Queen Elizabeth Central Hospital
Blantyre, Malawi
NCT Number: NCT03072433
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.
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Notify Me6 month–5 year
All sexes
Interventional
Not applicable
Blantyre, Malawi
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Kusamala Program
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.
Time frame: 6 months post-discharge from hospital
Gross motor, fine motor, language, and social development
Time frame: 6 months post-discharge from hospital
MUAC in millimeters
Time frame: 6 months post-discharge from hospital
Weight-for-length or -height z-scores and height-for-age z-scores
Time frame: 6 months post-discharge from hospital
Bilateral pitting oedema
Time frame: 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
Time frame: 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
Time frame: During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)
Number of clinical danger signs
Time frame: Within 6 months post-discharge from hospital
Requiring inpatient treatment
Time frame: Within 6 months post-discharge from hospital
Inpatient or post-discharge mortality
Time frame: 6 months post-discharge from hospital
Mental health of primary caregivers
Time frame: 6 months post-discharge from hospital
Stimulus and support for children in the household
Time frame: 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
Time frame: Day one of the intervention during hospital stay
Attendance of participants on day one of the intervention program
Time frame: Across the four days of the intervention during hospital stay
Attendance of participants on all four days of the intervention program
The Hospital for Sick Children
Other
The Effect of an Intervention Program for Primary Caregivers on the Development of Children With Severe Malnutrition: A Cluster Randomized Controlled Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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