The Medically Tailored Groceries and Mental Health Study

The PHQ-9 is a standardized clinical tool to diagnose and monitor depression. The survey consists of 9 questions, each with four possible responses, and is scored from 0 to 27. Standardized scoring is as follows: 1- 4 minimal depression, 5 - 9 mild depression, 10 - 14 moderate depression, 15-19 moderately severe depression, 20 - 27 severe depression. Each study participant (both treatment and control groups) will have a baseline PHQ-9 assessment at the time of randomization and a second assessment at program end (within the last month of program enrollment).

As part of the PHQ-9, if a participant reports any symptoms, then a follow-up question is promoted: "If you reported any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?" with responses ranging from "not difficult at all" to "extremely difficult".

Investigators will use the standardized General Anxiety Disorder (GAD-7) questionnaire, which is also routinely used in clinical care. The survey is 7-question tool used to screen for generalized anxiety disorder and assess severity of anxiety symptoms over the last two weeks. Scores range from 0 to 21, with higher numbers describing more severe anxiety.

As part of the GAD-7, if a participant reports any symptoms, then a follow-up question is promoted: "If you reported any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?" with responses ranging from "not difficult at all" to "extremely difficult".

The self-reported MENTAL health question is adapted from the Behavioral Risk Factor Surveillance System (BRFSS) and National Health Interview Survey (NHIS) surveys. This will assessed using: " Would you say that in general your MENTAL health is excellent, very good, good, fair, or poor?"

The five response options range from "poor" to "excellent."

This self-reported PHYSICAL health question is adapted from the Behavioral Risk Factor Surveillance System (BRFSS) and National Health Interview Survey (NHIS) surveys. This will be assessed using: " Would you say that in general your PHYSICAL health is excellent, very good, good, fair, or poor?"

The five response options range from "poor" to "excellent."

Investogators will use the 2-item Hunger Vital Sign, which is a validated screener used by Centers for Medicare and Medicaid Services (CMS) and most health systems that screen for food insecurity.

The validated, 1-item nutrition security screener assesses nutrition security using the following question: "Thinking about the last month, how hard was it for you or your household to regularly get and eat healthy foods? Include food from all sources when thinking about your response?" The five possible responses range from "Very hard" to "Not hard at all."

Total counts per 6 months (i.e., 6-month rate) and reasons for each admission. Analyses will also report rates for mental health-related admissions and all-cause admissions. As a secondary assessment of inpatient hospitalizations, investigators will also report the proportion of study participants with at least one admission.

Total counts per 6 months (i.e., 6-month rate) and reasons for each admission. Analyses will also report rates for mental health-related admissions and all-cause admissions. As a secondary assessment of Emergency Department (ED) utilization, investigators will also report the proportion of study participants with at least one ED visit.

Investigators will use the Dietary Screener Questionnaire (DSQ-10), a 10-item fruit and vegetable screener that is routinely used in similar research and promoted by the United States Department of Agriculture and the American Heart Association. The survey tool will report servings per day of fruits and vegetables. Response options range from "never" to "6 or more times per day" to measure average daily dietary intake.

Investigators will use the Dietary Screener Questionnaire, a survey tool promoted by the United States Department of Agriculture and the American Heart Association. The survey tool will report servings per day of dairy, including milk and cheese. Response options range from "never" to "6 or more times per day" to measure average daily dietary intake.

Investigators will use the Dietary Screener Questionnaire, a survey tool promoted by the United States Department of Agriculture and the American Heart Association. The survey tool will report servings per day of whole grains from all sources. Response options range from "never" to "6 or more times per day" to measure average daily dietary intake.

This measure will report the number of food box deliveries for each participant during program participation.

Self-reported consumption of food, as assessed by the following questions:

• "How much of the food from the Community Servings' Grocery Boxes did you usually eat?" Responses range from "None of the food" to "All of the food."
• If you didn't eat all of the food, what are the reasons why you didn't eat all of the food? Responses include, "I shared food with my family or friends; I didn't like some of the meals and ingredients; It was too much food for me; I had challenges cooking the food; If another reason, explain why [open ended response]".