MTM2MTG Pilot Ancillary Study

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT07620808
Status
Enrolling By Invitation

Conditions

  • Blood Pressure
  • Diet, Healthy
  • HbA1c

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Change in Diet Quality [ Time Frame: Baseline, 4 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Mailman School of Public HealthNew YorkNew York10032-

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Columbia University Mailman School of Public Health· New York, NY

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