An Intervention for Primary Caregivers to Improve Outcomes in Children With Severe Malnutrition
- Conditions
- Child Malnutrition
- Interventions
- Behavioral: Standard of CareBehavioral: Counseling Intervention Package
- Registration Number
- NCT03072433
- Lead Sponsor
- The Hospital for Sick Children
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 181
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care Standard of Care Comparison group will receive the current standard of care. Nurses are instructed to tell mothers about nutrition and water, sanitation and hygiene at any point prior to discharge from hospital. In addition, nurses will tell primary caregivers to play with their children even while they are receiving treatment in a play area with toys available. Counseling Intervention Package Counseling Intervention Package Primary caregivers in the intervention group receive group education sessions involving psychosocial stimulation, nutrition and feeding, and water, sanitation and hygiene components during a total of four days.
- Primary Outcome Measures
Name Time Method Malawi Developmental Assessment Tool Score 6 months post-discharge from hospital Gross motor, fine motor, language, and social development
- Secondary Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
Queen Elizabeth Central Hospital
🇲🇼Blantyre, Malawi