Diabetes Mellitus Type 2, Hypertension
Conditions
Keywords
Food is Medicine, Produce Prescriptions, Produce Rx, Community Pharmacy, Nutrition Security, Food Security, Nutrition Intervention, Food as Medicine
Brief summary
The goal of this clinical trial is to generate evidence on the feasibility and effectiveness of community pharmacies as the implementers of a produce prescription program for adults with diabetes and/or hypertension. The main question this study plans to answer is if using community pharmacies as a point-of-service for improving nutrition and health is feasible and effective. The trial also explores the impact of the program on food security, nutrition security, diet quality and health and patient centered outcomes. Participants will be enrolled in a produce prescription program to purchase healthy foods at the grocery store where they are currently receiving their pharmacy services. Participants will be asked to attend pharmacy visits to collect biometrics at two different time points and complete electronic surveys at three different time points.
Detailed description
Produce prescription programs are an increasingly common Food is Medicine (FIM) intervention, with over 100 programs launched in US healthcare systems over the past decade. Mounting evidence from these programs suggests health-related benefits, including reductions in household food insecurity, increased consumption of fruits and vegetables, and improvements in clinical outcomes such as diastolic blood pressure, hemoglobin A1c, and body mass index. Pharmacies routinely engage in vital screening and referral services, including monitoring blood glucose, blood pressure, cholesterol levels, and administering vaccinations, among other patient care services. However, the community pharmacy setting has remained a largely underutilized and understudied platform for advancing FIM. Historically, FIM interventions have been designed and delivered through hospitals, medical clinics, or community non-profit organizations. The next phase of FIM efforts involves expanding screening and referral for such programs to community pharmacies, including those affiliated or co-located with grocery stores. Community Pharmacy Produce Prescriptions study intervention will be delivered via a Produce Prescription (PRx) electronic benefit card. Each month, participants will receive a fixed amount of funds on the PRx card to purchase fruits, vegetables, beans, nuts, nut butters, seeds, plant-based oils, seafood, and yogurts from participating grocery stores. These funds will be provided after the initial baseline in-person visit is completed. The card will be reloaded monthly for a period of 6 months.
Interventions
OTHERProduce Prescription
Each month, participants will receive a fixed amount of funds on the PRx card. Participants will be able to use these funds to purchase fruits, vegetables, beans, nuts, nut butters, seeds, plant-based oils, seafood, and yogurts from participating grocery stores. These funds will be provided through an electronic PRx benefit card that is activated after the initial baseline in-person visit is completed. The card will be reloaded monthly for a period of 6 months.
BEHAVIORALNutrition Education
Participating pharmacies/grocery chains will have Registered Dietitians (RD/RDN) on staff who can provide participants with nutrition education programs, coaching, and/or nudges.
Sponsors
Tufts University
National Association of Chain Drug Stores
The Kroger Company
Walmart
Hy-Vee
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of signed and dated informed consent form * Age 18 years or older * Presence of one or more of the following conditions: type 2 diabetes or hypertension. (Type 2 diabetes and hypertension will be defined by the combination of a self-reported physician diagnosis of one of the conditions and at least one pharmacy prescription for one of the conditions.) * Able to converse, and complete the research surveys in English or Spanish, based on self-report. * Positive screening for food or nutrition insecurity by: 1. Hunger Vital Sign™ screening and, 2. Nutrition Security Screener
Exclusion criteria
* Unable to provide informed consent. * Unable to read and write. * Self-reported serious medical conditions that may be expected to shorten life expectancy to less than one year * A condition that limits participant's ability to grocery shop or choose food for themselves * Plans to move to a new home in the next 6 months that would require use of a different pharmacy * Currently pregnant or pregnancy planned within the next 6 months * Currently using or planning to start an insulin pump or other automated insulin delivery device within the next 6 months * Currently on a GLP-1 agonist or planning to start a GLP-1 agonist within the next 6 months * Currently receiving or planning to receive within the next 6 months another Food is Medicine program, like PRx, Grocery Rx, or Medically Tailored Meals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of PRx Program Utilization | Up to 6-months | The utilization rate will be calculated by dividing the number of PRx cards redeemed by the total number of PRx cards distributed at each pharmacy. |
| Rate of PRx Program Redemption | Up to 6-months | The redemption rates will be calculated based on the average proportion of dollar amounts redeemed over the total dollar amounts of benefits distributed. |
| Change in Food Security | baseline, 3-months, 6-months | Assessed by the USDA's Household Food Security Survey Module: Six-Item Short Form. The sum of affirmative responses to the six questions is the household's raw score. A raw score of 0-1 indicates food security, while a score of 2-6 indicates food insecurity. |
| Change in Nutrition Security | baseline, 3-months, 6-months | Assessed by the Nutrition Security Screener. Respondents will be classified as nutrition secure if they answer, "Not hard at all" or "Not very hard" to item 1 or nutrition insecure if they answer, "Somewhat hard", "Hard", or "Very Hard." |
| Change in Diet Quality | baseline, 3-months, 6-months | Assessed by a modified Mini-Eating Assessment Tool (EAT). A calculated score will be created such that a higher score is indicative of healthier dietary patterns. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c | baseline and 6-months | For participants with diabetes, pharmacy staff will conduct a point-of-care hemoglobin A1c measurement of blood obtained by fingerstick. |
| Change in Continuous Glucose Monitor (CGM) Time-in-range | baseline and 6-months | Time-in-range is the percentage of time spent with glucose levels in the target range. For participants with diabetes, pharmacy staff place a CGM, per product instructions, on the participant with a goal to wear for 10 days (each time). |
| Change in Blood Pressure | baseline and 6-months | Pharmacy staff will measure participants' systolic and diastolic blood pressure. |
| Change in Body Mass Index | baseline and 6-months | Pharmacy staff will collect height and weight. |
| Change in Patient Reported Health Related Quality of Life | baseline, 3-months, 6-months | Assessed by PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health, the scoring system converts responses from a 10-item questionnaire into T-scores for Global Physical Health (GPH) and Global Mental Health (GMH), where higher scores indicate better health. |
| Change in Disease Self-management | baseline, 3-months, 6-months | Assessed by the 6-item Self Efficacy for Managing Chronic Disease (SEMCD) scale. Scores will be calculated as the mean response to the six questions. A higher score is indicative of higher self-efficacy. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDariush Mozaffarian, MD, DrPH
The Food is Medicine Institute at the Friedman School of Nutrition Science and Policy at Tufts University
Outcome results
None listed