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Trial record 11 of 343 for:    Recruiting, Not yet recruiting, Available Studies | "nutrition disorders" | Child

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

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ClinicalTrials.gov Identifier: NCT03072433
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : June 26, 2019
Sponsor:
Collaborator:
University of Malawi
Information provided by (Responsible Party):
Robert Bandsma, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Child Malnutrition Behavioral: Counseling Intervention Package Behavioral: Standard of Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : December 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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 Name: Kusamala Program




Primary Outcome Measures :
  1. Malawi Developmental Assessment Tool Score [ Time Frame: 6 months post-discharge from hospital ]
    Gross motor, fine motor, language, and social development


Secondary Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072433


Contacts
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Contact: Allison Daniel, MSc +17789978764 allison.daniel@sickkids.ca

Locations
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Malawi
Queen Elizabeth Central Hospital Recruiting
Blantyre, Malawi
Contact: Allison Daniel, MSc    +265991514203    allison.daniel@sickkids.ca   
Sponsors and Collaborators
The Hospital for Sick Children
University of Malawi
Investigators
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Principal Investigator: Robert Bandsma, PhD The Hospital for Sick Children

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robert Bandsma, Staff Gastroenterologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03072433     History of Changes
Other Study ID Numbers: 1000053078
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Robert Bandsma, The Hospital for Sick Children:
child malnutrition
child development
counseling

Additional relevant MeSH terms:
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Malnutrition
Child Nutrition Disorders
Nutrition Disorders