Clinical trial NCT04597957: The Fruit and Vegetable Prescription Program Study
Official title: A Randomized Control Trial of a Fruit and Vegetable Prescription Program at a Federally Qualified Health System and Its Impact on Health Outcomes in Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield of Michigan Foundation
First posted: 2020-10-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* FQHC patients with history of type 2 diabetics with a history of a hemoglobin a1c \>8.0 % in the last 6 months.

Exclusion Criteria:

* individuals \<18 years of age
* Pregnant patients
* type 1 diabetics
* those that decline participation in the Fresh Rx program

Primary outcomes:
measure: Change in hemoglobin a1c (percent) of intervention and control group.
timeFrame: baseline, 3 months
measure: Change in systolic blood pressure (mmhg) of intervention and control group.
timeFrame: baseline, 3 months
measure: Change in diastolic blood pressure (mmhg) in intervention and control group.
timeFrame: baseline, 3 months
measure: Change in weight (pounds) in intervention and control group.
timeFrame: baseline, 3 months
Secondary outcomes:
measure: Number of visits to Clinic based farmers market (the mercardo) per participant in Fresh Rx program.
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Detroit
country: United States
facility: Richard Bryce
state: Michigan
Study officials:
affiliation: Chass Center
name: Richard Bryce, DO
role: PRINCIPAL_INVESTIGATOR
References: