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

  • STATUS
    Recruiting
  • participants needed
    600
  • sponsor
    Thomas Jefferson University
Updated on 19 February 2024
nutrition education
nutritional support
medical nutrition therapy

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.

Description

Despite the availability of evidence-based guidance and treatments, many patients with diabetes mellitus (DM) do not achieve optimal glycemic control. In prior work, patients with DM identified primary needs of improved access to food and nutrition education. Several innovative models for food services have emerged to address patient needs for improved healthy food access. Currently, select non-profit organizations across the U.S. deliver millions of medically-tailored meals (MTM) to patients with chronic illnesses, based on the premise that food can be as helpful as medicine in improving patient outcomes. While a handful of pilot studies have demonstrated success of MTM in reducing healthcare utilization and hemoglobin A1c (HbA1c) among patients with DM, no randomized trials have assessed the sustained impact of MTM on long-term outcomes for patients with DM. Similarly, individual studies of medical nutrition therapy (MNT), which includes individualized nutrition education and counseling, have shown benefit for improving DM outcomes. However, uptake of MNT across health systems has historically been extremely limited because of patient logistical barriers to attending the in-person visits. MNT delivered by telehealth (tele-MNT) has potential to overcome these barriers. Our goal is to evaluate the effect of MTM, with and without additional tele-MNT, on outcomes for patients with poorly controlled type 2 DM. The investigators will conduct a pragmatic randomized controlled trial with patients who have poorly controlled DM. Outcomes of interest include change in HbA1c, cost effectiveness, weight, diabetes self-efficacy, self-care, diabetes quality of life, and patient satisfaction. Investigators will assess the efficacy of 1) MTM and 2) MTM + tele-MNT compared to usual care in reducing HbA1c at 3, 6 (primary outcome) and 12 months and the cost effectiveness of each intervention compared to usual care up to 12 months. Patient perspectives regarding experiences with MTM and MTM + tele-MNT will also be explored to gain a better understanding of potential factors contributing to treatment failure and success within each group. The proposed research is innovative because it develops and tests a novel tele-MNT intervention tailored to recipients of MTM, provides a comprehensive solution to patient-identified nutrition needs, includes complete utilization data provided by the HealthShare Exchange, and leverages a unique health system and community group partnership to improve sustainability and scalability. Study results will inform 1) provider and payor decisions regarding offering and covering these services; 2) how services should be structured for scalability; and 3) integration of these services into the larger care delivery system to reduce DM disparities.

Details
Condition NIDDM
Age 18years - 100years
Treatment Medically Tailored Meals, Tele-Medical Nutrition Therapy (tele-MNT)
Clinical Study IdentifierNCT04264572
SponsorThomas Jefferson University
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
In police custody or incarcerated
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
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