The Medically Tailored Groceries and Mental Health Study
Recruiting · NCT07779707 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
3 locations listed across 1 US state.
- UMass Chan Medical School - Worcester, Massachusetts, United States
- Community Care Cooperative (C3) - Worcester, Massachusetts, United States
- UMass Memorial Health - Worcester, Massachusetts, United States