Medically Tailored Groceries for Healthy Eating

(MTM2MTG Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Columbia University
Stay on Your Current MedsYou can continue your current medications while participating
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 aims to determine if transitioning from medically tailored meals to medically tailored groceries can maintain health benefits for individuals with type 2 diabetes and high blood pressure. Participants will receive weekly grocery boxes to prepare approximately 10 heart-healthy, diabetes-friendly meals over four months. This trial is ideal for those who previously participated in a study using tailored meals but no longer qualify for them. As an unphased trial, it offers a unique opportunity to explore innovative dietary solutions for managing diabetes and high blood pressure.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves participants with type 2 diabetes and hypertension, it seems likely that you can continue your current medications.

What prior data suggests that medically tailored groceries are safe for participants with type 2 diabetes and elevated blood pressure?

Research shows that medically tailored groceries (MTG) are generally easy to use. Studies have found that providing food customized to medical needs can help manage conditions like high blood pressure and diabetes. For example, patients receive foods such as fruits, vegetables, and whole grains tailored to their health needs, like low salt and sugar for those with high blood pressure. This approach aims to improve well-being by meeting specific dietary requirements.

No major reports of problems have emerged from using MTGs. The focus remains on providing healthy foods that support health rather than causing risks. Participants in past studies successfully used these tailored groceries without major issues, demonstrating that MTGs are a safe option for those with chronic health conditions.12345

Why are researchers excited about this trial?

Researchers are excited about the Medically Tailored Groceries (MTG) program because it offers a personalized approach to managing type 2 diabetes and high blood pressure through nutrition. Unlike conventional treatments that typically focus on medications, this program emphasizes providing weekly grocery boxes tailored to support the preparation of heart-healthy, diabetes-appropriate meals. This method not only aims to maintain the health benefits achieved with medically tailored meals (MTMs) but also potentially enhances adherence by allowing more flexibility and engagement in meal preparation. By shifting the focus from medication to dietary management, the MTG program could represent a more sustainable and enjoyable lifestyle change for participants.

What evidence suggests that medically tailored groceries are effective for type 2 diabetes and high blood pressure?

Research has shown that specially designed grocery plans, known as medically tailored groceries (MTG), can significantly improve health for individuals with conditions like type 2 diabetes and high blood pressure. This trial will evaluate the MTG program, providing participants with one MTG box per week for four months. Studies have found that MTG helps control blood pressure and manage blood sugar levels. Specifically, one study reported that 98% of 281 patients with type 2 diabetes received groceries meeting their dietary needs. Another study found that patients who received MTG felt less stressed about their diabetes and had better access to healthy food. These findings suggest that MTG can be a valuable tool in managing long-term health issues.12678

Who Is on the Research Team?

NM

Nour Makarem, PhD, FAHA

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for adults who have completed a previous study involving medically tailored meals, likely with type 2 diabetes or high blood pressure. Participants should be able to transition to receiving groceries designed for their health needs.

Inclusion Criteria

I have high blood pressure or take medication for it.
Participation in parent trial investigating the impact of an 8-month medically-tailored meals (MTMs) intervention on cardiometabolic outcomes among adults with type 2 diabetes and elevated to high blood pressure who do not currently qualify for MTMs
I have been diagnosed with type 2 diabetes.

Exclusion Criteria

Severe psychiatric disorders
I have been diagnosed with cancer.
Non-English or non-Spanish speaking
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one box of medically tailored groceries each week for 4 months, supporting preparation of approximately 10 meals per week

16 weeks
Weekly grocery delivery

Follow-up

Participants are monitored for changes in diet quality, HbA1c, blood pressure, and other health measures

4 weeks
1 visit (in-person) for assessments

What Are the Treatments Tested in This Trial?

Interventions

  • Medically Tailored Groceries

Trial Overview

The study is testing if switching from prepared healthy meals to specially chosen groceries helps people keep up the health benefits, such as better blood sugar and blood pressure control.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Ancillary Study: Medically Tailored Groceries (MTG) ProgramExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

Citations

Impact of Medically Tailored Meals on Clinical Outcomes ...

Data collected on 72% of those getting the intervention showed significant improvements in food security, as well as reduced diabetes distress,

Published Research

Significant improvements in blood pressure among those with hypertension and hemoglobin A1C among those with diabetes were also observed,

A Systematic Review of “Food Is Medicine” Randomized ...

MTG, medically tailored groceries; among 281 patients with type 2 diabetes tested the impact. Feasibility was high, with 98% of deliveries ...

Medically Tailored Groceries and Food Resource Coaching

Type 2 diabetes and heart disease. a patient receives fruits, vegetables, whole grains, and low-salt, low-sugar foods if they have high blood pressure.

Health Impacts of Health System Implementation of a Food- ...

type 2 diabetes (29.5%). Patients with diabetes who attended the market had a smaller decrease in DBP (–0.94 vs –1.58 mm Hg;

Providing medically tailored groceries and food resource ...

This protocol paper describes the implementation of a study evaluating MTGs and food resource coaching in a food pantry setting.

Medically Tailored Groceries and Food Resource Coaching

For example, a patient receives fruits, vegetables, whole grains, and low-salt, low-sugar foods if they have high blood pressure. Food resource ...

Medically Tailored Groceries for Chronic Health Problems

This trial is for lower-income patients with chronic health issues like Type 2 diabetes or high blood pressure, who are treated at a safety-net clinic.