The Effect of an Intervention Program for Primary Caregivers on the Development of Children With Severe Malnutrition: A Cluster Randomized Controlled Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Child Malnutrition
- Sponsor
- The Hospital for Sick Children
- Enrollment
- 181
- Locations
- 1
- Primary Endpoint
- Malawi Developmental Assessment Tool Score
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Robert Bandsma
Staff Gastroenterologist
The Hospital for Sick Children
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Malawi Developmental Assessment Tool Score
Time Frame: 6 months post-discharge from hospital
Gross motor, fine motor, language, and social development
Secondary Outcomes
- Nutritional status based on: mid-upper arm circumference (MUAC)(6 months post-discharge from hospital)
- Nutritional status based on: World Health Organization (WHO) z-scores(6 months post-discharge from hospital)
- Nutritional status based on: nutritionally-induced bilateral pitting oedema(6 months post-discharge from hospital)
- Duration of hospital stay(During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days))
- Appetite(During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days))
- Clinical deterioration(During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days))
- Readmission(Within 6 months post-discharge from hospital)
- Mortality(Within 6 months post-discharge from hospital)