Recruiting

Medically Tailored Groceries

Sponsor:

University of Massachusetts, Worcester

Code:

NCT07779707

Conditions

Depression / Major Depressive Disorder

Food Insecurity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Medically Tailored, Home-delivered Groceries

Active Comparison Group: Monthly Grocery Gift Card

Study Details

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.

Conditions

Depression / Major Depressive Disorder

Food Insecurity

Study ID

NCT07779707

Start date

Aug 31, 2026

Status verified date

Apr, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Medically Tailored Grocery (MTG)

150 participants will be enrolled in Community Servings' MTG program, receiving 13 MTG boxes over a six-month intervention period with accompanying nutrition education and counseling, including the peer support sessions. There are two main meals plans that participants could select: 1) The standard Wellness MTG intervention, which adheres to guidelines set by the The Academy of Nutrition and Dietetics Nutrition Care Manual and dietary plans such as the Dietary Approaches to Stop Hypertension and recommendations from the American Heart Association and American Diabetes Association for individuals with cardiovascular disease and diabetes. This dietary plan is set as the default for participants. 2) A renal MTG intervention for those with kidney disease, given the unique dietary concerns for this population. In addition, the meals plans can be further customized based on allergies and personal preferences such as vegetarian meals.

active comparator: Food Subsidy

The other 150 participants will receive their usual medical care plus a monthly stipend of $30 for a six-month intervention period, provided as unrestricted grocery gift cards from a select food retailers, along with healthy eating information to guide use of that subsidy.

Interventions

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.

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 measure

  • 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) ]

Central Contacts and Locations

Central contacts

Kurt Hager, PhD, MS

508-856-3247Kurt.Hager1@umassmed.edu

Locations

Community Care Cooperative (C3)

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Kim Prendergast Vice President, Policy & Strategy at C3, MPP

1-866-676-9226kprendergast@c3aco.org

UMass Memorial Health

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Kurt Hager Assistant Professor, PhD, MS

(508) 856-8989kurt.hager1@umassmed.edu

More Information

Sponsor

University of Massachusetts, Worcester

Last update posted

Aug 26, 2026

Last verified

Apr, 2026

Keywords

  • Depression
  • Food insecurity
  • Food as Medicine
  • Mental Health
  • Medically tailored groceries
  • Randomized controlled trial
  • Nutrition
  • Food is Medicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Worcester on 2026-08-26.