NCT04597957

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for early_phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2018

Shorter than P25 for early_phase_1 diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

October 4, 2020

Last Update Submit

October 17, 2020

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

  • Change in hemoglobin a1c (percent) of intervention and control group.

    Both intervention and control groups will have hemoglobin a1c (%) tested at initial visit and 3 months after initial visit.

    baseline, 3 months

  • Change in systolic blood pressure (mmhg) of intervention and control group.

    Both intervention and control groups will have systolic blood pressure (mmhg) tested at initial visit and 3 months after initial visit.

    baseline, 3 months

  • Change in diastolic blood pressure (mmhg) in intervention and control group.

    Both intervention and control groups will have diastolic blood pressure (mmhg) tested at initial visit and 3 months after initial visit.

    baseline, 3 months

  • Change in weight (pounds) in intervention and control group.

    Both intervention and control groups will have weight (pounds) tested at initial visit and and 3 months after initial visit.

    baseline, 3 months

Secondary Outcomes (1)

  • Number of visits to Clinic based farmers market (the mercardo) per participant in Fresh Rx program.

    15 weeks

Study Arms (2)

Fresh Rx Intervention group

EXPERIMENTAL

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.

Dietary Supplement: Fresh Rx Intervention group

Diabetic Standard of Care Control group

ACTIVE COMPARATOR

Diabetic standard of care control group will receive no incentive for the community based farmers market.

Dietary Supplement: Fresh Rx Intervention group

Interventions

Fresh Rx Intervention groupDIETARY_SUPPLEMENT

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 groupFresh Rx Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Richard Bryce

Detroit, Michigan, 48209, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Richard Bryce, DO

    Chass Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Invesigator

Study Record Dates

First Submitted

October 4, 2020

First Posted

October 22, 2020

Study Start

July 12, 2018

Primary Completion

January 2, 2019

Study Completion

January 2, 2019

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)