Child MalnutritionNCT03072433
An Intervention for Primary Caregivers to Improve Outcomes in Children With Severe Malnutrition
A study testing Counseling Intervention Package in people with Child Malnutrition, run by The Hospital for Sick Children at 1 site in Malawi.
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. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Child Malnutrition
- What is being tested?
- Counseling Intervention Package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteMalawi
- Study dates
- Dec 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Child Malnutrition
- Being tested
- Counseling Intervention Package, Standard of Care
- Keywords
- child malnutrition, child development, counseling
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling Intervention PackageBehavioural
Also called Kusamala Program
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Counseling Intervention Package |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malawi Developmental Assessment Tool Score
Gross motor, fine motor, language, and social development
Measured: 6 months post-discharge from hospital
Secondary outcomes (8)
Nutritional status based on: mid-upper arm circumference (MUAC)
MUAC in millimeters
Measured: 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
Measured: 6 months post-discharge from hospital
Nutritional status based on: nutritionally-induced bilateral pitting oedema
Bilateral pitting oedema
Measured: 6 months post-discharge from hospital
Duration of hospital stay
Number of days that hospital treatment is required
Measured: 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
Measured: 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
Measured: During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)
Readmission
Requiring inpatient treatment
Measured: Within 6 months post-discharge from hospital
Mortality
Inpatient or post-discharge mortality
Measured: Within 6 months post-discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study startDec 2016
- Primary completionOct 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Child MalnutritionStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malawi
- Responsible party
- Principal investigator, Robert Bandsma, The Hospital for Sick Children
- Investigators
- Robert Bandsma, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072433
- Sponsor's protocol ID
- 1000053078
- Status last verified
- Dec 2022
- First submitted
- 17 Feb 2017
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 34447897Daniel 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.
PubMed 30258650Daniel 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.
PubMed 29149905
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03072433
- Acronym / sponsor ID
- 1000053078
- Conditions
- Child Malnutrition
- Keywords
- child malnutrition, child development, counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- University of Malawi
- Study start
- Dec 2016 (actual)
- Primary completion
- Oct 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 7 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Behavioral: Standard of CareComparison 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. |
| Counseling Intervention Package | Experimental | Behavioral: Counseling Intervention PackagePrimary 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. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counseling Intervention PackageAlso: Kusamala ProgramDaily 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. | Behavioural | Counseling Intervention Package |
| Standard of CareNutrition 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. | Behavioural | Standard of Care |
Primary outcome
Malawi Developmental Assessment Tool Score
Time frame: 6 months post-discharge from hospital
Gross motor, fine motor, language, and social development
8 secondary outcomes
Nutritional status based on: mid-upper arm circumference (MUAC)
Time frame: 6 months post-discharge from hospital
Nutritional status based on: World Health Organization (WHO) z-scores
Time frame: 6 months post-discharge from hospital
Nutritional status based on: nutritionally-induced bilateral pitting oedema
Time frame: 6 months post-discharge from hospital
Duration of hospital stay
Time frame: During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)
Appetite
Time frame: During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)
Clinical deterioration
Time frame: During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)
Readmission
Time frame: Within 6 months post-discharge from hospital
Mortality
Time frame: Within 6 months post-discharge from hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Derived from this study: PubMed 34447897Daniel 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.
- Derived from this study: PubMed 30258650Daniel 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.
- Derived from this study: PubMed 29149905Daniel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Bandsma, PhD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling Intervention Package in people with Child Malnutrition, run by The Hospital for Sick Children at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malawi Developmental Assessment Tool Score (time frame: 6 months post-discharge from hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03072433, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.