MalnutritionSNAPNCT02761876
Singida Nutrition and Agroecology Project
A study testing Mentor farmer training (Malawi), Mentor farmer training (Singida, Tanzania) and Mentor farmer visits and facilitation in people with Malnutrition, run by Cornell University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Mentor farmer training (Malawi), Mentor farmer training (Singida, Tanzania) and Mentor farmer visits and facilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Refuses to take part
About this study
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.
Read the 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.
- Conditions
- Malnutrition
- Being tested
- Mentor farmer training (Malawi), Mentor farmer training (Singida, Tanzania), Mentor farmer visits and facilitation
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentor farmer training (Malawi)Behavioural
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.
Mentor farmer training (Singida, Tanzania)Behavioural
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.
Mentor farmer visits and facilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Participatory education) | Experimental | Participatory education Receives: Behavioral: Mentor farmer training (Malawi); Behavioral: Mentor farmer training (Singida, Tanzania); Behavioral: Mentor farmer visits and facilitation |
| Control | No intervention | Delayed participatory education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dietary diversity score (mean and proportion of score >4)
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 ."
Measured: Twice a year for the first three years of study (2016, 2017, 2018) and once in the final year (2019)
Secondary outcomes (6)
Change in mean child's height-for-age z-score
According to World Health Organization growth chart
Measured: 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)
According to World Health Organization growth chart
Measured: 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
According to World Health Organization growth chart
Measured: 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)
According to World Health Organization growth chart
Measured: 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
Household Food Insecurity Access Scale (HFIAS)
Measured: 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
Household Food Insecurity Access Scale (HFIAS)
Measured: Twice a year for the first three years of study (2016, 2017, 2018) and once in the final year (2019)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Nelson Mandela African Institute of Science and Technology, Action Aid Tanzania, Ilonga Agricultural Research Institute
- Responsible party
- Sponsor
- Investigators
- Rachel N Bezner Kerr, MS PhD, Principal investigator, Cornell UniversitySera L Young, MA PhD, Principal investigator, Cornell UniversityElias Mtinda, Principal investigator, Action Aid Tanzania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761876
- Sponsor's protocol ID
- 1511005983
- Acronym
- SNAP
- Status last verified
- Oct 2020
- First submitted
- 11 Mar 2016
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Santoso MV, Bezner Kerr RN, Kassim N, Martin H, Mtinda E, Njau P, Mtei K, Hoddinott J, Young SL. A Nutrition-Sensitive Agroecology Intervention in Rural Tanzania Increases Children's Dietary Diversity and Household Food Security But Does Not Change Child Anthropometry: Results from a Cluster-Randomized Trial. J Nutr. 2021 Jul 1;151(7):2010-2021. doi: 10.1093/jn/nxab052.
PubMed 33973009
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Singida Nutrition and Agroecology Project
- ClinicalTrials.gov ID
- NCT02761876
- Acronym / sponsor ID
- SNAP / 1511005983
- Conditions
- Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- Nelson Mandela African Institute of Science and Technology, Action Aid Tanzania, Ilonga Agricultural Research Institute
- Study start
- Feb 2016
- Primary completion
- Feb 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Participatory education) | Experimental | Behavioral: Mentor farmer training (Malawi), Behavioral: Mentor farmer training (Singida, Tanzania), Behavioral: Mentor farmer visits and facilitationParticipatory education |
| Control | No intervention | –Delayed participatory education |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Refuses to take part
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention (Participatory education) |
| 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. | Behavioural | Intervention (Participatory education) |
| Mentor farmer visits and facilitationMentor 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. | Behavioural | Intervention (Participatory education) |
Primary outcome
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 ."
6 secondary outcomes
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 33973009Santoso MV, Bezner Kerr RN, Kassim N, Martin H, Mtinda E, Njau P, Mtei K, Hoddinott J, Young SL. A Nutrition-Sensitive Agroecology Intervention in Rural Tanzania Increases Children's Dietary Diversity and Household Food Security But Does Not Change Child Anthropometry: Results from a Cluster-Randomized Trial. J Nutr. 2021 Jul 1;151(7):2010-2021. doi: 10.1093/jn/nxab052.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel N Bezner Kerr, MS PhD principal investigator
Cornell University
Sera L Young, MA PhD principal investigator
Cornell University
Elias Mtinda principal investigator
Action Aid Tanzania
Questions about this trial
What is this clinical trial studying?
A study testing Mentor farmer training (Malawi), Mentor farmer training (Singida, Tanzania) and Mentor farmer visits and facilitation in people with Malnutrition, run by Cornell University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02761876, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.