Clinical trial NCT04036708: Caregiver Training to Prevent Konzo Disease in Children in Democratic Republic of Congo (DRC)
Official title: Caregiver Early Child Development Training for Preventing Konzo From Toxic Cassava in the Democratic Republic of Congo (DRC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Manihot Species Poisoning
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-07-30
Enrollment: 238
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mullen Scales of Early Learning (MSEL) Composite Score
timeFrame: Month 6, month 12
measure: Child Urine Thiocyanite Level
timeFrame: Month 6, month 12
Secondary outcomes:
measure: Home Observation for the Measurement of the Environment (HOME) Score
timeFrame: Month 6, month 12
measure: Child Physical Growth: Length for Age Z-score
timeFrame: Month 6, month 12
measure: Child Physical Growth: Weight for Age Z-score
timeFrame: Month 6, month 12
measure: Caregiver Anxiety Symptoms
timeFrame: Month 6, month 12
measure: Caregiver Depressive Symptoms
timeFrame: Month 6, month 12
Other outcomes:
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Institute National of Research National (INRB)
Study officials:
affiliation: Professor
name: Michael J Boivin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.