Depression / Major Depressive DisorderMTG : RCTNCT07779707
The Medically Tailored Groceries and Mental Health Study
A study testing Medically Tailored, Home-delivered Groceries and Active Comparison Group: Monthly Grocery Gift Card in people with Depression / Major Depressive Disorder and Food Insecurity, run by University of Massachusetts, Worcester at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression / Major Depressive Disorder, Food Insecurity
- What is being tested?
- Medically Tailored, Home-delivered Groceries and Active Comparison Group: Monthly Grocery Gift Card
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Aug 2026to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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?"
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
UMass Chan Medical School
Worcester, Massachusetts, 01605
- Recruiting
Community Care Cooperative (C3)
Worcester, Massachusetts, 01655
Kim Prendergast Vice President, Policy & Strategy at C3, MPP, 1-866-676-9226, kprendergast@c3aco.org
- Recruiting
UMass Memorial Health
Worcester, Massachusetts, 01655
Kurt Hager Assistant Professor, PhD, MS, (508) 856-8989, kurt.hager1@umassmed.edu
About this 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.
Read more
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.
Read the 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.
- Being tested
- Medically Tailored, Home-delivered Groceries, Active Comparison Group: Monthly Grocery Gift Card
- Keywords
- Depression, Food insecurity, Food as Medicine, Mental Health, Medically tailored groceries, Randomized controlled trial, Nutrition, Food is Medicine
- Medical subject headings
- Depression, Depressive Disorder, Major, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medically Tailored, Home-delivered GroceriesOther
Also called MTG
13-box home grocery delivery (1 Welcome Box of pantry and spice staples and 12 grocery boxes) for a six-month intervention period; nutrition and other resources to sustain the benefit of the intervention.
Active Comparison Group: Monthly Grocery Gift CardOther
Also called Food Subsidy
$30/month food subsidy in the form of gift cards to Amazon or Hannaford grocery stores
| Study group | Role | What they receive |
|---|---|---|
| Medically Tailored Grocery (MTG) | Experimental | 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. Receives: Other: Medically Tailored, Home-delivered Groceries |
| Food Subsidy | Active comparator | 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. Receives: Other: Active Comparison Group: Monthly Grocery Gift Card |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptoms as measured by Patient Health Questionnaire (PHQ-9) [Time Frame: 6 months]
The PHQ-9 is a standardized clinical tool to diagnose and monitor depression. The survey consists of 9 questions, each with four possible responses, and is scored from 0 to 27. Standardized scoring is as follows: 1- 4 minimal depression, 5 - 9 mild depression, 10 - 14 moderate depression, 15-19 moderately severe depression, 20 - 27 severe depression. Each study participant (both treatment and control groups) will have a baseline PHQ-9 assessment at the time of randomization and a second assessment at program end (within the last month of program enrollment).
As part of the PHQ-9, if a participant reports any symptoms, then a follow-up question is promoted: "If you reported any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?" with responses ranging from "not difficult at all" to "extremely difficult".
Measured: At baseline and within the last month of the program enrollment (6 months)
Secondary outcomes (10)
Anxiety symptoms as measured by the General Anxiety Disorder (GAD-7) questionnaire [Time Frame: 6 months]
Investigators will use the standardized General Anxiety Disorder (GAD-7) questionnaire, which is also routinely used in clinical care. The survey is 7-question tool used to screen for generalized anxiety disorder and assess severity of anxiety symptoms over the last two weeks. Scores range from 0 to 21, with higher numbers describing more severe anxiety.
As part of the GAD-7, if a participant reports any symptoms, then a follow-up question is promoted: "If you reported any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?" with responses ranging from "not difficult at all" to "extremely difficult".
Measured: At baseline and within the last month of the program enrollment (6 months)
Self-Reported MENTAL Health Status [Time Frame: 6 months]
The self-reported MENTAL health question is adapted from the Behavioral Risk Factor Surveillance System (BRFSS) and National Health Interview Survey (NHIS) surveys. This will assessed using: " Would you say that in general your MENTAL health is excellent, very good, good, fair, or poor?"
The five response options range from "poor" to "excellent."
Measured: At baseline and within the last month of the program enrollment (6 months)
Self-Reported PHYSICAL Health Status [Time Frame: 6 months]
This self-reported PHYSICAL health question is adapted from the Behavioral Risk Factor Surveillance System (BRFSS) and National Health Interview Survey (NHIS) surveys. This will be assessed using: " Would you say that in general your PHYSICAL health is excellent, very good, good, fair, or poor?"
The five response options range from "poor" to "excellent."
Measured: At baseline and within the last month of the program enrollment (6 months)
Food Insecurity, as measured by the Hunger Vital Sign [Time Frame: 6 months]
Investogators will use the 2-item Hunger Vital Sign, which is a validated screener used by Centers for Medicare and Medicaid Services (CMS) and most health systems that screen for food insecurity.
Measured: At baseline and within the last month of the program enrollment (6 months)
Nutrition Insecurity as measured by the Tufts-Kaiser Permanente 1-item screener [Time Frame: 6 months]
The validated, 1-item nutrition security screener assesses nutrition security using the following question: "Thinking about the last month, how hard was it for you or your household to regularly get and eat healthy foods? Include food from all sources when thinking about your response?" The five possible responses range from "Very hard" to "Not hard at all."
Measured: At baseline and within the last month of the program enrollment (6 months)
Unplanned, Inpatient Hospitalizations [Time Frame: 6 months]
Total counts per 6 months (i.e., 6-month rate) and reasons for each admission. Analyses will also report rates for mental health-related admissions and all-cause admissions. As a secondary assessment of inpatient hospitalizations, investigators will also report the proportion of study participants with at least one admission.
Measured: Total counts from baseline to program end (6 months)
Emergency Department Visits [Time Frame: 6 months]
Total counts per 6 months (i.e., 6-month rate) and reasons for each admission. Analyses will also report rates for mental health-related admissions and all-cause admissions. As a secondary assessment of Emergency Department (ED) utilization, investigators will also report the proportion of study participants with at least one ED visit.
Measured: Total counts from baseline to program end (6 months)
Fruit and Vegetable Consumption as measured by the Dietary Screener Questionnaire-10 [Time Frame: 6 months]
Investigators will use the Dietary Screener Questionnaire (DSQ-10), a 10-item fruit and vegetable screener that is routinely used in similar research and promoted by the United States Department of Agriculture and the American Heart Association. The survey tool will report servings per day of fruits and vegetables. Response options range from "never" to "6 or more times per day" to measure average daily dietary intake.
Measured: At baseline and within the last month of the program enrollment (6 months)
Dairy Consumption, servings per day as measured by the Dietary Screener Questionnaire [Time Frame: 6 months]
Investigators will use the Dietary Screener Questionnaire, a survey tool promoted by the United States Department of Agriculture and the American Heart Association. The survey tool will report servings per day of dairy, including milk and cheese. Response options range from "never" to "6 or more times per day" to measure average daily dietary intake.
Measured: At baseline and within the last month of the program enrollment (6 months)
Whole Grain Consumption, servings per day, as measured by the Dietary Screener Questionnaire [Time Frame: 6 months]
Investigators will use the Dietary Screener Questionnaire, a survey tool promoted by the United States Department of Agriculture and the American Heart Association. The survey tool will report servings per day of whole grains from all sources. Response options range from "never" to "6 or more times per day" to measure average daily dietary intake.
Measured: At baseline and within the last month of the program enrollment (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start29 Aug 2026
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression / Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Community Servings, Health Foundation of Central Massachusetts
- Responsible party
- Principal investigator, Kurt Hager, University of Massachusetts, Worcester
- Investigators
- Kurt Hager, Phd, Principal investigator, UMass Chan Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779707
- Sponsor's protocol ID
- STUDY00002964
- Other IDs
- STUDY00002964
- Acronym
- MTG : RCT
- Status last verified
- Apr 2026
- First submitted
- 14 Aug 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that can be deidentified without risk of a confidentiality breach will be shared upon written request to the study investigators. Deidentified individual data that supports the results will be shared, provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UMass Chan Medical School.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Medically Tailored Groceries and Mental Health Study
- ClinicalTrials.gov ID
- NCT07779707
- Acronym / sponsor ID
- MTG : RCT / STUDY00002964
- Keywords
- Depression, Food insecurity, Food as Medicine, Mental Health, Medically tailored groceries, Randomized controlled trial, Nutrition, Food is Medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Community Servings, Health Foundation of Central Massachusetts
- Study start
- 29 Aug 2026 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Medically Tailored Grocery (MTG) | Experimental | Other: Medically Tailored, Home-delivered Groceries150 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. |
| Food Subsidy | Active comparator | Other: Active Comparison Group: Monthly Grocery Gift CardThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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?"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medically Tailored, Home-delivered GroceriesAlso: MTG13-box home grocery delivery (1 Welcome Box of pantry and spice staples and 12 grocery boxes) for a six-month intervention period; nutrition and other resources to sustain the benefit of the intervention. | Other | Medically Tailored Grocery (MTG) |
| Active Comparison Group: Monthly Grocery Gift CardAlso: Food Subsidy$30/month food subsidy in the form of gift cards to Amazon or Hannaford grocery stores | Other | Food Subsidy |
Primary outcome
Depressive Symptoms as measured by Patient Health Questionnaire (PHQ-9) [Time Frame: 6 months]
Time frame: At baseline and within the last month of the program enrollment (6 months)
The PHQ-9 is a standardized clinical tool to diagnose and monitor depression. The survey consists of 9 questions, each with four possible responses, and is scored from 0 to 27. Standardized scoring is as follows: 1- 4 minimal depression, 5 - 9 mild depression, 10 - 14 moderate depression, 15-19 moderately severe depression, 20 - 27 severe depression. Each study participant (both treatment and control groups) will have a baseline PHQ-9 assessment at the time of randomization and a second assessment at program end (within the last month of program enrollment). As part of the PHQ-9, if a participant reports any symptoms, then a follow-up question is promoted: "If you reported any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?" with responses ranging from "not difficult at all" to "extremely difficult".
10 secondary outcomes
Anxiety symptoms as measured by the General Anxiety Disorder (GAD-7) questionnaire [Time Frame: 6 months]
Time frame: At baseline and within the last month of the program enrollment (6 months)
Self-Reported MENTAL Health Status [Time Frame: 6 months]
Time frame: At baseline and within the last month of the program enrollment (6 months)
Self-Reported PHYSICAL Health Status [Time Frame: 6 months]
Time frame: At baseline and within the last month of the program enrollment (6 months)
Food Insecurity, as measured by the Hunger Vital Sign [Time Frame: 6 months]
Time frame: At baseline and within the last month of the program enrollment (6 months)
Nutrition Insecurity as measured by the Tufts-Kaiser Permanente 1-item screener [Time Frame: 6 months]
Time frame: At baseline and within the last month of the program enrollment (6 months)
Unplanned, Inpatient Hospitalizations [Time Frame: 6 months]
Time frame: Total counts from baseline to program end (6 months)
Emergency Department Visits [Time Frame: 6 months]
Time frame: Total counts from baseline to program end (6 months)
Fruit and Vegetable Consumption as measured by the Dietary Screener Questionnaire-10 [Time Frame: 6 months]
Time frame: At baseline and within the last month of the program enrollment (6 months)
Dairy Consumption, servings per day as measured by the Dietary Screener Questionnaire [Time Frame: 6 months]
Time frame: At baseline and within the last month of the program enrollment (6 months)
Whole Grain Consumption, servings per day, as measured by the Dietary Screener Questionnaire [Time Frame: 6 months]
Time frame: At baseline and within the last month of the program enrollment (6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that can be deidentified without risk of a confidentiality breach will be shared upon written request to the study investigators. Deidentified individual data that supports the results will be shared, provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UMass Chan Medical School.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kurt Hager, Phd principal investigator
UMass Chan Medical School
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medically Tailored, Home-delivered Groceries and Active Comparison Group: Monthly Grocery Gift Card in people with Depression / Major Depressive Disorder and Food Insecurity, run by University of Massachusetts, Worcester at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kurt Hager, PhD, MS (508-856-3247, Kurt.Hager1@umassmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Symptoms as measured by Patient Health Questionnaire (PHQ-9) [Time Frame: 6 months] (time frame: At baseline and within the last month of the program enrollment (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.