Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04597957 |
| Other study ID # |
10511 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
July 12, 2018 |
| Est. completion date |
January 2, 2019 |
Study information
| Verified date |
October 2020 |
| Source |
Henry Ford Health System |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The Fruit and Vegetable Prescription Program Study is a pilot randomized controlled trial of
patients with type 2 diabetes participating in a fruit and vegetable prescription program
from a Federally Qualified Health Center in Detroit, MI . Changes in hemoglobin A1C (%),
blood pressure (BP) and weight (lbs.) will be assessed changes to discern the impact on those
that participated in a fruit and vegetable prescription program compared to those that
received non-incentivized diabetes standard of care.
Description:
Fresh Prescription (Fresh Rx) Program is a fruit and vegetable prescription program that
brings together the healthcare system and the food system. This fosters innovative
relationships to enhance the understanding of the correlation between food choices and
health, increase consumption of locally grown fruits and vegetables, and build a healthy
sustainable food system. This promising approach to a healthier food system connects patients
to fresh, locally grown produce while providing direct economic benefits to small and midsize
farmers and improving health and quality of life for participants.
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.
