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Enrolling By Invitation
NCT07620808
MTM2MTG Pilot Ancillary Study
Conditions: Diet, Healthy, HbA1c, Blood Pressure
Sex: All
Ages: 20 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Columbia University
Location: Columbia University Mailman School of Public Health New York New York
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.
Eligibility Criteria
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)
Source: ClinicalTrials.gov (NCT07620808). StuddyBuddy aggregates publicly available trial information.