Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
200 participants
INTERVENTIONAL
2018-07-12
2019-01-02
Brief Summary
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Detailed Description
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The Fresh Rx program allots up to $80 ($10 per visit for up to eight visits) for purchase of fresh fruits and vegetables at that FQHC's farmers' market (referred to as the Mercado). The Mercado, which is located outside the entrance to the health center, is a collection of several local produce farmers. The Mercado operates every Thursday (9am-1pm) and will occur over 15 weeks from June 2018-October 2018. In addition to selling fresh produce, the Mercado also offers many other positive health promoting activities including cooking demonstrations, nutrition education and exercise events.
Fresh Rx participants are able fill their prescription at the Mercado for fresh produce up to eight times during the 15-week Fresh Rx program. The visits can, but do not necessarily need to be in consecutive weeks. The provided debit cards are loaded with the $10 stipend at each visit.
A list will be generated from the electronic medical records of the FQHC, of all non-pregnant patients with type 2 diabetes who had a HbA1C \>8.0% over the 6 months prior to the start of the Fresh Rx Program. Using simple randomization, the list was randomized into two groups: The Intervention group and the control group. Those selected for the intervention group and the control group will be contacted by telephone and offered participation by a Community Health Worker. Once agreeable to participate, both groups will be brought into the center to sign an informed consent. At that time, they will have their BP, weight and HbA1C tested.
All Fresh Rx participants will complete a basic program orientation that includes receiving their Fresh Rx debit card that can be used with Mercado vendors. All participants will then have their BP, weight and HbA1C checked inside the FQHC after their last visit to the Mercado or within three months of the completion of the Fresh Rx program (January 2, 2019).
All control group participants will be given flyers describing all the health and wellness programs at the FQHC including the Mercado. No incentive will be given for the Mercado. Control group participants will be given a $10 gift card to a national brand pharmacy (no fresh produce available). The enrollment time for the control group will overlap the Fresh Rx group (June-September 2018). After a 3-month time period, control group participants will return and have a repeat BP, weight and HbA1C tested. They then will be given a $20 gift card to the same national brand pharmacy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Fresh Rx Intervention group
The Fresh Rx intervention group will receive up to 8 visits to the community based farmers market with $10 incentive for fruits and vegetables at each visit.
Fresh Rx Intervention group
Fresh Rx Intervention participants will be able to fill their prescription at the FQHC based Farmers Market for fresh produce up to eight times during the 15-week Fresh Rx program. The provided debit cards will be loaded with the $10 stipend at each visit. At each market session, cooking demonstrations will take place that reinforce healthy food options and how to prepare foods that were available at the Mercado.
All control group participants will be given flyers describing all the health and wellness programs at the FQHC including the Mercado. Control group participants will receive a $10 gift card to a national brand pharmacy (no fresh produce available). The enrollment time for the control group will overlap with the Fresh Rx group. After a 3-month time period, the control group will follow up and be given a $20 gift card to the same national brand pharmacy.
Diabetic Standard of Care Control group
Diabetic standard of care control group will receive no incentive for the community based farmers market.
Fresh Rx Intervention group
Fresh Rx Intervention participants will be able to fill their prescription at the FQHC based Farmers Market for fresh produce up to eight times during the 15-week Fresh Rx program. The provided debit cards will be loaded with the $10 stipend at each visit. At each market session, cooking demonstrations will take place that reinforce healthy food options and how to prepare foods that were available at the Mercado.
All control group participants will be given flyers describing all the health and wellness programs at the FQHC including the Mercado. Control group participants will receive a $10 gift card to a national brand pharmacy (no fresh produce available). The enrollment time for the control group will overlap with the Fresh Rx group. After a 3-month time period, the control group will follow up and be given a $20 gift card to the same national brand pharmacy.
Interventions
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Fresh Rx Intervention group
Fresh Rx Intervention participants will be able to fill their prescription at the FQHC based Farmers Market for fresh produce up to eight times during the 15-week Fresh Rx program. The provided debit cards will be loaded with the $10 stipend at each visit. At each market session, cooking demonstrations will take place that reinforce healthy food options and how to prepare foods that were available at the Mercado.
All control group participants will be given flyers describing all the health and wellness programs at the FQHC including the Mercado. Control group participants will receive a $10 gift card to a national brand pharmacy (no fresh produce available). The enrollment time for the control group will overlap with the Fresh Rx group. After a 3-month time period, the control group will follow up and be given a $20 gift card to the same national brand pharmacy.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant patients
* type 1 diabetics
* those that decline participation in the Fresh Rx program
18 Years
ALL
No
Sponsors
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Blue Cross Blue Shield of Michigan Foundation
OTHER
Henry Ford Health System
OTHER
Responsible Party
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Richard Bryce
Principal Invesigator
Principal Investigators
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Richard Bryce, DO
Role: PRINCIPAL_INVESTIGATOR
Chass Center
Locations
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Henry Ford Health System
Detroit, Michigan, United States
Richard Bryce
Detroit, Michigan, United States
Countries
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Other Identifiers
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10511
Identifier Type: -
Identifier Source: org_study_id
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