Depression / Major Depressive Disorder, Food Insecurity
Conditions
Keywords
Depression, Food insecurity, Food as Medicine, Mental Health, Medically tailored groceries, Randomized controlled trial, Nutrition, Food is Medicine
Brief summary
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.
Detailed description
Food insecurity, defined as limited or uncertain access to adequate food for an active and healthy life, is strongly associated with poor mental health outcomes, including depression. Individuals experiencing food insecurity often face chronic stress, reduced dietary quality, and barriers to managing health conditions, all of which can worsen depressive symptoms. Despite this well-established relationship, there is limited rigorous evidence evaluating food-based interventions as a primary strategy to improve mental health. Medically tailored grocery (MTG) programs are an emerging "Food is Medicine" intervention that provides groceries tailored to an individual's health needs, along with nutrition education and support. Unlike medically tailored meals, MTG programs support individuals in preparing their own meals, which may improve dietary quality, increase self-efficacy, and reduce food insecurity. While prior studies suggest that food-based interventions may improve mental health outcomes, no randomized controlled trials have evaluated MTG with depression as the primary outcome. This study is a single-site, open-label, randomized controlled trial designed to evaluate the efficacy of an MTG intervention among adults with depression and food insecurity. A total of 300 participants will be recruited by Community Servings and UMass Chan Medical School and randomized 1:1 to either the MTG intervention or a control group receiving usual care plus a food subsidy. Participants in the intervention group will receive 13 medically tailored grocery boxes over six months, along with nutrition support. The control group will receive usual care and a $30 monthly food subsidy for six months. The primary outcome is the change in depressive symptoms measured by the Patient Health Questionnaire (PHQ-9). Secondary outcomes include anxiety symptoms, food insecurity, dietary quality, and healthcare utilization, including emergency department visits and hospitalizations. This trial is designed to generate rigorous evidence on the role of medically tailored grocery programs in improving mental health and to inform future clinical and policy decisions regarding the integration of nutrition interventions into healthcare.
Interventions
OTHERMedically 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.
OTHERActive Comparison Group: Monthly Grocery Gift Card
$30/month food subsidy in the form of gift cards to Amazon or Hannaford grocery stores
Sponsors
University of Massachusetts, Worcester
Community Servings
Health Foundation of Central Massachusetts
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Owing to the nature of the intervention, participants, providers, and many study staff will know which group individual participants have been randomized to. However, we will keep the analysts blinded to the study arms throughout the trial.
Intervention model description
Participants will be assigned to one of two intervention arms in a 1:1 ratio. The interventions arms include receipt of either home-delivered, medically tailored groceries and optional nutritional counseling or a $30 monthly grocery gift card, both provided for 6 months. Participants will not be blinded to the intervention that they receive.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms as measured by Patient Health Questionnaire (PHQ-9) [Time Frame: 6 months] | 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". |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety symptoms as measured by the General Anxiety Disorder (GAD-7) questionnaire [Time Frame: 6 months] | At baseline and within the last month of the program enrollment (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] | At baseline and within the last month of the program enrollment (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] | At baseline and within the last month of the program enrollment (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] | At baseline and within the last month of the program enrollment (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. |
| Nutrition Insecurity as measured by the Tufts-Kaiser Permanente 1-item screener [Time Frame: 6 months] | At baseline and within the last month of the program enrollment (6 months) | 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." |
| Unplanned, Inpatient Hospitalizations [Time Frame: 6 months] | Total counts from baseline to program end (6 months) | 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. |
| Emergency Department Visits [Time Frame: 6 months] | Total counts from baseline to program end (6 months) | 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. |
| Fruit and Vegetable Consumption as measured by the Dietary Screener Questionnaire-10 [Time Frame: 6 months] | At baseline and within the last month of the program enrollment (6 months) | 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. |
| Dairy Consumption, servings per day as measured by the Dietary Screener Questionnaire [Time Frame: 6 months] | At baseline and within the last month of the program enrollment (6 months) | 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. |
| Whole Grain Consumption, servings per day, as measured by the Dietary Screener Questionnaire [Time Frame: 6 months] | At baseline and within the last month of the program enrollment (6 months) | 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. |
Countries
United States
Contacts
CONTACTKurt Hager, PhD, MS
PRINCIPAL_INVESTIGATORKurt Hager, Phd
UMass Chan Medical School
Outcome results
None listed