MTM + ILI for Diabetes Mellitus, Type 2

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of North Carolina at Chapel Hill, Chapel Hill, NC
Diabetes Mellitus, Type 2+1 More
MTM + ILI - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a medically tailored meal + intensive lifestyle intervention can improve health outcomes for people with diabetes and food insecurity.

See full description

Eligible Conditions

  • Diabetes Mellitus, Type 2
  • HIV Infections

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether MTM + ILI will improve 1 primary outcome, 14 secondary outcomes, and 42 other outcomes in patients with Diabetes Mellitus, Type 2. Measurement will happen over the course of 6 months.

12 Months
Diastolic Blood Pressure at Month 12
Food Insecurity Score at Month 12
Self-Reported CD4+ Count at Month 12
Self-Reported HIV Viral Load at Month 12
Systolic Blood Pressure at Month 12
12 months
ARMS-D Medication Adherence Score at Month 12
Bodyweight at Month 12
Cost-Related Medication Underuse at Month 12
Depressive Symptom Score at Month 12
Diabetes Distress Score as assessed by PAID-11 at Month 12
Diabetes Self-Care Activities Medication Adherence Score at Month 12
Diet Quality Score at Month 12
Diet Self-Efficacy Score at Month 12
Food/Medication Trade-offs at Month 12
Health-Related Quality of Life Score as assessed by PROMIS-29 at Month 12
Hemoglobin A1c at Month 12
Perceived Diabetes Self-Management Self-Efficacy Score at Month 12
Stress Score at 12 months
18 Months
Diastolic Blood Pressure at Month 18
Food Insecurity Score at Month 18
Self-Reported CD4+ Count at Month 18
Self-Reported HIV Viral Load at Month 18
Systolic Blood Pressure at Month 18
18 months
ARMS-D Medication Adherence Score at Month 18
Bodyweight at Month 18
Cost-Related Medication Underuse at Month 18
Depressive Symptom Score at Month 18
Diabetes Distress Score as assessed by PAID-11 at Month 18
Diabetes Self-Care Activities Medication Adherence Score at Month 18
Diet Quality Score at Month 18
Diet Self-Efficacy Score at Month 18
Food/Medication Trade-offs at Month 18
Health-Related Quality of Life Score as assessed by PROMIS-29 at Month 18
Hemoglobin A1c at Month 18
Perceived Diabetes Self-Management Self-Efficacy Score at Month 18
Stress Score at 18 months
6 Months
Cluster of Differentiation 4 (CD4+) Count at Month 6
Diastolic Blood Pressure at Month 6
Food Insecurity Score at Month 6
HIV Viral Load at Month 6
Self-Reported CD4+ Count at Month 6
Self-Reported HIV Viral Load at Month 6
Systolic Blood Pressure at Month 6
6 months
Adherence to Refills and Medications Scale-Diabetes (ARMS-D) Medication Adherence Score at Month 6
Bodyweight at Month 6
C-Reactive Protein (CRP) at Month 6
Cost-Related Medication Underuse at Month 6
Depressive Symptom Score at Month 6
Diabetes Distress Score as assessed by Problem Areas in Diabetes (PAID)-11 at Month 6
Diabetes Self-Care Activities Medication Adherence Score at Month 6
Diet Quality Score at Month 6
Diet Self-Efficacy Score at Month 6
Food/Medication Trade-offs at Month 6
Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at Month 6
Hemoglobin A1c at Month 6
Perceived Diabetes Self-Management Self-Efficacy Score at Month 6
Stress Score at 6 months

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Standard MTM
1 of 2
Medically Tailored Meal (MTM) + Intensive Lifestyle Intervention (ILI)
1 of 2
Active Control
Experimental Treatment

This trial requires 200 total participants across 2 different treatment groups

This trial involves 2 different treatments. MTM + ILI is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Medically Tailored Meal (MTM) + Intensive Lifestyle Intervention (ILI)
Behavioral
The Medically Tailored Meal (MTM) + Intensive Lifestyle Intervention (ILI) consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 20-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.
Standard MTM
Behavioral
The Standard Medically Tailored Meal (MTM) intervention (ILI) consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and an initial consultation with a dietitian.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 18 months for reporting.

Closest Location

University of North Carolina at Chapel Hill - Chapel Hill, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Diagnosis of Type 2 Diabetes Mellitus
You have been diagnosed with HIV. show original
You have hemoglobin A1c ≥ 6.5% and ≤ 12.0% in the last 12 months. show original
You have experienced food insecurity in the past month. show original
English speaking
BMI ≥23 kg/m^2
No plans to move from the area for at least 1 year
Free living to the extent that participant has control over dietary intake
You are willing and able to provide written informed consent and participate in all study activities. show original

Patient Q&A Section

What is diabetes mellitus, type 2?

"The prevalence of diabetes in the US is 20.1%. Approximately 29 million adults have diabetes. With 1 in 3 adults in the US having diabetes, healthcare and public investment on diabetes continue to be large. Diabetes in the US is caused by a complex interaction of a number of environmental and genetic factors.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of diabetes mellitus, type 2?

"Diabetes mellitus type 2 may present with a myriad of clinical complaints. A person with diabetes mellitus type 2 is at increased risk of developing complications and is likely to present with acute symptoms that may mimic acute heart disease and neurological symptoms." - Anonymous Online Contributor

Unverified Answer

How many people get diabetes mellitus, type 2 a year in the United States?

"Results from a recent paper suggests that about 80% to 90% of Americans will develop diabetes by age 55. Diabetes is not just a problem for the nation as a whole because individuals from the highest ethnic and socioeconomic groups are at greatest risk." - Anonymous Online Contributor

Unverified Answer

Can diabetes mellitus, type 2 be cured?

"Diabetes, type 2 cannot be cured. It becomes an incurable disease when it progresses to complications. And, many patients with [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes) can live with no or very mild symptoms." - Anonymous Online Contributor

Unverified Answer

What are common treatments for diabetes mellitus, type 2?

"Effective, affordable medical treatments exist for diabetic foot ulcers (DFUs) and lower extremity neuropathy, and for other cardiovascular complications. Because of their effectiveness, proper referral, and affordability, medical management often yields a durable functional outcome as well as improved clinical status. These treatments may also decrease disease-related morbidity and mortality. We anticipate that improved treatment will decrease the prevalence of DFUs and lower extremity neuropathy." - Anonymous Online Contributor

Unverified Answer

What causes diabetes mellitus, type 2?

"It is clear that genetic and environmental factors are involved in the development of diabetes mellitus, type 2. There is evidence that the disorder may be associated with the consumption of alcohol but there is no direct causal relationship." - Anonymous Online Contributor

Unverified Answer

Is mtm + ili safe for people?

"Patients with Mtm+ili are no more likely to have diabetes or heart disease compared with people who do not have the mutation. The risk of pancreatitis may be greater when pancreatitis occurs, but the risk is still low. It is also possible that the mutation causes an increased risk for developing a type of cancers, especially pancreas cancer, but this is still uncertain." - Anonymous Online Contributor

Unverified Answer

Does diabetes mellitus, type 2 run in families?

"Results indicate that the genetic basis for diabetes mellitus in American Indian families is predominantly genetically based rather than being a result of a defect in the action or utilization of the insulin pathway." - Anonymous Online Contributor

Unverified Answer

What does mtm + ili usually treat?

"This meta-analysis has identified important treatment differences in type 1 and type 2 DM between patients who receive insulin and those who do not, which could have a significant impact on the health-care system, on resource usage and the overall effectiveness of diabetes. Data from a recent study warrant more in-depth analyses to find the most effective treatment strategy to reduce morbidity in diabetic patients. Data from a recent study, therefore, could prompt a discussion regarding the need for a structured and well-designed clinical trial, focusing on patients with type 1 and type2 DM, for evaluating this issue." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets diabetes mellitus, type 2?

"The average age that diabetes mellitus, type 2 occurs among whites with high or low BMI and high or low triglyceride levels is 5 and 19 years old, respectively." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of mtm + ili?

"MTM + ili (MMT + DM + MI): Side effects are as follows: headache, dizziness, dizziness, weakness. It is important to follow the above-mentioned side effects by a healthcare provider(e.g. doctor) for further investigation and treatment.\n" - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving mtm + ili?

"At the present time there are no clinical trials for patients diagnosed with type 2 Diabetes and MTM2 mutation. Further studies should be undertaken for patients who have different clinical and histological manifestations and for patients with different genetic variants, with and without an iliac crest bone biopsy." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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