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PURPOSE: The purpose of this study was to assess participants' perceptions and experiences while participating in a Food is Medicine medically tailored meal plus intensive nutrition counseling intervention to create a theoretical explanation about how the intervention worked. METHODS: This interpretive qualitative study included the use of semi-structured interviews with active participants in a randomized controlled trial aimed at understanding how a medically tailored meal plus nutrition counseling intervention worked for vulnerable individuals with lung cancer treated at four cancer centers across the USA. During the 8-month long study, participants in the intervention arm were asked to be interviewed, which were recorded, transcribed verbatim, and analyzed using conventional content analysis with principles of grounded theory. RESULTS: Twenty individuals participated. Data analysis resulted in a theoretical explanation of the intervention's mechanism of action. The explanatory process includes three linked and propositional categories leading to patient resilience: engaging in treatment, adjusting to diagnosis, and active coping. The medically tailored meals plus nutrition counseling engaged participants throughout treatment, which helped participants adjust to their diagnosis, leading to active coping through intentional self-care, behavior change, and improved quality of life. CONCLUSIONS: These findings provide evidence that a Food is Medicine intervention may buffer some of the adversity related to the diagnosis of lung cancer and create a pathway for participants to experience post-traumatic growth, develop resilience, and change behaviors to actively cope with lung cancer. Medically tailored meals plus intensive nutrition counseling informed by motivational interviewing supported individuals' adjustment to their diagnosis and resulted in perceived positive behavior change.

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OBJECTIVES: While several food assistance programs in the United States tackle food insecurity, a relatively new program, "Food is Medicine," (FIM) initiated in some cities not only addresses food insecurity but also targets chronic diseases by customizing the food delivered to its recipients. This review describes federal programs providing food assistance and evaluates the various sub-programs categorized under the FIM initiative. METHODS: A literature search was conducted from July 7, 2023 to November 9, 2023 using the search term, "Food is Medicine", to identify articles indexed within three major electronic databases, PubMed, Medline, and Cumulative Index to Nursing and Allied Health Literature (CINAHL). Eligibility criteria for inclusion were: focus on any aspect of the FIM initiative within the United States, and publication as a peer-reviewed journal article in the English language. A total of 180 articles were retrieved; publications outside the eligibility criteria and duplicates were excluded for a final list of 72 publications. Supporting publications related to food insecurity, governmental and organizational websites related to FIM and other programs discussed in this review were also included. RESULTS: The FIM program includes medically tailored meals, medically tailored groceries, and produce prescriptions. Data suggest that it has lowered food insecurity, promoted better management of health, improved health outcomes, and has, therefore, lowered healthcare costs. CONCLUSIONS: Overall, this umbrella program is having a positive impact on communities that have been offered and participate in this program. Limitations and challenges that need to be overcome to ensure its success are discussed.

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Purpose: The purpose of this study was to assess participants' perceptions and experiences while participating in a Food is Medicine medically tailored meal plus nutrition counseling intervention to create a theoretical explanation about how the intervention worked. Methods: This interpretive qualitative study included the use of semi-structured interviews with active intervention participants. Purposeful sampling included vulnerable (uninsured, rural zip code residency, racial/ethnic minority, 65 years old, and/or low-income) individuals with lung cancer treated at four cancer centers across the United States. Interviews were recorded, transcribed verbatim, and analyzed using conventional content analysis with principles of grounded theory. Results: Twenty individuals participated. Data analysis resulted in a theoretical explanation of the intervention's mechanism of action. The explanatory process includes 3 linked and propositional categories leading to patient resilience: engaging in treatment, adjusting to diagnosis, and active coping. The medically tailored meals plus intensive nutrition counseling engaged participants throughout treatment, which helped participants adjust to their diagnosis, leading to active coping through intentional self-care, behavior change, and improved quality of life. Conclusions: These findings provide evidence that a food is medicine intervention may buffer some of the adversity related to the diagnosis of lung cancer and create a pathway for participants to experience post-traumatic growth, develop resilience, and change behaviors to actively cope with lung cancer. Medically tailored meals plus intensive nutrition counseling informed by motivational interviewing supported individuals' adjustment to their diagnosis and resulted in perceived positive behavior change.

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OBJECTIVE: Hemodialysis patients face one of the most difficult diets among clinical patient populations. Furthermore, dialysis dietary adherence is generally reported as low with providers generally lacking the time and resources to implement effective behavior change. The purpose of this study was to elucidate measures of patient and provider engagement with home-delivered medically tailored meals (MTMs). METHODS: We surveyed patients and staff at dialysis centers within the Denver metropolitan area. Surveys focused on 1) patient dietary intake, 2) awareness, support, and utilization of meal programs, and 3) nutritional challenges and barriers (including food security). RESULTS: We surveyed 118 patients (mean age 61.0 ± 14.2 year, 58.5% male, and dialysis vintage of 4.6 ± 4.9 years) and 26 staff across the included dialysis facilities. Patients were 20.3% White/Non-Hispanic, 35.6% Hispanic/Latin, and 31.4% Black/African American. Most patients reported eating 2 meals per day (N = 53, 44.9%) and 52.2% reported difficulty with following a kidney diet. The most cited reasons for not following the diet were behavioral or knowledge (38.5%), taste (26.3%), time/convenience (26.9%) and food autonomy (16.9%). Sixty participants (52.2%) reported living in a food desert and 26.3% reported food insecurity. Seventy-one patients (61.2%) were aware of MTMs but only 40.5% had been referred. Most (76.9%) dialysis providers were aware of MTMs but only 15 (57.7%) had actually referred patients to such a service. Black individuals were less likely to be referred for MTMs than White or Hispanics/Latin (29.7% vs 48.1% White and 45.0% Hispanic/Latin) individuals. CONCLUSION: Medically tailored meals (MTMs) represent a potential method to alleviate or bypass some of the many barriers expressed by patients. Our findings reveal a critical need for education around MTMs for both patients and providers. Medically tailored meals (MTMs) could potentially demonstrate health kidney dietary patterns that might translate to altered dietary preferences or toward future behavior change.

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BACKGROUND: Globally, poor nutrition is a driver of many chronic diseases and is responsible for more deaths than any other risk factor. Accordingly, there is growing interest in the direct provision of healthy foods to patients to tackle diet-linked chronic diseases and mortality. AIM: To assess the effect of two healthy food interventions in conjunction with nutrition counseling and education on select chronic disease markers, food insecurity, diet quality, depression, and on self-efficacy for healthy eating, healthy weight, and chronic disease management. METHODS: This parallel-arm quasi-randomized control trial will be conducted between January 2022 and December 2023. Seventy adult patients recruited from a single academic medical center will be randomly assigned to receive either: i) daily ready-made frozen healthy meals or ii) a weekly produce box and recipes for 15 weeks. Participants will, additionally, take part in one individual nutrition therapy session and watch videos on healthy eating, weight loss, type 2 diabetes, and hypertension. Data on weight, height, glycated hemoglobin, blood pressure, and diabetes and blood pressure medications will be collected in-person at the baseline visit and at 16 weeks from baseline and via medical chart review at six months and 12 months from enrollment. The primary outcome of the study is weight loss at 16 weeks from baseline. Pre- and post-intervention survey data will be analyzed for changes in food insecurity, diet quality, depression, as well as self-efficacy for health eating, healthy weight, and chronic disease management. Through retrospective chart review, patients who received standard of care will be matched to intervention group participants as controls based on body mass index, type 2 diabetes, and/or hypertension. FINDINGS: By elucidating the healthy food intervention with better health outcomes, this study aims to offer evidence that can guide providers in their recommendations for healthy eating options to patients.

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BACKGROUND: Policy initiatives have provided funding for non-acute nutrition interventions to address food insecurity as a social determinant of health, but more research is needed to understand the outcomes of these initiatives in order to determine the areas of highest impact. Therefore, the purpose of this systematic review was to evaluate the outcomes that were assessed in three nutrition interventions (produce prescription programs, medically tailored meals, and community supported agriculture) that aim to address food insecurity as a social determinant of health, and this was undertaken in order to identify future areas of study that can heighten impact. METHODS: This systematic review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) criteria. A list of search terms and keywords were compiled by the research team. A Boolean search was conducted from 1 January 2000 to 1 January 2023 in the PubMed advanced search database. RESULTS: A total of 1015 articles were initially pulled from the PubMed database, and, after a screening process, 21 articles were included in our review. Nineteen of the articles focused on adult populations or families and two focused on children. The main outcomes assessed were changes in self-reported dietary intake, while a few of the articles addressed feasibility and cost-related outcomes. CONCLUSIONS: More research is needed to assess whether nutritional interventions to address food insecurity as a social determinant of health are feasible and more cost effective in the long term. Additionally, more work should be conducted in pediatric populations, which could have a robust return on investment in terms of both healthcare utilization and healthcare expenditure.

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BACKGROUND: 'Food is medicine' strategies aim to integrate food-based nutrition interventions into healthcare systems and are of growing interest to healthcare providers and policy makers. 'Medically Tailored Meals' (MTM) is one such intervention, which involves the 'prescription' by healthcare providers of subsidized, pre-prepared meals for individuals to prevent or manage chronic conditions, combined with nutrition education. OBJECTIVE: This study will test the efficacy of an MTM program in Australia among participants with type 2 diabetes (T2D) and hyperglycemia, who experience difficulties accessing and eating nutritious food. METHODS: This study will be a two-arm parallel trial (goal n = 212) with individuals randomized in a 1:1 ratio to a MTM intervention group or a control group (106 per arm). Over 26 weeks, the intervention group will be prescribed 20 MTM per fortnight and up to 3 sessions with an accredited dietitian. Controls will continue with their usual care. The primary outcome is glycated hemoglobin (HbA1c, %) and secondary outcomes include differences in blood pressure, blood lipids and weight, all measured at 26 weeks. Process and economic data will be analyzed to assess the feasibility, acceptability, scalability, and cost-effectiveness of the intervention. Recruitment commenced in the first quarter of 2023, with analyses and results anticipated to be available by March 2025. DISCUSSION: Few randomized controlled trials have assessed the impact of MTM on clinical outcomes. This Australian-first trial will generate robust data to inform the case for sustained, large-scale implementation of MTM to improve the management of T2D among vulnerable populations. ANZCTR: ACTRN12622000852752. PROTOCOL VERSION: Version 1.1, July 2023.

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Food insecurity affects nearly 50 million Americans and is linked to cardiovascular disease risk factors and health disparities. The purpose of this single-arm pilot study was to determine the feasibility of a 16-week dietitian-led lifestyle intervention to concurrently address food access, nutrition literacy, cooking skills, and hypertension among safety-net primary care adult patients. The Food Resources and Kitchen Skills (FoRKS) intervention provided nutrition education and support for hypertension self-management, group kitchen skills and cooking classes from a health center teaching kitchen, medically tailored home-delivered meals and meal kits, and a kitchen toolkit. Feasibility and process measures included class attendance rates and satisfaction and social support and self-efficacy toward healthy food behaviors. Outcome measures included food security, blood pressure, diet quality, and weight. Participants (n = 13) were on average {mean (SD)} aged 58.9 ± 4.5 years, 10 were female, and 12 were Black or African American. Attendance averaged 19 of 22 (87.1%) classes and satisfaction was rated as high. Food self-efficacy and food security improved, and blood pressure and weight declined. FoRKS is a promising intervention that warrants further evaluation for its potential to reduce cardiovascular disease risk factors among adults with food insecurity and hypertension.

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BACKGROUND: Food insecurity is associated with worse glycemic management for individuals with type 2 diabetes mellitus (T2DM), but whether medically tailored meals (MTM), a food insecurity intervention, can improve glycemic management is unclear. OBJECTIVE: To describe the protocol for a trial assessing whether an MTM plus lifestyle intervention improves hemoglobin A1c (HbA1c) and participant-reported outcomes, relative to a food subsidy (money that can be spent on foods participants choose), for adults with both T2DM and food insecurity. METHODS: The Food as Medicine for Diabetes (FAME-D) randomized clinical trial (goal n = 200) is a pragmatic trial with an active comparator. Participants, who will have T2DM and report food insecurity, will be randomly assigned to a 6-month MTM plus telephone-delivered lifestyle change intervention, or a 6-month food subsidy ($40/month). The primary outcome is HbA1c at 6 months. Secondary outcomes include HbA1c at 12 months to assess whether the intervention effect (if any) is sustained, along with weight, food insecurity, diabetes distress, and health-related quality of life. Qualitative analyses of semi-structured interviews will help understand why, how, and under what circumstances the intervention achieved its observed results. CONCLUSION: Results from FAME-D will help inform clinical management of food insecurity when it co-occurs with T2DM. Further, results may be useful as healthcare payors are considering coverage for MTM interventions. CLINICALTRIALS: gov: NCT04828785.

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OBJECTIVE: In this study, we aim to review the current evidence of Food is Medicine interventions on diabetes outcomes among low-income or food-insecure individuals. METHODS: Seven databases were searched from January 1, 2000 to October 26, 2021 for full-text articles written in English. The studies included experimental studies of any duration and design which addressed the effect of Food is Medicine interventions on fruit and vegetable (F&V) intake and glycated hemoglobin (A1C) levels among low-income or food-insecure populations with prediabetes or diabetes of any age group. Only direction of effect of interventions on F&V intake were ascertained due to high variability in outcome measurement. A1C results were pooled using generic inverse variance with a fixed-effects model. Heterogeneity was assessed using Cochran's Q and quantified by I2. RESULTS: Sixteen studies were included. Five of the 8 studies reported a significant increase in F&V intake. Seven of the 14 studies reported a significant decrease in A1C levels. A meta-analysis of 5 randomized controlled trials (n=843) resulted in clinically meaningful reductions in A1C compared with control (mean difference, -0.47%; 95% confidence interval, -0.66 to -0.29, I2=88%, p<0.0001). Half (n=8) of the studies have a high risk of bias due to missing data, detection bias, and confounding. CONCLUSIONS: Food is Medicine interventions are effective in increasing F&V intake and reducing A1C levels of the target population. More randomized controlled studies are needed to validate the results.

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BACKGROUND: To evaluate the impact of home-delivered, medically tailored meals and medical nutrition therapy among food-insecure patients following hospitalization for congestive heart failure by comparing clinical outcomes to a retrospectively matched cohort. METHODS: Patients at high risk for readmission and food insecurity received up to three months of medically tailored meals and medical nutrition therapy after discharge. Pre-intervention and post-intervention weight, body mass index, blood pressure, and dietary intake were assessed. A combination of difference-in-difference and logistic regression models were used to compare changes between cohorts and evaluate impact attributable to the program. RESULTS: Thirty-nine program participants were compared to a matched cohort of 117 unexposed patients. Participants experienced a marginal reduction in body mass index and an increase in systolic and diastolic blood pressure; however, these results were not statistically significant. To determine relevance to clinical cut-offs, logistic regressions were used, demonstrating that exposure to the intervention resulted in higher odds of a categorical reduction in blood pressure (OR: 1.85), though this did not reach statistical significance (95% CI: 0.67-5.32). Pre vs. post trends indicated that more-healthful foods and drinks increased numerically or remained similar to baseline, while less-healthful foods decreased numerically or remained similar to baseline. CONCLUSIONS AND IMPLICATIONS: These findings highlight the need for more longitudinal research on medically tailored meals and medical nutrition therapy interventions using clinical outcomes while setting realistic suggestions for program implementation. This study additionally illustrates the promise of integrating electronic medical record data and matched cohorts into medical nutrition program evaluation within the health sector.

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BACKGROUND: Research has shown that among people with type 2 diabetes mellitus, reduction in hemoglobin A1c (HbA1c) prevents long term complications. Medically tailored meals (MTM) and telehealth-delivered medical nutrition therapy (tele-MNT) are promising strategies for patient-centered diabetes care. OBJECTIVES: Project MiNT will determine whether provision of MTM with and without the addition of telehealth-delivered medical nutrition therapy improves HbA1c and is cost effective for patients with type 2 diabetes mellitus. METHODS: Patients with poorly controlled type 2 diabetes mellitus (HbA1c >8%) will be recruited from Jefferson Health. Eligible patients will be randomized to one of three arms: 1) usual care, 2) 12 weeks of home-delivered MTM, or 3) MTM + 12 months of tele-MNT. All participants (n = 600) will complete three follow-up assessments at 3, 6, and 12 months. The primary outcome is change in HbA1c at 6 months. Secondary outcomes include change in HbA1c at 3 and 12 months and cost-effectiveness of the intervention at 6 and 12 months. Conclusion Findings from Project MiNT will inform MTM coverage and financing decisions, how to structure services for scalability and system-wide integration, and the role of these services in reducing health disparities.

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BACKGROUND: Medically-tailored meal programs that provide home-delivered medically-appropriate food are an emerging intervention when type 2 diabetes co-occurs with food insecurity (limited or uncertain access to nutritious food owing to cost). We sought to understand the experiences of medically-tailored meal program participants. METHODS: We conducted semi-structured interviews with participants in a randomized trial of medically-tailored meals (NCT02426138) until reaching content saturation. Participants were adults (age > 20 years) with type 2 diabetes in eastern Massachusetts, and the interviews were conducted from April to July 2017. Interviews were transcribed verbatim and coded by two independent reviewers. We determined emergent themes using content analysis. RESULTS: Twenty individuals were interviewed. Their mean age was 58 (SD: 13) years, 60.0% were women, 20.0% were non-Hispanic black, and 15.0% were Hispanic. Key themes were 1) satisfaction and experience with medically-tailored meals 2) food preferences and cultural appropriateness, 3) diabetes management and awareness, and 4) suggestions for improvement and co-interventions. Within these themes, participants were generally satisfied with medically-tailored meals and emphasized the importance of receiving culturally appropriate food. Participants reported several positive effects of medically-tailored meals, including improved quality of life and ability to manage diabetes, and stress reduction. Participants suggested combining medically-tailored meals with diabetes self-management education or lifestyle interventions. CONCLUSIONS: Individuals with diabetes and food insecurity expressed satisfaction with the medically-tailored meal program, and reported that participation reduced stress and the burden of diabetes management. Suggestions to help ensure the success of medically-tailored meal programs included a strong emphasis on culturally acceptability and accommodating taste preferences for provided foods, and combining medically-tailored meals with diabetes education or lifestyle intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT02426138.

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