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

NCT03072433 | Completed

• 1 other identifier: 1000053078
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Malnutrition

Keywords

child malnutrition; child development; counseling

Outcome Measures

Primary Outcomes (1)

• Malawi Developmental Assessment Tool Score

  Gross motor, fine motor, language, and social development

  6 months post-discharge from hospital

Secondary Outcomes (8)

• 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)

Other Outcomes (5)

• Self Reporting Questionnaire (SRQ-20)

  6 months post-discharge from hospital

• Home Observation for Measurement of the Environment (HOME) Inventory

  6 months post-discharge from hospital

• Primary caregiver knowledge, attitudes, and practices

  6 months post-discharge from hospital

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

Counseling Intervention Package

EXPERIMENTAL

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

Interventions

Counseling Intervention Package BEHAVIORAL

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.

Also known as: Kusamala Program

Counseling Intervention Package

Standard of Care BEHAVIORAL

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.

Standard of Care

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• University of Malawi: collaborator

Study Sites (1)

Queen Elizabeth Central Hospital

Blantyre, Malawi

Location

Related Publications (3)

• 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.

  PMID: 34447897 DERIVED

• 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.

  PMID: 30258650 DERIVED

• 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.

  PMID: 29149905 DERIVED

MeSH Terms

Conditions

Child Nutrition Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Robert Bandsma, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Gastroenterologist

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: March 7, 2017
• Study Start: December 1, 2016
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 22, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)