There is sufficient evidence that medically tailored food packages contribute to improved social outcomes, while health, healthcare cost, utilization, and value need additional research to determine efficacy.
The findings below synthesize the results of the studies on medically tailored food packages across three domains of measurement:
Food-related needs fall into three interrelated categories: food insecurity, nutrition insecurity, and dietary quality.
Food Insecurity
Food insecurity is defined as not having access to enough food due to limited financial resources[1]. In 2021, 10.2% (13.5 million) of United States (U.S.) households reported experiencing food insecurity. Of families experiencing food insecurity, 6.4% (8.4 million) were identified as having low food security and 3.8% (5.1 million) were identified as having very low food security[2]. Food insecurity varies by race, ethnicity, household makeup, and income. Rates of food insecurity are higher than the national average (10.2%) for families that identify as Black (19.8%) or Hispanic/Latino (16.2%), for households with children (12.5%), and for households with income below 185% of the Federal Poverty Level (FPL) (26.5%)[3]. The majority of Medicaid enrollees have household incomes below 185% FPL. Additionally, food insecurity may be more common for those whose employment status, neighborhood of residence, and access to transportation further reduce their food access[4],[5],[6].
Nutrition Insecurity
Nutrition insecurity is defined as the lack of “consistent and equitable access to nutritious, safe, affordable foods essential to optimal health and wellbeing[7].” While most households that experience food insecurity also experience nutrition insecurity, households that experience food security can also experience nutrition insecurity. As most screenings focus on food security rather than nutrition security, national data on the prevalence of nutrition insecurity is not yet available. The concept of nutrition insecurity has been adopted by the United States Department of Agriculture (USDA) and the Centers for Disease Control and Prevention (CDC) as a core goal for their food-related initiatives. Nutrition security, beyond just food security, is necessary to reduce the development and exacerbation of chronic illnesses resulting from poor nutrition[8].
Dietary Quality
While food and nutrition insecurity are primary drivers of poor diet, other factors such as food availability (food deserts), personal preference, religious and cultural dietary practices, nutrition knowledge, and other psychosocial factors may contribute to dietary options and choices[9]. Analysis found that 45% of U.S. adults have a poor diet[10]. According to analysis of a representative sample of U.S. high school students, only “8.5% of high school students nationwide met [USDA] fruit recommendations and 2.1% met vegetable recommendations[11].” Research on adult dietary consumption has shown that income is a predictor for inadequate vegetable consumption (only 7% of adults below or close to the FPL consume an adequate amount of vegetables) but even high income groups had inadequate vegetable consumption (only 11.4% of adults in the highest income categories consume an adequate amount of vegetables)[12]. Healthy People 2030 includes a number of specific nutrition objectives including increasing calcium, potassium, fruit, and vegetable (including dark green, red and orange, beans and peas) consumption in people over age two[13],[14],[15],[16],[17],[18],[19].
Health Impacts of Food and Nutrition Insecurity and Poor Diet
Having an unhealthy diet and poor nutrition is associated with a range of physical and behavioral health conditions that are disproportionately experienced by people of color[20]. Poor diet is associated with both obesity and type 2 diabetes, as well as other chronic health conditions such as cardiovascular disease and cancer[21],[22],. Individuals experiencing food and nutrition insecurity have a higher risk of long-term chronic health conditions including obesity, diabetes, and hypertension[23],[24],[25],[26],[27]. Individuals experiencing food insecurity are more likely to go to the emergency room (ER), less likely to have a usual source of care, and have higher healthcare costs[28],[29],[30],[31].
The length of time a person experiences food insecurity is related to the severity of the health impacts[32]. A study examining food insecurity in children over four years of age found that children who experienced food insecurity for longer periods of time had worse health outcomes[33].
According to the CDC, the prevalence of obesity among those ages two to 19 was 19.7%, or about 14.7 million children, adolescents, and young adults. Childhood obesity is also more prevalent among certain racial and ethnic groups (26.2% among Hispanic/Latino children, 24.8% among non-Hispanic Black children). Obesity-related conditions include high blood pressure, high cholesterol, type 2 diabetes, breathing problems such as asthma and sleep apnea, and joint problems[34].
The impacts of food insecurity extend beyond diet-related conditions. Children who experience food insecurity have a higher risk of iron deficiency anemia, low non-cognitive performance, asthma, depression, suicide ideation, and tooth decay[35]. Food insecurity has been shown to be a major stressor in early childhood with implications for cognitive, language, motor, and socio-emotional skills[36].
Medically tailored food packages (MTFP) are meals or food boxes designed to meet the specific dietary and nutritional needs of individuals with serious health conditions, such as diabetes, heart disease, or kidney disease[37]. These packages are prescribed by healthcare providers and created by registered dietitians to align with medical guidelines for disease management. They typically include:
MTFPs are generally tailored to individuals who are capable of shopping for and preparing food at home (as determined by the provider) and are generally referred by a healthcare provider or plan[38]. Individual MTFPs need to be customized according to taste, dietary restrictions, allergies, cultural appropriateness, and medication interactions. MTFPs constitute one type of food is medicine intervention (also referred to as FIM or Food as Medicine). Please note that there is a separate evidence assessment for Medically Tailored Meals.
In Massachusetts, a multi-stakeholder coalition, Food is Medicine Massachusetts (FIMMA)[39], was organized to enhance the role of nutrition in healthcare to effectively address rising rates of chronic illnesses while controlling healthcare costs[40]. From February 2019 to October 2020 FIMMA formed a task force comprised of 76 different stakeholders, including healthcare, government, nutrition providers, and community-based organizations to “reach consensus on [food is medicine] intervention definitions and intervention standards[41].” The task force’s final findings around MTFP included the following[42]:
In late 2022, the White House held a conference on hunger, nutrition, and health and included a panel on Food is Medicine: Bringing Nutrition Out of the Shadows of Health Care. The conference raised the profile and interest around FIM programs. There are a growing number of government, medical providers, and for-profit companies offering or planning to provide FIM products, including MTFPs. The Centers for Medicare and Medicaid Services (CMS) has approved FIM interventions through both 1115 demonstration initiatives (“waivers”) and in lieu of services coverage[43],[44],.
Adult English- and Spanish-speaking individuals at risk for type 2 diabetes at 12 community food distribution sites (food banks) in Alameda County, California. The pilot enrolled 244 participants (90.6% female; 80.1% Hispanic; 49.1% had an annual household income less than $20,000, and 68.8% were food insecure at baseline).
A food bank-delivered intervention including monthly diabetes-appropriate food packages, text-based health education, and referrals to healthcare. Intervention food packages were designed to increase access to and consumption of foods appropriate for diabetes prevention. Packages were created to approximately mirror the USDAs MyPlate and Choose Healthy Options Program. These guidelines emphasize fresh produce, vegetables and fruits, whole grains, lean proteins, low-fat dairy, and healthy fats. Project packages contained shelf-stable products, including lean proteins, legumes, fruits and vegetables, and whole grains. Only canned products that were low in sodium and low in added sugars were included. Study participants who received project-specific food packages also had access to foods generally available at the food pantry sites.
Pre-post analysis. Food bank staff members administered surveys to participants at baseline, six months (midpoint), and 12 months (postintervention); participants self-reported all responses. Primary outcomes assessed were food security status, dietary intake, health-related behaviors, and body mass index. Information on demographic characteristics, food pantry access, healthcare use, and symptoms of depression was also collected.
Health: Results at six-months indicated improved health status, and depression scores (P < .001 for each).
Social: Results indicated improved food security, dietary intake, and physical activity (P< .001 for each) at 6-months post-intervention.
Adults with congestive heart failure served at a Boston, MA Federally Qualified Health Center. Individuals must have had at least one hospitalization or emergency department visit between February 2019 and July 2020, access to a kitchen with available refrigeration and heating element, and at least one household member who spoke or read in English or Spanish.
The program consisted of six bi-weekly cooking classes and weekly meal kits with ingredients for fourteen meals per week. Due to COVID-19, virtual classes were held and meal kits were delivered to participants' doors. Classes were in English and Spanish.
The pre-post analysis study included 10 adults meeting inclusion criteria and pre-, mid-, and post-surveys collecting info regarding nutritional understanding of the individual’s condition, Minnesota Living with Heart Failure Questionnaire (MLHFQ), and Quality of Life Survey (QOLS) (English and Spanish).
Health: Results indicated statistically significant improvement (p < 0.05) on both the MLHFQ and QOLS instruments used to measure participants' health status. However, due to the small sample size, the results are not generalizable.
Food pantry clients with diabetes in Texas, California, and Ohio.
The intervention used food banks and their partner food pantries to provide diabetes support by implementing a pilot intervention with four major components: screening for diabetes and monitoring of glycemic control, distributing diabetes-appropriate food, referring clients who lacked a usual source of care to primary care providers, and providing diabetes self-management support and education. The intervention food boxes, planned by project personnel who were registered dietitians or certified diabetes educators, contained whole grains, lean meats, beans, low-sodium vegetables, no-sugar-added fruit, and shelf-stable dairy products. The boxes were supplemented with perishable food: fresh produce, milk, yogurt, cheese, bread, and frozen lean meat.
Pre-post analysis. At baseline, the study reported on 768 enrolled participants; the final analytic sample contained 687 participants.
Health: Results at six-month follow-up found overall improvements in glycemic control (hemoglobin A1c decreased from 8.11% to 7.96%; p<0.01). Among participants with elevated hemoglobin A1c (HbA1c) (at least 7.5%) at baseline, HbA1c improved from 9.52% to 9.04% (p<0.001). Sub-analysis found the proportion with very poor glycemic control (n=411 at baseline) (HbA1c >9%) declined from 28% to 25% (p<0.10). Self-efficacy and medication adherence also showed improvement.
Social: Results found improvements in fruit and vegetable intake increasing from 2.8 to 3.1 servings per day (p<0.01).
Individuals with diabetes in Oakland, California; Detroit, Michigan; and Houston, Texas. Eligible participants had an HbA1c of greater than or equal to 7.5%, identified as an existing or new pantry client, were aged 18 years or older, spoke English or Spanish, had a phone or mailing address, and intended to remain in the area for 12 months.
Over the course of six months, intervention participants received twice-monthly food packages containing diabetes-appropriate foods, formal diabetes self-management classes, one-on-one check-ins with educators, and referrals to primary care. Food packages contained shelf-stable and perishable products, including lean proteins, eggs and low-fat dairy, legumes and nuts, fruits and vegetables, whole grains, and canned products low in sodium and added sugars. Blood glucose and HbA1c testing was conducted at months three and six.
Randomized controlled trial. The study randomized 568 total participants (n=285 intervention, n=283 control) (average age 55 years; 52% Latino, 33% Black).
Health: There were no differences in self-management (depressive symptoms, diabetes distress, self-care, hypoglycemia, self-efficacy) or HbA1c (risk difference [RD] = 0.24; 95% confidence interval [CI] = −0.09, 0.58).
Social: Results found significant improvement among the intervention group in food security (relative risk [RR] = 0.85; 95% CI = 0.73, 0.98), food stability (RR = 0.77; 95% CI = 0.64, 0.93), and fruit and vegetable intake (RD= 0.34; 95% CI = 0.34, 0.34).
Adults who either self-enrolled or were identified for the program by a healthcare or social work provider at two University of Oklahoma-affiliated clinics that provided free, ongoing chronic disease management to uninsured patients.
Upon enrollment, participants received an initial food package, educational booklet, and five recipe cards. Medical providers oriented participants to the booklet and items from the food box. Participants were eligible to receive one food package each month for the next six months.
The study included 80 adult participants across two clinic sites at the University of Oklahoma. Enrollment occurred between July 2016 and July 2017. The mean age of participants was 51.7 years (SD = 7.5). All participants had hypertension, diabetes, prediabetes, and/or hyperlipidemia. The majority of participants were female (66%), earned <$15,000/y (74%), were food insecure (87%), and reported choosing between food and medicine at least once in the past year (67%). Slightly more than half (55%) received benefits through the Supplemental Nutrition Assistance Program (SNAP).
Health: For participants who accessed food assistance at least four times and who had high blood pressure (BP) at enrollment (n=17), diastolic BP significantly improved (mean 90.9 decreased to 83.9; P=.009).
Social: Significant improvement in daily dietary fiber intake among participants (daily intake frequency mean 14.0 grams improved to 17.1; grams P < .001), and a slight yet nonsignificant increase in daily fruit and vegetable intake (mean 3.4 increased to 3.6 cups; P = .12).
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