The Effect of an Intervention Program for Primary Caregivers on the Development of Children With Severe Malnutrition: A Cluster Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 181
- Locations
- 1
- Primary Endpoint
- Malawi Developmental Assessment Tool Score
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Months to 5 Years (Child)
- Sex
- All
- Accepts 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.
Arms & Interventions
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.
Intervention: Standard of Care (Behavioral)
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.
Intervention: Counseling Intervention Package (Behavioral)
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
- Readmission(Within 6 months post-discharge from hospital)
- 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))
- Mortality(Within 6 months post-discharge from hospital)
Investigators
Robert Bandsma
Staff Gastroenterologist
The Hospital for Sick Children