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The Medically Tailored Groceries and Mental Health Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 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)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether groceries chosen for a person's health needs can ease depression over 6 months. It is for adults with depression symptoms who do not have reliable access to enough food. One group gets grocery boxes every two weeks and optional food counseling; the other gets usual medical care and a $30 grocery gift card each month.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a depression diagnosis and a recent PHQ-9 score of 5 or higher, or no depression diagnosis and a score of 10 or higher. The PHQ-9 is a survey about depression symptoms.
  • Do not have reliable access to enough food.
  • Live in Worcester County in Central Massachusetts.
  • Get care at UMass Memorial Health or a clinic linked to Community Care Cooperative (C3).
  • Can prepare and cook meals yourself, or have a family member or caregiver who can.

Who can't join

  • Are pregnant or gave birth within the past year when the study starts. People who become pregnant during the study may stay in it.
  • Were newly diagnosed with depression within the past 3 months.
  • Have bipolar depression or bipolar disorder, which can cause major changes in mood and energy.
  • Answer “nearly every day” at the first depression screening when asked about thoughts of being better off dead or hurting yourself over the past two weeks.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 * Expresses suicide ideation in baseline depression screening defined as responding "nearly everyday" to question #9 in the Patient Health Questionnaire: "Over the last 2 weeks, how often have you been bothered by any of the following problems - Thoughts that you would be better off dead, or of hurting yourself?"

Study sites (3)

MA