Cassava Intervention Project
Condition: Neurotoxicity Syndrome, Cassava; Neurotoxicity Syndrome, Cyanate; Neurotoxicity Syndrome, Cyanide; Neurotoxicity Syndrome, Thiocyanate
MeSH terms: Neurotoxicity Syndromes; Syndrome
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Non Inferiority WTM Interventional Trial
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: We 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 (Arm 1 = women training other women in the WTM) with that by community-health worker specialists (Arm 2= specialist led intervention arm)
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cassava; Konzo; Cyanide; Cyanate; Thiocyanate; Carbamoylation; Isoprostanes; Oxidative Damage