MTM2MTG Pilot Ancillary Study

NCT07620808 | Enrolling By Invitation

• 1 other identifier: AAAV0681 - Ancillary Study
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct an ancillary study of participants in a completed RCT of medically tailored meals to determine whether transitioning these participants to a medically tailored groceries (MTG) program is a feasible approach to sustain health effects.

Conditions

Diet, Healthy; HbA1c; Blood Pressure

Keywords

Medically Tailored Groceries; Type 2 Diabetes; Hypertension; Multiple Cardiometabolic Morbidity; Food Is Medicine; Medically Tailored Meals; Elevated Blood Pressure

Outcome Measures

Primary Outcomes (3)

• Change in Diet Quality

  The Mediterranean Eating Pattern for Americans (MEPA) scale, which captures adherence to a heart healthy dietary pattern, will be used to assess diet quality. The MEPA score ranges from 0-16 with higher scores indicating better diet quality. The change in MEPA scores from baseline to 4 months will be calculated.

  Baseline, 4 months

• Change in HbA1c

  A fast and accurate HbA1c fingerstick test will assess changes in glycemic control from baseline to 4 months.

  Baseline, 4 months

• Change in systolic blood pressure

  The change in office systolic blood pressure (mmHg) from baseline to 4 months will be calculated.

  Baseline, 4 months

Secondary Outcomes (11)

• Change in diastolic blood pressure

  Baseline, 4 months

• Acceptability of Implementation

  4 monthd

• Feasibility of Implementation

  4 months

• Appropriateness of Implementation

  4 months

• Satisfaction with Intervention

  4 months

Study Arms (1)

Ancillary Study: Medically Tailored Groceries (MTG) Program

OTHER

Participants in this ancillary study are adults with type 2 diabetes and elevated to high blood pressure who do not currently qualify for medically tailored meals (MTMs) but received them as part of a RCT for 8 months. This ancillary study evaluates whether transitioning from MTMs to MTGs is a feasible approach to maintain MTM intervention health effects and could be a better tolerated intervention for participants who are not engaged with the MTM intervention. Participants will receive one MTG box per week for 4 months, supporting preparation of \~10 heart healthy, diabetes appropriate meals per week. Outcomes will be assessed at the end of the 4-month MTG intervention period using questionnaires and clinic measurements (blood pressure and HbA1c). The 8-month primary endpoint visit for the parent RCT will serve as the baseline for this study.

Behavioral: Medically Tailored Groceries

Interventions

Medically Tailored Groceries BEHAVIORAL

God's Love We Deliver's current MTG program (Health Harvest), which consists of weekly home-delivered MTG boxes, recipes and educational materials/webinars developed by Registered Dietitian Nutritionist for a 4-month period. The participants in the ancillary study will receive 1 MTG box/week which provides food sufficient for approximately 10 meals/week and includes fresh fruits, vegetables, whole grains, and proteins for a period of 4 months.

Ancillary Study: Medically Tailored Groceries (MTG) Program

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes diagnosis (physician diagnosed or HbA1c greater than or equal to 6.5% or diabetes medication use)
• Hypertension diagnosis (systolic blood pressure greater than or equal to 130 mmHg and/or diastolic blood pressure greater than or equal to 80 mmHg or physician diagnosis or hypertension medication use) or elevated blood pressure (defined as systolic blood pressure greater than or equal to 120 mmHg)
• 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.

You may not qualify if:

• Cancer diagnosis
• Undergoing cancer treatment
• Non-English or non-Spanish speaking
• Not cognitively able to complete study requirements
• Severe psychiatric disorders
• Inability to provide informed consent
• Health conditions that could prevent safe participation or impact study outcomes (e.g., substance use disorder, dialysis, neurodegenerative conditions)

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Mailman School of Public Health

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nour Makarem, PhD, FAHA

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)