Source: UNIV OF CALIFORNIA-SAN DIEGO submitted to
¡MÁS FRESCO! MORE FRESH FRUIT AND VEGETABLE PRESCRIPTION PROGRAM FOR FAMILIES WITH T2DM
Sponsoring Institution
National Institute of Food and Agriculture
Project Status
EXTENDED
Funding Source
Reporting Frequency
Annual
Accession No.
1027421
Grant No.
2021-70030-35796
Project No.
CALW-2021-06512
Proposal No.
2021-06512
Multistate No.
(N/A)
Program Code
PPR
Project Start Date
Sep 1, 2021
Project End Date
Aug 31, 2025
Grant Year
2021
Project Director
Rhee, K.
Recipient Organization
UNIV OF CALIFORNIA-SAN DIEGO
9500 GILMAN DRIVE
LA JOLLA,CA 92093
Performing Department
Pediatrics
Non Technical Summary
Prior to COVID-19, 35.2 million people in the U.S., including 5.3 million children, were food insecure, resulting in poor nutritional intake and nutrition-related chronic diseases. To address this issue, Rady Children's Hospital San Diego (RCHSD) and Northgate Gonzalez Markets will implement a Produce Prescription Program that leverages existing relationships and infrastructure that were cultivated in ourpreviously developed ¡Más Fresco! More Freshprogram. 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. Each electronic voucher will have a unique ID which will allow us to track where and how many vouchers were redeemed by each family.The goal of this program is to increase the purchase and consumption of fresh FV, decrease household food insecurity, and improve metabolic outcomes among low-income children with T2DM. We will collaborate with our Pediatric Endocrinologists at RCHSD who already provide nutrition education to these families, and evaluate how adding a FVRx program to ongoing nutrition education impacts metabolic outcomes, FV consumption, and household food insecurity of low-income families with T2DM. By addressing these nutrition-related illnesses in childhood, we aim to decrease the long-term impact of poor nutrition on child growth and development and ultimately decrease the economic burden of these chronic diseases.
Animal Health Component
0%
Research Effort Categories
Basic
0%
Applied
100%
Developmental
0%
Classification

Knowledge Area (KA)Subject of Investigation (SOI)Field of Science (FOS)Percent
70460201170100%
Goals / Objectives
The overarching goals of this program are to: 1) Develop an integrated health and food system; 2) Increase access for low-income families with nutrition-related illnesses to healthy fruits and vegetables; 3) Improve health outcomes for children with T2DM; and 4) Decrease household food insecurity. We will achieve these goals through the development of the ¡Más Fresco! More Fresh FVRx program in collaboration with Northgate Gonzalez (NG) Markets and Rady Children's Hospital San Diego RCHSD, specifically the Division of Pediatric Endocrinology.We will collaborate with our Pediatric Endocrinologists at RCHSD who already provide nutrition education to these families, and evaluate how adding a FVRx program to ongoing nutrition education impacts metabolic outcomes, FV consumption, and household food insecurity of low-income families with T2DM.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. Each electronic voucher will have a unique ID which will allow us to track where and how many vouchers were redeemed by each family. With the implementaion of thisProduce Prescription Program, we expect to: 1) increase the purchase and consumption of fresh FV, 2) decrease child and household food insecurity, and 3) improve metabolic outcomes among low-income children with T2DM.
Project Methods
The overarching goals of this program are to: 1) Develop an integrated health and food system; 2) Increase access for low-income families with nutrition-related illnesses to healthy fruits and vegetables; 3) Improve health outcomes for children with T2DM; and 4) Decrease household food insecurity. We will achieve these goals through the development of the ¡Más Fresco! More Fresh FVRx program in collaboration with NG Markets and RCHSD, specifically the Division of Pediatric Endocrinology. Using an electronic voucher redeemable at any participating NG Markets, we will conduct a randomized delayed-control trial with 200 families on Medi-Cal who have children with T2DM attending the RCHSD Pediatric Diabetes Clinic. The goal is to assess the impact of adding nutrition incentives to ongoing diabetes nutrition education on pediatric health outcomes, FV intake, and household food insecurity.During the start-up period, the PI and Pediatric Endocrinologists will submit the appropriate IRB application to the UC San Diego Human Research Protections Program. Online forms that are integrated into the EHR have already been developed in the Pediatric Endocrinology Diabetes Clinic that can screen for food insecurity, identify Medi-Cal enrollment, and provide resources as needed. Adjustments will be made to these forms to include information about the¡Más Fresco! More Fresh FVRx Programand links to CalFresh for those who are interested in enrolling. The Pediatric Diabetes Clinic has dedicated social workers and clinical fellows (MDs) who will be trained on the enrollment process for the¡Más Fresco! More Fresh FVRx program.They also have dedicated dietitians and diabetes nurses who will continue to provide nutrition education to these families according to the American Academy of Pediatrics and American Dietetic Association nutrition guidelines for children with type 2 diabetes.Families who are eligible to participate in this program (receiving Medi-Cal and have a child <18 years old with T2DM and have a HbA1C >6.5) will be flagged in the EHR and recruitment materials will be sent to them via mail or EPIC MyChart messaging. Patients are being seen in the clinic every 3-6 months, and families will be screened again for eligibility at the time of their endocrinology visit. Those who are interested will receive additional information about the FVRx program from their provider (pediatric endocrinologist, fellow, or nurse practitioner). Interested families will complete the informed consent process with the Pediatric Endocrinology Fellow.Using a delayed-control design, patients will be randomized to either receive the FVRx immediately (intervention group) or after a 6-month waiting period (delayed-control group).Families will be given a prescription which includes information about their target FV intake goals and a link to the¡Más Fresco! More FreshFVRxwebsite (available in English and Spanish) where they can learn more about the program and complete the electronic surveys. Families will also receive an enrollment packet at the clinic which will include details regarding the¡Más Fresco! More Fresh FVRx program,and how and where they can use their vouchers. Families will be able to use their electronic vouchers at any nearby NG Markets in San Diego or Riverside Counties (n=9 stores). Upon completion of the baseline surveys, families will receive seven $15 FVRx vouchers ($105 total) that can be used each month to purchase GusNIP-eligible fresh FV at participating NG Markets. Families will be able to use up to 2 vouchers ($30) during any one transaction at the store. Since all vouchers will have a bar code and unique identifier, we will be able to collect and monitor transaction data monthly at each store. Families in the intervention group will receive one month's worth of vouchers (7 cards) during this visit (Month 1) and at each follow-up visit (beginning of Month 4, 7, and 10). For all other months, they will be mailed their monthly vouchers (Month 2, 3, 5, 6, 8, 9, 11, 12). Those randomized to the delayed-control group will begin receiving their vouchers at the 6-month visit and continue to receive vouchers on the same schedule and method as the intervention group.To complement the incentives in the FVRx program, the RCHSD dietitian will continue to provide direct nutrition education promoting the benefits of increased FV consumption during the clinic visit. Their efforts will provide more direct counseling to each participant that can be tailored to the family's specific questions and needs. Healthy recipes incorporating fresh FV will also be shared with the families at this time.Baseline assessments will include standard laboratory measures (HbA1c, total cholesterol, HDL cholesterol, and liver function tests (LFTs)), anthropometric measurements (height and weight to calculate BMI), and blood pressure. Additional assessments will align with those recommended by the NTAE and include the Dietary Screener Questionnaire (DSQ) for youth and parents and the 18-item US Household Food Security Survey Module.These laboratory and self-report measures will be repeated at the 6-, 12-, and 18-month time points and allow us to compare changes in these measures between those who received nutrition incentives immediately or after a 6-month waiting period. An additional research laboratory measure (beta-carotene) will be obtained at baseline and 12-months to correlate with the DSQ. Our primary outcomes will align with the original goals of this program: 1) change in self-reported consumption of fresh FV (assessed via the DSQ for parents and children, and correlated with beta-carotene levels in children); 2) change in metabolic outcomes (assessed via HbA1C); and 3) change in household food security levels. Secondary measures of health will include child BMI z-score, total cholesterol, HDL, LFTs, and blood pressure. Changes in health care utilization and medication use will also be assessed via a review of the electronic health record. We will obtain IRB approval for all activities outlined above and obtain parent consent/child assent before enrollment.We will use regression analyses to compare between-group and within-group changes in primary and secondary outcomes, adjusting for relevant covariates (e.g., level of self-reported monthly CalFresh benefit received, age, gender, race/ethnicity, household size, and baseline laboratory values and BMI z-score).The process evaluation will use multiple methods to describe the implementation of the ¡Más Fresco! More Fresh FVRx Program.The internal process and outcomes evaluation will adhere to the funder evaluation requirements, and also coordinate with the external evaluator to provide all requested firm-level and participant-level data to the NTAE core dataset.The process evaluation includes three components designed to provide insight into program implementation and to provide feedback on the implementation and operations process: (1) program data collection, (2) a family satisfaction survey, and (3) an intervention site-visit to participating NG Markets sites and RCHSD Diabetes clinic. These are designed to answer the following questions:Is the ¡Más Fresco! More Fresh FVRx Program (i.e., FVRx and nutrition education):Being implemented according to the original project timeline and budget?Reaching the expected number of Medi-Cal recipients and NG Market sites?Being utilized by families (i.e., are vouchers being redeemed)?Culturally relevant to these participants?Are fresh FV promoted through Northgate educational activities being purchased by participants?Are any aspects of implementing the program challenging, and why? Which components were challenging for the health care setting and which components were challenging for the retailer?What strategies are being developed to address any challenges?

Progress 09/01/22 to 08/31/23

Outputs
Target Audience:During this reporting period (9/1/22-8/31/23) we conducted outreach to 56 eligible families, resulting in the enrollment of 35 families (63%) in the ¡Más Fresco! More Fresh FVRx program. We have enrolled a total of 97 families as of 8/31/23 since the beginning of the program Eligibility criteria for the FV Rx program include: Family is receiving Medi-Cal benefits Family includes a child: < 18 years old AND with a diagnosis of T1DM, T2DM or Pre-diabetes AND who is being seen in our RCHSD Diabetes Clinic Families who are eligible to participate in the program are identified in the EHR) and recruitment materials are sent to them. To do this, we requested a partial waiver of HIPAA Authorization from our IRB. If patients meet the age criteria, have a diagnosis of T1DM, T2DM, or pre-diabetes, and receive Medi-Cal insurance, their families will receive these recruitment materials via mail or through RCHSD's electronic health record system, EPIC MyChart messaging, the EPIC system patient portal. If patients are interested, they can call the number or send a message (via MyChart, email, or text) to the contact information on the recruitment materials. If they consent to participate, they will undergo the consent process and have all their questions answered. If patients/families are still interested in participating, we will obtain verbal consent at that time. When families come to the clinic for their baseline assessment, we will obtain full written consent at that time. Randomization will occur when written consent is obtained. As patients are seen in Diabetes Clinic every 3-6 months, families will also be screened again for eligibility at their endocrinology visit. Families will receive additional information about the FVRx program during their scheduled appointment at the Diabetes Clinic and will complete the informed consent form with the Pediatric Endocrinology Fellow or exercise physiologist. At that time, they will be randomized to one of the two study groups. We aim to enroll a total of 300 families through our RCHSD Pediatric Diabetes Clinic over the course of 1.5 years (12 families per month). Randomization will occur at a 1:1 ratio. Families will be given a prescription which will include daily goals for fresh fruit and vegetable intake and a link to the ¡Más Fresco! More Fresh FVRx website (available in English and Spanish) where they can learn more about the program and complete the electronic surveys. Families will also receive an enrollment packet at the clinic which will include details regarding the ¡Más Fresco! More Fresh FVRx program, and how and where they can use their vouchers. Depending on the group to which they are randomized, they will either receive monthly vouchers immediately or after a 6-month waiting period. From the baseline surveys collected to date (n=80 adult surveys, n=75 child surveys), we know that our participants are approximately 80% Latino, and 94% of the participating parents are female, while the participating children are split more evenly by gender (45% female, 49% male, 6% self-describe or unreported). Over half of participating households have low (39%) or very low (18%) food security based on the USDA 18-item screener. Over half (58%) of parents report receiving CalFresh, and of these, the mean amount received each month is $389. Based on the DSQ FV screener, parents report eating 2.6 cup equivalents of fruits and vegetables per day at baseline, while children report 2.4 cup equivalent servings per day. Changes/Problems: Recruitment continues to be slower than anticipated since many families live too far from Northgate to consider shopping there and redeem the vouchers. Many have asked for food delivery options or whether Northgate can provide food boxes at the hospital or clinics. As mentioned above, discussions with the CMO of the hospital have been started, but due to construction at the hospital, there is limited space to allow for fresh produce to be brought to the hospital and stored in such a way to meet regulatory standards. Payment for delivery options are being explored, but is challenging since this requires additional funds outside of GusNIP funding. The program has been expanded to include children with T1DM as a way to increase the reach of the program. We have also been unable to recruit anyone from Riverside Countyas of yet and are currently exploring strategies for increasing reach and enrollment in this region. We still have some reports from participants that cashiers at Northgate are unaware of the program or are misinformed about how the vouchers work. We follow up with our contacts at Northgate for each report, and conversely, we have also heard from Northgate staff that they will occasionally encounter a participant that has misconceptions about how the program/vouchers work. We have developed participant and cashier-specific training materials to help promote consistent understanding of the ¡Más Fresco! More Fresh FVRx program across both participants and Northgate staff. What opportunities for training and professional development has the project provided?Between 9/1/2022 and 8/31/2023 the ¡Más Fresco! More Fresh FVRx program has provided the following opportunities for professional development: Sarah Hiller-Venegas, our data management/research analyst, was able to travel to Los Angeles with the Principal Investigator, Dr. Rhee, to attend the Fruit and Vegetable Prescription Program Convening organized by MIFMA and the Fair Food Network. The convening was partly co-hosted by the UCSD team and moved to San Diego for the 2nd half of the meeting. This convening facilitated information sharing and allowed for in depth and nuanced conversations among FV Rx grantees about their respective programs' successes and challenges, especially as it pertained to promoting health equity and reducing disparities in health outcomes. We developed training and informational materials and videos for participants and Northgate cashiers to improve understanding of how the FV Rx program works. We trained an exercise physiologist to participate in the recruitment and enrollment process in the clinic. Student Volunteers/Interns: We also have one student volunteer who received training and experience supporting the FVRx program. She focuses on conducting outreach, supporting follow-up survey completion, and data management. How have the results been disseminated to communities of interest?Between 9/1/2022 and 8/31/2023 the ¡Más Fresco! More Fresh FVRx program has disseminated information about how to implement FVRx programs. Dr. Rhee and Dr. Chan have spoken about the FVRx project at UCSD Health and Rady Children's Hospital Grand Rounds Forum, hospital-wide staff meetings, Division of Endocrinology faculty meetings, and the multi-disciplinary clinical committee. They address food insecurity and describe the goals of the program to increase participant recruitment. Dr. Rhee and Ms. Hiller also discussed these processes and implementation measures during the Produce Prescription Convening in October 2022. An abstract with preliminary results was presented at the UCSD Rady Children's Hospital annual research symposium in May 2022 by Dr. Chan. What do you plan to do during the next reporting period to accomplish the goals?During the next reporting period, the ¡Más Fresco! More Fresh FVRx program plans to engage in the following activities to continue to accomplish these goals: Recruit additional clinical staff to continue to support enrollment and program implementation at Rady Children's. Dr. Chan's fellowship ended in June 2023, and the new exercise physiologist was educated on how to take over recruitment and enrollment in the clinic. Additional staff may still be needed to assist with this process. Engage in outreach to support participant utilization of the program and retention, especially given the waitlist control study design. Continue to collect voucher data from Northgate, and survey, lab, and appointment data from child/parent participant pairs. Conversations have begun with the CMO of Rady Children's Hospital to discuss measures that would help families access Northgate Gonzalez Markets and utilize the vouchers. The team is investigating whether transportation or home delivery of healthy food would increase program utilization.

Impacts
What was accomplished under these goals? Between 9/1/2022 and 8/31/2023 the ¡Más Fresco! More Fresh FVRx program has accomplished the following in alignment with our stated goals: Continued to enroll participants (total to date: 97, 49 during the reporting period) and distribute FVRx vouchers to families. Continued to collect survey data and abstract lab and appointment data from the electronic health record. Survey data is directly entered into Qualtrics forms that are sent to families via secure email or text message links. Continued to provide support to participants and training to Northgate cashiers as needed to improve understanding of the program. Expanded the program to include children with T1DM. This required obtaining approval from Dr. Koening, modifying the IRB consent forms, and updating all recruitment and program materials. Modified and maintained IRB approval through the continuing review process. Trained the exercise physiologist in the clinic (Allison Milano) to assist with recruitment and enrollment. Issued over $83,595 in FV Rx vouchers, of which $44,400 had been redeemed as of 8/31/23 (Note: participants are given up to 3 months of vouchers at a time which explains the lag between the amount issued and the amount redeemed).

Publications

  • Type: Websites Status: Published Year Published: 2022 Citation: www.masfresco.org/fvrx
  • Type: Conference Papers and Presentations Status: Accepted Year Published: 2023 Citation: �M�s Fresco! More Fresh: Impact of a Fruit and Vegetable Prescription Program in a Pediatric Type 2 Diabetes Clinic, Karen Chan, Sarah P. Hiller-Venegas, Jane J. Kim, Karen O. Klein, Kyung E. Rhee Department of Pediatrics, University of California San Diego, Annual Research Symposium, April 14, 2023.


Progress 09/01/21 to 08/31/22

Outputs
Target Audience:During this reporting period (9/1/21-8/31/22) we conducted outreach to 127 eligible families, resulting in the enrollment of 61 families (48%) in the ¡Más Fresco! More Fresh FVRx program. Eligibility criteria for the FV Rx program include: - Family is receiving Medi-Cal benefits - Family includes a child: o < 18 years old AND o with a diagnosis of T2DM or Pre-diabetes AND o who is being seen in our RCHSD Diabetes Clinic Families who are eligible to participate in the program are identified in the EHR and recruitment materials are sent to them. To do this, we requested a partial waiver of HIPAA Authorization from our IRB. If patients meet the age criteria, have a diagnosis of T2DM or pre-diabetes, and have Medi-Cal, their families will receive these recruitment materials via mail or through RCHSD's electronic health record system, EPIC via messaging in MyChart, the EPIC system patient portal.. If patients are interested, they can call the number or send a message (via MyChart, email, or text) to the contact information on the recruitment materials. If they consent to participate, they will undergo the consent process and have all their questions answered. If patients/families are still interested in participating, we will obtain verbal consent at that time. When families come to the clinic for their baseline assessment, we will obtain full written consent at that time. Randomization will occur when written consent is obtained. As patients are seen in Diabetes Clinic every 3-6 months, families will also be screened again for eligibility at their endocrinology visit. Families will receive additional information about the FVRx program during their scheduled appointment at the Diabetes Clinic and will complete the informed consent form with the Pediatric Endocrinology Fellow. At that time, they will be randomized to one of the two study groups. We aim to enroll a total of 300 families through our RCHSD Pediatric Diabetes Clinic over the course of 1.5 years (12 families per month). Randomization will occur at a 1:1 ratio. Families will be given a prescription which will include daily goals for fresh fruit and vegetable intake and a link to the ¡Más Fresco! More Fresh FVRx website (available in English and Spanish) where they can learn more about the program and complete the electronic surveys. Families will also receive an enrollment packet at the clinic which will include details regarding the ¡Más Fresco! More Fresh FVRx program, and how and where they can use their vouchers. Depending on the group to which they are randomized, they will either receive monthly vouchers immediately or after a 6-month waiting period. From the baseline surveys collected to date, we know that our participants are approximately 80% Latino, and 90% of the participating parents are female, while the participating children are split more evenly by gender (48% female, 52% male). Over half of participating households have low (42%) or very low (19%) food security based on the USDA 18-item screener. Half (50%) of parents report receiving CalFresh, and of these, the mean amount received each month is $390. Based on the DSQ FV screener, parents report eating 2.6 cup equivalents of fruits and vegetables per day at baseline, while children report 2.4 cup equivalent servings per day. Changes/Problems: Recruitment has been slower than anticipated; based on anecdotal feedback from potential participants, some live too far to consider shopping at Northgate markets where the vouchers can be redeemed, or are unaccustomed to shopping at that specific chain. We have also been unable to recruit anyone from Riverside county as of yet and are currently exploring strategiesfor increasing reach and enrollment in this region. Due to technical limitations, we are unable to link specific participants to the specific vouchers that were used, and are taking steps to ameliorate the impact of this deficiency in our data analysis (e.g., asking participants to self-report how many vouchers they have remaining at follow up to estimate the number that have been used). However, we do receive aggregate data back from Northgate about how many vouchers were used by day and by store, so we have an accurate sense of redemptions. We have had some reports from participants that cashiers at Northgate are unaware of the program or are misinformed about how the vouchers work. We follow up with our contacts at Northgate for each report, and conversely, we have also heard from Northgate staff that they will occasionally encounter a participant that has misconceptions about how the program/vouchers work. We have developed participant and cashier-specific training materials to help promote consistent understanding of the ¡Más Fresco! More Fresh FVRx program across both participants and Northgate staff. What opportunities for training and professional development has the project provided?Between 9/1/2021 and 8/31/2022 the ¡Más Fresco! More Fresh FVRx program has provided the following opportunities for professional development: Our clinical lead (Dr. Karen Chan) has gained extensive experience in the day-to-day operation of an intervention study including pre-screening using EHR queries, outreach and recruitment, consent procedures, ordering special labs and navigating hospital billing procedures, collecting survey data, and abstracting lab/appointment data. We developed training and informational materials for participants and Northgate cashiers to improve understanding of how the FV Rx program works. Dr. Chan has also held informal informational trainings with social workers and dietitians who are part of the Diabetes Clinic to educate them about how the FV Rx program works to support recruitment and help answer participant questions. Student Volunteers/Interns: We also have 2 student volunteers who receive training and experience supporting the FV Rx program; one student is focused more on conducting outreach and supporting follow up survey completion, while the other student is more focused on research, data management, analysis, and the dissemination of findings. How have the results been disseminated to communities of interest?Between 9/1/2021 and 8/31/2022 the ¡Más Fresco! More Fresh FVRx program has disseminated results to communities of interest in the following ways: Dr. Rhee and Dr. Chan have spoken about the FV Rx project at UCSD Health and Rady Children's Hospital Grand Rounds Forum, hospital-wide staff meetings, Division of Endocrinology faculty meetings, and the multi-disciplinary clinical committee to address food insecurity to increase awareness of the program and build support for further participant recruitment. Produce Prescription Convening Planning: During the reporting period, planning and preparation also took place to present the program and preliminary data at the FV Rx convening in October 2022. What do you plan to do during the next reporting period to accomplish the goals?During the next reporting period, the ¡Más Fresco! More Fresh FVRx program plans to engage in the following activities to continue to accomplish these goals: Expand recruitment to similar populations (e.g., Type 1 diabetes patients and Fatty Liver Clinic), pending USDA approval and IRB amendment. This will allow us to reach our recruitment goals. Recruit additional clinical staff to continue to support enrollment and program implementation at Rady Children's, as Dr. Chan's fellowship will end in 2023. Engage in outreach to support participant utilization of the program and retention, especially given the waitlist control study design. Continue to collect voucher data from Northgate, and survey, lab, and appointment data from child/parent participant pairs.

Impacts
What was accomplished under these goals? Between 9/1/2021 and 8/31/2022 the ¡Más Fresco! More Fresh FVRx program has accomplished the following in alignment with our stated goals: Designed and obtained FV Rx vouchers in collaboration with Northgate Gonzalez Market Obtained IRB approval from UCSD and Rady Children's Hospital Recruited and trained a clinical lead (Endocrinology fellow Dr. Karen Chan) to lead enrollment at Rady Children's Hospital Diabetes clinic Developed an enrollment protocol and online data collection forms to record parent and child survey responses and abstract lab and appointment data from electronic health records; data collection into these forms can be conducted in person via iPad or through secure links sent to participants via email or text message Developed training and informational materials for participants and Northgate cashiers to improve understanding of how the FV Rx program works Conducted outreach to 127 eligible families, resulting in the enrollment of 61 families in the ¡Más Fresco! More Fresh FVRx program Issued over $20,000 in FV Rx vouchers, of which $6,795 had been redeemed as of 8/31/22 (Note: participants are given up to 3 months of vouchers at a time which explains the lag between the amount issued and the amount redeemed).

Publications