Progress 09/15/23 to 09/14/24

Outputs
Target Audience:During year 2 of our grant cycle, we continued the Fresh Food Rx intervention study and comparison cohort. At the start of year 2, we had 112 (of125 enrolled)participants remaining in the Fresh Food Rx intervention and 44 (of 92) recruited into the comparison cohort. The comparison cohort completed phone surveys at baseline (pre) and 6 months later (post) while the intervention group had visits at baseline, 6 months and 12 months offering opportunity to identify if change is maintained or improved between 6 and 12 months post intervention. Between Sept - December2023, we completed the 6 month study visits for the intervention group and completedrecruitment into the comparison cohort. Recruitment for the comparison cohort was completed using the Atrium Health Wake Forest Baptist electronic medical records to closelymatch our intervention group for age, gender, race, health history and Medicaid enrollment. There were numerous challenges to comnpleting the match including phone numbers not in service, death of potential participant, not returning messages and/or not interested in participating. To minimize confounding variables, we strived to keep the study period similar and endedrecruitment for the comparison cohortonce all intervention participants (n=112) had completed their 6 month visits, Dec 2023. Our comparison group contained 92 participants whenrecruitment was ended. There wereno significant differences in baseline characteristics including self-identified sex, age, race/ethnicity, marital status, living aloneor household size between the interventionand comparison groups. Between January and June 2024, we completed the 9 month (quarterly) phone survey and 12 month in-person visits for the intervention group as well as the 6 month (post) phonevisit for comparison cohort. Produce box delivery was completed for all participants by June 2024. Changes/Problems:Problem 1: We intended to have the same number of participants in our intervention group and comparison group. Recruitment for the comparison group was extremely difficult while matching our participants across demographics and chronic disease. In order to keep the timelines consistent which coudl otherwise be a confounding variable, we decided to complete recruiting once all 6 month visits were complete. This allowed the comparison group 6 month followup up visits to be completed at the same time as the intervention 12 month followup. Problem 2: Health care utilization data collection had to be put on hold during year 2 when budget was a concern. Now that mostexpenses are paid, we have found the budget can cover this data collection and analysis fee and we will be collecting this data during year 3. What opportunities for training and professional development has the project provided?As a GusNIP grantee, we have education opportunities through the NTAE and Fair Share Network as well as the project directors meeting in New Orleans, in Dec 2023. These opportunities have expanded our networking ability andfacilitated learning about Medicare Waiver 1115 which could offer support for participants to continue their intake of fresh produce for better health. It is heartbreaking when aPRx program ends and participants dont know how they can afford fresh produce, especially when they have seen their health improve during the 12 month program. The program also facilitated networking and collaboration between community partners. For example, HOPE of Winston Salem offered their space for one of our education programs and participants were able to learn about their new hydroponic greenhouses as well as weekly produce market. Our participants also shared their praise and, at times, concerns with produce quality. This helped everyone learn more about the optimnal way to extend the shelf life of the produce whiel also offering constructive feedback and improvements to The Produce Box standards. Finally, our data showed significant improvement in depression severity between baseline and 6 months. There could be several reasons for this improvement including connections/touch points between staff and participants, participants "feeling respected" and/or "treated like high class citizens", decreases in stress from worrying how they can pay their bills and buy food and/or the quality of diet and impact on microbiome. The connection between mental health and produce intake has prompted us to research this connection and to incorporate these measures into future studies. How have the results been disseminated to communities of interest?The Fresh Food Rx program created an advisory board which consists of leaders from community organizations to learn about our program and to provide feedback to us during the intervention. Our adivsory board met twiceduring year 2 to understand the program and the feedback from participants. During year 3 of our grant, we will meet to provide study outcomes and next steps tothe advisory group. We plan toinvite a few participants to join our meeting to offer lived experience and constructive feedback to our team as well as the advisory group. What do you plan to do during the next reporting period to accomplish the goals?Data Analysis: In Year 3, we will complete ourdata analysis for the intervention and matched cohort groups. We anticipate publishing a journal article on the findings of the comparison groups as well as the qualitative interviews completed with 15 participants in our intervention group. We will be presenting a poaster at the SIREN conference and have submitted to present at the convening in May 2025. Health Care Utilization: We had budget constraints mid-study and had to put health care utilization data collection on hold until the study was complete and we could reassess the budget. Budget requests for this project have been received and are being finalized. We expect to complete this work during year 3 of the grant cycle.

Impacts
What was accomplished under these goals? Duringyear 2 of our grant cycle, we completed the intervention and comparison cohort arms of our study. For the intervention arm, we completed the outstanding6-month study visits for a total of 112 participants. The 12-month study visits began in February and were completed by June 1, 2024. Between 6 and 12 months, we had 2 participants pass away and 5 others lost to followup with 105 participants complete the 12 month visit.Produce boxes were delivered weekly to each participantfor a total of 52 weeks accomplishinggoal 1 of our program. Nutrition Education:Participantsreceived monthly newsletters in their produce boxes. In addition, there were 3 education events offered to participants during this grant cycle which accomplished goal 3 of our program. These events are described under the "product, educational aids" tab. Summarizing attendance at our 4 education events (June 2023, Oct 2023, Nov 2023 and Feb 2024), we had 45 (40%) participantsattend at least1 eventand 19 (17%) attend 2 or more education events. Nutrition Coaching:Although most 1:1 nutrition coaching sessions were offered during year 1, we did have a few participants complete these visits during year 2. Everyone received their first nutrition coaching at the baseline visit. In addition, we had 107/112 (96%) complete 1 followup visit and 95/112 (85%) complete 2 follow up visits. Reasons for not participating inall nutrition coaching sessions offered included limited/no phone access and/or not keeping scheduled appointments, other health issues took priority, or not interested at the time. Of the 17 participants who had no 1:1 nutrition followup, two attended at least 1 group education session. Quarterly Surveys: Participants were asked to complete a quarterly survey throughout the study. This was done by phone at 3 and 9 months and in person at the 6 and 12 month visits. Quareterly survey completion was as follows: 3 months 83/112; at 6 months 112/112(part of the 6 month in person visit);at 9 months was 92/110 (2 had passed away)and at 12 months 105/105. Most people enjoyed providing feedback on the program. Wellness Checks: Participants 60 and over or anyone with a PHY9 score greater than 10 qualified for a wellness check. These calls were done as part of the quarterly survey so the participation numbers are the same. Transportation:Throughout our study, we were able to utilize the drivers and vans available through Atrium Health Wake Forewst Baptist. We offered transportation for baseline, 6 month and 12 month study visits which was paid for by the participant level stipend offered by Gretchen Swanson Center for Nutrition Health Impact. We also offered transportation to education events which was paid through our GusNIP grant. Qualitative Interviews:Semi-structured interviews were conducted with 15 randomly selected FFRx participants to gain their perceptions of the program, using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework.Participants identified five key themes: 1) motivations for participation, 2) benefits of program engagement, 3) factors influencing program continuation, 4) barriers and facilitation to participation, and 5) Sustaining of healthy habits post-program. Social connections and community support were highlighted as critical facilitators of program engagement. Specific feedback offered during these interviews include: 1) Reach: Motivation for participation: "I figured if it was voluntary, and there was some benefit in terms of getting fresh produce, why not?" I was interested in seeing how it would help me with my overall health. 2) Effectiveness: Benefits of Program Engagement: "I learned that the way you cook your food makes a difference...I like to do new recipes. I like to see how other people do stuff and adapt what they do to see if it will help me" "The education classes and workshops... increase your knowledge about how to combine fresh things with other foods and make it a well-balanced and nutritious meal" "I like connecting with other people. I might meet a buddy who wants to exercise with me...I want to make friends who have the same frame of mind." 3) Adoption: Factors Influencing Program Continuation: "She [dietician] was very positive. It was very motivational... [the education event] was fun and meetin' the other people that was in it was great" "It helps me be more aware of what I'm eating, what I'm putting in my body. Like I said, it's a blessing for me. It encouraged me to try new recipes, to do things that I wouldn't even do" "That box is helping me a whole lot. That's the mental part, not worrying about having and not having" 4) Implementation: Barrier to Participation: "Telephone was a lot better for me because of the financial. I live on social security and the gas it takes to get there" 5) Maintenance: Sustaining healthy habits: participants expressed a strong desire to maintain healthy eating habits but many were unsure how to do so and if they would be able to afford the produce. "I'll be eating just the way I am now, everything just healthy. Im'ma continue eating fruits and vegetables like I do now. I got used to eating it. I'm used to it now, so I have to do it. Findings: Year 3 will be focused on data analysis and publication. Preliminary findings showed significant improvements (p< .001) in fruitand vegetable intake, moderate or severe depression and diastolic blood pressure were observed between baseline and 6 months in the intervention vs matched cohort group. Within the intervention group, the improvements seen at 6 months were maintained at 12 months. During year 3, we will be submitting abstracts to the SIREN meeting, National Convening and possibly the Anti-Hunger Plocy Conference; we also intend to submit an article on the findings of the main study as well as the finding from the qualitative interviews. Health Care Utilization: We had budget constraints mid-study and had to put health care utilization data collection on hold until the intervention study was complete and we could reassess the budget. Budget requests for this project have been received and are being finalized. We expect to collect health care utilization dataduring year 3 of the grant cycle.

Publications

Progress 09/15/22 to 09/14/23

Outputs
Target Audience:During year 1 of our grant cycle, the Fresh Food Rx study enrolled125 participants in our intervention group and 44 of 112participants needed in our comparison cohort. Theparticipants are SNAP and/or Medicaid enrolled or eligible and have a history ofa nutrition related chronic disease including Type 2 diaabetes, prediabtes, hypertension, high cholesterol and/or obesity. Enrollment into our intervention group began Feb 27, 2023 and was complete June 1, 2023. Recruitment strategies included provider referrals, referral by RD, word of mouth and a produce prescripton flyerposted at community centers in underserved neighborhoods of East Winston Salem. The intervention group ranges in age from 26 years to 83 years and is 26% male and 74% female. Our study population is 63.2% African American, 26.4% Caucasian/White, 8% Hispanic and 2.4% more than one race. Eighty percent of our participants are enrolled inMedicaid and 80% are enrolled inSNAP benefits. The chronic diseases reportedby these participants include68% with hypertension, 52% with pre-diabetes or type 2 diabetes and 34% with obesity. Recruitment to the comparison cohort group began in July2023. By the timerecruitment into the comparison cohort began, we had 13 participants drop from the intervention group so the comparison group enrollment is112 participants. A potential participant listwas generated usingthe Atrium Health Wake Forest Baptist electronic medical records. All study participants are offered Walmart gift card incentives of $40 per participant. For the intervention group, $10gift cards areprovided at baseline and at 6-month visits and $20 gift cards are providedat 12-month visits. For the comparison group, $20gift cards are providedat both the baseline andthe 6-month end of study visit. Changes/Problems:The Fresh Food Rx study design was modified and approved in Feb 2023. Our original study would have enrolled 250 participants, provided produce delivery 2x/month for 12 months and did not include acomparison group. This study would have reached more people with food insecurity but was less likely to impacttheir health. In January 2023, we opted to modifyour design to enroll 125 participants who receive weekly produce delivery weekly for 12 months and add a matched comparison cohortwho completes all questionnairesat baseline and 6 months but does not have produce, coaching or education intervention. The primary reason for this change was to assess the impact of the reduction in SNAP dollars (due to covid funding ending) and to see if weekly changes in produce intake would impact chronic disease management. Recruiting into the intervention arm went smoothly and weekly produce delivery was easier to implement on the produce and delivery sideof the study. Recruitment into the comparison cohort has been slow. Wematchedparticipants on demographics and disease using electronic records and many matches had changes to phone numbers, and address. Many calls were made but messages are not often returned which made recruitment slow. As of Sept 15, we had enrolled 44 of the 112 participants needed for the comparison cohort. Enrollment into the intervention group began Feb 27, 2023 and continued rapidly for 3 months until we reached our target of 125 participants. By March, we had executed an agreement with The Produce Box as a study partner and produce delivery and invoicing was in place. Between March and August, we negotiated an agreement with Wake Forest University Health Sciences (WFUHS) but there was an underlyingconcernwith the indirect costs budget. The study continued with participants while both the YMCA and WFUHS reevaluated the budget and expenses from year 1 and expected costs from year 2. A new budget was submitted to and approved by the USDA early in year 2 of the grant cycle. What opportunities for training and professional development has the project provided?As a GusNIP grantee, we haveeducation opportunities through the NTAE and Fair Share Network. Learning about other programs and education tools available has allowed us to incorporate new ideas into our programming and brainstorm wasy to address our challenges. We partnered with Second Harvest Food Bank for our first education program, learning tips and sharing recipes which we then disseminate to our participants. Partnering with The Produce Box has also provided insight on growing, harvesting and storing fresh produce in NC. Sometimes our participants shared a recipe which we could share with others in the program, i.e. one participantpreparedcabbage by slicing it like a steak and grilling it with olive oil and garlic for a unique way to use the cabbage from their produce box. We were able to attend and present our program at the National Convening in DC in June 2023. Our program is unique in that we deliver produce for 12 months whereas many programs are 3-6 months duration. We also are collecting data on depression, loneliness and fatigue which was a topic of interest at the convening. We know there is a connection between food and mental health, produce intake and microbiome composition. We also are noticing improvement in participants outlook and overall happiness throughout the program and look forward to analyzing our results. While there can be multiple reasons beyond produce intake which may impact mental health, we are hopeful the coaching and behavior support in combination with fresh produce will demonstrateimprovements in the mental health ofour participants and look forward to analyzing our results. How have the results been disseminated to communities of interest?Our results have not been disseminated as of yet but we have created an Advisory Council for our study. This council is made up of external scientists, community leaders, and members of food-based organizations who addressfood insecurity in Forsyth County. We have 18people serving on our AdvisoryCouncil and meet on a quarterly basis to provide information and feedback on our program and to solicit input to our study. What do you plan to do during the next reporting period to accomplish the goals?In year 2 of our grant cycle, we will finish the 6-month visits, continue to provide weekly produce boxes to participant homes and complete the12-month visitsfor the intervention group. For the comparison cohort, we will complete recruitment and 6-month post studyvisits. Produce delivery and all study visits will be completed by the end of June 2024 and analyses completedby late August 2024. We intend to finishour study by the end of year 2 of the grant cycle. For our participants, we will continue to distribute monthly newsletters through May for those still receiving produce. Three additional education sessions will also be offered during year 2 of the grant cycle. These will bea Lunch and Learn program with nutrition and exercise breakout sessions, a virtual nutrition session title 5 A Day You Way, and a session educating participants "how to read anutrition label"in combination with a Grocery Store tour. We know our participants are benefitting physically, socially, emotionally, and financially from our program and we are challenged to find resources for themwhen the study is complete. We will be creating a "what's next?" document to giveour participants at this12-month visit. This document will provide resources and ideas to help them maintain their health promoting behaviorsand to continue to access farm fresh produce in the area. We will help eligible participants enroll in SNAP benefits and share ways to help budget those dollars to include produce for better health. We intend tooffer participants the opportunity to transition to produce box delivery using their SNAP dollars for anyone interested.

Impacts
What was accomplished under these goals? The Fresh Food Rx study is progressing very well. All 125 participants were enrolled into the intervention arm ofthe study between Feb 27 and June 1, 2023. Within the first 6months of enrollment,wehad 11 participants drop from the program for various personal reasons and 2participants die. The first 6 months of our study incorporates multiple touch points fromhealth/nutrition coaching sessions, wellness checks (for participants over 60 or with PHQ score >10) and quarterly phone surveys. Nutrition visits: All participants received individual nutrition/health coaching at their baseline visit and were offered the opportunity for follow-up visits in person or virtually. Of the 112active participants, 83% completed abaseline and2 follow-upnutrition coaching sessions, 12% completedbaseline and1 follow-upnutrition coaching session and 4% completed the baseline nutrition coaching session only. Quarterly Survey: All participants are contacted quarterly and asked to complete a brief phone survey assessingthe impact of health/nutrition coaching and education, produce delivery,and pros and cons of the intervention. Aminimum of 3 attempts are made to connect with each participant. During year 1 of the grant cycle, the first quarterly survey was completed by 73% of our participants. Wellness Checks: Participants 60 and over or anyone with a PHQ score greater than 10 qualified for wellness checks. Of those who qualified, at least 3 wellness checks were completed with these participants. 6-Month Visits:As of Sept 14, wehad31 6-month visits completed. Preliminary Findings: Our program has been very well received and we continue to have inquiries about enrolling into the Fresh Food Rx study. Weobtain feedback on our program during the quarterly phone survey, at nutrition coaching sessions andat the 6-month visit. This feedback is mostly positive, though a few people stated sometime produce spoiled quickly. Mostparticipants arevery appreciative of the produce delivery, reportimprovements in their A1c levels, improved weight management and/or generally feeling better. Comments from our participants shows that the Fresh Food Rx program improvesmeal planning, fruit and vegetable intake andother dietary habits, inspiresthem to move more, and helped them feed their families healthier meals. A sample of specific feedback providedis highlighted below: "I love receiving the fresh veggies and other things in the produce box. I am able to buy other things that I need because of this produce that I get" "It makes me want to eat less junk foods and motivated me to decrease my soda intake" "I get to try different things. I really appreciate it" "me and my daughter enjoy cooking with the produce that we get in the box each week. She loves to bring the box in and we unbox it together. We love the fresh veggies and fruits" "Seeing it on the front porch gets the whole family excited. We love to see what's inside and plan what to do with the food. We have been cooking together and eating healthier food" "I feel special and high class, like people care about me" "I am eating breakfast daily now and my A1c has improved" "very honestly, it has really improved my health. My doctors say I look great. I can even afford my medications and have stayed out of the hospital" While many participants had overall improvements in their health, three individuals had remarkable success sowe want to share their stories. Participant 1: When this participant enrolled in the program, they were ready to make changes and lose weight. They have obesity, hypertension and type 2 diabetes. At baseline, there was NO specific information provided to encourage or guide weight loss rather thenutrition coaching was focused on healthier eating,making choices to support a stable blood glucose and setting goals. They were engaged in health coaching sessions, consistently attended all follow-up visits as scheduled and asked many questions to improve the choices. As weight loss progressed, they began more walking and even tried the silver sneakers class at the YMCA a couple of times. Direct participant feedback was "My A1c has dropped from 6.1 to 5.4! I am learning new recipes and it makes me excited to get the veggies and plan meals. I have recently lost 31 lbs and the boxes remind me to eat healthy. I am excited to continue to lose weight and the program inspires me". Participant 2: When this person enrolled, they were using a walker due to pain from degenerative disc disease andsevere knee pain. They needed to lose some weight before qualifying for a knee replacement. Other health history reported includes hypertension, type 2 diabetes, anxiety and memory issues. They actively participated in Nutrition Coaching sessions, set realistic goals and made a conscientious effort to make healthier choices without focusing on weight loss. Direct participant feedback was "This program has allowed me to make positive changes in my diet and my mental health has benefitted! Iwas able to join the Y with your help and now Iswim 3-4 times per week and even made friends at the Y. I have lost 11 lbs and have less pain in my knees now too. I am so grateful for this program. It has helped me so much" Participant 3: This participant enrolled primarily for the free food. Their reported history includesMI,coronary bypass surgery and hypertension. This participant was overweight at baseline but shared they were morbidly obese in theirteen years. They were homeless in the past and admitted to not liking vegetables and drinking >12cans of soda each day.They shared that sugary foods are inexpensive and vegetables lead to stomach issues. The coaching was focused on less sugar and increasingfiber slowly with foods in the produce boxes. They called often, had many complaints and almost dropped out early in the study. They were encouraged to keep trying and only consume 1-2 servings of produceper day to adjust to higher fiber intake. They didparticipate in allhealthcoaching sessions. At the 6 month visit, the change was remarkable, both physically and mentally. Their feedback was "I feel really good now and have lost 14 lbs! I didn't like vegetables in the beginning because they gave me stomach problems but lwas taught to add them slowly to my diet and now I love them. I am happier and feel good" Transportation:Transportation continues to be a challenge for our participants. Atrium Health Wake Forest Baptist Geriatrics has a transportation service which we have been able to tap into for our participants. We have arranged transport for about 50% of our participants for baseline and 6-month visits and will do the same for 12-month visits for those in need. We have also provided transportation for our education program for those who need and want it. The stipend and our GusNIP transportation budget together has supported our participants needs;we have a large number of participants who rely on the citybus system or Trans-Aid for medically disabled.

Publications