Food & Video-Based Nutrition Education for Type 2 Diabetes
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?
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive medically tailored meals (MTM) for 12 weeks, with meals prepared and delivered by MANNA.
Tele-Medical Nutrition Therapy (MNT)
Participants receive tele-MNT over 12 months, focusing on nutrition assessment, intervention, and care coordination.
Follow-up
Participants are monitored for changes in HbA1c, self-care, and quality of life after treatment.
What Are the Treatments Tested in This Trial?
Interventions
- Medically Tailored Meals
- Tele-Medical Nutrition Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Thomas Jefferson University
Lead Sponsor
Rutgers University
Collaborator
West Chester University of Pennsylvania
Collaborator