MalnutritionNCT04036708

Caregiver Training to Prevent Konzo Disease in Children in Democratic Republic of Congo (DRC)

A study testing Wetting method (WTM) and Mediational Intervention for Sensitizing Caregivers (MISC) in people with Malnutrition and Manihot Species Poisoning, run by Michigan State University at 1 site in Democratic Republic of the Congo.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The proposed research adapted the caregiver training and child neurodevelopmental assessment capacity that the PI previously built in Uganda beginning in 2008, to a community-based intervention model for the prevention of konzo in the Democratic Republic of Congo. Read more about this study

Who is it for?: Ages 1 year to 4 yearsHealthy volunteers can take part
Conditions the study is for: Malnutrition, Manihot Species Poisoning
What is being tested?: Wetting method (WTM) and Mediational Intervention for Sensitizing Caregivers (MISC)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 238 participants
Where: 1 siteDemocratic Republic of the Congo
Study dates: 1 Apr 2021to 31 Aug 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 1 year to 4 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Mother with at least one child aged between 1 and 4 years
Mother is the primary caregiver of child
Mother is 18 years of age or older

Who cannot join

History of brain injury (infectious, traumatic, birth) in child
Konzo disease in any family member of household
Epilepsy in child
Any neurodisability in child
Caregiver is unable to participate in the year-long training

Trial locations and contacts

1 site in 1 country.

Democratic Republic of the Congo1 site

Institute National of Research National (INRB)
Kinshasa

Other trials in Democratic Republic of the Congo

About this study

Official title: Caregiver Early Child Development Training for Preventing Konzo From Toxic Cassava in the Democratic Republic of Congo (DRC)

Read the detailed description

Early childhood (1 through 4 yrs) is a period of dramatic developmental change that can be seriously compromised by exposure to toxic cyanogenic cassava (konzo disease), with potentially great impact throughout central and western sub-Sahara Africa in regions dependent on this food staple. In the face of ongoing economic instability and nutritional, medical and educational deprivation affecting konzo at-risk communities in the Democratic Republic of Congo, no programs exist for sustaining a favorable developmental milieu for these children. By establishing the viability of caregiver training interventions to enhance functionality among caregivers and improve caregiving quality while preventing konzo, this research l can benefit tens of millions of children at-risk neurodevelopmentally; not only from poorly processed cyanogenic cassava, but also from a myriad of other non-infectious and infectious diseases.

Conditions: Malnutrition, Manihot Species Poisoning
Being tested: Wetting method (WTM), Mediational Intervention for Sensitizing Caregivers (MISC)
Medical subject headings: Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Wetting method (WTM)Behavioural
The wetting method is an evidence-based, simple process to remove cyanogens from cassava flour. It involves teaching women to add water to cassava flour and allow it to stand for 2 h in the sun or 5 h in the shade for the hydrogen cyanide gas to escape. Colorfully illustrated and durable laminated posters depicting the WTM were distributed to participating households. Women received this training bi-weekly for 12 months.
Mediational Intervention for Sensitizing Caregivers (MISC)Behavioural
The study team used MISC to train DRC mothers in practical day-to-day activities with their children to enhance 5 key mediational processes: 1) focusing (getting the child's attention and engaging directing them to learning experiences); 2) exciting (communicating excitement, appreciation, and affection with the learning experience); 3) expanding (making the child aware of how the learning experience transcends the present situation and can include past and future issues beyond the immediate need of the moment); 4) encouraging (emotional support to foster the child's sense of security and competence); and 5) regulating (helping to direct the child's behavior in constructive ways with a goal towards self-regulation).

Study groups in NCT04036708
Study group	Role	What they receive
MISC and WTM	Experimental	Wetting method (WTM)+ Mediational Intervention for Sensitizing Caregivers (MISC) bi-weekly for 12 months. Receives: Behavioral: Wetting method (WTM); Behavioral: Mediational Intervention for Sensitizing Caregivers (MISC)
WTM only	Active comparator	WTM trainings only (recommended standard of care) bi-weekly for 12 months. Receives: Behavioral: Wetting method (WTM)

What is being measured

The primary outcome is the main question the study is designed to answer.

Mullen Scales of Early Learning (MSEL) Composite Score
The Mullen Scales of Early Learning (MSEL) assesses child developmental domains: visual reception, gross motor skills, fine motor skills, receptive language, and expressive language. A composite t-score derived from standardized t-scores of the four domains (excluding gross motor) provides a measure of g, the general measure of fluid intelligence thought to underlie general cognitive ability. The composite t-score ranges from 40 to 130. The t-scores have mean 100 and standard deviation 15 in the Western population. Higher scores reflect better outcome. Measure is applicable to children only, not collected from caregivers
Measured: Month 6, month 12
Child Urine Thiocyanite Level
Technicians collected samples of urine on the same day as child assessments, so that they are contiguous with level of cyanide exposure from current poorly processed cassava. Urine thiocyanite levels in urine were measured in micromol per liter. The range was 0-1032, higher scores reflect worse outcome. Data collected from children only, not collected from caregivers.
Measured: Month 6, month 12

Secondary outcomes (5)

Home Observation for the Measurement of the Environment (HOME) Score
Home Observation for the Measurement of the Environment (HOME) composite measure designed to assess the quality and quantity of stimulation that the child is exposed to in their home environment. The Infant/Toddler version includes 45 items answered on the scale from 0=none to 3=good. A total HOME score was generated by summing item responses. Potential range is 0 to 135. Higher HOME scores indicate higher quality of home environment. Measure applies to children only.
Measured: Month 6, month 12
Child Physical Growth: Length for Age Z-score
Length for age z-score was determined using the World Health Organization algorithm using child's length, sex, and age at the time of measurement. The world population mean is 0 with standard deviation 1. Z-scores of -2 or below are often used to indicate stunting.
Measured: Month 6, month 12
Child Physical Growth: Weight for Age Z-score
Weight for age z-score was determined using the World Health Organization algorithm using child's length, sex, and age at the time of measurement. The world population mean is 0 with standard deviation 1.
Measured: Month 6, month 12
Caregiver Anxiety Symptoms
The modified Hopkins Symptom Checklist was used to assess caregiver anxiety. The instrument included 9 yes/no items, and the item responses were summed into the total score. The potential range was 0-9 with higher score indicating worse anxiety. Measure applicable to caregiver only. Data were not collected from children.
Measured: Month 6, month 12
Caregiver Depressive Symptoms
The modified Hopkins Symptom Checklist was used to assess caregiver depressive symptoms. The instrument included 9 yes/no items, and the item responses were summed into the total score. The potential range was 0-9 with higher score indicating worse depressive symptoms. Measure applies to caregivers only, data were not collected from children.
Measured: Month 6, month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 202131 Aug 2022

First posted30 Jul 2019
Study start1 Apr 2021
Primary completion31 Aug 2022
Study completion31 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for MalnutritionStudies of the same condition, open and under way.
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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 238 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04036708
Sponsor's protocol ID: 2272
Other IDs: R21HD098588
Status last verified: Mar 2024
First submitted: 23 Jul 2019
Last updated: 24 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The study coordinator assigns a unique identification number to each research subject at entry into the study. The first page of the risk-factor questionnaire, which contains identifying information, names and addresses, is removed after data entry and stored at the field office in a locked file dedicated to this research study. The data files will include only study numbers, which are linked through a security system to a named file maintained for the purpose of informing individuals of information pertinent to their health. The name file is only accessible to the PI Professor Michael Boivin.

Publications

Tshala-Katumbay D, Mumba N, Okitundu L, Kazadi K, Banea M, Tylleskar T, Boivin M, Muyembe-Tamfum JJ. Cassava food toxins, konzo disease, and neurodegeneration in sub-Sahara Africans. Neurology. 2013 Mar 5;80(10):949-51. doi: 10.1212/WNL.0b013e3182840b81.
PubMed 23460617
Boivin MJ, Okitundu D, Makila-Mabe B, Sombo MT, Mumba D, Sikorskii A, Mayambu B, Tshala-Katumbay D. Cognitive and motor performance in Congolese children with konzo during 4 years of follow-up: a longitudinal analysis. Lancet Glob Health. 2017 Sep;5(9):e936-e947. doi: 10.1016/S2214-109X(17)30267-X.
PubMed 28807191
Boivin MJ, Okitundu D, Makila-Mabe Bumoko G, Sombo MT, Mumba D, Tylleskar T, Page CF, Tamfum Muyembe JJ, Tshala-Katumbay D. Neuropsychological effects of konzo: a neuromotor disease associated with poorly processed cassava. Pediatrics. 2013 Apr;131(4):e1231-9. doi: 10.1542/peds.2012-3011. Epub 2013 Mar 25.
PubMed 23530166
Kashala-Abotnes E, Sombo MT, Okitundu DL, Kunyu M, Bumoko Makila-Mabe G, Tylleskar T, Sikorskii A, Banea JP, Mumba Ngoyi D, Tshala-Katumbay D, Boivin MJ. Dietary cyanogen exposure and early child neurodevelopment: An observational study from the Democratic Republic of Congo. PLoS One. 2018 Apr 17;13(4):e0193261. doi: 10.1371/journal.pone.0193261. eCollection 2018.
PubMed 29664942

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Caregiver Early Child Development Training for Preventing Konzo From Toxic Cassava in the Democratic Republic of Congo (DRC)
ClinicalTrials.gov ID: NCT04036708
Acronym / sponsor ID: 2272
Conditions: Malnutrition, Manihot Species Poisoning
Study type: Interventional
Recruitment status: Completed
Enrolment: 238 participants (actual)
Lead sponsor: Michigan State UniversityUniversity, hospital or other
Collaborators: Institut National de Recherche Biomedicale (INRB), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 1 Apr 2021 (actual)
Primary completion: 31 Aug 2022 (actual)
Study completion: 31 Aug 2022 (actual)
First posted: 30 Jul 2019 (actual)
Results: Posted 24 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
MISC and WTM	Experimental	Behavioral: Wetting method (WTM), Behavioral: Mediational Intervention for Sensitizing Caregivers (MISC)Wetting method (WTM)+ Mediational Intervention for Sensitizing Caregivers (MISC) bi-weekly for 12 months.
WTM only	Active comparator	Behavioral: Wetting method (WTM)WTM trainings only (recommended standard of care) bi-weekly for 12 months.

Who may qualify

Ages: 1 year to 4 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Mother with at least one child aged between 1 and 4 years
Mother is the primary caregiver of child
Mother is 18 years of age or older

Key exclusion criteria (5 listed)

History of brain injury (infectious, traumatic, birth) in child
Konzo disease in any family member of household
Epilepsy in child
Any neurodisability in child
Caregiver is unable to participate in the year-long training

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
Wetting method (WTM)The wetting method is an evidence-based, simple process to remove cyanogens from cassava flour. It involves teaching women to add water to cassava flour and allow it to stand for 2 h in the sun or 5 h in the shade for the hydrogen cyanide gas to escape. Colorfully illustrated and durable laminated posters depicting the WTM were distributed to participating households. Women received this training bi-weekly for 12 months.	Behavioural	MISC and WTM, WTM only
Mediational Intervention for Sensitizing Caregivers (MISC)The study team used MISC to train DRC mothers in practical day-to-day activities with their children to enhance 5 key mediational processes: 1) focusing (getting the child's attention and engaging directing them to learning experiences); 2) exciting (communicating excitement, appreciation, and affection with the learning experience); 3) expanding (making the child aware of how the learning experience transcends the present situation and can include past and future issues beyond the immediate need of the moment); 4) encouraging (emotional support to foster the child's sense of security and competence); and 5) regulating (helping to direct the child's behavior in constructive ways with a goal towards self-regulation).	Behavioural	MISC and WTM

Primary outcome

Mullen Scales of Early Learning (MSEL) Composite Score
Time frame: Month 6, month 12
The Mullen Scales of Early Learning (MSEL) assesses child developmental domains: visual reception, gross motor skills, fine motor skills, receptive language, and expressive language. A composite t-score derived from standardized t-scores of the four domains (excluding gross motor) provides a measure of g, the general measure of fluid intelligence thought to underlie general cognitive ability. The composite t-score ranges from 40 to 130. The t-scores have mean 100 and standard deviation 15 in the Western population. Higher scores reflect better outcome. Measure is applicable to children only, not collected from caregivers
Child Urine Thiocyanite Level
Time frame: Month 6, month 12
Technicians collected samples of urine on the same day as child assessments, so that they are contiguous with level of cyanide exposure from current poorly processed cassava. Urine thiocyanite levels in urine were measured in micromol per liter. The range was 0-1032, higher scores reflect worse outcome. Data collected from children only, not collected from caregivers.

5 secondary outcomes

Home Observation for the Measurement of the Environment (HOME) Score
Time frame: Month 6, month 12
Child Physical Growth: Length for Age Z-score
Time frame: Month 6, month 12
Child Physical Growth: Weight for Age Z-score
Time frame: Month 6, month 12
Caregiver Anxiety Symptoms
Time frame: Month 6, month 12
Caregiver Depressive Symptoms
Time frame: Month 6, month 12

Results and safety

Results posted to the registry on 24 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MISC and WTM, Children	79	65
WTM Only, Children	40	36
MISC and WTM, Caregivers	79	65
WTM Only, Caregivers	40	36

Primary outcome: Mullen Scales of Early Learning (MSEL) Composite Score

Time frame: Month 6, month 12. Least squares mean (Standard Error). Unit: t-score

Measure	MISC and WTM, Children n = 79	WTM Only, Children n = 40
Month 6	73.63 (1.33)	74.33 (1.90)
Month 12	77.04 (1.48)	76.75 (1.93)

MISC and WTM, Children vs WTM Only, Children: Mean Difference (Final Values): 0.69 (95% CI -3.93 to 5.32), p = .77, Mixed Models Analysis
MISC and WTM, Children vs WTM Only, Children: Mean Difference (Final Values): -0.30 (95% CI -5.14 to 4.54), p = .90, Mixed Models Analysis

Population analysed: Children

Primary outcome: Child Urine Thiocyanite Level

Time frame: Month 6, month 12. Least squares mean (Standard Error). Unit: Micromol per Liter

Measure	MISC and WTM, Children n = 79	WTM Only, Children n = 40
Month 6	74.98 (13.94)	139.00 (20.17)
Month 12	146.45 (14.36)	108.91 (20.18)

MISC and WTM, Children vs WTM Only, Children: Mean Difference (Final Values): 64.03 (95% CI 15.26 to 112.8), p = .01, Mixed Models Analysis
MISC and WTM, Children vs WTM Only, Children: Mean Difference (Final Values): -37.53 (95% CI -86.92 to 11.85), p = .13, Mixed Models Analysis

Population analysed: Children

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months after enrollment into the study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MISC and WTM, Children	0 of 79 (0%)	0 of 79 (0%)	0 of 79
WTM Only, Children	0 of 40 (0%)	0 of 40 (0%)	0 of 40
MISC and WTM, Caregivers	0 of 79 (0%)	0 of 79 (0%)	0 of 79
WTM Only, Caregivers	0 of 40 (0%)	0 of 40 (0%)	0 of 40

Limitations and caveats (from the sponsor): The study was exploratory and developmental in nature. Where statistical significance was not reached, estimates of the means and standard deviations will be used to formally power future trials of MISC and WTM interventions.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23460617Tshala-Katumbay D, Mumba N, Okitundu L, Kazadi K, Banea M, Tylleskar T, Boivin M, Muyembe-Tamfum JJ. Cassava food toxins, konzo disease, and neurodegeneration in sub-Sahara Africans. Neurology. 2013 Mar 5;80(10):949-51. doi: 10.1212/WNL.0b013e3182840b81.
Background: PubMed 28807191Boivin MJ, Okitundu D, Makila-Mabe B, Sombo MT, Mumba D, Sikorskii A, Mayambu B, Tshala-Katumbay D. Cognitive and motor performance in Congolese children with konzo during 4 years of follow-up: a longitudinal analysis. Lancet Glob Health. 2017 Sep;5(9):e936-e947. doi: 10.1016/S2214-109X(17)30267-X.
Background: PubMed 23530166Boivin MJ, Okitundu D, Makila-Mabe Bumoko G, Sombo MT, Mumba D, Tylleskar T, Page CF, Tamfum Muyembe JJ, Tshala-Katumbay D. Neuropsychological effects of konzo: a neuromotor disease associated with poorly processed cassava. Pediatrics. 2013 Apr;131(4):e1231-9. doi: 10.1542/peds.2012-3011. Epub 2013 Mar 25.
Background: PubMed 29664942Kashala-Abotnes E, Sombo MT, Okitundu DL, Kunyu M, Bumoko Makila-Mabe G, Tylleskar T, Sikorskii A, Banea JP, Mumba Ngoyi D, Tshala-Katumbay D, Boivin MJ. Dietary cyanogen exposure and early child neurodevelopment: An observational study from the Democratic Republic of Congo. PLoS One. 2018 Apr 17;13(4):e0193261. doi: 10.1371/journal.pone.0193261. eCollection 2018.
Individual participant dataSharing planned: No. The study coordinator assigns a unique identification number to each research subject at entry into the study. The first page of the risk-factor questionnaire, which contains identifying information, names and addresses, is removed after data entry and stored at the field office in a locked file dedicated to this research study. The data files will include only study numbers, which are linked through a security system to a named file maintained for the purpose of informing individuals of information pertinent to their health. The name file is only accessible to the PI Professor Michael Boivin.

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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.

Michael J Boivin, PhD principal investigator

Professor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 24 Apr 2024. 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 Democratic Republic of the Congo. 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?

Yes. Results are posted in the registry (first posted 24 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mullen Scales of Early Learning (MSEL) Composite Score (time frame: Month 6, month 12). The study lists 2 primary outcomes in all. 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 NCT04036708, which also lists 4 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 24 Apr 2024.