Clinical trial NCT04264572: Project MiNT: Assessing the Impact of Food & Video-Based Nutrition Education on Patients With Poorly Controlled Diabetes
Official title: A Pragmatic Randomized Controlled Trial Assessing the Impact of Medically Tailored Meals and Medical Nutrition Therapy Via Telehealth Among Patients With Poorly Controlled Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Rutgers University
name: West Chester University of Pennsylvania
First posted: 2020-02-11
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Have type 2 diabetes mellitus (DM)
2. Are 18 years or older of age
3. English speaking
4. Are a patient in the ED or inpatient at TJUH or Methodist Hospital
5. Have a HbA1c \>8% as assessed during enrollment screening
6. Have a PCP or Endocrine provider
7. Have access to a device (e.g., smartphone, tablet, computer with WiFi) that can support video visits
8. Have access to an email account (either own or family member)
9. Are able to keep food fresh for a week after delivery (e.g., not homeless) and reheat food using a microwave or oven
10. Live in the MANNA service area

Exclusion Criteria:

1. 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)
2. Pregnant, planning to be pregnant, or currently breastfeeding, as these patients have unique nutritional requirements outside the MNT curriculum
3. Does not eat by mouth (i.e. receives tube feeds or total parenteral nutrition \[TPN\])
4. History of severe gastroparesis
5. Has a life expectancy of less than one year, per clinician
6. Inability to provide informed consent
7. Psychiatric co-morbidity that would preclude study participation
8. Major communication barriers such as visual or hearing impairment that would compromise the ability to participate in a video visit
9. Lives in or is being discharged to a facility (incarcerated, IP rehab, nursing home)
10. Currently receiving MTM from MANNA or another provider
11. Have life threatening food allergies
12. Currently participating in DM-I or PREVENT study
13. Has 3 or more ED visits for alcohol or other substance use in past month

Primary outcomes:
measure: Change in hemoglobin A1C for patients with poorly controlled type 2 diabetes mellitus
timeFrame: 6 months
Secondary outcomes:
measure: Change in hemoglobin A1C for patients with poorly controlled type 2 diabetes mellitus
timeFrame: 3 months
measure: Change in hemoglobin A1C for patients with poorly controlled type 2 diabetes mellitus
timeFrame: 12 months
measure: Intervention costs of 1) medically tailored meals, 2) medically tailored meals + telehealth-delivered medical nutrition therapy, and 3) usual care
timeFrame: 6 months
measure: Intervention costs of 1) medically tailored meals, 2) medically tailored meals + telehealth-delivered medical nutrition therapy, and 3) usual care
timeFrame: 12 months
measure: Healthcare costs
timeFrame: 6 months
measure: Healthcare costs
timeFrame: 12 months
measure: Health care quality of life as measured by the EQ-5D-5L
timeFrame: 6 months
measure: Health care quality of life as measured by the EQ-5D-5L
timeFrame: 12 months
measure: Incremental Cost-Effectiveness Ratio (ICER)
timeFrame: 6 months
measure: Incremental Cost-Effectiveness Ratio (ICER)
timeFrame: 12 months
measure: Change in weight for patients with poorly controlled type 2 diabetes mellitus
timeFrame: 3 months
measure: Change in weight for patients with poorly controlled type 2 diabetes mellitus
timeFrame: 6 months
measure: Change in weight for patients with poorly controlled type 2 diabetes mellitus
timeFrame: 12 months
measure: Change in diabetes self-efficacy for patients with poorly controlled type 2 diabetes mellitus as measured by The Diabetes Self Efficacy Scale
timeFrame: 6 months
measure: Change in diabetes self-efficacy for patients with poorly controlled type 2 diabetes mellitus as measured by The Diabetes Self Efficacy Scale
timeFrame: 12 months
measure: Change in self-care for patients with poorly controlled type 2 diabetes mellitus as measured by the Summary of Diabetes Self-Care Activities (SDSCA)
timeFrame: 6 months
measure: Change in self-care for patients with poorly controlled type 2 diabetes mellitus as measured by the Summary of Diabetes Self-Care Activities (SDSCA)
timeFrame: 12 months
measure: Change in diabetes quality of life for patients with poorly controlled type 2 diabetes mellitus as measured by Diabetes Quality of Life (DQoL) instrument
timeFrame: 6 months
measure: Change in diabetes quality of life for patients with poorly controlled type 2 diabetes mellitus as measured by Diabetes Quality of Life (DQoL) instrument
timeFrame: 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References: