About this trial
This randomized controlled trial will test whether providing medically tailored groceries for 6 months can improve depressive symptoms among adults with depression and food insecurity.
The intervention under study is a 6-month, medically tailored grocery program provided by the Boston-based non-profit organization, Community Servings. Food boxes are mailed to participants' homes every two weeks and are designed by a registered dietitian nutritionists to support an individuals' health needs. Participants may also attend optional nutritional counseling sessions.
In this randomized clinical trial, 300 adults with depression and food insecurity will be assigned to one of two groups. The intervention group will receive medically tailored grocery boxes delivered to their home every two weeks for six months (13 boxes total), along with nutritional counseling support. The comparison group will receive usual medical care plus a $30 monthly grocery gift card for six months to be used to purchase any products of their choice.
Participants will be recruited from UMass Memorial Health and health centers associated with Community Care Cooperative (C3) in the greater Worcester area in Massachusetts.The main goal of the study is to determine whether the grocery program reduces symptoms of depression. The study will also examine effects on anxiety, food insecurity, diet quality, and healthcare use.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A depression diagnosis with active symptoms, defined as having a recent Patient Health Questionnaire (PHQ-9) screening of 5+, or no depression diagnosis but a recent PHQ-9 screening of 10+
Experiencing food insecurity (could be either low or very low food security)
Lives in Central Massachusetts in Worcester County
Receives care at UMass Memorial Health, or receives care at clinics affiliated with Community Care Cooperative (C3)
Disqualifiers
Pregnant women and women who are within one year postpartum at baseline. Women who become pregnant during trial will be allowed to finish their food programming and study participation.
New depression diagnosis within the past 3 months
Has bipolar depression or bipolar disorder
Expresses suicide ideation in baseline depression screening defined as responding "nearly everyday" to question #9 in the Patient Health Questionnaire: "Over the last 2 weeks, how often have you been bothered by any of the following problems - Thoughts that you would be better off dead, or of hurting yourself?"
Trial design
Parallel
Treatments tested in this trial
Medically Tailored, Home-delivered Groceries
Other intervention13-box home grocery delivery (1 Welcome Box of pantry and spice staples and 12 grocery boxes) for a six-month intervention period; nutrition and other resources to sustain the benefit of the intervention.
Active Comparison Group: Monthly Grocery Gift Card
Other intervention$30/month food subsidy in the form of gift cards to Amazon or Hannaford grocery stores
Treatment groups
Trial outcomes
Primary outcomes
Depressive Symptoms as measured by Patient Health Questionnaire (PHQ-9) [Time Frame: 6 months]
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".
Secondary outcomes
Anxiety symptoms as measured by the General Anxiety Disorder (GAD-7) questionnaire [Time Frame: 6 months]
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".
Self-Reported MENTAL Health Status [Time Frame: 6 months]
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."
Self-Reported PHYSICAL Health Status [Time Frame: 6 months]
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."
Food Insecurity, as measured by the Hunger Vital Sign [Time Frame: 6 months]
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.
Other outcomes
Program Adherence: Deliveries, as measured by number of food box deliveries per participant [Time Frame: 6 months]
This measure will report the number of food box deliveries for each participant during program participation.
Program Adherence, Self-Reported Consumption of Food [Time Frame: 6 months]
Self-reported consumption of food, as assessed by the following questions: 1. "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." 2. 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 \[open ended response\]".
Sponsors and contacts
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University of Massachusetts, Worcester
Lead sponsor
Community Servings
Collaborator
Health Foundation of Central Massachusetts
Collaborator