The Medically Tailored Groceries and Mental Health Study
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- 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.
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
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Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of Massachusetts, Worcester
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.
