Diet, HealthyMTM2MTGNCT07620808
MTM2MTG Pilot Ancillary Study
A study testing Medically Tailored Groceries in people with Diet, Healthy and HbA1c, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diet, Healthy, HbA1c, Blood Pressure
- What is being tested?
- Medically Tailored Groceries
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2026to Jun 2027
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Columbia University Mailman School of Public Health
New York, New York, 10032
About this study
Official title: 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.
Read the 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.
- Conditions
- Diet, Healthy, HbA1c, Blood Pressure
- Being tested
- Medically Tailored Groceries
- Keywords
- Medically Tailored Groceries, Type 2 Diabetes, Hypertension, Multiple Cardiometabolic Morbidity, Food Is Medicine, Medically Tailored Meals, Elevated Blood Pressure
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medically Tailored GroceriesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Medically Tailored Groceries |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 months
Change in HbA1c
A fast and accurate HbA1c fingerstick test will assess changes in glycemic control from baseline to 4 months.
Measured: Baseline, 4 months
Change in systolic blood pressure
The change in office systolic blood pressure (mmHg) from baseline to 4 months will be calculated.
Measured: Baseline, 4 months
Secondary outcomes (11)
Change in diastolic blood pressure
The change in office diastolic blood pressure (mmHg) from baseline to 4 months will be calculated.
Measured: 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.
Measured: 4 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start25 Aug 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nour Makarem, PhD, Columbia University
- Investigators
- Nour Makarem, PhD, FAHA, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620808
- Sponsor's protocol ID
- AAAV0681 - Ancillary Study
- Acronym
- MTM2MTG
- Status last verified
- Oct 2026
- First submitted
- 27 May 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data may be shared upon request to PI.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medically Tailored Groceries for Cardiovascular Health
- ClinicalTrials.gov ID
- NCT07620808
- Acronym / sponsor ID
- MTM2MTG / AAAV0681 - Ancillary Study
- 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
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Jun 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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary Study: Medically Tailored Groceries (MTG) Program | Other | Behavioral: Medically Tailored GroceriesParticipants 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Cancer diagnosis
- Undergoing cancer treatment
- Non-English or non-Spanish speaking
- Not cognitively able to complete study requirements
- Severe psychiatric disorders
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 GroceriesGod'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. | Behavioural | Ancillary Study: Medically Tailored Groceries (MTG) Program |
Primary outcome
Change in Diet Quality
Time frame: Baseline, 4 months
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.
Change in HbA1c
Time frame: Baseline, 4 months
A fast and accurate HbA1c fingerstick test will assess changes in glycemic control from baseline to 4 months.
Change in systolic blood pressure
Time frame: Baseline, 4 months
The change in office systolic blood pressure (mmHg) from baseline to 4 months will be calculated.
11 secondary outcomes
Change in diastolic blood pressure
Time frame: Baseline, 4 months
Acceptability of Implementation
Time frame: 4 months
Feasibility of Implementation
Time frame: 4 months
Appropriateness of Implementation
Time frame: 4 months
Satisfaction with Intervention
Time frame: 4 months
Food Insecurity
Time frame: Baseline, 4 months
Nutrition Insecurity
Time frame: Baseline, 4 months
Sleep Duration
Time frame: Baseline, 4 months
Pittsburgh Sleep Quality Index
Time frame: Baseline, 4 months
Self-rated health
Time frame: Baseline, 4 months
General Health Status
Time frame: Baseline, 4 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 26 Oct 2026.
- Individual participant dataSharing planned: No. Data may be shared upon request to PI.
Related trials for Diet, Healthy
Recruiting
The Sleep2BWell Trial
Blood Pressure, Sleep Health
Active, not recruiting
Motivational Interviewing Intervention for Families With Overweight and Obesity
Obesity & Overweight
Active, not recruiting
The Impact of Postbiotic Supplementation on Tolerability and Physiological/Metabolic Parameters
Gastrointestinal Health
Not yet recruitingPhase 1/2
A Study of Single and Combination Lipase Dietary Supplements to Increase Fatty Acid Absorption in Generally Health Adults
Digestive Symptoms, Gastrointestinal Symptoms
Recruiting
Investigation of Egg Intake and the Relationship Between Gut Microbiome, Metabolic, and Immune Profiles
Obesity (BMI Equal to or >30), Immune Function
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.
Nour Makarem, PhD, FAHA principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medically Tailored Groceries in people with Diet, Healthy and HbA1c, run by Columbia University at 1 site 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 3 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diet Quality (time frame: Baseline, 4 months). The study lists 3 primary outcomes in all. 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 26 Oct 2026.