Source: MONTEFIORE MEDICAL CENTER submitted to NRP
FRESH TAKES!: ADDRESSING HEALTH OUTCOMES FOR PATIENTS WITH DIABETES AND PREDIABETES BY COMBATING FOOD INSECURITY
Sponsoring Institution
National Institute of Food and Agriculture
Project Status
ACTIVE
Funding Source
Reporting Frequency
Annual
Accession No.
1029491
Grant No.
2022-70424-38499
Cumulative Award Amt.
$500,000.00
Proposal No.
2022-06998
Multistate No.
(N/A)
Project Start Date
Sep 15, 2022
Project End Date
Sep 14, 2026
Grant Year
2022
Program Code
[PPR]- Produce Prescription
Recipient Organization
MONTEFIORE MEDICAL CENTER
111 E 210TH ST
BRONX,NY 10467
Performing Department
(N/A)
Non Technical Summary
Fresh Takes!, aims to improve health outcomes for those with prediabetes or overt diabetes by increasing consistent access to high quality fruits and vegetables, thereby reducing food insecurity, and providing on-going nutrition support and education. Leveraging our existing partnership with Westside Campaign Against Hunger, Fresh Takes! will enhance BHC's food distribution services, promote systematic data collection and analysis of patient health outcome data, and provide on-going nutrition support to help individuals with diabetes and prediabetes improve their health outcomes.Once deemed eligible by our team based on age, diabetes-specific criteria and eligibility for food assistance or Medicaid, patient participation in Fresh Takes! includes individual assessments with a Registered Dietitian, bimonthly food box distributions for 6 months, and an education session and food demonstration at each food pick-up. We predict that participation in Fresh Takes! will be associated with increased consumption of fruits and vegetables and consistent use of strategies that result in healthier eating practices and lifestyle change. The potential impact of Fresh Takes! extends beyond meaningful improvement in health outcomes for diabetic control, ultimately working towards combatting health disparities that exist in some of the most under resourced communities of the South Bronx, as well as potential cost-savings for patients with diabetes and prediabetes more generally.
Animal Health Component
(N/A)
Research Effort Categories
Basic
100%
Applied
(N/A)
Developmental
(N/A)
Classification

Knowledge Area (KA)Subject of Investigation (SOI)Field of Science (FOS)Percent
70460991010100%
Goals / Objectives
The overall aim of Fresh Takes! is to normalize glucose levels for individuals with prediabetes and improve diabetic control for individuals with diabetes. This will be accomplished by meeting the following goals, objectives, and outcomes.Goal 1: Assure sufficient enrollment/engagement in Fresh Takes! to document outcomes.Goal 1 Objective 1: Identify/enroll eligible patients with prediabetes or diabetes in Fresh Takes!a. Outcome 1.1.a: Enroll 80 individuals in 4 cohorts over the 3-year grant (320 total patients)b. Outcome 1.1.b: Participants will pick up at least 80% of their Fresh Takes! food boxesc. Outcome 1.1.c: 70% of participants will attend at least 6 education sessionsGoal 2: Fresh Takes! participants will increase fruit and vegetable consumption.Goal 2 Objective 1: By the end of the 6-month Fresh Takes! program, participants will increase fruit and vegetable intake.a. Outcome 2.1.a: 80% of participants will report a daily increase of 1 serving of fruit and vegetables on their exit survey compared to intake surveyGoal 3: Reduce Food Insecurity.Goal 3 Objective 1: By the end of the 6-month Fresh Takes! program, participants will report less food insecurity on a validated measure of food insecurity.a. Outcome 3.1.a: Change in prevalence of food insecurity will be assessed by comparing pre-and-post-program responses on an adapted validated measure of food insecurity, the 2 item Hunger Vital sign (adapted to include a 6-month lookback rather than the original 12month).Goal 4: By the end of the 6-month Fresh Takes! program, participants will demonstrate improved HbAIc levels.Goal 4 Objective 1: Participants with diabetes will demonstrate improved glucose control.a. Outcome 4.1.a: Participants with diabetes who are < 65 years with a HbA1c > 7.5% at entry will have a 0.5% reduction in HbA1c level after participating in Fresh Takes!b. Outcome 4.1.b: Participants with diabetes who are ≥ 65 years with a HbA1c >8.5% at entry will have a 0.5% reduction in their HbA1c level after participating in Fresh Takes!c. Outcome 4.1.c: Participants enrolled in Fresh Takes! with diabetes will demonstrate better glucose control than diabetes not enrolled in the program receiving usual care at the conclusion of the program and at follow up 6 months later.Goal 4 Objective 2: Participants with prediabetes will normalize their blood glucose levels by the end of the program.a. Outcome 4.2.a: Patients with prediabetes will have significantly lower HbA1c levels by the end of the program.b. Outcome 4.2.b: Individuals with prediabetes enrolled in Fresh Takes! will have lower HbA1c levels at the end of the program compared to individuals not in the program receiving usual care.Goal 5: Participants in Fresh Takes! will demonstrate lower health care utilization.Goal 5 Objective 1: Participants will have fewer medical and emergency room visits.a. Outcome 5.1.a: Participants will have fewer excess diabetes-related visits (defined as > 1 visit in a 6-month period) during the 6 months of the program and in the subsequent 6 months (1 year inclusive) than individuals not enrolled in the program receiving usual care.b. Outcome 5.1.b: Individuals enrolled in Fresh Takes! will report fewer emergency room visits for diabetes management on their exit survey compared to their intake survey.Goal 5 Objective 2: BHC will explore the development of a partnership with one of our larger insurance partners to be able to compare health care costs related to diabetes care for participants enrolled in Fresh Takes! compared to health care costs for individuals in care at BHC with diabetes who do not participate in the program.a. Outcome 5.2.a: Identify a willing insurance partner by month 6b. Outcome 5.2.b: Establish a data sharing agreement with an insurance partner by month 9c. Outcome 5.2.c: Compare health care costs provided by our insurance partner to compare costs for patients enrolled in the program compared to those in usual care.
Project Methods
BHC's Center for Research, Evaluation, and Preventive Health is composed of data analysts and public health experts with deep knowledge of data metrics and evaluation. The team has the capacity to extract data, create systems to monitor process and outcome metrics, and to analyze and interpret the results of the program, as well as to assist in disseminating the results of the program in professional presentations and publications.Throughout the program, the data team will create tracking systems to monitor 1) enrollment and engagement in the program, including numbers of individuals who are eligible, accept, and then enroll in the program; 2) the numbers and percentages of participants who engage in the program defined as picking up biweekly food boxes, receiving assessments by an RD, and attending educational sessions; and 3) the numbers and percentages of individuals who complete intake and exit surveys and obtain timely HbA1c tests. Process on these goals (i.e. qualitative data) will be reviewed monthly at the Nutrition Team Meeting and Chronic Care Team meeting and quarterly at the weekly BHC Grant Team meeting. These multi-disciplinary meetings include nurse, physician, case management, administrative and data analyst representatives. Fresh Takes! will be a standing agenda item at these meetings to allow the team to identify challenges and successes and quickly adapt workflows as needed to ensure success.The quantitative data collected for this project is data pulled from our Electronic Medical Record (EMR), program logs, and patient-completed surveys. Surveys consist of fixed-choice items on food frequency; food insecurity; use of community resources; medical and emergency room utilization, and self-assessment of health are completed by participants at entry and exit from the program. The data team at BHC has access to several data extraction tools to pull patient demographics (age, race/ethnicity, insurance), pertinent health data (BMI, comorbidities, blood pressure), visit history and visit-related ICD codes; and laboratory tests (HbA1c) from the EMR.Program logs will be used to monitor enrollment and retention in the program as well as participation in food pickups and educational assessment. The Nutrition Team, consisting of the Director of Nutrition, two Registered Dietitians, and the Food Pantry Coordinator, are primarily responsible for food distribution activities, and manage a food distribution tracking sheet in Excel; they will continue to do so. The nutrition team will also monitor the timeliness of intake and exit surveys to ensure compliance.The impact of Fresh Takes! will also be assessed though changes in several measures: 1) blood glucose levels as measured by pre-and post-program HBAIC levels, and 2) self-reported fruit and vegetable intake, food insecurity, and emergency room use from the beginning to the end of the program. We hope to work with one of the largest insurance providers for BHC patients to get comparative costs of diabetes-related care for those in Fresh Takes! compared to individuals not enrolled in Fresh Takes!. Lower health care costs will be assessed using three methodologies: 1) comparing the number of diabetes-related health care visits for Fresh Takes! participants compared to those in usual care, 2) comparing the frequency of self-reported emergency room visits for diabetes on intake and exit surveys, and 2) comparing diabetes-related costs as reported by insurance for those enrolled in Fresh Takes! to those in usual care. The first two measures are retrieved from our EMR or program files; our success in reporting out on the third measure is dependent on the type and quality of data that can be provided by insurance companies.

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

Outputs
Target Audience:To be eligible for Fresh Takes!, patients must be 18-75 years of age and be identified as 1) having diabetes based on an ICD diagnosis code placed in the Electronic Medical Record (EMR) or by having a less than ideal HbA1c level, defined as >7% within the preceding 12 months or 2) having prediabetes based on an ICD diagnosis code in the EMR or by having a HbA1c level between 5.7% - 6.4% in the preceding 12 months. Changes/Problems: While our Fresh Takes! program is now running smoothly, we were significantly delayed in getting IRB approval. This delay pushed back the launch of our program. Further, we were also overly optimistic about the amount of time it would take to close out a cohort and recruit for the next one. We had budgeted a 4-week gap between programs but we actually need at minimum 8 to 10 weeks since each participant needs to have an individual session to complete surveys and measurements. In the gap between programs, we need to schedule appointments for 140 or more individuals, which is time intensive. Therefore, between the initial delay in the launch of the program and the extra time needed between cohorts, it is taking us longer to carry out this project than anticipated. This means that we will need to extend the program beyond the grant period. We anticipate that we will run Cohort 3 from March to August 2025 and Cohort 4 from November/December 2025 to May/June 2026. Our grant period ends 9/14/2025. Consequently, we will need to apply for a no-cost extension. We are also grateful that we have been approved to continue to use our internal RedCap system for data management. Because we are collecting additional information not required by GUSNIP, using RedCap has been much easier for us in tracking our data collection and making our data analysis smoother. We can easily download our data from the RedCap system and submit the required GUSNIP data. We have also made several significant changes to our protocol. First, we changed our educational approach. We had originally anticipated that we would hold a nutrition session for participants at each food pickup. However, patients arrive at different times and cannot necessarily stay for a scheduled nutrition session. Therefore, we created a YouTube channel featuring videos of recipes using the contents of the biweekly food box. At each food pickup, each participant is offered a taste of the featured food items from the food box as part of the food demonstration, as well as the recipe. Patients also receive a text message with the link to the food demonstration video. In addition, we have randomized each cohort so that one group receives the standardized education as described above and the other group receives additional recipes and food storage information. We are curious if extra information is associated with greater use of the food box. Secondly, we have received approval from our IRB to add Veggie Meter readings to our assessment strategy. Because individuals may have difficulty accurately reporting their dietary intake, we are excited to obtain an objective measurement of dietary intake. The Veggie Meter device measures skin carotenoid concentrations using noninvasive, reflective spectroscopy. This involves placing the fingertip into a scanner that projects UV light onto the skin and measuring the wavelength of light that is reflected off the skin. Veggie Meter scores range from 0 to 800, with higher scores representing higher skin concentrations of carotenoids. Carotenoids are antioxidants that are found in a variety of fruits and vegetables. Physiologically, they are involved in replenishing vitamin A stores in the body, regulating cell growth, ensuring appropriate gene expression, and supporting the immune response. We will be obtaining Veggie Meter readings at intake, midway, and at the end of the program, along with dietary assessments. Lastly, we are pleased to have received additional funding from the Capacity Building Fund to reduce the burden of participating in the Fresh Takes! Program. Not only must participants take time out of their busy lives to pick up food boxes, but they also must pay the cost of transportation to and from the food distribution site. Because the food boxes are heavy, some participants need to use Uber or hire a private car to come pick up their food boxes. Thanks to the generosity of the Capacity Building Fund, we can now reimburse participants $15 for each food box pickup, as well as provide a $25 stipend when participants come on-site to complete the end of the program surveys, Veggie Meter readings, and other measurements. These changes are reflected in our most recently approved protocol (dated 9/19/2024), which can be found in the Appendix. What opportunities for training and professional development has the project provided?During this grant period, our team has participated in valuable training and professional development opportunities. Nine nutrition students were trained as emerging professionals through hands-on experience with the project. This past June our Registered Dietitian also participated in the New to GusNIP Mini convening in New York City as part of the Produce Prescription group. This experience promoted collaboration with other grantees to share insights on challenges, successes, and best practices in order to reduce the learning curve of new practitioners to GusNIP programs. Additionally, our nutrition team had the opportunity to present their work at local and national conferences, including the New York City Research Improvement Networking Group (NYCRING), which fosters local collaboration among NYC researchers, and the Food and Nutrition Conference & Expo (FNCE), the nation's premier nutrition event held in Minnesota earlier this year. How have the results been disseminated to communities of interest?Our Administrative Clinical Dietitian and Registered Dietitian have actively shared the results of their work with key communities of interest. In addition to presenting at the conferences mentioned above, they also engaged directly with BHC staff and Community Advisory Council members, ensuring that their findings reached the communities most impacted by their efforts.?? What do you plan to do during the next reporting period to accomplish the goals?We will recruit and enroll patients into our upcoming Fresh Takes! cohorts, with the next one planned to launch in February or March 2025. We have developed workflows for recruitment and enrollment, program management, and data collection and analysis that are all working well. Therefore, we do not anticipate facing any challenges in reaching our target sample size or in collecting sufficient information to analyze the impact of the program. In the next reporting period, we will work on developing a partnership with an insurance company so that we can get a comprehensive look at the financial costs associated with caring for individuals with diabetes and to determine if these costs differ for Fresh Takes! participants compared to our general population.

Impacts
What was accomplished under these goals? BHC achievements are detailed below, organized under each goal. Note that we will be reporting outcome data only on Cohort 1 since Cohort 2 is still in progress. Of note, these are preliminary results as our power calculations indicate that we need a minimum of 256 individuals with complete data to be able to report meaningful results. Goal 1: Assure sufficient enrollment/engagement in?Fresh Takes!? 1.1.a: Our goal is to enroll a total of 320 individuals in 4 cohorts over the course of the 3-year grant to achieve an analytical sample of 256 individuals. While we had a delayed start which will require us to ultimately request a no-cost extension, we have made excellent progress. To date, we have enrolled 161 patients and 146 have completed the program. We will be launching Cohort 3 in February/March 2025. 1.1.b: Of the 77 individuals in Cohort 1, 75 participants picked up at least one food box out of the 12 biweekly food boxes. Of these 75 participants, 61% picked up 80% or more of the 12 food boxes. However, a small minority of participants picked up infrequently, which drove our pick-up percentage downwards. On average, participants picked up 9 (SD 3) out of 12 food boxes over the course of the program. 1.1.c: Because educational sessions were paired with food pick up, participation in educational sessions was high; 89% participated in at least 6 educational sessions. Goal 2:?Fresh Takes!?participants will increase fruit and vegetable consumption. 2.1.a: Of the 75 participants in Cohort 1, 59 had a pre and post survey on F and V intake, of these 25 (42%) had an increase of 1 serving of fruits/vegetables and an additional 6 had a ½ serving increase in their intake of fruits and vegetables. Overall, 53% of the participants in Cohort 1 demonstrated a clinically significant increase of at minimum a ½ serving of fruits and vegetables. ? Goal 3: Reduce Food Insecurity. 3.1.a: At baseline, a high percentage of participants reported low food security: 32% had very low food security and 47% low food security whereas only 21% reported high food security. At 6 months, rates of food insecurity declined with 23% reporting very low food insecurity and 37% reporting low food security. Rates of high food security increased to 40%. Of the 60 participants who completed both pre and post food insecurity surveys, participants in Fresh Takes reported significant improvements in food security on USDA Six-Item Short Form of the Food Security Survey Module. Lower scores on this measure are associated with better food security.?Scores declined on this measure from a mean of 3.2 (1.97) at baseline to 2.3 (2.05) at 6 months, p=.002. Goal 4: Participants will demonstrate improved HbAIc levels. Cohort 1 consists of 58 patients with diabetes and 17 patients with pre-diabetes. Participants with Diabetes: Our analysis was divided by age category and HBAIC status since the American Dietetic Association sets different goals by age and by baseline control level. For example, the HbAIC level of concern for individuals less than 65 years is lower (HbA1c > 7.5%) than it is for older individuals (HbA1c >8.5% for individuals ≥ 65 years). Both groups will achieve clinically significant improved control if they reduce their HbAIC levels by a minimum of 0.5. Of the 58 individuals with diabetes in Cohort 1, we have pre and post program HbAIC levels for 57 individuals. We matched HbAIC levels for 47 younger individuals and 10 older individuals. Of the 47 younger participants with diabetes, 20 had a baseline HbA1C level above the level of concern (7.5%), with a mean HbAIC of 9.31 (SD:1.85). Of the 20 with elevated HbAIC at baseline, 20% of them had a 0.5% reduction in HbA1C levels while the other 80% either experienced limited change or slightly increased. Of the 10 older participants, 2 had a baseline Hba1C level above the level of concern (8.5), with a mean HbAIC of 10.3 (SD 0.28). Both participants (100%) experienced a 0.5% reduction in HbA1C levels. Thus, for our full sample of diabetes with elevated HbAIC levels, 27% demonstrated significant improvements in diabetic control by the end of the program. We then compared changes in HbAIC levels for Fresh Takes! participants to patients with diabetes in care in the general population in the same time period (n = 154) using the same criteria for age and control. There was no significant difference in the changes in HbA1C levels between the 2 groups by the conclusion of the program: 0.05 mean change for the general population vs. 0.35 mean change for Fresh Takes participants, p=.13. Participants with Prediabetes: Our goal is to help patients with prediabetes normalize their blood glucose level. However, evaluating whether we have achieved this goal is difficult because individuals with prediabetes are covered by insurance for screening with a HbAIC only once a year. This time frame does not work neatly around a program that is 6 months in length. In addition, there is no agreed upon marker of improvement like there is in diabetes where a .5 reduction in HbAIC levels is considered a significant improvement. Rather for those with prediabetes the goal is to have a HbAIC level of less than 5.7. Further, the number of individuals in our sample with prediabetes so far is small, consisting of only 17 individuals.Of the 17 individuals with prediabetes, we have pre and post program HbAIC levels for all 17 individuals. None of the individuals with prediabetes normalized their blood sugar, although 5 had lower HbAIC levels at follow up than at their baseline. Comparing the 17 prediabetic participants to the larger Bronx Health Collective prediabetic population (n = 27) in care in the same time period, there was no significant difference in the changes in A1C levels between the 2 groups by the conclusion of the program. Goal 5: Participants in?Fresh Takes!?will demonstrate lower health care utilization. Fewer medical and emergency room visits. 5.1.a: Because Fresh Takes! participants receive healthy foods and regular check-in visits with the nutrition staff, it was hypothesized that they would utilize less health care than individuals without this type of support. Individuals with diabetes in good control only require one visit every 6 months to monitor their condition. Therefore, excess care was defined as needing more than 1 diabetes-related health care visit in a 6-month period of time. However, when using this definition to compare Fresh Takes! participants (n=58) to the general population seeking care in the same time period (n=333), the proportion of excess care was similar. Nearly one-third (33%) of Fresh Takes participants had excess diabetes-related care at BHC compared to 36% of the general population. While the proportion was lower among Fresh Take participants, this did not reach statistical significance, odds ratio 0.86 (95% CI 0.48?to?1.56). 5.1.b: Only 24 individuals answered this question on intake and exit surveys and none reported using emergency room services at baseline. Therefore, we were not able to evaluate this outcome. Objective 2: Partnership with an insurance partner. We have deferred addressing this goal until midway through the program. We wanted enough data on our Fresh Takes! participants to be able to determine the most appropriate insurance company to approach depending on which insurance plans are most used by our participants. We also wanted to have preliminary outcome data to be able to share with a potential partner. For example, while not a deliverable for this project, our preliminary analysis shows that individuals enrolled in Fresh Takes! have significantly lower blood pressure levels after participating in the program. Because an insurance partner will need to invest resources in helping explore whether Fresh Takes! participants have lower diabetes-related health care costs, we wanted to have some preliminary outcomes to make the investment seem potentially worthwhile.

Publications

  • Type: Conference Papers and Presentations Status: Published Year Published: 2024 Citation: Vega Avendano M,?Saballos Tercero F, Hackley B, Sarmiento A, Magan M, Shankar V, Concepcion L, Qadeer R. Fresh Takes!?The Impact of Receiving Fresh Food Boxes on the Health and Well-being of?? Individuals Living with Diabetes or Prediabetes in Under-resourced Communities in the South Bronx.?2024 Food & Nutrition Conference & Expo, Poster Presentation, Minneapolis MN, October 6-8, 2024.
  • Type: Conference Papers and Presentations Status: Published Year Published: 2024 Citation: Vega Avendano M,?Saballos Tercero F, Hackley B, Sarmiento A, Magan M, Shankar V, Concepcion L, Qadeer R. Fresh Takes!?The Impact of Receiving Fresh Food Boxes on the Health and Well-being of?? Individuals Living with Diabetes or Prediabetes in Under-resourced Communities in the South Bronx.?2024 NYC RING Convocation of Clinical Practices. Poster Presentation, Bronx, NY, October 24, 2024.


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

Outputs
Target Audience:To be eligible for Fresh Takes!, patients must be 18-75 years of age and be identified as 1) having diabetes based on an ICD diagnosis code placed in the Electronic Medical Record (EMR) or by having a less than ideal HbA1c level, defined as >7% within the preceding 12 months or 2) having prediabetes based on an ICD diagnosis code in the EMR or by having a HbA1c level between 5.7% - 6.4% in the preceding 12 months. These are the individuals that will be targeted for enrollment in the program cohorts. Changes/Problems: The IRB approval took much longer than anticipated, therefore the implementation of our first cohort was much delayed. We are still planning to conduct 4 cohorts of patients in an effort to collect the necessary data for our analysis and evaluation of the program. We are aware that our timeline has shifted and would be interested in discussing the possibility of a no-cost extension if that is feasible. We made some changes in ourmeasures on food insecurity. For ease of recruitment, we used the two item food insecurity measure, Household Food Security Survey, with a 12 month look back. Individuals with diabetes or prediabetes needed to endorse at least one item to be eligible for the program. In addition, we changed our measure to determine change in food security from the 2-item Hunger Vital Sign to the required food security metric, the 6 item USDA Food Security Survey. What opportunities for training and professional development has the project provided? Nothing Reported How have the results been disseminated to communities of interest?We have not yet disseminated information to communities of interest, as there have been no results to disseminate. Once the first cohort completes the program and their results are analyzed, we will begin disseminating our results to communities of interest, beginning first with our Community Advisory Board. What do you plan to do during the next reporting period to accomplish the goals?In the next reporting period, we will begin, complete, and analyze the results of the first cohort of the Fresh Takes! program, which will conclude in March/April 2024. After the first cohort is complete (and still within the next reporting period), we will start the second cohort by enrolling eligible patients and initiating the program again, approximately May/June 2024.

Impacts
What was accomplished under these goals? Between 9/15/22-9/14/23, the Fresh Takes! team successfully wrote, submitted, and revised an application to the Institutional Review Board within our hospital system. The IRB approved our submission, allowing us to move forward with program implementation and patient recruitment. By September, we developed a system of recruitment and began enrolling patients into our first cohort of the program. The Fresh Takes! teamalso finalized the logistics for food delivery and accounting with our community partner, the West Side Campaign Against Hunger. We also have set up our RedCAP tracking system to monitor program participation and to enter the data fromour program questionnaires, including our baseline, mid-program, and end-of-program surveys and food box usage questionnaires. Because RedCAP is new to the team, this required major effort with consultation by our statistician to set up correctly.

Publications