What this study is
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.
What's being tested
- Medically Tailored Groceries
Intervention · 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.
Study details
- Official title
- Medically Tailored Groceries for Cardiovascular Health
- Sponsor
- Columbia University
- Conditions
- Diet, Healthy · HbA1c · Blood Pressure
- Enrolling
- 80 people
- Starts
- 2026-08-25
- Est. completion
- 2027-06
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 20 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openColumbia University Mailman School of Public Health
New York, New York, United States
Study team
Sponsor
Columbia University
Study ID AAAV0681 - Ancillary Study
Principal investigator
Nour Makarem, PhD, FAHA
Columbia University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.