Pilot research to test improved nutritional intervention and stimulation care for children with severe acute malnutrition in Tanzania
| ISRCTN | ISRCTN13947785 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13947785 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | MR/T003731/1 |
| Sponsor | National Institute for Medical Research |
| Funders | Department of Health and Social Care, Foreign, Commonwealth and Development Office, Medical Research Council, Wellcome Trust |
- Submission date
- 08/03/2025
- Registration date
- 12/03/2025
- Last edited
- 12/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims.
Children with severe acute malnutrition (SAM) are at high risk of impaired development. Contributing causes include the inadequate intake of specific nutrients such as polyunsaturated fatty acids (PUFAs) and a lack of adequate stimulation. A ready-to-use therapeutic food (RUTF) has been developed with an essential fatty acid (EFA) content, which should improve the ratio between omega-6 (n-6) and omega-3 (n-3) EFA in the diet. This study tested the acceptability among children with SAM and their caregivers and assessed the EFA profile and variability before and after the interventions. This was compared with that of non-SAM children. The long-term plan is to conduct a larger study of a novel RUTF and psychosocial (PS) training intervention to determine their individual and potentially synergistic effects on cognitive development of children with SAM. The present development project will aid this by developing the content and delivery mode of the PS intervention; assessing acceptability of both RUTF and PS interventions; determining contextual factors influencing intervention delivery and uptake; determining variability in EFA and child development outcomes to aid sample size calculations; engaging with local health care staff managing SAM and providers of interventions to ensure that they are appropriate and locally owned; and, investigating the mechanisms that drive feasibility of implementation of the two interventions.
Who can participate?
Children aged 6-36 months old with SAM defined as mid-upper arm circumference (MUAC) <115 mm or weight-for-height (WHZ) z-score <-3 as per WHO growth standards or bilateral pitting oedema and caregivers giving consent ≥ 18 years
What does the study involve?
1. Acceptability of improved RUTF
Mothers with children recovering from SAM whose children asked to consume standard RUTF were asked to try the new RUTF.
2. Development of PS intervention
For the qualitative situational analysis, the study identified health and NGO managers from local organisations to conduct semi-structured interviews. Interviews were also conducted with up to 20 caregivers of children within units for children with malnutrition.
3. Pilot of combined interventions
For the piloting of the interventions, children aged 6-36 months were recruited who were in treatment for SAM and the caregivers of these children.
Control children were to be frequency matched to the SAM children, based on age, sex and neighbourhood to assure similar socioeconomic level.
What are the possible benefits and risks of participating?
The benefits include involving a population of children with SAM during their critical period of brain development (6–36 months) who were provided with a locally created feasible intervention linked with local organizations.
Children with SAM were treated with RUTF and mothers were encouraged to provide psychosocial stimulation to improve nutritional and cognitive outcomes. No direct immediate risk was foreseen for those participating in the study.
Where is the study run from?
Mwanza, Tanzania.
Who is funding the study?
The study was funded by a joint global health trial development grant from the Department of Health and Social Care(DHSC), the Foreign, Commonwealth &Development Office (FCDO), the UK Medical Research Council (MRC) and Wellcome Trust
Who is the main contact?
Dr George PrayGod, george.praygod@nimr.or.tz, gpraygod@gmail.com
Contact information
Public, Scientific, Principal investigator
National Institute for Medical Research , Muhimbili Research Centre
P.O BOX. 3436
Dar -es - Salaam
0000
Tanzania
 ORCID ID |
0000-0002-0329-4839 |
|---|---|
| Phone | +255714226305 |
| george.praygod@nimr.or.tz |
Scientific
Department of Infectious Diseases, Rigshospitalet
Copenhagen
000
Denmark
| Phone | +4528340979 |
|---|---|
| mette.frahm.olsen@regionh.dk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional feasibility study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | BRIGHT-SAM: BRaIn development, Growth and HealTh in children with Severe Acute Malnutrition |
| Study acronym | BRIGHT-SAM |
| Study objectives | Management of severe acute malnutrition can be improved through optimized nutritional treatment and integrated psychosocial support to improve child development and thus mitigate the consequences of climate change. |
| Ethics approval(s) |
1. Approved 06/02/2020, Medical Research Coordinating Commitee (National Institute for Medical Research, Box 9653, Dar es Salaam, 0000, Tanzania; +2552121400; ethics@nimr.or.tz), ref: NIMR/HQ/R.8a/Vol.IX/3340 2. Approved 23/03/2020, Ethics Committee of The London School of Hygiene and Tropical Medicine (Keppel Street, London, WC1E 7HT, United Kingdom; +44 (0)2076368636; study@lshtm.ac.uk), ref: Approval no. 17831 |
| Health condition(s) or problem(s) studied | Treatment of children with severe acute malnutrition (SAM) |
| Intervention | This was a trial development interventional study conducted to inform the feasibility of providing therapeutic feeding with optimised essential fatty acids composition to children treated for severe acute malnutrition(SAM) in Tanzania alongside a psychosocial (PS) training programme to enable counselling with respect to child development for caregivers of children with SAM under the age of three years. The study components included: A) Acceptability of improved ready-to-use therapeutic food (RUTF) B) Development of PS intervention C) Piloting of interventions D) Process evaluation. A piloting procedure for assessing whether measures to assess the effectiveness of the package of care are appropriate for a larger randomized trial of intervention effects in the future. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
Child development measured using the Malawi Development Assessment Tool (MDAT) at baseline and 8 weeks |
| Key secondary outcome measure(s) |
1. Fatty acid status measured in whole blood using gas chromatography at baseline and 8 weeks |
| Completion date | 03/12/2022 |
Eligibility
| Participant type(s) | Patient, Carer |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 36 Months |
| Sex | All |
| Target sample size at registration | 200 |
| Total final enrolment | 170 |
| Key inclusion criteria | 1. 6-36 months old 2. SAM defined as mid-upper arm circumference (MUAC) <115 mm or weight-for-height (WHZ) z-score <-3 as per WHO growth standards or bilateral pitting oedema 3. Age of caregiver giving consent ≥ 18 years |
| Key exclusion criteria | 1. Allergy to peanuts or other ingredients of the RUTF 2. Any severe disorder preventing children from receiving interventions (e.g. not able to swallow RUTF) |
| Date of first enrolment | 05/05/2020 |
| Date of final enrolment | 15/02/2022 |
Locations
Countries of recruitment
- Tanzania
Study participating centre
Mwanza
0000
Tanzania
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 28/02/2024 | 10/03/2025 | Yes | No | |
| Other publications | A qualitative interpretivist study used in-depth interviews to explore the ‘subjective interpreted’ reality of parents/caregivers of SAM children, and professionals providing SAM services | 09/05/2024 | 10/03/2025 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/03/2025: Study's existence confirmed by the Medical Research Council.
