Source: CLEMSON UNIVERSITY submitted to NRP
PRODUCE PRESCRIPTION AND NUTRITIONAL EDUCATION TO IMPROVE HEALTH OUTCOMES OF PATIENTS WITH TYPE-2 DIABETES LIVING IN A RURAL AND MEDICALLY UNDERSERVED COUNTY IN SOUTH CAROLINA
Sponsoring Institution
National Institute of Food and Agriculture
Project Status
ACTIVE
Funding Source
OTHER GRANTS
Reporting Frequency
Annual
Accession No.
1029573
Grant No.
2022-70424-38554
Cumulative Award Amt.
$500,000.00
Proposal No.
2022-07037
Multistate No.
(N/A)
Project Start Date
Sep 15, 2022
Project End Date
Sep 14, 2025
Grant Year
2022
Program Code
[PPR]- Produce Prescription
Recipient Organization
CLEMSON UNIVERSITY
(N/A)
CLEMSON,SC 29634
Performing Department
(N/A)
Non Technical Summary
Evidence continues to mount about the health benefits of consuming fresh, minimally processed fruits and vegetables as part of a healthy balanced diet. A healthy diet is linked with improved immune function, improved mental health, and decreased incidence and risk for chronic diseases, including obesity, heart disease, and diabetes. Rural, underserved, and disadvantaged communities have limited access to fresh foods due to lack of availability (food deserts) and affordability. Moreover, people in these communities often lack the knowledge and training about the relationships between food and health, and how to prepare and select foods for optimal health. Not surprisingly, these communities suffer higher incidence of diet-related chronic health conditions, including Type-2 diabetes.The proposed work uses a produce box, prescription produce strategy combined with intensive nutritional training and food preparation demonstration to 1) improve A1c and other clinical measures for people living with Type-2 diabetes, 2) increase access to healthy food options, 3) increase understanding of how foods impact health and mitigate Type-2 diabetes and other diet-related chronic conditions, and 4) educate participants on how to prepare vegetables and fruits and how to maximize SNAP benefits. Our work will take place in Abbeville County, South Carolina, a rural county with high poverty (15.3%, Census 2020), and a higher incidence of Type-2 diabetes (13%) and obesity (38%) compared to the mean percentage for SC. Working with our clinical partners, we will identify people at risk or currently suffering from Type-2 diabetes, especially in the minority and elderly communities which disproportionally suffer from this condition.We hypothesize that a combined strategy of prescribing healthy produce and delivering comprehensive nutritional education targeted to increase knowledge about the benefits of healthy diets and to optimize healthy food use (cooking demonstrations) and healthy food access (optimizing SNAP benefits) will: 1) improve A1C and other clinical measures in people with Type-2 diabetes, 2) improve food and nutrition security, and 3) increase medical savings associated with management and treatment of Type-2 diabetes and related chronic conditions. Our project is unique because it uses a produce box approach with culturally tailored recipes. The produce box exposes participants to a variety of vegetables and fruits they may not have considered before and that are optimal for managing Type-2 diabetes. We also measure if the effect of the intervention is sustained through a 9-12 month follow-up with each participant. We believe this study will:Demonstrate the effectiveness of prescription produce/nutritional education programs in Type-2 diabetes prevention and management,Inform best policy and practices for the management and prevention of Type-2 diabetes and related chronic illnesses in rural, underserved, and disadvantaged communities,Decrease health disparities in rural, underserved, and disadvantaged communities, andIncrease medical cost savings associated with Type-2 diabetes management.
Animal Health Component
0%
Research Effort Categories
Basic
100%
Applied
0%
Developmental
0%
Classification

Knowledge Area (KA)Subject of Investigation (SOI)Field of Science (FOS)Percent
70450101010100%
Knowledge Area
704 - Nutrition and Hunger in the Population;

Subject Of Investigation
5010 - Food;

Field Of Science
1010 - Nutrition and metabolism;
Goals / Objectives
The longterm goal of this project is to improve health and wellbeing outcomes of people with type-2 diabetes living in disadvantaged counties in South Carolina. Towards this goal,the proposed project will evaluate the short-term and long-term effect of a produce box incentive and nutritional education on the primary outcome of HbA1c reduction in low-income patients with type-2 diabetes, and secondary outcomes includingchanges in fruit and vegetable consumption, literacy in nutrition, health and chronic diseases, food and nutrition security, SNAP utilization, lipid profile, BMI, BP, and healthcare utilization and costs. This near-term goal will be achieved using a single arm, pre and post intervention study design with the following two objectives: 1) identify, recruit, and enroll 215 low income and medically underservedparticpantswith type-2 diabetes,and 2) implement and analyze the effect of a produce box and nutritional education interventionto test if a short term administered produce food box incentive and nutritional education improves HbA1c (primary outcome),and secondary outcomes in a sustained manner in low-income patients with type-2 diabetes.
Project Methods
In collaboration with our medical clinic partners, we will identifyand enroll 215, low-income type-2 diabetic patients from Abbeville County. Within a 14 weekfollow-up, we will provide an intervention including 7 food demonstrations, 3individual nutrition counseling sessions, and 7food boxesto each enrolled participant. We will measure the primary outcome of HbA1c at the enrollment (baseline) and at the end of the 14 week intervention. Similarily, secondary outcomemetrics will be collected at baseline and at 14 weeks and includefruit and vegetable consumption, SNAP utilization,food and nutrition security, and health and chronic disease literacy using a survey instrument. Additionalclinical secondary metrics include blood pressure (BP), body mass index (BMI), lipids, and healthcare utilization and cost. A final post-intervention follow-up will be conducted at9-12 months; all primary andsecondary measures will be collected.We will compare patients' outcomes pre- and post-intervention using apaired t-test for comparison of continuous variables and McNemar test for comparison of categorical variables.

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

Outputs
Target Audience:This project aims to reach rural, low income, medically underserved people living with diabetes who could benefit from prescription produce and nutrition education to improve clinical outcomes (Hba1c, lipid profile, BMI and blood pressure) and health-related social needs (HRSN). We are emphasizing recruitment in minority populations, especially African American communities who experience higher rates of diabetes and other diet related diseases in the Abbeville community. Changes/Problems: Nothing Reported What opportunities for training and professional development has the project provided?Presented Preliminary Findings at the following conferences: South Carolina Office of Rural Health on November 16, 2023 Live Healthy on December 7, 2023 Georgia Academy of Nutrition and Dietetics on March 14, 2024 South Carolina Public Health Association on March 27, 2024 Abby Morningstar (Lead dietitian and progrma manager)-mental health first aid training Undergraduate Student research experiences How have the results been disseminated to communities of interest?Presented Preliminary Findings at the following conferences: South Carolina Office of Rural Health on November 16, 2023 Live Healthy on December 7, 2023 Georgia Academy of Nutrition and Dietetics on March 14, 2024 South Carolina Public Health Association on March 27, 2024 Regular verbal dissimination about projectat: Food is Medicine coalition (monthly) Be Well Abbeville coalition (monthly) What do you plan to do during the next reporting period to accomplish the goals?• We have reached our target recruitment of 215 participants and have stopped recruitment; we will continue with 14-week and 9-12 month follow-up appointmentsand measures. All participants will have completedthe program by August 2025. • Continue to track project process measures to ensure studyfidelity and adherence to the study timeline. • Conduct a full finalanalysis of primary and secondary outcomes according to the data analysis plan. * Submit findings to peer reviewed journal * Dissemiantefindings to Abbeville community ad other communites using online platforms, community meetings and impact reports * Disseminate findings throughprofessional meetings (including GUSNIP meetings). We have submitted a proposal for the 2025 GusNIP convening . *Continue referring participants to the Foodshare program to sustain access to affordable fresh fruits and vegtables after completing the Fresh fr Life PRx program. * The Advisory comittee will continue discussions on sustainabilty and seek funding for subsequent PRx programs.

Impacts
What was accomplished under these goals? Under the two primary objectives stated above, and for the reporting period of Sept 15, 2023, to Oct 15, 2024 Objective 1: Enrollment/Recruitment: Our clinical partners continue to support and promotethe program through referral. This relationshiphas been critical to the success of the program. During the reporting period, 210 patients were referred by Abbeville AreaMedical Center and the Abbeville United Christian Ministries free clinic. We enrolled 153 participants (71% of our targeted enrollment of 215) who qualified for the program (i.e. diagnosedwith type 2 diabetes and eligible forreceiving SNAP benefits). We continue to recruit moreminority participants who disproportionately experiencediet-related diseases including Type 2 diabetes.Of those enrolled,53% identifiedas black or African American, 43% identified aswhite, and 3%identifiedas American Indian or AlaskanNative. The average age was62, and 71% identifiedas female, 26% identifiedas male and 1% preferred to self-describe. All participantswere either enrolled in SNAP (23%) or qualified for SNAP by income, and 47% reported beingfood insecure. Objective1 Processmeasures: Enrollment rate for the reporting period is 80% [(enrolled / referred-ineligible/unable to reach)*100], however, the inability to reach referred patients by phone was the primary reason patients were not recruited which is a common issue among the study population. No patients recruited by phone declined the study. Study retention is 95% 10 dropouts, 2 to death unrelated to the study, 2 to moving out of South Carolina, and 6 with transportation and occupation limitations resulting in an inability to participate Objective 2: Implement and analyze the impact of the Fresh For Life program Description of the primary components for enrolling and participating in the Fresh For Life Program Clinical partnerreferral: Partnerclinicians pre-screen and flag people who may qualify for the program based on Type-2 diagnosis and income. Partners give a flier topotential participants and briefly describe the program; if they are interested they are referred to the Clemson Rural Health study team. Enrollment appointment: the participant is consented, intro to study, and pre-assessment measures including 1) baseline clinical measures taken (HbA1c, lipid panel, BMI, BP), 2) health history and social determinants and 3) GusNIP Survey_Pre. Intervention (14 wks): the participant: 1) attends 4, individual medical nutrition therapy (MNT) sessions either via telehealth or in person, 2) receives twice monthly fresh produce boxes with recipes (total of 8), and 3) has the option to attend once monthly in person group cooking demonstrations (up to 4) where participants can sample recipes made with box contents and receive nutrition education, shopping on a budget, and label reading. Intervention roll-off: 14-week post-intervention follow-up appointment, post-intervention measures are collected including: 1) clinical measures, 2) medical history and social determinants, and 3) GusNIP Survey_Post_1. The patient is also given resources to continue nutrition and diabetes education and assistance with acquiring SNAP benefits if they are not enrolled. 9 to 12 month follow-up: all measures are repeated including GusNIP Survey_Post_2; Note: a patient receives a $15 gift certificate for taking each survey. Clinical team-study team communications: there is continuous communicationfrom the study team to the clinical team about the participant's progress through theprogram or any issues they may be experiencing. For example, if a participant screens positive for depressionor unstable housing, the study team alerts the appropriateclinical resources.This is a crucial element to the success of the program for recruitment, retention and we believe, positivehealth outcomes. Objective 2 Process measures: (Participants completing the 14-week intervention during the current reporting period) 100% completion rate for baseline and 14-week, and 9-12 month surveys for those completing the program (N=117). Produce Box (N=124): 100% received at least 6 produce boxes; 92% received all 8 boxes Individual Medical Nutrition Therapy(MNT) sessions (N=117): 88% attended all 4 MNT sessions 100% attended at least two least 2 MNT sessions Food demonstration (4 total, optional, N= 124) 47% attended at least 1 demonstration 22% attended all 4 sessions Objective 2 key outcomes: (cumulative since program start, N=139) Primary outcome: HbA1c Among the 139 participants who completed the 14-week intervention, 103 (71.1%) experienced a decrease in A1c. The mean A1c decreased from 7.78 to 7.33. The difference (0.45, 95% confidence interval: 0.24, 0.66), was statistically significant (p=<0.0001). For the subpopulation that experienced a decrease in A1c (N=103), 56 participants (54.4%) experienced a clinically meaningful change (i.e. 0.5%); the average decrease in A1c was 0.4%. The mediandecreasewas0.5%. Selected Secondary outcome: Food Insecurity When asked," food we bought didn't lastand we did not have money toget more", 18.7% people responding"often true" at baselinedecreased to 3.9% after the 14-week program (p=< 0.0001; N=139). When asked, "we could not afford balancedmeals", 16.1% people responding "often true" at baselinedecreased to 5.8% after the 14-week program.(p=< 0.0001; N=139) When asked "Did you cut the size of your meals or skip meals", 21.0% people responding"yes" at baseline decreased to 7.6% after the 14-week program.(p=< 0.0001; N=139) When asked, "did you ever eat less than you felt you should because there wasn't enough money for food?". 22.5% people responding "yes" at baseline decreased to 10.0% after the 14-week program (p=0.0002; N=135) When asked, "were you ever hungry but didn't eat because there wasn't enough money for food?", 14.4% people responding "yes" at baseline decreased to 6.3% after the 14-week program. (p=0.0029; N=135). Out of 139 responses, 113 (82%) said they learned to like a vegetable or fruit that they did not like before. No 9-12 month follow-up outcomes to report during this reporting period ?Impacts and Sustainability We reached our target population and recruitment number which provided sufficient power to determine the significance for our primary outcome- Hba1v. We achieved the goal to decrease A1c through the Fresh For Life program intervention and showed that a 4-month PRX program with integrated nutrition education is an effective dose for lowering A1c in patients with Type-diabetes. All measures of food security assessed at 14 weeks showed a statistically significantimprovement compared to baseline. Using recipes,varied and localproduce selection,and food demonstrations,we strivedto teach about the importance eating a variety of fruits and vegetables. To date, amajority of participants have learned to like a food that they did not like before participatingin the program.We integrated culturally relevant foods and recipes with healthieroptions in the produce boxes and in our cooking demonstrations. We also integrated a variety of low glycemic foods, many locally sourced. We successfully implemented the program in tight coordinationwith clinical partners which we feel influenced the high retention and completion rates for the program; this success will inform best practices for implementing PRx programs in the future. We fulfilled a goal of oursustainability plan by starting a permanent produceprogram (Foodshare) with local partners. This program supplies boxes of affordable fruits and vegetables (18-21lbs) and nutrition information bi-monthly for $20/box or $5 using SNAP EBT.

Publications

  • Type: Conference Papers and Presentations Status: Other Year Published: 2023 Citation: South Carolina Office of Rural Health November 16, 2023
  • Type: Conference Papers and Presentations Status: Other Year Published: 2023 Citation: Live Healthy on December 7, 2023
  • Type: Conference Papers and Presentations Status: Other Year Published: 2024 Citation: Georgia Academy of Nutrition and Dietetics on March 14, 2024
  • Type: Conference Papers and Presentations Status: Other Year Published: 2024 Citation: South Carolina Public Health Association on March 27, 2024
  • Type: Other Status: Published Year Published: 2024 Citation: Clemson Rural Health Impact Report


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

Outputs
Target Audience:This project aims to reach rural, low income, medically underserved people living with diabeteswho couldbenefitfrom prescriptionproduce and nutrition education to improve clinical outcomes (Hba1c, lipid profile, BMI andblood pressure) and health-relatedsocial needs (HRSN). We are emphasizingrecruitment in minority populations, especially African American communities whoexperience higher rates of diabetes and other diet related diseases. For the reporting period (Sept 15, 2022- Sept 14, 2023) we enrolled 54 people, 60.2% peopleindentifedas Black or African American, 5.38% idenitifed as American Idian or Alaska Native and 34.4% indentify as White. Changes/Problems: Nothing Reported What opportunities for training and professional development has the project provided?Three undergraduate studentsmajoring in health related fields have assistedwith this project. How have the results been disseminated to communities of interest? Nothing Reported What do you plan to do during the next reporting period to accomplish the goals? Continue to recruit/enroll participants using community networks (library, United Way, churches, etc.) and support including out two clinical partners (one is a free clinic) and project advisory committee. As part of the recruitment effort, we will stage 2-3 free Hb a1c screening clinics in census tracts where diabetes and food insecurity are most prevalent with the goal of finding people who are living with undiagnosed diabetes or pre-diabetes. These community members will be referred to our partner clinics for diabetes care and invited to enroll in our program/study called, "Fresh For Life" prescription produce and nutrition education program and study. Continue to be flexible with programming needs such as increasing days/times so that all participants can attend group food demonstration. Continue to track project process measures to ensure studyfidelity and adherence to the study timeline. Conduct a full interim analysis of primary and secondary outcomes. Discuss and implement sustainabilty intiatives via the program advisory committee and other stakeholders. Disseminate findings through verbal and written reportsin peer reviewed journals, professional meetings (including GusNIP meetings) and community based organizations.

Impacts
What was accomplished under these goals? Under the two primary objectives stated above: Objective 1: We enrolled 54 participants (25% of our targeted enrollment of 215). A majority of those enrolled are people of color (66%), are food insecure (53%), low income (i.e., SNAP eligible or currently enrolled in SNAP) and living with type-2 diabetes.Study retention is 100% during the reporting period. Enrollment rate for reporting period is 69% [(enrolled / referred-ineligible)*100], however, the inability to reach referred patients by phone was the reason paitents were not recruited which is common issue among the study population. No patients recruited by phone declined the study. Objective 2: The PRx and nutrition education intervention has the following components: Enrollment appointment: participant is consented, intro to study, and pre-assessment measures including 1) baseline clinical measures taken (HbA1c, lipid panel, BMI, BP), 2) health history and social determinants and 3) GusNIP Survey_Pre. Intervention (14 wks): the participant: 1) attends 4, individual medical nutrition therapy (MNT) sessions either via telehealth or in person, 2) receives twice monthly fresh produce boxes with recipes (total of 8), and 3) has the option to attend once monthly in person group cooking demonstrations (up to 4) where participants can sample recipes made with box contents and receive nutrition education, shopping on a budget, and label reading. Intervention roll-off: 14- week post intervention follow-up appointment, post-intervention measures are collected including: 1) clinical measures, 2) medical history and social determinants, and 3) GusNIP Survey_Post_1. The patient is also given resources to continue on nutrition and diabetes education and assistance with acquiring SNAP benefits if they are not enrolled. 9 to12 month follow-up: all measures are repeated including GusNIP Survey_Post_2;Note: patient receives $15 gift certificate for taking each survey Process measure outcomes for Objective 2: Of the 48 particpants who enrolled AND had time to complete the intervention during thereporting period: No dropouts 100% participants enrolled completed all baseline measures including surveys Produce Box: 100% received at least 6 produce boxes; 96% received all 8 boxes; Individual MNT sessions: 100% attended at least 2 MNT sessions; 96% attended all 4 appointments (96%) Group food demonstration (optional): 60% attended at least 1 food demo; 15% attended all 4 sessions, 13% attended 3 sessions, 6% attended 2 sessions, and 27% attended 1 session. No intervention roll-off outcomes to report during this reporting period No 9-12 month follow-up outcomes to report during this reporting period

Publications