Diabetes Mellitus, Type 2Early Phase 1NCT04597957
The Fruit and Vegetable Prescription Program Study
A Early Phase 1 study testing Fresh Rx Intervention group in people with Diabetes Mellitus, Type 2, run by Henry Ford Health System at 2 sites in United States.
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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Fresh Rx Intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Jul 2018to 2 Jan 2019
- Phase
- Early Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- FQHC patients with history of type 2 diabetics with a history of a hemoglobin a1c >8.0 % in the last 6 months.
Who cannot join
- individuals <18 years of age
- Pregnant patients
- type 1 diabetics
- those that decline participation in the Fresh Rx program
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Henry Ford Health System
Detroit, Michigan, 48202
Richard Bryce
Detroit, Michigan, 48209
About this 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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Fresh Rx Intervention group
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Fresh Rx Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 3 months
Secondary outcomes (1)
Number of visits to Clinic based farmers market (the mercardo) per participant in Fresh Rx program.
Fresh Rx participants were able fill their prescription at the Mercado for fresh produce up to eight times during the 15-week Fresh Rx program. The visits could, but did not necessarily need to be in consecutive weeks. The number of visits to the Mercado per participant will be recorded.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start12 Jul 2018
- Primary completion2 Jan 2019
- Study completion2 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Responsible party
- Principal investigator, Richard Bryce, Henry Ford Health System
- Investigators
- Richard Bryce, DO, Principal investigator, Chass Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597957
- Sponsor's protocol ID
- 10511
- Status last verified
- Oct 2020
- First submitted
- 4 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04597957
- Acronym / sponsor ID
- 10511
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 2 Jan 2019 (actual)
- Study completion
- 2 Jan 2019 (actual)
- First posted
- 22 Oct 2020 (actual)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh Rx Intervention group | Experimental | Dietary Supplement: Fresh Rx Intervention groupThe 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. |
| Diabetic Standard of Care Control group | Active comparator | Dietary Supplement: Fresh Rx Intervention groupDiabetic standard of care control group will receive no incentive for the community based farmers market. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- FQHC patients with history of type 2 diabetics with a history of a hemoglobin a1c >8.0 % in the last 6 months.
Key exclusion criteria (4 listed)
- individuals <18 years of age
- Pregnant patients
- type 1 diabetics
- those that decline participation in the Fresh Rx program
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 |
|---|---|---|
| Fresh Rx Intervention groupFresh 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. | Dietary supplement | Diabetic Standard of Care Control group, Fresh Rx Intervention group |
Primary outcome
Change in hemoglobin a1c (percent) of intervention and control group.
Time frame: baseline, 3 months
Both intervention and control groups will have hemoglobin a1c (%) tested at initial visit and 3 months after initial visit.
Change in systolic blood pressure (mmhg) of intervention and control group.
Time frame: baseline, 3 months
Both intervention and control groups will have systolic blood pressure (mmhg) tested at initial visit and 3 months after initial visit.
Change in diastolic blood pressure (mmhg) in intervention and control group.
Time frame: baseline, 3 months
Both intervention and control groups will have diastolic blood pressure (mmhg) tested at initial visit and 3 months after initial visit.
Change in weight (pounds) in intervention and control group.
Time frame: baseline, 3 months
Both intervention and control groups will have weight (pounds) tested at initial visit and and 3 months after initial visit.
1 secondary outcome
Number of visits to Clinic based farmers market (the mercardo) per participant in Fresh Rx program.
Time frame: 15 weeks
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 22 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Richard Bryce, DO principal investigator
Chass Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fresh Rx Intervention group in people with Diabetes Mellitus, Type 2, run by Henry Ford Health System at 2 sites 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 1 inclusion and 4 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in hemoglobin a1c (percent) of intervention and control group. (time frame: baseline, 3 months). The study lists 4 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 22 Oct 2020.