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Completed

NCT Number: NCT03072433

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

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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Key information

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Elizabeth Central Hospital

Blantyre, Malawi

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Kusamala Program

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.

Primary outcomes

  1. Malawi Developmental Assessment Tool Score

    Time frame: 6 months post-discharge from hospital

    Gross motor, fine motor, language, and social development

Secondary outcomes

  1. Nutritional status based on: mid-upper arm circumference (MUAC)

    Time frame: 6 months post-discharge from hospital

    MUAC in millimeters

  2. Nutritional status based on: World Health Organization (WHO) z-scores

    Time frame: 6 months post-discharge from hospital

    Weight-for-length or -height z-scores and height-for-age z-scores

  3. Nutritional status based on: nutritionally-induced bilateral pitting oedema

    Time frame: 6 months post-discharge from hospital

    Bilateral pitting oedema

  4. Duration of hospital stay

    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

  5. Appetite

    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

  6. Clinical deterioration

    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

  7. Readmission

    Time frame: Within 6 months post-discharge from hospital

    Requiring inpatient treatment

  8. Mortality

    Time frame: Within 6 months post-discharge from hospital

    Inpatient or post-discharge mortality

Other outcomes

  1. Self Reporting Questionnaire (SRQ-20)

    Time frame: 6 months post-discharge from hospital

    Mental health of primary caregivers

  2. Home Observation for Measurement of the Environment (HOME) Inventory

    Time frame: 6 months post-discharge from hospital

    Stimulus and support for children in the household

  3. Primary caregiver knowledge, attitudes, and practices

    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

  4. Participant engagement

    Time frame: Day one of the intervention during hospital stay

    Attendance of participants on day one of the intervention program

  5. Participant adherence

    Time frame: Across the four days of the intervention during hospital stay

    Attendance of participants on all four days of the intervention program

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • University of Malawi

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 7, 2017
Registry last updated
Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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