Singida Nutrition and Agroecology Project (SNAP)

October 6, 2020 updated by: Cornell University
The purpose of this study is to test if a participatory, agroecological peer farmer-led education intervention can be effective at improving legume production, food security, and infant and young child feeding practices in Singida District, Tanzania.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Approximately 40% of under five children in Tanzania are stunted, with higher levels in rural areas. Our inception research in Singida identified five pressing issues faced by smallholder farmers that may contribute to this high rate of stunting. They are (A) hierarchical, or "top down" farmer education, (B) low soil fertility and little knowledge of agroecological solutions, (C) high levels of gender inequality and high workloads for women, (D) food insecurity and low dietary diversity, and (E) sub-optimal infant and young child feeding. Singida Nutrition and Agroecology Project (SNAP) is a randomized effectiveness trial of a participatory, agroecological peer farmer education intervention. Each intervention village will choose 2 mentor farmers, 1 man and 1 woman, who will participate in a field visit to and training by existing mentor farmers in Malawi and a two week long follow-up and refresher trainings in Tanzania integrating agroecology, climate change, nutrition, and gender equality. Mentor farmers will then conduct monthly visits to participating households and support the households in conducting experimentation with agroecological practices and/or new behaviors regarding nutrition and gender equality. Quarterly meetings among mentor farmers and biannual meeting of participating farmers within each village will be held to discuss progress and challenges of peer education and household experimentations.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
700

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 100 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Are among the most vulnerable, as indicated by food insecurity
  • Have a child who will be <= 1 year old in February 2016
  • Are farmers who have regular access to the same farms/plots (but they do not need to own the land per se)
  • Female headed households are acceptable, so long as not more than half the selected households in the village are female headed (to be able to detect change in gender equity)
  • Willing to stay in study for 3 years, i.e. do not plan to move
  • Interested in experimenting with new farming techniques

Exclusion Criteria:

  • Refuses to take part

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention (Participatory education)
Participatory education
Behavioral: Mentor farmer training (Malawi)
Mentor farmers, 1 man, 1 woman, from each village will participate in a field visit to and training by existing mentor farmers in Malawi. Only the intervention arm of this study will receive mentor farmer training in Malawi, delayed intervention arm will receive mentor farmer training from farmers participating in the initial intervention in Tanzania.
Behavioral: Mentor farmer training (Singida, Tanzania)
Mentor farmers will receive training in Singida, Tanzania on agroecology practices, climate change, nutrition, and gender equality. Intervention villages will receive training in 2016. Delayed intervention villages will receive training in 2019.
Behavioral: Mentor farmer visits and facilitation
Mentor farmers will conduct monthly visits to participating households and support the households in conducting experimentation with agroecological practices and/or new behavior regarding nutrition and gender equality. Quarterly meetings among farmers within each village will be held to discuss progress and challenges of household experimentations. Intervention households will receive support and facilitation for approximately 2 years. Delayed intervention households will receive support and facilitation for approximately 6 months after end line survey.
NO_INTERVENTION: Control
Delayed participatory education

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in dietary diversity score (mean and proportion of score >4)
Time Frame: Twice a year for the first three years of study (2016, 2017, 2018) and once in the final year (2019)
As defined by World Health Organization (see Citations), this refers to the number of food groups (out of 7) consumed by children the previous day ."
Twice a year for the first three years of study (2016, 2017, 2018) and once in the final year (2019)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in mean child's height-for-age z-score
Time Frame: Twice a year for the first three years of study (2016, 2017, 2018) and once in the final year (2019)
According to World Health Organization growth chart
Twice a year for the first three years of study (2016, 2017, 2018) and once in the final year (2019)
Change in proportion of children who are stunted (HAZ<-2)
Time Frame: Twice a year for the first three years of study (2016, 2017, 2018) and once in the final year (2019)
According to World Health Organization growth chart
Twice a year for the first three years of study (2016, 2017, 2018) and once in the final year (2019)
Change in mean child's weight-for-height z-score
Time Frame: Twice a year for the first three years of study (2016, 2017, 2018) and once in the final year (2019)
According to World Health Organization growth chart
Twice a year for the first three years of study (2016, 2017, 2018) and once in the final year (2019)
Change in proportion of children who are wasted (WHZ<-2)
Time Frame: Twice a year for the first three years of study (2016, 2017, 2018) and once in the final year (2019)
According to World Health Organization growth chart
Twice a year for the first three years of study (2016, 2017, 2018) and once in the final year (2019)
Change in mean Food Insecurity Score
Time Frame: Twice a year for the first three years of study (2016, 2017, 2018) and once in the final year (2019)
Household Food Insecurity Access Scale (HFIAS)
Twice a year for the first three years of study (2016, 2017, 2018) and once in the final year (2019)
Change in proportion of households with severe or moderate food insecurity
Time Frame: Twice a year for the first three years of study (2016, 2017, 2018) and once in the final year (2019)
Household Food Insecurity Access Scale (HFIAS)
Twice a year for the first three years of study (2016, 2017, 2018) and once in the final year (2019)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cornell University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nelson Mandela African Institute of Science and Technology
Action Aid Tanzania
Ilonga Agricultural Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rachel N Bezner Kerr, MS PhD, Cornell University
  • Principal Investigator: Sera L Young, MA PhD, Cornell University
  • Principal Investigator: Elias Mtinda, Action Aid Tanzania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1511005983

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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