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

NCT04264572 | Completed DMC

• 1 other identifier: 19F.258
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin A1C for patients with poorly controlled type 2 diabetes mellitus

  Change in hemoglobin A1C for patients with poorly controlled type 2 diabetes mellitus who receive 1) medically tailored meals and 2) medically tailored meals + telehealth-delivered medical nutrition therapy compared to usual care

  6 months

Secondary Outcomes (19)

• Change in hemoglobin A1C for patients with poorly controlled type 2 diabetes mellitus

  3 months

• Change in hemoglobin A1C for patients with poorly controlled type 2 diabetes mellitus

  12 months

• Intervention costs of 1) medically tailored meals, 2) medically tailored meals + telehealth-delivered medical nutrition therapy, and 3) usual care

  6 months

• Intervention costs of 1) medically tailored meals, 2) medically tailored meals + telehealth-delivered medical nutrition therapy, and 3) usual care

  12 months

• Healthcare costs

  6 months

Study Arms (3)

Medically Tailored Meals (MTM)

EXPERIMENTAL

Participants in this arm will receive MTM for 12 weeks. Meals will be prepared and delivered by MANNA, a non-profit organization that has provided MTM for patients with chronic illnesses in Philadelphia and Southern New Jersey since 1990. MANNA will deliver 21 complete meals to the patient's home each week, providing 45-60 grams of carbohydrates per meal for optimal glucose control based on ADA guidelines and 100% of overall nutritional requirements based on USDA guidelines. In addition, children and any senior dependents for whom the participant is the primary caregiver will receive meals for the entire 12 weeks for no additional cost, as this is standard of care of MANNA services. MANNA registered dieticians will cater the program to meet the specific needs (e.g., dietary restrictions, cultural preferences). Investigators will provide information on community resources in the area, including food resources, for all patients.

Other: Medically Tailored Meals

MTM + tele-Medical Nutrition Therapy (MNT)

EXPERIMENTAL

Patients in this arm will receive MTM services as well as tele-MNT over 12 months. The tele-MNT intervention will be delivered by a registered dietician within the Jefferson endocrine clinic, with assistance by other endocrine dieticians and fellows. In the first months, video visits focus on supporting individuals who are not selecting, preparing or purchasing their own meals. As the end of MTM services approaches, the intervention shifts to focus on the transition from MTM to self-directed eating. Based on Academy of Nutrition and Dietetics recommendations, each participant's MNT will include the following core features: nutrition assessment, intervention, care coordination, monitoring and evaluation. The following will also be addressed: nutrition prescriptions, nutrient intake, energy intake, glycemic index and load, alcohol consumption and physical activity. The schedule includes individual visits in the first 6 months and monthly group session in months 7-12.

Other: Medically Tailored Meals; Behavioral: Tele-Medical Nutrition Therapy (tele-MNT)

Usual Care

NO INTERVENTION

Patients in this arm will receive usual services offered at Jefferson for patients with DM, which includes regular visits with a diabetes provider (primary care or endocrine), standard ADA information pamphlets and referral to 1) diabetes education classes and 2) nutrition counseling by dieticians and nurse practitioners. During routine office visits, providers reinforce messages about self-management and provide lists of local and national resources related to nutrition and diabetes self-management (e.g., diabetes.org). The standard of care at Jefferson for patients with DM is to begin with a single group MNT visit lasting from 60-90 minutes. Each participant's need for additional sessions and general time-frame for follow-up is individually determined following the group session, based on patient preference. Historically, only about 2% of the Jefferson population engages in these services, thus minimizing dilution of the effect of the tele-MNT.

Interventions

Medically Tailored Meals OTHER

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.

MTM + tele-Medical Nutrition Therapy (MNT); Medically Tailored Meals (MTM)

Tele-Medical Nutrition Therapy (tele-MNT) BEHAVIORAL

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.

MTM + tele-Medical Nutrition Therapy (MNT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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 \[TPN\])
• History of severe gastroparesis
• Has a life expectancy of less than one year, per clinician
• Inability to provide informed consent
• 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
• Lives in or is being discharged to a facility (incarcerated, IP rehab, nursing home)
• Currently receiving MTM from MANNA or another provider
• Have life threatening food allergies
• Currently participating in DM-I or PREVENT study
• Has 3 or more ED visits for alcohol or other substance use in past month

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Rutgers University: collaborator
• West Chester University of Pennsylvania: collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: A computer-generated list of random numbers will be prepared in advance by the study biostatistician and loaded into a REDCap randomization tool to ensure the research staff are blinded to assignment pre-randomization. It is not feasible to blind participants and clinic staff to assignment post enrollment; however, HbA1c is an objective outcome, and as such lack of blinding should not be a significant limitation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enrolled patients with HbA1c\>8% will be randomized to 1 of 3 arms: 1) MTM; 2) MTM + tele- MNT; or 3) usual care in a 1:1:1 ratio using random permuted blocks stratified by HbA1c (\>8 to \<10 vs. \>10) and hospital discharge site (inpatient vs ED). The size of any particular block will be randomly selected and only known by the study biostatistician. This stratification approach was selected as investigators hypothesize that the interventions may have differential effects based on how poorly controlled an individual's DM is at baseline, as well as the degree of acute decompensation of the patient at time of enrollment.

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: February 11, 2020
• Study Start: January 21, 2020
• Primary Completion: May 9, 2025
• Study Completion: May 9, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

US (1)