Recruiting

The Medically Tailored Groceries and Mental Health Study

ClinicalTrials.gov IDNCT07779707

PhaseNA

Enrollment300

SponsorUniversity of Massachusetts, Worcester

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Depression / Major Depressive Disorder, Food Insecurity

About this study

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 outcomes

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))

Eligibility information

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 * 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?"

Study locations

UMass Chan Medical School, Worcester, Massachusetts 01605 United States
Community Care Cooperative (C3), Worcester, Massachusetts 01655 United States
UMass Memorial Health, Worcester, Massachusetts 01655 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.