300 Participants NeededMy employer runs this trial

Medically Tailored Groceries for Depression

(MTG : RCT Trial)

Recruiting at 2 trial locations
KH
Overseen ByKurt Hager, PhD, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Massachusetts, Worcester
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether specially designed grocery deliveries can improve depression in adults who struggle to afford food. One group will receive boxes of healthy groceries tailored to their health needs every two weeks for six months, along with optional nutrition advice. Another group will receive their usual care plus a monthly grocery gift card. People with depression who face challenges in accessing enough food and live in Central Massachusetts might be a good fit for this trial. The goal is to determine if these medically tailored, home-delivered groceries can reduce depression and improve overall health. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new ways of supporting mental and physical health.

What prior data suggests that this grocery program is safe for individuals with depression and food insecurity?

Research has shown that home-delivered groceries tailored for medical needs are generally well-received by recipients. One study found that receiving these meals improved depressive symptoms for some individuals. This suggests the program might be beneficial for mental health. Other studies have demonstrated that these meal programs also enhance food security. Reports of major problems with these programs are absent, indicating they are safe to use.12345

Why are researchers excited about this trial?

Unlike traditional treatments for depression, which often involve medications like SSRIs or therapy, the Medically Tailored Groceries (MTG) program is unique because it focuses on nutrition as a means to improve mental health. Researchers are excited about this approach because it delivers personalized meal plans directly to participants' homes, addressing dietary needs and preferences while providing nutrition education and peer support. This holistic method could offer a new way to manage depression, potentially reducing reliance on medications and enhancing overall well-being through dietary changes.

What evidence suggests that medically tailored groceries could be effective for depression?

This trial will compare the effects of medically tailored, home-delivered groceries with a food subsidy program. Research has shown that grocery programs designed for specific medical needs can improve health. Some studies indicate that these programs help people manage their health better and reduce food insecurity. Participants in those studies have seen improvements in their diet and overall health. Additionally, evidence suggests that these programs can lead to fewer hospital visits and better control of long-term health issues. While direct evidence on depression is still developing, the positive effects on health management and food security suggest potential benefits for people with depression and food insecurity.46789

Who Is on the Research Team?

KH

Kurt Hager, Phd

Principal Investigator

UMass Chan Medical School

Are You a Good Fit for This Trial?

This trial is for adults living in the greater Worcester, MA area who have depression and are struggling to afford enough food. Participants must be patients at UMass Memorial Health or certain local health centers.

Inclusion Criteria

I have depression with active symptoms or a recent PHQ-9 score of 10 or higher.
Experiencing food insecurity (could be either low or very low food security)
Lives in Central Massachusetts in Worcester County
See 2 more

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
I have been diagnosed with bipolar disorder or bipolar depression.
I was diagnosed with depression in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive medically tailored grocery boxes every two weeks for six months, along with optional nutritional counseling

6 months
13 deliveries (home delivery every two weeks)

Follow-up

Participants are monitored for changes in depressive symptoms and other health outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Medically Tailored, Home-delivered Groceries

Trial Overview

The study compares two groups: one gets home-delivered, medically tailored groceries every two weeks plus optional nutrition counseling for six months; the other receives usual care and a $30 monthly grocery gift card for six months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Medically Tailored Grocery (MTG)Experimental Treatment1 Intervention
Group II: Food SubsidyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials
372
Recruited
998,000+

Community Servings

Collaborator

Trials
4
Recruited
510+

Health Foundation of Central Massachusetts

Collaborator

Citations

A Systematic Review of Interventions That Address Food ...

Self-management improved in 50% (3/6) of studies that evaluated this outcome. Self-efficacy improved in 40% (2/5) of studies, and improvements were seen in ...

Food is Medicine Initiative for Mitigating Food Insecurity in ...

Data suggest that it has lowered food insecurity, promoted better management of health, improved health outcomes, and has, therefore, lowered ...

Pearl Anna McElfish

To determine the impact of a home-delivered, medically tailored grocery intervention on glycemic control and diet quality among participants with type 2 ...

A Systematic Review of “Food Is Medicine”... : Circulation

This review identified a total of 14 randomized controlled trials of Food Is Medicine interventions in the United States with noncommunicable disease outcomes, ...

HCXF Data Vault Summary

This document provides summaries of the studies and participants available in the. Health Care by Food (HCXF) Data Vault.

Measuring the Health Impact of Reliable Access to ...

“The data highlighted the significant food insecurity that are members with chronic conditions are navigating in these communities,” says Pam ...

Division of Cancer Control & Population Sciences - Food ...

A study among a cohort of underserved cancer patients in New York City showed that 56% were food insecure, with 38% of the cohort with very low food security.

Preventive Services for Food Insecurity Evidence Report ...

Of the 2 fair-quality studies, 1 randomized crossover study (n = 44) found that home delivery of medically tailored meals was associated with ...

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Is in-home telepsychology for major depressive disorder in older adults as effective as same-room treatment on clinical and process outcomes? 2. Is in-home ...