The Medically Tailored Groceries and Mental Health Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Massachusetts, Worcester
About this trial
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.
Eligibility criteria
Qualifiers
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
Can prepare and cook meals independently, or has a family member or caregiver able to prepare food
Disqualifiers
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
Trial design
Treatments tested in this trial
- Medically Tailored, Home-delivered Groceries
- Active Comparison Group: Monthly Grocery Gift Card
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Massachusetts, Worcester
Lead sponsor
Community Servings
Collaborator
Health Foundation of Central Massachusetts
Collaborator
Source ClinicalTrials.gov