The Medically Tailored Groceries and Mental Health Study
The Medically Tailored Groceries and Mental Health 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 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.
Inclusion Criteria:
Exclusion Criteria:
Kurt.Hager1@umassmed.edu508-856-3247
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.