MTM2MTG Pilot Ancillary Study (MTM2MTG)

Medically Tailored Groceries for Cardiovascular Health

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Blood Pressure; Diet, Healthy; HbA1c
• Intervention / Treatment: Behavioral: Medically Tailored Groceries

Detailed Description

This ancillary study is a single arm, pre-post design among adults with co-existing 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 their participation in an 8-month RCT on MTMs and cardiometabolic outcomes. The purpose of the ancillary study is to determine whether transitioning participants from a MTM to a MTG program (i.e., a hybrid MTM to MTG intervention) is a feasible approach to improve outcomes and sustain health effects. Participants will receive one box of medically tailored groceries each week for a period of 4 months, with each box supporting preparation of approximately 10 meals per week. No additional baseline visit will be required, as measurements collected at the 8-month visit in the parent clinical trial will serve as baseline values for the ancillary study. All participants will have their HbA1c and blood pressure measured and complete questionnaires about their diet quality, health and lifestyle behaviors, and program engagement and implementation at 4 months post receiving their first MTG box.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Mailman School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Type 2 diabetes diagnosis (physician diagnosed or HbA1c greater than or equal to 6.5% or diabetes medication use)
2. 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)
3. 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Ancillary Study: Medically Tailored Groceries (MTG) Program; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in diastolic blood pressure	The change in office diastolic blood pressure (mmHg) from baseline to 4 months will be calculated.	Baseline, 4 months
Acceptability of Implementation	Acceptability will be measured by questionnaire. Items are adapted from the validated Acceptability of Implementation Measure (AIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better intervention acceptability. The items are analyzed individually and not summed to a total score.	4 monthd
Feasibility of Implementation	Feasibility will be measured by questionnaire using items adapted from the validated Feasibility of Implementation Measure (FIM) and rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better feasibility. The items are analyzed individually and not summed to a total score.	4 months
Appropriateness of Implementation	Appropriateness will be measured by questionnaire. Items are adapted from the validated Implementation Appropriateness Measure (IAM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better appropriateness. The items are analyzed individually and not summed to a total score.	4 months
Satisfaction with Intervention	Satisfaction with the intervention components will be measured by questionnaire. Participants will rate their satisfaction with intervention by indicating how likely they are to recommend it to others on a 10-point scale with higher scores indicating greater satisfaction (net promoter score). They will also be asked to rate the quality of the intervention as poor, fair, good, very good, or excellent. The items are analyzed individually and not summed to a total score.	4 months
Food Insecurity	The USDA Household Food Security Survey (FSSM-6 item) will be administered at baseline, 3 months, and 8 months. The scores range from 0-6 such that a score of 0-1 indicates high or marginal food security, 2-4 indicates low food security, and 5-6 indicates very low food security. Changes in the score from baseline to follow up at 4 months.	Baseline, 4 months
Nutrition Insecurity	The Gretchen Swanson 4-item nutrition screener will be administered at baseline, 4 months (score range: 0-4 with higher scores indicating higher nutrition security). Changes in the score from baseline to follow up at 4 months will be evaluated.	Baseline, 4 months
Sleep Duration	Sleep duration will be self-reported using the Pittsburgh Sleep Quality Index (PSQI, score range: 0-21). Changes in self-reported habitual hours of sleep from baseline to follow up at 4 months will be evaluated.	Baseline, 4 months
Pittsburgh Sleep Quality Index	Global sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI, score range: 0-21). Changes in the overall PSQI score (continuous and categorical) and its components from baseline to follow up at 4 months will be evaluated.	Baseline, 4 months
Self-rated health	Participant will rate their health as excellent, very good, good, fair, or poor at baseline,4 months. Changes in self-rated health from baseline to follow up at 4 months will be computed.	Baseline, 4 months
General Health Status	The EuroQoL 5-Dimension 5-Level (EQ-5D-5L) will be used to measure general health status and quality of life. This will be captured based on five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Based on the participant's response for reach dimension they will receive a 1-digit number, and the digits for the five dimensions will be combined into a 5-digit number that describes the patient's health state. This study will evaluate changes in this measure from baseline to follow up at 4 months. I	Baseline, 4 months

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Nour Makarem, PhD, FAHA, Columbia University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Hypertension; Type 2 Diabetes; Elevated Blood Pressure; Medically Tailored Meals; Medically Tailored Groceries; Food Is Medicine; Multiple Cardiometabolic Morbidity
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Hypertension; Diabetes Mellitus, Type 2
• Other Study ID Numbers: AAAV0681 - Ancillary Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data may be shared upon request to PI.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No