Type 2 DiabetesNCT05138432
More Fresh Fruit and Vegetable Prescription Program for Families With Type 2 Diabetes Mellitus
A study testing Fruit and Vegetable Prescription Voucher in people with Type 2 Diabetes, run by University of California, San Diego at 1 site in United States.
Trial summary
Rady Children's Hospital San Diego (RCHSD), UCSD Division of Child and Community Health and the Center for Community Health, and Northgate Gonzalez (NG) Markets will collaborate to create a Produce Prescription Program (Fruit and Vegetable Prescription Program) to be implemented in the RCHSD Diabetes Clinic. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Fruit and Vegetable Prescription Voucher
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2021to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age < 18 years old
- Diagnosis of type 2 diabetes mellitus
- Hemoglobin A1c greater than or equal to 6.5
- Receiving care at the Rady Children's Hospital Diabetes Clinic
Who cannot join
- Another immediate family member living in the same household who is already recruited into the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah Hiller-Venegas, MPH contact
United States1 site, 1 recruiting
- Recruiting
Rady Children's Hospital San Diego
San Diego, California, 92123
Karen Chan, 858-576-1700 ext. 221857, masfrescoFVRX@health.ucsd.edu
Kyung Rhee, MD
About this study
Rady Children's Hospital San Diego (RCHSD), UCSD Division of Child and Community Health and the Center for Community Health, and Northgate Gonzalez (NG) Markets will collaborate to create a Produce Prescription Program (Fruit and Vegetable Prescription Program) to be implemented in the RCHSD Diabetes Clinic. We will provide families on Medi-Cal who have a child with T2DM with a fruit and vegetable prescription (FVRx) which will enhance their ability to purchase GusNIP-eligible fresh fruits and vegetables (FV). These prescriptions will be delivered in the form of an electronic voucher that can be filled at any NG Markets throughout San Diego and Riverside counties. The goal of this program is to increase the purchase and consumption of fresh fruits and vegetables, decrease food insecurity, and improve metabolic outcomes for children with type 2 diabetes mellitus (T2DM).
Read the detailed description
Participants upon enrollment will be randomized into two groups, either to immediately receive nutrition incentive vouchers for 12 months (intervention group) or to receive nutrition incentive vouchers for 12 months after a 6-month delay (delayed-intervention group). To evaluate the implementation and outcomes of this program, we will collect fruit and vegetable prescription (FVRx) voucher data in addition to standardized laboratory studies, (hemoglobin A1c (HbA1c), total cholesterol, HDL cholesterol and liver function tests (LFTs)) and physiologic assessments (height, weight) at the child's follow-up appointments through the Diabetes Clinic. These markers will be evaluated at baseline, 6-, 12- and 18-months. Additionally, we will ask participants to complete online or phone surveys including the Dietary Screener Questionnaire (DSQ) for youth and parents and the 18-item US Household Food Security Survey Module every 6 months.
- Conditions
- Type 2 Diabetes
- Being tested
- Fruit and Vegetable Prescription Voucher
- 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.
Fruit and Vegetable Prescription VoucherBehavioural
Each participant will immediately (intervention group) or after a 6-month waiting period (delayed-intervention group) receive seven $15 vouchers (value $105 per month) for 12 months. Up to 4 vouchers ($60 total) can be redeemed at any one transaction for purchase of fresh fruits and vegetables, dried beans and legumes at participating Northgate Gonzalez markets. Both groups will continue to receive diabetes and nutrition education as is standard in their practice.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Other | Monthly fruit and vegetable vouchers for 12 months, to start immediately after enrollment. Receives: Behavioral: Fruit and Vegetable Prescription Voucher |
| Delayed Intervention Group | Other | Monthly fruit and vegetable vouchers for 12 months, to start after a 6-month waiting period. Receives: Behavioral: Fruit and Vegetable Prescription Voucher |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Household food security
18-item US Household Food Security Survey Module
Measured: Survey will be completed at baseline and 12 months
Change in Hemoglobin A1c
Point of care A1c
Measured: Measured as part of the participant's routine care in the Diabetes Clinic at baseline and 12 months
Secondary outcomes (7)
Change in BMI z-score
BMI calculated by measured height and weight and converted to BMI z-score
Measured: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic
Change in Total cholesterol
Serum Total cholesterol
Measured: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic
Change in Liver function tests
Serum aspartate transaminase (AST), serum alanine transaminase (ALT)
Measured: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic
Change in Blood pressure
Systolic and diastolic BP
Measured: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic
Change in beta carotene
serum beta carotene levels
Measured: Measured at baseline and 12 months
Change in fruit and vegetable intake
Change in child fruit and vegetable intake as measured by the DSQ
Measured: Survey will be completed at baseline and 12 months.
Change in HDL cholesterol
Serum HDL cholesterol
Measured: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start29 Nov 2021
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants upon enrollment will be randomized into two groups, either to immediately receive up to $105 per month in vouchers for 12 months (intervention group) or to receive $105 per month in incentives for 12 months after a 6-month delay (delayed-intervention group)
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), Rady Children's Hospital, San Diego
- Responsible party
- Principal investigator, Kay Rhee, University of California, San Diego
- Investigators
- Kyung Rhee, MD, MS, MA, Principal investigator, University of California San Diego, Rady Children's Hospital San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138432
- Sponsor's protocol ID
- 1027421
- Status last verified
- Nov 2025
- First submitted
- 8 Nov 2021
- Last updated
- 19 Nov 2025
- 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 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- More Fresh Fruit and Vegetable Prescription Program for Families With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05138432
- Acronym / sponsor ID
- 1027421
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), Rady Children's Hospital, San Diego
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 Dec 2021 (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.
Rady Children's Hospital San Diego (RCHSD), UCSD Division of Child and Community Health and the Center for Community Health, and Northgate Gonzalez (NG) Markets will collaborate to create a Produce Prescription Program (Fruit and Vegetable Prescription Program) to be implemented in the RCHSD Diabetes Clinic. We will provide families on Medi-Cal who have a child with T2DM with a fruit and vegetable prescription (FVRx) which will enhance their ability to purchase GusNIP-eligible fresh fruits and vegetables (FV). These prescriptions will be delivered in the form of an electronic voucher that can be filled at any NG Markets throughout San Diego and Riverside counties. The goal of this program is to increase the purchase and consumption of fresh fruits and vegetables, decrease food insecurity, and improve metabolic outcomes for children with type 2 diabetes mellitus (T2DM).
Detailed description
Participants upon enrollment will be randomized into two groups, either to immediately receive nutrition incentive vouchers for 12 months (intervention group) or to receive nutrition incentive vouchers for 12 months after a 6-month delay (delayed-intervention group). To evaluate the implementation and outcomes of this program, we will collect fruit and vegetable prescription (FVRx) voucher data in addition to standardized laboratory studies, (hemoglobin A1c (HbA1c), total cholesterol, HDL cholesterol and liver function tests (LFTs)) and physiologic assessments (height, weight) at the child's follow-up appointments through the Diabetes Clinic. These markers will be evaluated at baseline, 6-, 12- and 18-months. Additionally, we will ask participants to complete online or phone surveys including the Dietary Screener Questionnaire (DSQ) for youth and parents and the 18-item US Household Food Security Survey Module every 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants upon enrollment will be randomized into two groups, either to immediately receive up to $105 per month in vouchers for 12 months (intervention group) or to receive $105 per month in incentives for 12 months after a 6-month delay (delayed-intervention group)
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Other | Behavioral: Fruit and Vegetable Prescription VoucherMonthly fruit and vegetable vouchers for 12 months, to start immediately after enrollment. |
| Delayed Intervention Group | Other | Behavioral: Fruit and Vegetable Prescription VoucherMonthly fruit and vegetable vouchers for 12 months, to start after a 6-month waiting period. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age < 18 years old
- Diagnosis of type 2 diabetes mellitus
- Hemoglobin A1c greater than or equal to 6.5
- Receiving care at the Rady Children's Hospital Diabetes Clinic
Key exclusion criteria (1 listed)
- Another immediate family member living in the same household who is already recruited into the study
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 |
|---|---|---|
| Fruit and Vegetable Prescription VoucherEach participant will immediately (intervention group) or after a 6-month waiting period (delayed-intervention group) receive seven $15 vouchers (value $105 per month) for 12 months. Up to 4 vouchers ($60 total) can be redeemed at any one transaction for purchase of fresh fruits and vegetables, dried beans and legumes at participating Northgate Gonzalez markets. Both groups will continue to receive diabetes and nutrition education as is standard in their practice. | Behavioural | Delayed Intervention Group, Intervention Group |
Primary outcome
Change in Household food security
Time frame: Survey will be completed at baseline and 12 months
18-item US Household Food Security Survey Module
Change in Hemoglobin A1c
Time frame: Measured as part of the participant's routine care in the Diabetes Clinic at baseline and 12 months
Point of care A1c
7 secondary outcomes
Change in BMI z-score
Time frame: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic
Change in Total cholesterol
Time frame: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic
Change in Liver function tests
Time frame: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic
Change in Blood pressure
Time frame: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic
Change in beta carotene
Time frame: Measured at baseline and 12 months
Change in fruit and vegetable intake
Time frame: Survey will be completed at baseline and 12 months.
Change in HDL cholesterol
Time frame: Measured at baseline and 12 months as part of the participant's routine care in the Diabetes Clinic
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- 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.
Sarah Hiller-Venegas, MPH contact
Kyung Rhee, MD, MS, MA principal investigator
University of California San Diego, Rady Children's Hospital San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruit and Vegetable Prescription Voucher in people with Type 2 Diabetes, run by University of California, San Diego at 1 site 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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kay Rhee, MD, MS, MA (858-576-1700 ext. 858-966-5841, masfrescoFVRX@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Household food security (time frame: Survey will be completed at baseline and 12 months). The study lists 2 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 19 Nov 2025.