Food SecurityPhase 2NCT03930472
#WYMarketsMatter: Testing Two Farmers Market Voucher Strategies to Increase Food Security
A Phase 2 study testing Market vouchers in people with Food Security and Produce Consumption, run by University of Wyoming at 1 site in United States.
Trial summary
University of Wyoming (UW) and Wyoming Food for Thought Project (WFFTP) propose to collaboratively develop, pilot, and evaluate a trial on the impact of market vouchers on food security and fruit and vegetable (F\&V) consumption. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Security, Produce Consumption
- What is being tested?
- Market vouchers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2019to 30 Aug 2020
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible for the intervention, a participant must be an adult aged ≥18 years old whose household is enrolled in or eligible for SNAP, free or reduced school lunch program, and/or WIC (i.e., incomes of ≤185% of poverty for household size). UW staff wills screen for eligibility by verifying a participant has an EBT card. If no card is available, participants will be asked to self-report household income and size and UW staff will use the Federal Poverty Level chart to determine the individual's eligibility. They must also self-identify as living in Casper, Wyoming. They must come in person to the market on July 30th, 2019, to enroll.
Who cannot join
- Not meeting the criteria above.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing Two Farmers Market Voucher Strategies to Increase Food Security
University of Wyoming (UW) and Wyoming Food for Thought Project (WFFTP) propose to collaboratively develop, pilot, and evaluate a trial on the impact of market vouchers on food security and fruit and vegetable (F\&V) consumption. We will (a) provide farmers market vouchers to families who are enrolled in WIC, SNAP, or free or reduced lunch and/or have incomes ≤185% of poverty line; (b) assess impacts of these supports on household food security and F\&V consumption; and (c) test feasibility and impacts of vouchers valid only for F\&V vs. for any foods that can be purchased with SNAP.
To test the feasibility and preliminary impacts of this approach, we will enroll 30 individuals/households in this study, randomizing 10 to each of the 2 intervention arms and 10 to waitlist control. Qualifying individuals and families will be able to enroll in the study at the WFFTP Tuesday afternoon/evening market on July 30th, 2019. They will be randomized upon enrollment to one of three conditions: receiving $20 in vouchers at each of up to 4 markets ($80 total) that are good for F\&V only, receiving $20 vouchers at each of up to 4 markets that are good for any foods that SNAP/EBT benefits can be used for; or delayed intervention/waitlist control (who, at the final data gathering, will receive 5 x $20 in vouchers good at the WFFTP 2019 and 2020 markets).
- Conditions
- Food Security, Produce Consumption
- Being tested
- Market vouchers
- Keywords
- Farmers Markets, Vouchers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Market vouchersBehavioural
Receiving $80 in vouchers good for fruits and vegetables or for SNAP-eligible foods at 4 out of 5 markets in late July and in August, 2019.
| Study group | Role | What they receive |
|---|---|---|
| Voucher intervention F&V | Experimental | Receiving $20 in vouchers at each of up to 4 markets ($80 total) that are good for F\&V only Receives: Behavioral: Market vouchers |
| Voucher intervention SNAP | Experimental | Receiving $20 vouchers at each of up to 4 markets that are good for any foods that SNAP/EBT benefits can be used for Receives: Behavioral: Market vouchers |
| Waitlist control | No intervention | Delayed intervention/waitlist control (who, at the final data gathering, will receive 5 x $20 in vouchers good at the WFfT 2019 and 2020 markets). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food security
USDA six-item short form Food Security Survey Module. They have been adapted to reflect food security in the previous 30 days (as opposed to 12 months) in order to compare food security before and during the intervention. Survey and tools available online at http://www.ers.usda.gov/topics/food-nutrition-assistance/food-security-in-the-us/survey-tools.aspx#.VEk0Bfl4qug
Measured: five week intervention, questions for past 30 days
Fruit and vegetable consumption
The 16 relevant questions from the National Institutes of Health survey "Eating at America's Table Study: Quick Food Scan."
Measured: five week intervention, questions for past 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start30 Jul 2019
- Primary completion30 Sep 2019
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food SecurityStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- With delayed intervention for control group, but those outcomes not assessed.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wyoming
- Sponsor type
- University, hospital or other
- Collaborators
- Wyoming Food for Thought
- Responsible party
- Principal investigator, Christine Porter, University of Wyoming
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930472
- Sponsor's protocol ID
- 3077662143
- Status last verified
- Nov 2020
- First submitted
- 24 Apr 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Two Farmers Market Voucher Strategies to Increase Food Security
- ClinicalTrials.gov ID
- NCT03930472
- Acronym / sponsor ID
- 3077662143
- Conditions
- Food Security, Produce Consumption
- Keywords
- Farmers Markets, Vouchers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of WyomingUniversity, hospital or other
- Collaborators
- Wyoming Food for Thought
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 29 Apr 2019 (actual)
- 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.
University of Wyoming (UW) and Wyoming Food for Thought Project (WFFTP) propose to collaboratively develop, pilot, and evaluate a trial on the impact of market vouchers on food security and fruit and vegetable (F\&V) consumption. We will (a) provide farmers market vouchers to families who are enrolled in WIC, SNAP, or free or reduced lunch and/or have incomes ≤185% of poverty line; (b) assess impacts of these supports on household food security and F\&V consumption; and (c) test feasibility and impacts of vouchers valid only for F\&V vs. for any foods that can be purchased with SNAP.
To test the feasibility and preliminary impacts of this approach, we will enroll 30 individuals/households in this study, randomizing 10 to each of the 2 intervention arms and 10 to waitlist control. Qualifying individuals and families will be able to enroll in the study at the WFFTP Tuesday afternoon/evening market on July 30th, 2019. They will be randomized upon enrollment to one of three conditions: receiving $20 in vouchers at each of up to 4 markets ($80 total) that are good for F\&V only, receiving $20 vouchers at each of up to 4 markets that are good for any foods that SNAP/EBT benefits can be used for; or delayed intervention/waitlist control (who, at the final data gathering, will receive 5 x $20 in vouchers good at the WFFTP 2019 and 2020 markets).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- With delayed intervention for control group, but those outcomes not assessed.
| Arm | Type | Receives |
|---|---|---|
| Voucher intervention F&V | Experimental | Behavioral: Market vouchersReceiving $20 in vouchers at each of up to 4 markets ($80 total) that are good for F\&V only |
| Voucher intervention SNAP | Experimental | Behavioral: Market vouchersReceiving $20 vouchers at each of up to 4 markets that are good for any foods that SNAP/EBT benefits can be used for |
| Waitlist control | No intervention | –Delayed intervention/waitlist control (who, at the final data gathering, will receive 5 x $20 in vouchers good at the WFfT 2019 and 2020 markets). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To be eligible for the intervention, a participant must be an adult aged ≥18 years old whose household is enrolled in or eligible for SNAP, free or reduced school lunch program, and/or WIC (i.e., incomes of ≤185% of poverty for household size). UW staff wills screen for eligibility by verifying a participant has an EBT card. If no card is available, participants will be asked to self-report household income and size and UW staff will use the Federal Poverty Level chart to determine the individual's eligibility. They must also self-identify as living in Casper, Wyoming. They must come in person to the market on July 30th, 2019, to enroll.
Key exclusion criteria (1 listed)
- Not meeting the criteria above.
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 |
|---|---|---|
| Market vouchersReceiving $80 in vouchers good for fruits and vegetables or for SNAP-eligible foods at 4 out of 5 markets in late July and in August, 2019. | Behavioural | Voucher intervention F&V, Voucher intervention SNAP |
Primary outcome
Food security
Time frame: five week intervention, questions for past 30 days
USDA six-item short form Food Security Survey Module. They have been adapted to reflect food security in the previous 30 days (as opposed to 12 months) in order to compare food security before and during the intervention. Survey and tools available online at http://www.ers.usda.gov/topics/food-nutrition-assistance/food-security-in-the-us/survey-tools.aspx#.VEk0Bfl4qug
Fruit and vegetable consumption
Time frame: five week intervention, questions for past 30 days
The 16 relevant questions from the National Institutes of Health survey "Eating at America's Table Study: Quick Food Scan."
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 3 Nov 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Market vouchers in people with Food Security and Produce Consumption, run by University of Wyoming at 1 site in United States.
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 1 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 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Food security (time frame: five week intervention, questions for past 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2020.