Food InsecurityNCT02558660
Evaluating Use of a Farmers Market Incentive Program Among Low-Income Health Center Patients
A study testing Education and voucher in people with Food Insecurity and Non-use of Existing State-wide SNAP Incentive Program, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the impact of a brief clinic-based educational intervention on utilization of Double Up Food Bucks (DUFB)-a Michigan-wide Supplemental Nutrition Assistance Program (SNAP) healthy food incentive--among low income health center patients at a community health center in Southeast… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity, Non-use of Existing State-wide SNAP Incentive Program
- What is being tested?
- Education and voucher
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Oct 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patient or family member of patient
- at least 18 years of age
- currently SNAP-enrolled
- identifies as one of primary food shoppers for household
- English or Spanish-speaking
Who cannot join
- under 18
- not currently SNAP-enrolled
- not one of primary food shoppers for household
- unable to complete a telephone survey in English or Spanish
- unable to provide a working telephone number where they could be contacted
Trial locations and contacts
1 site in 1 country.
United States1 site
Ypsilanti Health Center, University of Michigan
Ypsilanti, Michigan, 48198
About this study
The purpose of this study is to evaluate the impact of a brief clinic-based educational intervention on utilization of Double Up Food Bucks (DUFB)-a Michigan-wide Supplemental Nutrition Assistance Program (SNAP) healthy food incentive--among low income health center patients at a community health center in Southeast Michigan.
Read the detailed description
Study participants were provided a 3-5 minute explanation of DUFB, written program materials, and initial $10 market voucher. Participants were surveyed four times over five months, and a subset are also participating in post-intervention focus groups.
- Being tested
- Education, voucher
- Keywords
- Supplemental Nutrition Incentive Program (SNAP), economic incentive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Educational intervention about an existing SNAP healthy food incentive program
voucherBehavioural
$10 voucher to spend on produce at farmers markets
| Study group | Role | What they receive |
|---|---|---|
| Double Up Food Bucks | Experimental | Clinic-based educational intervention about an existing SNAP healthy food incentive program, as well as a $10 voucher to spend on produce at farmers markets Receives: Behavioral: Education; Behavioral: voucher |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of participant DUFB use over time, as assessed by an interviewer-administered survey using structured open-ended questions
Use of DUFB at baseline assessed with yes/no response. At each of the the 3 follow-up surveys waves (1.5 months, 3 months, and 5 months), participants will be asked if they have used DUFB in the past month (yes/no), and if yes, how many times.
Measured: 5 months
Participant-perceived barriers and facilitators to DUFB use following educational intervention, as assessed by an interviewer-administered survey using structured open-ended questions and semi-structured focus group questions
Through an iterative process, three team members will independently conduct thematic analyses, compared codes, resolve discrepancies, and summarize key thematic findings.
Measured: 12 months
Secondary outcomes (1)
Change from baseline fruit and vegetable consumption at 1.5 months, 3 months, and 5 months, as assessed by a validated 2 question fruit and vegetable screener
Servings/day range from 0 to >=4 (scale applied separately to fruit consumption and vegetable consumption. Change will be calculated from two time points at each of three follow-up periods (1.5 months, 3 months, and 5 months) minus the baseline
Measured: baseline, 1.5 months, 3 months, 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startAug 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Alicia Cohen, University of Michigan
- Investigators
- Alicia Cohen, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558660
- Sponsor's protocol ID
- HUM00076630
- Status last verified
- Dec 2015
- First submitted
- 4 Sep 2015
- Last updated
- 28 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Use of a Farmers Market Incentive Program Among Low-Income Health Center Patients
- ClinicalTrials.gov ID
- NCT02558660
- Acronym / sponsor ID
- HUM00076630
- Keywords
- Supplemental Nutrition Incentive Program (SNAP), economic incentive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Aug 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 24 Sep 2015 (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 evaluate the impact of a brief clinic-based educational intervention on utilization of Double Up Food Bucks (DUFB)-a Michigan-wide Supplemental Nutrition Assistance Program (SNAP) healthy food incentive--among low income health center patients at a community health center in Southeast Michigan.
Detailed description
Study participants were provided a 3-5 minute explanation of DUFB, written program materials, and initial $10 market voucher. Participants were surveyed four times over five months, and a subset are also participating in post-intervention focus groups.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Double Up Food Bucks | Experimental | Behavioral: Education, Behavioral: voucherClinic-based educational intervention about an existing SNAP healthy food incentive program, as well as a $10 voucher to spend on produce at farmers markets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient or family member of patient
- at least 18 years of age
- currently SNAP-enrolled
- identifies as one of primary food shoppers for household
- English or Spanish-speaking
Key exclusion criteria (5 listed)
- under 18
- not currently SNAP-enrolled
- not one of primary food shoppers for household
- unable to complete a telephone survey in English or Spanish
- unable to provide a working telephone number where they could be contacted
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 |
|---|---|---|
| EducationEducational intervention about an existing SNAP healthy food incentive program | Behavioural | Double Up Food Bucks |
| voucher$10 voucher to spend on produce at farmers markets | Behavioural | Double Up Food Bucks |
Primary outcome
Prevalence of participant DUFB use over time, as assessed by an interviewer-administered survey using structured open-ended questions
Time frame: 5 months
Use of DUFB at baseline assessed with yes/no response. At each of the the 3 follow-up surveys waves (1.5 months, 3 months, and 5 months), participants will be asked if they have used DUFB in the past month (yes/no), and if yes, how many times.
Participant-perceived barriers and facilitators to DUFB use following educational intervention, as assessed by an interviewer-administered survey using structured open-ended questions and semi-structured focus group questions
Time frame: 12 months
Through an iterative process, three team members will independently conduct thematic analyses, compared codes, resolve discrepancies, and summarize key thematic findings.
1 secondary outcome
Change from baseline fruit and vegetable consumption at 1.5 months, 3 months, and 5 months, as assessed by a validated 2 question fruit and vegetable screener
Time frame: baseline, 1.5 months, 3 months, 5 months
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 28 Dec 2015.
Related trials for Food Insecurity
Recruiting
Developing a Support Application for Food Pantries (SAFPAS) to Improve Client Access to Healthy Foods & Enhance Emergency Preparedness
Improving Healthy Food Access in Food Insecurity Populations in Normal and Emergency Situations
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
Not yet recruitingObservational study
Addressing Food Insecurity in Pregnancy
Food Insecurity, Pregnancy
Active, not recruiting
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
Nutrition, Type 2 Diabetes
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.
Alicia Cohen, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and voucher in people with Food Insecurity and Non-use of Existing State-wide SNAP Incentive Program, run by University of Michigan 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 5 inclusion and 5 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 28 Dec 2015. 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.
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?
Prevalence of participant DUFB use over time, as assessed by an interviewer-administered survey using structured open-ended questions (time frame: 5 months). 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 28 Dec 2015.