Cassava Intervention Project

Ministry of Public Health, Democratic Republic of the Congo1,200 enrolled

Overview

Investigators will implement a novel cassava processing method (wetting method, WTM) that safely removes cyanogenic compounds from cassava flour prior to human consumption in a stratified village-cluster randomized non-inferiority trial so as to compare the effectiveness of a peer-led intervention (women training other women in the WTM) with that by community-health worker specialists.

The proposed project seeks methods to prevent and elucidate biomarkers of neurocognition and motor deficits associated with chronic dietary reliance on cyanogenic cassava, a staple food crop for more than 600 millions of people living in the tropics. Aim 1 will implement a novel cassava processing method (wetting method, WTM) that safely removes cyanogenic compounds from cassava flour prior to human consumption in a stratified village-cluster randomized non-inferiority trial so as to compare the effectiveness of a peer-led intervention (women training other women in the WTM) with that by community-health worker specialists (2 intervention training arms). Aim 2 will determine whether post-intervention reductions in cassava cyanogenic content and child U-SCN are associated with changes in biomarkers of cassava neurotoxicity particularly 8,12-iso-iPF2α-VI isoprostane (oxidant marker), carbamoylated albumin fragments KVPQVSTPTLVEVSR (residues 438-452) and LDELRDEGKASSAK (residues 206-219), or homocitrulline (carbamoylating markers), and scores at the KABC-II cognition and BOT-2 motor testing.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,200

Conditions

Neurotoxicity Syndrome, Cassava Neurotoxicity Syndrome, Cyanate Neurotoxicity Syndrome, Cyanide Neurotoxicity Syndrome, Thiocyanate

Interventions

Non Inferiority WTM Interventional TrialOTHER

The intervention will implement the WTM cassava processing technique in participating households. Twenty women (in leading roles) will be our principal candidates to serve as peer trainers. Together with a 20 community health worker specialists, these women will be trained in the WTM technique by the Kinshasa team of community health workers who are experts in the WTM method. Those who master the technique will then be certified as trainers to train and support other small groups of other mothers throughout a two-year period in the implementation of the WTM for the safer processing of food for their families. Both the community health worker specialists and trained women (prospective trainers) would have to be able to bring the cassava cyanogenic content to the lowest achievable level, which must be \< 10 ppm as per the recommendations of the World Health Organization.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Households with a konzo child and non-konzo sibling between 5 and 12 years * Presence of a biological mother primarily responsible for the household food preparation and caring for the children * Mother consenting to participate in this study Exclusion Criteria: * History of seizures * History of cerebral malaria * History of retroviral (HIV-HTLV) infections

Locations (1)

INRB

Kinshasa, Democratic Republic of the Congo