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Project MiNT: Assessing the Impact of Food & Video-Based Nutrition Education on Patients With Poorly Controlled Diabetes

NCT04264572 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-09-29

No results posted yet for this study

Summary

This pragmatic randomized controlled trial will assess the efficacy of medically tailored meals and medical nutrition therapy via telehealth on clinical outcomes for patients with poorly controlled type 2 diabetes. The goal of these interventions is to improve outcomes for patients with diabetes by impacting self-care behaviors and diet self-efficacy in the short and long term. This study leverages a unique health system and community group partnership to inform the utility of reimbursement for medically tailored meal programs and medical nutrition therapy, which would ultimately facilitate their scalability and sustainability within the healthcare system.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

OTHER

Medically Tailored Meals

MTM are meals designed by a Registered Dietitian Nutritionist to reflect appropriate dietary therapy according to evidence-based nutrition practice guidelines. They address medical diagnoses, symptoms, allergies, inability to chew or swallow, medication management, and side effects to ensure the best possible nutrition-related health outcomes.

BEHAVIORAL

Tele-Medical Nutrition Therapy (tele-MNT)

Medical nutrition therapy (MNT) is offered as a component of usual care in many health systems, and consists of individuals receiving nutrition education tailored to their unique medical needs. Tele-MNT is the use of video technology to deliver MNT.

Sponsors & Collaborators

  • Rutgers University

    collaborator OTHER

  • West Chester University of Pennsylvania

    collaborator OTHER

  • Thomas Jefferson University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-21
Primary Completion
2025-05-09
Completion
2025-05-09

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04264572 on ClinicalTrials.gov