Child Malnutrition
Conditions
Keywords
child malnutrition, child development, counseling
Brief summary
This cluster-randomized controlled trial will evaluate the effectiveness of a four-day hospital-based intervention program for primary caregivers of children with severe malnutrition.
Detailed description
Mortality rates remain high in hospitalized children with severe malnutrition and long-term impairments in child development exist in children that do survive. Hospitalized children with severe malnutrition will be allocated to an intervention or standard of care group in each one-week cycle. The intervention package consists of a counseling and support program that includes three modules: 1) psychosocial stimulation; 2) nutrition and feeding; and 3) water, sanitation and hygiene. Assessments will be done at baseline (t=0) and follow-up (t=6 months). The primary outcome is child development, which will be assessed using the Malawi Developmental Assessment Tool, a validated tool for gross and fine motor, language, and social development.
Interventions
BEHAVIORALCounseling Intervention Package
Daily 45 minutes of group teaching for primary caregivers, followed by 45 minutes of supervised play and stimulation with their children for a total of four days. Teaching modules consist of psychosocial stimulation, nutrition and feeding, and water, sanitation and hygiene practices.
BEHAVIORALStandard of Care
Nutrition and water sanitation and hygiene counseling at any point prior to discharge from hospital as per the local nutrition rehabilitation unit standard of care. In addition, primary caregivers will be stimulated to play with their children in a play area.
Sponsors
University of Malawi
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
* Child 6-59 months of age with severe malnutrition * Child admitted to hospital because of severe malnutritionwith medical complications as defined by the current World Health Organization guidelines or has no appetite if there are no complications * Primary caregiver (self-identified) present at hospital.
Exclusion criteria
* Primary caregiver declined to give informed consent; * Child with a known terminal illness (i.e. in the opinion of the treating physician the child is likely to die within six months) * Child requires a surgical procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Malawi Developmental Assessment Tool Score | 6 months post-discharge from hospital | Gross motor, fine motor, language, and social development |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional status based on: nutritionally-induced bilateral pitting oedema | 6 months post-discharge from hospital | Bilateral pitting oedema |
| Duration of hospital stay | During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days) | Number of days that hospital treatment is required |
| Appetite | During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days) | Number of days that nasogastric tube is required |
| Clinical deterioration | During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days) | Number of clinical danger signs |
| Readmission | Within 6 months post-discharge from hospital | Requiring inpatient treatment |
| Mortality | Within 6 months post-discharge from hospital | Inpatient or post-discharge mortality |
| Nutritional status based on: mid-upper arm circumference (MUAC) | 6 months post-discharge from hospital | MUAC in millimeters |
| Nutritional status based on: World Health Organization (WHO) z-scores | 6 months post-discharge from hospital | Weight-for-length or -height z-scores and height-for-age z-scores |
Other
| Measure | Time frame | Description |
|---|---|---|
| Primary caregiver knowledge, attitudes, and practices | 6 months post-discharge from hospital | Questionnaire with the following modules: hygiene and sanitation, nutrition and feeding with a 24-hour food recall of the child (follow-up only), and malnutrition knowledge and attitudes |
| Participant engagement | Day one of the intervention during hospital stay | Attendance of participants on day one of the intervention program |
| Participant adherence | Across the four days of the intervention during hospital stay | Attendance of participants on all four days of the intervention program |
| Self Reporting Questionnaire (SRQ-20) | 6 months post-discharge from hospital | Mental health of primary caregivers |
| Home Observation for Measurement of the Environment (HOME) Inventory | 6 months post-discharge from hospital | Stimulus and support for children in the household |
Countries
Malawi
Outcome results
None listed