladesh has to go far away to achieve the SDG target 22 by 2025 It was observed that despite having recovery rate above the minimum standards of 75 post-discharge relapse rates of AM were very high 78 for MAM 69 while 9 for SAM in Bangladesh and Southern Ethiopia 721 375 for MAM and 346 for SAM Chang et al 2013 found 27 17 for MAM and 10 for SAM relapse cases in Malawi Therefore after recovery and discharge a child should be followed up to assess the maintenance of the nutritional status because it is likely that children who recovered from AM may recur as AM after returning to the same environment
Knowledge gap
Based on the current consensus children with MAM should also be managed at homecommunity Essential nutrition activities such as breastfeeding promotion and support education and nutrition counselling for caregivers should be an integral part of management of children aged 6-59 months with MAM or uncomplicated SAM WHO 19 Technical Group and Community Management of Acute Malnutrition CMAM Forum 2014 recommended nutritional supplements and nutrition counselling for children with MAM However the latest WHO recommendation on MAM management is that it should not provide nutritional supplements routinely unless the context is highly food insecure WHO 2017
In Bangladesh children with MAM receive basic medical treatment and motherscaregivers are provided with counselling on the use of high energynutrient dense local foods fortified with micronutrients in the outpatient care Community outreach activities are given priority in promotion and support of appropriate infant and young child feeding IYCF practices identification care referral and follow up of children with AM
Relevance
In spite of the large burden of acute malnutrition in the country the CMAM protocol approved in Bangladesh highly deviates from the WHO normative guidance in that it does not support the use of any currently existing nutritional products for MAM cases it relies solely on nutrition counselling On another hand some non-governmental organizations NGOs are implementing programs making a standard use of specialized nutritional supplements like Wheat Soy Blend WSB to manage MAM cases in children of Forcibly Displaced Myanmar Nationals FDMNs in the refugee camps situated at the south-eastern region of the country and in some crisis-affected districts as well
The no-food CMAM policy for MAM is decreasing the cost of treatment yet this may undermine effectiveness and impact In this context policy makers need evidence regarding context specific effective and scalable interventions for CMAM
Hypothesis
The study hypothesizes that improved nutrition counselling provided together with 15 MNP is equally effective recovery rate as super cereal WSB in treating children aged 6-59 months with MAM for a period of 4 months 120 days
Objectives
Primary Objectives
1 To assess the daily weight gain and recovery rate among MAM children aged 6-59 months provided with 15 MNP with improved nutrition counselling and WSB with nutrition counselling provided for a period of 4 months 120 days
2 To identify the predictors for the not recoverednon-responder to the treatments and regression to SAM among MAM children at the end of 4 months 120 days
Secondary objectives
1 To evaluate the effects of nutrition counselling combined with 15 MNP and WSB on relapse of MAM children during a period of 6 months 180 days post treatment long term
2 To evaluate the effects of nutrition counselling combined with 15 MNP and WSB provided solely on body composition lean and fat mass of MAM children at the end of 4 months 120 days and 6 months 180 days post treatment long term
3 To evaluate the effects of nutrition counselling combined with 15 MNP and WSB on cognitive development of MAM children at the end of 4 months 120 days and 6 months 180 days post treatment long term
4 To identify concurrent illness and gut microbiota in a sub-sample at baseline and end of intervention period
5 To evaluate the cost-effectiveness of community management of MAM children aged 6-59 months provided with nutrition counselling combined with 15 MNP and WSB
6 To define challenges and opportunities in scaling up the tested interventions if proven to be effective alone or cost effective as well
Methods
Study site
The study will be conducted in the host communities in Teknaf and Ukhiya sub-districts of Coxs Bazar district of Bangladesh
Study Population
This trial will be conducted in children aged 6-59 months with MAM residing in Teknaf and Ukhiya sub-districts of Coxs Bazar district of Bangladesh
Inclusion criteria
The inclusion criteria for enrolment in the study will include
i Children of either sex aged between 6-59 months having MUAC 125 mm andor WHZWLZ -2 SD ii Absence of edema or morbidities that necessitate hospitalization iii Children with appetite iv Motherscaregivers sign the consent form v Willing to bring the child to the study site every two weeks for MAM and have a plan to stay in the community for at least next 9-10 months
vi Accept the intervention package and home visits for data collection and morbidity follow up
Exclusion criteria
The study will not include children with- i Bipedal edema ii MAM with clinically severe anemia suspected tuberculosis other chronic diseases or any congenital disorder or deformity an ongoing episode of diarrhea a history of persistent diarrhea in the past month
iii Complicated SAM cases
Study plan In this cluster randomized-controlled trial cRCT 560 eligible MAM children will be enrolled treated for 4 months 120 days and then followed up for 6 months 180 days post treatment completion
Study design
This cluster randomized control trial cRCT will include children aged 6-59 months suffering from MAM who will be assigned to receive either of the 2 different treatment packages for a period of 4 months 120 days Then followed up for 6 months 180 days post treatment completion Each arm will consist of 280 children with MAM Both the arms will receive nutrition counselling along with the study intervention as follows
In the first arm the treatment packages for children with MAM will include a standard use of specialized nutritional products developed to address the nutritional needs of these children in acute crisisemergency settings and widely used internationally children with MAM will receive WSB with nutrition counselling for a period of 4 months 120 days
In the second arm children with MAM will receive 15 MNP with improved nutrition counselling for a period of 4 months 120 days
Sampling technique A cluster sampling technique will be used to enroll participants Each Community Clinic and Union Health Family Welfare Centers will serve as unit of cluster for the randomization
Field implementation of the interventions
The intervention will take place in 28 community clinics CCs and 6 Union Health Family Welfare Centers UHFWCs in the host communities in Teknaf and Ukhiya sub-districts of Coxs Bazar district of Bangladesh As per the national CMAM guidelines all the participating CCUHFWC provides the standard care and nutrition counselling for children with MAM or uncomplicated SAM Children with MAM from catchment areas of the selected 10 CCs UHFWCs will take part in each arm Research team Community Health Care Providers CHCPs Health Assistants HAs Family Welfare Assistants FWAs and local NGOs field workers will work to conduct this study All participating children would be receiving standard health and nutrition counselling at each occasion they attend the CCsUHFWC
Outcome measuresvariables
Primary effectiveness outcomes
1 Daily weight gain gkgd between enrolment and end of the treatment period for 4 months or 120 days If recovery was reached before the full duration of the treatment daily weight gain will be calculated between enrolment and recovery without stopping the treatment
2 Recovery rate at the end of the treatment period 4 months or 120 days
3 Proportion of children free from acute malnutrition at the end of the treatment period 4 months or 120 days
Secondary effectiveness outcomes
1 Proportion of non-response death defaulter and regression of MAM to SAM among MAM children at the end of treatment period 4 months or 120 days
2 Incidence of relapse during a period of 6 months 180 days post-treatment
3 Change in lean and fat mass between enrollment and end of the treatment period 4 months or 120 days and 6 months post-treatment
4 Prevalence of concurrent infections at the end of the treatment period 4 months or 120 days and 6 months post-treatment
5 Motor language and personal-social development at the end of the treatment period 4 months or 120 days and 6 months post-treatment
6 Cost-effectiveness analysis
7 Challenges and opportunities in scaling up the tested interventions
8 Feasibility and acceptability of the interventions
9 Knowledge attitudes and practices regarding nutritional and social care of MAM
Safety outcomes
- Incidence of diarrhea pneumonia malaria etc among children during study period 9-10 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None