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

Child Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03072433
• Other study ID #: 1000053078
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2020

Study information

• Verified date: December 2022
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: December 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Malnutrition
• Child Nutrition Disorders
• Malnutrition

Intervention

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.
• 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.

Locations

Country	Name	City	State
Malawi	Queen Elizabeth Central Hospital	Blantyre

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	University of Malawi

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self Reporting Questionnaire (SRQ-20)	Mental health of primary caregivers	6 months post-discharge from hospital
Other	Home Observation for Measurement of the Environment (HOME) Inventory	Stimulus and support for children in the household	6 months post-discharge from hospital
Other	Primary caregiver knowledge, attitudes, and practices	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	6 months post-discharge from hospital
Other	Participant engagement	Attendance of participants on day one of the intervention program	Day one of the intervention during hospital stay
Other	Participant adherence	Attendance of participants on all four days of the intervention program	Across the four days of the intervention during hospital stay
Primary	Malawi Developmental Assessment Tool Score	Gross motor, fine motor, language, and social development	6 months post-discharge from hospital
Secondary	Nutritional status based on: mid-upper arm circumference (MUAC)	MUAC in millimeters	6 months post-discharge from hospital
Secondary	Nutritional status based on: World Health Organization (WHO) z-scores	Weight-for-length or -height z-scores and height-for-age z-scores	6 months post-discharge from hospital
Secondary	Nutritional status based on: nutritionally-induced bilateral pitting oedema	Bilateral pitting oedema	6 months post-discharge from hospital
Secondary	Duration of hospital stay	Number of days that hospital treatment is required	During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)
Secondary	Appetite	Number of days that nasogastric tube is required	During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)
Secondary	Clinical deterioration	Number of clinical danger signs	During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)
Secondary	Readmission	Requiring inpatient treatment	Within 6 months post-discharge from hospital
Secondary	Mortality	Inpatient or post-discharge mortality	Within 6 months post-discharge from hospital