Medically Tailored Meals for Type 2 Diabetes
(FAME-D Trial)
Recruiting in Palo Alto (17 mi)
Overseen bySeth Berkowitz, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of North Carolina, Chapel Hill
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The investigators propose a single-site, open-label, Phase II, community-based randomized clinical explanatory trial to test the efficacy of a medically tailored meal (MTM) interventions for adults with food insecurity and T2DM (Type 2 Diabetes Mellitus). While the efficacy of MTM needs to be established, given the nature of the population served by MTM, it is important to design the study to enhance the external validity/generalizability of the findings as much as possible. The investigators will recruit 200 participants from the referral list of Community Servings, a Boston-based MTM provider, and randomly assign them to MTM (N=100) or usual care + monthly food subsidy (N=100). MTM intervention will consist of 6 months of weekly delivery of 10 ready-to-eat meals (approximately half an individual's weekly food intake), along with telephone-based lifestyle intervention that prepares participants for the post-treatment period. The usual care + food subsidy recipients will receive usual care along with 6 months of a $40/month food subsidy.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you intermittently use medications like glucocorticoids that affect blood sugar, you may not be eligible to participate.
What data supports the idea that Medically Tailored Meals for Type 2 Diabetes is an effective treatment?
The available research shows that Medically Tailored Meals (MTM) can be effective for people with Type 2 Diabetes, especially those who struggle to access nutritious food. These meals help improve health and reduce healthcare costs for food-insecure patients. Participants in MTM programs reported being able to eat the right foods, which suggests that these meals help manage diabetes better than usual care. While more studies are needed, the current evidence supports the idea that MTM can be a valuable treatment option for managing Type 2 Diabetes.
12345What safety data exists for medically tailored meals for type 2 diabetes?
The provided research does not explicitly mention safety data for medically tailored meals (MTM) for type 2 diabetes. However, the studies suggest that MTM interventions are beneficial in managing chronic conditions like type 2 diabetes, improving health outcomes, and reducing healthcare costs. Further studies are needed to validate these findings and potentially support policy changes for insurance coverage.
12345Is the treatment Food As Medicine a promising treatment for Type 2 Diabetes?
Yes, Food As Medicine, which includes Medically Tailored Meals, is a promising treatment for Type 2 Diabetes. It helps improve the health of people who struggle to get enough nutritious food and can lower healthcare costs. This approach involves providing healthy, pre-prepared meals to manage diabetes better.
12345Eligibility Criteria
This trial is for adults with food insecurity and Type 2 Diabetes Mellitus who speak English, plan to stay in the area for a year, have specific levels of Hemoglobin A1c and BMI, can control their diet, consent to participate, and aren't planning pregnancy. Excluded are those with severe psychiatric issues or substance misuse, involved in similar research recently, without stable housing or phone access, certain medical conditions including advanced kidney disease or recent cancer (except some localized cases).Inclusion Criteria
I have been diagnosed with Type 2 Diabetes.
Willing and able to provide written informed consent and participate in all study activities
Your average blood sugar level (Hemoglobin A1c) is between 7.0% and 12.0% in the past year.
+5 more
Exclusion Criteria
Known psychosis or major psychiatric illness that prevents participation with study activities
Another family member or household member is a study participant. Only one member of each household may take part in this study.
I have had cancer other than non-melanoma skin cancer, but it was cured or has been in remission for over 5 years.
+8 more
Participant Groups
The study compares two approaches: one group receives medically tailored meals (MTM) plus lifestyle calls for six months; the other gets usual diabetes care plus a monthly food subsidy. The MTM includes weekly delivery of ready-to-eat meals covering half of weekly intake.
2Treatment groups
Experimental Treatment
Active Control
Group I: Medically Tailored Meal (MTM)Experimental Treatment1 Intervention
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
Group II: Food SubsidyActive Control1 Intervention
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
Food As Medicine is already approved in United States, Australia for the following indications:
🇺🇸 Approved in United States as Medically Tailored Meals (MTM) for:
- Type 2 Diabetes Mellitus (T2DM)
🇦🇺 Approved in Australia as Food-as-Medicine Program for:
- Type 2 Diabetes Mellitus (T2DM)
- Heart Disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of North Carolina at Chapel HillChapel Hill, NC
Loading ...
Who Is Running the Clinical Trial?
University of North Carolina, Chapel HillLead Sponsor
Community ServingsCollaborator
Community ServingsCollaborator
Massachusetts General HospitalCollaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Protocol for a randomized controlled trial of medically tailored meals compared to usual care among individuals with type 2 diabetes in Australia. [2023]'Food is medicine' strategies aim to integrate food-based nutrition interventions into healthcare systems and are of growing interest to healthcare providers and policy makers. 'Medically Tailored Meals' (MTM) is one such intervention, which involves the 'prescription' by healthcare providers of subsidized, pre-prepared meals for individuals to prevent or manage chronic conditions, combined with nutrition education.
Comparing two durations of medically tailored meals posthospitalization: A randomized clinical trial. [2023]Medically tailored meals (MTM) may be beneficial to patients after hospital discharge.
Medically Tailored Meals as a Prescription for Treatment of Food-Insecure Type 2 Diabetics. [2020]Type 2 diabetes mellitus is an immense burden to the health of our population and to our current health care system, and the weight of this burden is only projected to multiply in coming years. A nutritious diet is an indispensable aspect of diabetes treatment, and the lack of access to food engenders poor disease-state control, which correlates with increased health care utilization. Interventions aimed at improving access to food through medically tailored meals (MTMs) have demonstrated effectiveness in improving the health of food-insecure type 2 diabetic patients and reducing health care costs. Further studies are necessary to increase the external validity of existing positive research on medically tailored meals in food-insecure diabetic patients and to provide evidence to support potential policy changes under which the costs of medically tailored meals for diabetics might be covered by insurers.
Association of National Expansion of Insurance Coverage of Medically Tailored Meals With Estimated Hospitalizations and Health Care Expenditures in the US. [2023]Medically tailored meals (MTMs) are associated with lower health care utilization among patients with complex diet-related diseases but are not a covered benefit in Medicare or Medicaid. The potential impact of extending insurance coverage for MTMs nationally remains unknown.
"I was able to eat what I am supposed to eat"-- patient reflections on a medically-tailored meal intervention: a qualitative analysis. [2020]Medically-tailored meal programs that provide home-delivered medically-appropriate food are an emerging intervention when type 2 diabetes co-occurs with food insecurity (limited or uncertain access to nutritious food owing to cost). We sought to understand the experiences of medically-tailored meal program participants.