The Medically Tailored Groceries and Mental Health Study

Part of paid clinical trials in Worcester, Massachusetts.

Sponsor
University of Massachusetts, Worcester
Study ID
NCT07779707
Status
Not Yet Recruiting

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Conditions

  • Depression / Major Depressive Disorder
  • Food Insecurity

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Medically Tailored, Home-delivered Groceries — OTHER
    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 — OTHER
    $30/month food subsidy in the form of gift cards to Amazon or Hannaford grocery stores

Study Details

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 and health centers associated with Community Care Cooperative 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.

Key Dates

First listed
Aug 21, 2026
Start date
Aug 31, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
UMass Chan Medical SchoolWorcesterMassachusetts01605-

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By research site
UMass Chan Medical School· Worcester, MA

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