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

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.

Study Overview

• Status: Completed
• Conditions: Child Malnutrition
• Intervention / Treatment: Behavioral: Standard of Care; Behavioral: Counseling Intervention Package

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 Type: Interventional
• Enrollment (Actual): 181
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Blantyre, Malawi
    • Queen Elizabeth Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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.	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.; Other Names: Kusamala Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Malawi Developmental Assessment Tool Score	Gross motor, fine motor, language, and social development	6 months post-discharge from hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional status based on: mid-upper arm circumference (MUAC)	MUAC in millimeters	6 months post-discharge from hospital
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
Nutritional status based on: nutritionally-induced bilateral pitting oedema	Bilateral pitting oedema	6 months post-discharge from hospital
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)
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)
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)
Readmission	Requiring inpatient treatment	Within 6 months post-discharge from hospital
Mortality	Inpatient or post-discharge mortality	Within 6 months post-discharge from hospital

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self Reporting Questionnaire (SRQ-20)	Mental health of primary caregivers	6 months post-discharge from hospital
Home Observation for Measurement of the Environment (HOME) Inventory	Stimulus and support for children in the household	6 months post-discharge from hospital
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
Participant engagement	Attendance of participants on day one of the intervention program	Day one of the intervention during hospital stay
Participant adherence	Attendance of participants on all four days of the intervention program	Across the four days of the intervention during hospital stay

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: University of Malawi
• Investigators: Principal Investigator: Robert Bandsma, PhD, The Hospital for Sick Children

Publications and helpful links

General Publications

• Daniel AI, Bwanali M, Tenthani JC, Gladstone M, Voskuijl W, Potani I, Ziwoya F, Chidzalo K, Mbale E, Heath A, Bourdon C, Njirammadzi J, van den Heuvel M, Bandsma RHJ. A Mixed-Methods Cluster-Randomized Controlled Trial of a Hospital-Based Psychosocial Stimulation and Counseling Program for Caregivers and Children with Severe Acute Malnutrition. Curr Dev Nutr. 2021 Jul 21;5(8):nzab100. doi: 10.1093/cdn/nzab100. eCollection 2021 Aug.
• Daniel AI, van den Heuvel M, Gladstone M, Bwanali M, Voskuijl W, Bourdon C, Potani I, Fernandes S, Njirammadzi J, Bandsma RHJ. A mixed methods feasibility study of the Kusamala Program at a nutritional rehabilitation unit in Malawi. Pilot Feasibility Stud. 2018 Sep 24;4:151. doi: 10.1186/s40814-018-0347-8. eCollection 2018.
• Daniel AI, van den Heuvel M, Voskuijl WP, Gladstone M, Bwanali M, Potani I, Bourdon C, Njirammadzi J, Bandsma RHJ. The Kusamala Program for primary caregivers of children 6-59 months of age hospitalized with severe acute malnutrition in Malawi: study protocol for a cluster-randomized controlled trial. Trials. 2017 Nov 17;18(1):550. doi: 10.1186/s13063-017-2299-3.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: February 17, 2017
• First Submitted That Met QC Criteria: March 1, 2017
• First Posted (Actual): March 7, 2017

Study Record Updates

• Last Update Posted (Estimate): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: counseling; child development; child malnutrition
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Child Nutrition Disorders
• Other Study ID Numbers: 1000053078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No