Ignite Creation Date:
2025-12-25 @ 4:39 AM
Ignite Modification Date:
2026-01-09 @ 7:35 PM
Study NCT ID:
NCT06781918
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-17
First Post:
2024-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Severe Acute Malnutrition and Child Development Clinical Trial in Mwanza
Sponsor:
National Institute for Medical Research, Tanzania
Organization:
Study Overview
Official Title:
BRAIN DEVELOPMENT, GROWTH and HEALTH in CHILDREN with SEVERE ACUTE MALNUTRITION
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-01
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:
BRIGHTSAM
Brief Summary:
This is a randomized clinical trial to learn whether ready-to-use therapeutic foods enriched with choline and docosahexaenoic acid (DHA) together with psychosocial stimulating activities work well to improve child development in children with severe acute malnutrition(SAM). The overall question this trial aims to answer is can the health and development outcomes of children with SAM be improved through optimized nutritional treatment and integrated psychosocial support.
Researchers will compare the new ready-to-use therapeutic food and an integrated psychosocial stimulation to a standard look-alike nutritional supplement that contains no additional nutrients being investigated and the standard nutritional counseling given locally and assess its effects on child development in children with severe acute malnutrition.
Participants will:
* Be given the trial interventions which will be delivered over 12 weeks
* After the 12 weeks of intervention, participants will return for outcome evaluations (week 12 study visit), which will be repeated at follow-up visits after 24 and 48 weeks.
Researchers will compare the new ready-to-use therapeutic food and an integrated psychosocial stimulation to a standard look-alike nutritional supplement that contains no additional nutrients being investigated and the standard nutritional counseling given locally and assess its effects on child development in children with severe acute malnutrition.
Participants will:
* Be given the trial interventions which will be delivered over 12 weeks
* After the 12 weeks of intervention, participants will return for outcome evaluations (week 12 study visit), which will be repeated at follow-up visits after 24 and 48 weeks.
Detailed Description:
Background Estimated, 13.6 million children were affected by severe acute malnutrition (SAM) in 2022. Early childhood is a critical period of brain development and children exposed to malnutrition in early life have poorer school performance and lower income in adult life. Introduction of Ready to use therapeutic foods (RUTF) has greatly improved the nutritional recovery of children with SAM. However, SAM remains associated with adverse effects on child cognitive and social development. The balance in the RUTF between polyunsaturated n-6 and n-3 essential fatty acids (EFAs) in RUTF has been questioned. Essential fatty acid (EFA) status is associated with child development, and children given the standard RUTF do not improve their n-3 EFA status after recovery.
A trial in Malawi found a positive effect on cognitive scores six months after completing nutritional therapy with RUTF with added preformed docosahexaenoic acid (DHA), a long-chain polyunsaturated fatty acid (PUFA) of the n-3 series, which is essential for neural growth. There is also a potential for improving the content of other nutrients of importance for neurodevelopment in early childhood like choline, which is essential for neurotransmitter synthesis and phospholipids in the brain. Studies have indicated a synergistic relationship between n-3 EFAs and choline, suggesting that low levels of one or both may negatively impact cognition.
Deficits in child development associated with SAM are not only caused by inadequate diets. Families exposed to malnutrition are often affected by psychological distress, consequently children are likely to be offered little stimulation and responsive care. However, in practice, support for psychosocial stimulation and responsive caregiving is rarely offered during hospital-based treatment, and it is still not included in the guidelines for community-based treatment of SAM. The intensity of this intervention is difficult under the constraints of most health services in low- and middle-income countries (LMIC). More recent packages for promoting responsive care have shown some effects, but often not when implemented at scale or within systems of care.
In this study we hypothesize that optimized nutritional treatment and integrated psychosocial support can improve the health and development outcomes of children with SAM.
Specific objectives:
1. to assess the effects of a modified RUTF and psychosocial stimulation, individually and combined, on attention, cognitive, motor, language and psycho-emotional development in children treated for SAM;
2. to investigate the pathways of intervention effects on cognitive development by assessing the role of DHA and choline status in the child as well as caregiver factors which include caregiver-child interaction, home stimulation and maternal psychological distress;
3. to assess how, why and for whom the modified RUTF and psychosocial interventions work within the trial context, perceptions of their feasibility of implementation within the routine health system, and the climate and environmental sustainability of interventions.
Methods:
This trial is designed as a 2x2 factorial randomized clinical trial to assess the effects of DHA and choline enriched vs. standard RUTF and psychosocial stimulation vs. standard counselling in management of SAM. Participants will be individually randomised to nutritional intervention arms and clusters will be randomized to psychosocial intervention arms.
The interventions will be delivered over a period of 12 weeks. After enrolment and baseline data collection, participants will receive their first RUTF sachets. They will then be requested to return to the study site for a total of seven visits during the intervention period to receive interventions. After the 12 weeks of intervention, participants will return for outcome evaluations (week 12 study visit), which will be repeated at follow-up visits after 24 and 48 weeks. The study will take place in Mwanza region, Tanzania. The trial will include children with uncomplicated SAM aged 6-36 months from eight health care facilities in Ilemela municipality, Nyamagana municipality and Magu district.
Outcomes:
The primary outcomes is the change in child development scores, which will be assessed at baseline, 12, 24 and 48 weeks and compared with intervention groups. These will assess gross, fine motor, language and psycho -emotional skills by validated tool called (MDAT) Malawi Development Assessment Tool) and neurocognitive function will be accessed by eye-tracking. Secondary outcomes will allow us to assess proximate effects of the interventions, which may mediate long-term effects on development
Analysis:
The primary analysis will be based on the intention-to-treat principle using available case data. The analysis will assess intervention effects based on the 2x2 factorial design by comparing changes in outcomes between baseline and intervention endline (i.e., 12 weeks) using a linear regression model adjusted for sex, age and month of inclusion to account for possible seasonal effects.
Secondary analysis will include assessment of intervention effects at 24- and 48-weeks follow-up using a linear mixed model to include repeated measurements. The models will include the baseline value of the outcome as fixed effect and participant as random effect to account for the correlation between measurements from the same participant. These models will also include adjustment for other variables as appropriate.
Secondary analyses will include per-protocol analyses to assess effects within groups with high compliance with the interventions
Ethics:
Ethical approval has been sought from the Medical Research Coordinating Committee (MRCC) of the National Institute for Medical Research in Tanzania and the London School of Hygiene and Tropical Medicine ethics committee.
A trial in Malawi found a positive effect on cognitive scores six months after completing nutritional therapy with RUTF with added preformed docosahexaenoic acid (DHA), a long-chain polyunsaturated fatty acid (PUFA) of the n-3 series, which is essential for neural growth. There is also a potential for improving the content of other nutrients of importance for neurodevelopment in early childhood like choline, which is essential for neurotransmitter synthesis and phospholipids in the brain. Studies have indicated a synergistic relationship between n-3 EFAs and choline, suggesting that low levels of one or both may negatively impact cognition.
Deficits in child development associated with SAM are not only caused by inadequate diets. Families exposed to malnutrition are often affected by psychological distress, consequently children are likely to be offered little stimulation and responsive care. However, in practice, support for psychosocial stimulation and responsive caregiving is rarely offered during hospital-based treatment, and it is still not included in the guidelines for community-based treatment of SAM. The intensity of this intervention is difficult under the constraints of most health services in low- and middle-income countries (LMIC). More recent packages for promoting responsive care have shown some effects, but often not when implemented at scale or within systems of care.
In this study we hypothesize that optimized nutritional treatment and integrated psychosocial support can improve the health and development outcomes of children with SAM.
Specific objectives:
1. to assess the effects of a modified RUTF and psychosocial stimulation, individually and combined, on attention, cognitive, motor, language and psycho-emotional development in children treated for SAM;
2. to investigate the pathways of intervention effects on cognitive development by assessing the role of DHA and choline status in the child as well as caregiver factors which include caregiver-child interaction, home stimulation and maternal psychological distress;
3. to assess how, why and for whom the modified RUTF and psychosocial interventions work within the trial context, perceptions of their feasibility of implementation within the routine health system, and the climate and environmental sustainability of interventions.
Methods:
This trial is designed as a 2x2 factorial randomized clinical trial to assess the effects of DHA and choline enriched vs. standard RUTF and psychosocial stimulation vs. standard counselling in management of SAM. Participants will be individually randomised to nutritional intervention arms and clusters will be randomized to psychosocial intervention arms.
The interventions will be delivered over a period of 12 weeks. After enrolment and baseline data collection, participants will receive their first RUTF sachets. They will then be requested to return to the study site for a total of seven visits during the intervention period to receive interventions. After the 12 weeks of intervention, participants will return for outcome evaluations (week 12 study visit), which will be repeated at follow-up visits after 24 and 48 weeks. The study will take place in Mwanza region, Tanzania. The trial will include children with uncomplicated SAM aged 6-36 months from eight health care facilities in Ilemela municipality, Nyamagana municipality and Magu district.
Outcomes:
The primary outcomes is the change in child development scores, which will be assessed at baseline, 12, 24 and 48 weeks and compared with intervention groups. These will assess gross, fine motor, language and psycho -emotional skills by validated tool called (MDAT) Malawi Development Assessment Tool) and neurocognitive function will be accessed by eye-tracking. Secondary outcomes will allow us to assess proximate effects of the interventions, which may mediate long-term effects on development
Analysis:
The primary analysis will be based on the intention-to-treat principle using available case data. The analysis will assess intervention effects based on the 2x2 factorial design by comparing changes in outcomes between baseline and intervention endline (i.e., 12 weeks) using a linear regression model adjusted for sex, age and month of inclusion to account for possible seasonal effects.
Secondary analysis will include assessment of intervention effects at 24- and 48-weeks follow-up using a linear mixed model to include repeated measurements. The models will include the baseline value of the outcome as fixed effect and participant as random effect to account for the correlation between measurements from the same participant. These models will also include adjustment for other variables as appropriate.
Secondary analyses will include per-protocol analyses to assess effects within groups with high compliance with the interventions
Ethics:
Ethical approval has been sought from the Medical Research Coordinating Committee (MRCC) of the National Institute for Medical Research in Tanzania and the London School of Hygiene and Tropical Medicine ethics committee.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| DFC file no. 23-13-RH | OTHER_GRANT | DANIDA under Danish Ministry of Foreign Affairs | View |