NCT04264572Completed
Project MiNT: Assessing the Impact of Food & Video-Based Nutrition Education on Patients With Poorly Controlled Diabetes
A Pragmatic Randomized Controlled Trial Assessing the Impact of Medically Tailored Meals and Medical Nutrition Therapy Via Telehealth Among Patients With Poorly Controlled Diabetes
Source: ClinicalTrials.gov · Last updated 29 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 600 (actual)
- First submitted
- 3 Jan 2020
- Start date
- 21 Jan 2020
- Primary completion date
- 9 May 2025
- Lead sponsor
- Thomas Jefferson University
- Diseases
- Type 2 diabetes
- NCT number
- NCT04264572
What you commit to
- Study type: Interventional
- Participants enrolled: 600
- From 21 Jan 2020 to the primary completion date, 9 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have type 1 DM (to reduce confounding related to underlying differences in pathophysiology and primary treatment approaches (lifestyle change vs medication regimens) between type 1 and type 2 DM)
- Currently receiving MTM from MANNA or another provider
Other illness
- History of severe gastroparesis
- Psychiatric co-morbidity that would preclude study participation
- Major communication barriers such as visual or hearing impairment that would compromise the ability to participate in a video visit
- Have life threatening food allergies
Other
- Pregnant, planning to be pregnant, or currently breastfeeding, as these patients have unique nutritional requirements outside the MNT curriculum
- Does not eat by mouth (i.e. receives tube feeds or total parenteral nutrition \[TPN\])
- Has a life expectancy of less than one year, per clinician
- Inability to provide informed consent
- Lives in or is being discharged to a facility (incarcerated, IP rehab, nursing home)
- Currently participating in DM-I or PREVENT study
- Has 3 or more ED visits for alcohol or other substance use in past month
Who the study is looking for
- Have type 2 diabetes mellitus (DM)
- Are 18 years or older of age
- English speaking
- Are a patient in the ED or inpatient at TJUH or Methodist Hospital
- Have a HbA1c \>8% as assessed during enrollment screening
- Have a PCP or Endocrine provider
- Have access to a device (e.g., smartphone, tablet, computer with WiFi) that can support video visits
- Have access to an email account (either own or family member)
- Are able to keep food fresh for a week after delivery (e.g., not homeless) and reheat food using a microwave or oven
- Live in the MANNA service area
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Thomas Jefferson University Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.