NCT03072433

An Intervention for Primary Caregivers to Improve Outcomes in Children With Severe Malnutrition

The Effect of an Intervention Program for Primary Caregivers on the Development of Children With Severe Malnutrition: A Cluster Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 6 Months – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Child Malnutrition

Interventions

Type	Name	Description
BEHAVIORAL	Counseling 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.
BEHAVIORAL	Standard 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.

Timeline

• Start date: 2016-12-01
• Primary completion: 2020-10-01
• Completion: 2020-12-01
• First posted: 2017-03-07
• Last updated: 2022-12-22

Locations

1 site across 1 country: Malawi