Cassava Intervention Project

Sponsor

Ministry of Public Health, Democratic Republic of the Congo (Other)

Overall Status

Completed

CT.gov ID

NCT03157336

Collaborator

National Institutes of Health (NIH) (NIH), Oregon Health and Science University (Other), Michigan State University (Other), University of Kinshasa (Other), National Institute of Environmental Health Sciences (NIEHS) (NIH)

1,200

Enrollment

Location

Arms

58.1

Actual Duration (Months)

20.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neurotoxicity Syndrome, Cassava Neurotoxicity Syndrome, Cyanate Neurotoxicity Syndrome, Cyanide Neurotoxicity Syndrome, Thiocyanate	Other: Non Inferiority WTM Interventional Trial	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1200 participants

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)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

Official Title:

Toxicodietary and Genetic Determinants of Susceptibility to Neurodegeneration

Actual Study Start Date :

Jul 30, 2017

Actual Primary Completion Date :

Jun 1, 2022

Actual Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Peer-led Intervention Peers (community women in leading roles) training other women in the wetting method for safe processing of cassava in a non-inferiority intervention trial.	Other: Non Inferiority WTM Interventional Trial 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.
Experimental: Specialist-led Intervention Specialists (nutritionists) training other women in the wetting method for safe processing of cassava in a non-inferiority intervention trial..	Other: Non Inferiority WTM Interventional Trial 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.

Arm

Intervention/Treatment

Experimental: Peer-led Intervention

Peers (community women in leading roles) training other women in the wetting method for safe processing of cassava in a non-inferiority intervention trial.

Other: Non Inferiority WTM Interventional Trial

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.

Experimental: Specialist-led Intervention

Specialists (nutritionists) training other women in the wetting method for safe processing of cassava in a non-inferiority intervention trial..

Other: Non Inferiority WTM Interventional Trial

Outcome Measures

Primary Outcome Measures

Change in food cyanogenic exposure [From baseline to 6-month time points]
Cassava cyanogenic content
Change in internal cyanogenic exposure [From baseline to 6-month time points]
Urinary concentrations of thiocyanate (U-SCN)
Change in oxidation damage [From baseline to 6-month time points]
Serum isoprostanes
Change in carbamoylation [From baseline to 6-month time points]
serum albumin peptidic carbamoylation
Change in carbamoylation surrogate [From baseline to 6-month time points]
serum homocitrulline

Secondary Outcome Measures

Change in cognition performance [From baseline to 6-month time points]
Kaufman Assessment Battery for Children (KABC-II) for cognition testing score
Change in motor proficiency [From baseline to 6-month time points]
Motor proficiency Bruininks/Oseretsky Testing (BOT-2) score

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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