600 Participants Needed

Food & Video-Based Nutrition Education for Type 2 Diabetes

KL
AM
Overseen ByAnna Marie C Chang, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Thomas Jefferson University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

Is it safe to participate in a clinical trial involving medically tailored meals for type 2 diabetes?

The research does not provide specific safety data for medically tailored meals, but these meals are generally considered safe as they are designed to meet the nutritional needs of individuals with specific health conditions.12345

How is the treatment of medically tailored meals and tele-medical nutrition therapy unique for type 2 diabetes?

This treatment is unique because it combines medically tailored meals, which are customized to meet the nutritional needs of individuals with type 2 diabetes, with tele-medical nutrition therapy, providing remote education and support. This approach addresses food insecurity and improves access to nutritious meals, which can lead to better disease management and reduced healthcare costs.34678

What data supports the effectiveness of the treatment Medically Tailored Meals, Nutritional Support, Food Supplements, and Tele-Medical Nutrition Therapy for Type 2 Diabetes?

Research shows that medically tailored meals can improve health outcomes and reduce healthcare costs for food-insecure patients with type 2 diabetes by providing access to nutritious meals, which is crucial for managing the condition.135910

Are You a Good Fit for This Trial?

This trial is for adults over 18 with poorly controlled type 2 diabetes (HbA1c >8%), who speak English, have a device for video visits, can store and reheat food, live in the MANNA service area, and are not pregnant or breastfeeding. Excluded are those with life expectancy under one year, severe dietary restrictions or psychiatric conditions that affect participation.

Inclusion Criteria

Live in the MANNA service area
Are able to keep food fresh for a week after delivery (e.g., not homeless) and reheat food using a microwave or oven
I have type 2 diabetes.
See 6 more

Exclusion Criteria

I do not have major hearing or vision problems that would prevent me from participating in a video call.
You have a mental health condition that would make it difficult for you to take part in the study.
You have severe food allergies that could be life-threatening.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive medically tailored meals (MTM) for 12 weeks, with meals prepared and delivered by MANNA.

12 weeks
Weekly meal deliveries

Tele-Medical Nutrition Therapy (MNT)

Participants receive tele-MNT over 12 months, focusing on nutrition assessment, intervention, and care coordination.

12 months
Individual visits in the first 6 months, monthly group sessions in months 7-12

Follow-up

Participants are monitored for changes in HbA1c, self-care, and quality of life after treatment.

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Medically Tailored Meals
  • Tele-Medical Nutrition Therapy
Trial Overview Project MiNT tests if medically tailored meals and telehealth nutrition therapy improve diabetes control. Participants will be randomly assigned to receive these interventions or standard care to see which helps more with self-care behaviors and diet efficacy.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Medically Tailored Meals (MTM)Experimental Treatment1 Intervention
Group II: MTM + tele-Medical Nutrition Therapy (MNT)Experimental Treatment2 Interventions
Group III: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials
475
Recruited
189,000+

Rutgers University

Collaborator

Trials
127
Recruited
2,814,000+

West Chester University of Pennsylvania

Collaborator

Trials
6
Recruited
1,300+

Published Research Related to This Trial

A study involving 650 patients with chronic conditions found that receiving medically tailored meals (MTM) for 2 weeks led to a significant reduction in anxiety and depression scores compared to baseline, while the 4-week group did not show similar improvements.
However, there were no significant differences in overall patient outcomes, such as activities of daily living, nutritional risk, or rates of emergency department visits and rehospitalizations, between the 2-week and 4-week MTM groups.
Comparing two durations of medically tailored meals posthospitalization: A randomized clinical trial.Boxer, R., Drace, ML., Kelly, C., et al.[2023]
This study will evaluate the efficacy of a Medically Tailored Meals (MTM) program for individuals with type 2 diabetes and hyperglycemia, involving 212 participants over 26 weeks, to see if it can improve their blood sugar levels and overall health.
The trial aims to provide valuable data on the clinical outcomes of MTM, which could support its large-scale implementation in healthcare systems to help manage chronic conditions like diabetes.
Protocol for a randomized controlled trial of medically tailored meals compared to usual care among individuals with type 2 diabetes in Australia.Law, KK., Coyle, DH., Neal, B., et al.[2023]
In a study comparing two meal plans for hospitalized diabetes patients, the patient-controlled meal plan led to higher patient satisfaction and more opportunities for nutrition education, but also resulted in a significantly higher frequency of hypoglycemia (3.23% vs 0.39%).
The standard consistent-carbohydrate meal plan was associated with less hypoglycemia and required less oversight from clinicians, suggesting that while both meal plans can be effective, the patient-controlled option may need additional monitoring to ensure safety.
Menu selection, glycaemic control and satisfaction with standard and patient-controlled consistent carbohydrate meal plans in hospitalised patients with diabetes.Curll, M., Dinardo, M., Noschese, M., et al.[2010]

Citations

Comparing two durations of medically tailored meals posthospitalization: A randomized clinical trial. [2023]
Protocol for a randomized controlled trial of medically tailored meals compared to usual care among individuals with type 2 diabetes in Australia. [2023]
Menu selection, glycaemic control and satisfaction with standard and patient-controlled consistent carbohydrate meal plans in hospitalised patients with diabetes. [2010]
Medically Tailored Meals as a Prescription for Treatment of Food-Insecure Type 2 Diabetics. [2020]
Evidence-based medical nutrition therapy for diabetes. [2017]
Association of National Expansion of Insurance Coverage of Medically Tailored Meals With Estimated Hospitalizations and Health Care Expenditures in the US. [2023]
"I was able to eat what I am supposed to eat"-- patient reflections on a medically-tailored meal intervention: a qualitative analysis. [2020]
Education with a multimedia web platform improves knowledge and HbA1c of Mexican patients with type 2 diabetes. Open clinical trial. [2022]
Multimedia education program and nutrition therapy improves HbA1c, weight, and lipid profile of patients with type 2 diabetes: a randomized clinical trial. [2022]
Is There a Role for Diabetes-Specific Nutrition Formulas as Meal Replacements in Type 2 Diabetes? [2023]
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