Medically tailored groceries to help depression in people with food insecurity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-site, open-label randomized trial assigns 300 adults with depression and food insecurity in Central Massachusetts to receive either medically tailored, home-delivered groceries for six months with optional nutrition counseling or usual care plus a monthly grocery gift card. Groceries are designed by registered dietitian nutritionists to meet health needs and are mailed every two weeks. The study aims to determine if this food-as-medicine approach can improve depressive symptoms compared with standard care. Primary outcomes focus on changes in mood and depressive severity, with secondary assessments of dietary quality and food security. Recruitment is conducted through UMass Chan Medical School and partner clinics in Worcester, MA.

Why it matters

Who can join: the full rules

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?"

Where it's running

• Community Care Cooperative (C3)
  Worcester, Massachusetts, United States Recruiting
• UMass Memorial Health
  Worcester, Massachusetts, United States Recruiting
• UMass Chan Medical School
  Worcester, Massachusetts, United States Not yet recruiting

Study contacts

• Principal investigator: Kurt Hager, Phd — UMass Chan Medical School
• Study coordinator: Kurt Hager, PhD, MS
• Email: Kurt.Hager1@umassmed.edu
• Phone: 508-856-3247

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Understanding how the orbitofrontal cortex guides approach vs. avoidance in depression

  This study tests how different parts of the orbitofrontal cortex influence whether people pursue rewards or risk loss, and whether this pattern is altered in Major Depressive Disorder.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07896343

• Health education program to help depression in older adults and caregivers in Ho Chi Minh City

  A community-based education program for people 60+ and their caregivers is being tested to see if it can lower depression and improve quality of life compared with standard care.

  Recruiting University of Medicine and Pharmacy at Ho Chi Minh City · Ho Chi Minh City, Cho Lon · NCT07877571

• Prucalopride for low mood: testing a 5-HT4 receptor activator for cognition and sleep

  This study tests whether prucalopride, a 5-HT4 receptor drug, can improve thinking and sleep in adults with low mood or major depressive disorder compared to a placebo.

  Recruiting University of Oxford · Oxford, Oxfordshire · NCT07848477

• Testing different stipend schedules and a mobile program to help adults with binge eating and food insecurity

  This study tests whether varying ways of paying participants and access to a mobile tool can help adults who binge eat and have limited food security.

  Recruiting Northwestern University · Chicago, Illinois · NCT07845461

• Pre-visit Companion Brief: a primary care AI-assisted check for depression and anxiety

  This pilot tests an AI-powered pre-visit assessment that creates a concise Companion Brief for clinicians to help identify depression and anxiety during routine primary care.

  Recruiting Singula Health, Inc. · Brentwood, New York and 1 other locations · NCT07834684

• Pediatric Food Is Medicine for Families with Food Insecurity

  This study tests different ways to help families with young children use food prescription programs to eat more fruits and vegetables and improve health among kids on Medicaid.

  Recruiting State University of New York at Buffalo · Buffalo, New York · NCT07770490

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.