Food & Video-Based Nutrition Education for Type 2 Diabetes

Overseen By Anna Marie C Chang, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Type 1 DM, Pregnant, Gastroparesis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

600 Participants Needed

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. ^{1 2 3 4 5}

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. ^{3 4 6 7 8}

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. ^{1 3 5 9 10}

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.

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.

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?

Group I: Medically Tailored Meals (MTM) Experimental Treatment 1 Intervention

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.

Group II: MTM + tele-Medical Nutrition Therapy (MNT) Experimental Treatment 2 Interventions

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.

Group III: Usual Care Active Control 1 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Medically tailored meals (MTMs) have been shown to effectively improve health outcomes for food-insecure patients with type 2 diabetes, highlighting the importance of nutrition in diabetes management.

Improving access to nutritious food through MTMs not only benefits patient health but also has the potential to reduce overall healthcare costs, suggesting a need for further research to support insurance coverage for these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medically Tailored Meals as a Prescription for Treatment of Food-Insecure Type 2 Diabetics. Rabaut, LJ.[2020]

Medical nutrition therapy (MNT) is an effective approach for managing glycemia, lipids, and blood pressure in individuals with diabetes, as supported by the 2002 American Diabetes Association guidelines.

MNT should evolve from focusing on weight management to improving insulin resistance and metabolic control, especially as beta-cell function declines, necessitating a shift from dietary management alone to combinations with oral medications and insulin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based medical nutrition therapy for diabetes. Franz, MJ.[2017]

Implementing national coverage for medically tailored meals (MTMs) could potentially prevent approximately 1.6 million hospitalizations and save $13.6 billion in health care costs annually for patients with diet-related diseases.

Over a 10-year period, MTM coverage could lead to an estimated 18.3 million averted hospitalizations and $484.5 billion in reduced health care expenditures, highlighting the significant cost-effectiveness of this intervention for patients with chronic diet-sensitive conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of National Expansion of Insurance Coverage of Medically Tailored Meals With Estimated Hospitalizations and Health Care Expenditures in the US. Hager, K., Cudhea, FP., Wong, JB., et al.[2023]

Participants in a medically-tailored meal program for individuals with type 2 diabetes reported high satisfaction and noted improvements in their quality of life and diabetes management, highlighting the program's effectiveness.

The study emphasized the importance of culturally appropriate meals and suggested that combining these meal programs with diabetes education could enhance their impact on managing diabetes and reducing stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I was able to eat what I am supposed to eat"-- patient reflections on a medically-tailored meal intervention: a qualitative analysis. Berkowitz, SA., Shahid, NN., Terranova, J., et al.[2020]

A 12-month clinical trial involving 161 patients with type 2 diabetes showed that using a multimedia site for nutritional therapy significantly improved diabetes knowledge and metabolic control, including reductions in HbA1c and waist circumference.

Patients receiving the multimedia education (TN+Nutriluv) had better outcomes compared to those receiving only nutritional therapy, highlighting the effectiveness of combining education with dietary management in improving health indicators for diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education with a multimedia web platform improves knowledge and HbA1c of Mexican patients with type 2 diabetes. Open clinical trial. Reséndiz Lara, T., Muñoz Torres, AV., Mendoza Salmerón, G., et al.[2022]

Diabetes-specific nutrition formulas (DSNFs) are designed with slowly-digestible carbohydrates and healthy fats, showing significant improvements in post-meal blood sugar levels and long-term glycemic control in patients with type 2 diabetes (T2D).

Clinical trials indicate that DSNFs not only help manage blood sugar levels but also positively impact various cardiometabolic health outcomes, making them a valuable tool in nutrition therapy for T2D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is There a Role for Diabetes-Specific Nutrition Formulas as Meal Replacements in Type 2 Diabetes? Noronha, JC., Mechanick, JI.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Comparing two durations of medically tailored meals posthospitalization: A randomized clinical trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Protocol for a randomized controlled trial of medically tailored meals compared to usual care among individuals with type 2 diabetes in Australia. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Menu selection, glycaemic control and satisfaction with standard and patient-controlled consistent carbohydrate meal plans in hospitalised patients with diabetes. [2010]

4. United States pubmed.ncbi.nlm.nih.gov

Medically Tailored Meals as a Prescription for Treatment of Food-Insecure Type 2 Diabetics. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Evidence-based medical nutrition therapy for diabetes. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Association of National Expansion of Insurance Coverage of Medically Tailored Meals With Estimated Hospitalizations and Health Care Expenditures in the US. [2023]

7. England pubmed.ncbi.nlm.nih.gov

"I was able to eat what I am supposed to eat"-- patient reflections on a medically-tailored meal intervention: a qualitative analysis. [2020]

8. Spain pubmed.ncbi.nlm.nih.gov

Education with a multimedia web platform improves knowledge and HbA1c of Mexican patients with type 2 diabetes. Open clinical trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Multimedia education program and nutrition therapy improves HbA1c, weight, and lipid profile of patients with type 2 diabetes: a randomized clinical trial. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Is There a Role for Diabetes-Specific Nutrition Formulas as Meal Replacements in Type 2 Diabetes? [2023]