NCT07779707 · University of Massachusetts, Worcester
The Medically Tailored Groceries and Mental Health Study
(MTG : RCT)
What this study is about
This randomly assigned 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.
View original scientific description
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.
Interventions
OTHER
Medically Tailored, Home-delivered Groceries
13-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.
OTHER
Active Comparison Group: Monthly Grocery Gift Card
$30/month food subsidy in the form of gift cards to Amazon or Hannaford grocery stores
Primary outcome measures
Depressive Symptoms as measured by Patient Health Questionnaire (PHQ-9) [Time Frame: 6 months]
Time frame: At baseline and within the last month of the program enrollment (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".
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
- Can prepare and cook meals independently, or has a family member or caregiver able to prepare food
Exclusion criteria
- 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
Where
- Worcester, Massachusetts
Collaborators
Community Servings, Health Foundation of Central Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 26, 2026 · Source of record for eligibility and locations