Dataset Information

Assessing the impact of medically tailored meals and medical nutrition therapy on type 2 diabetes: Protocol for Project MiNT.

ABSTRACT:

Background

Research has shown that among people with type 2 diabetes mellitus, reduction in hemoglobin A1c (HbA1c) prevents long term complications. Medically tailored meals (MTM) and telehealth-delivered medical nutrition therapy (tele-MNT) are promising strategies for patient-centered diabetes care.

Objectives

Project MiNT will determine whether provision of MTM with and without the addition of telehealth-delivered medical nutrition therapy improves HbA1c and is cost effective for patients with type 2 diabetes mellitus.

Methods

Patients with poorly controlled type 2 diabetes mellitus (HbA1c >8%) will be recruited from Jefferson Health. Eligible patients will be randomized to one of three arms: 1) usual care, 2) 12 weeks of home-delivered MTM, or 3) MTM + 12 months of tele-MNT. All participants (n = 600) will complete three follow-up assessments at 3, 6, and 12 months. The primary outcome is change in HbA1c at 6 months. Secondary outcomes include change in HbA1c at 3 and 12 months and cost-effectiveness of the intervention at 6 and 12 months. Conclusion Findings from Project MiNT will inform MTM coverage and financing decisions, how to structure services for scalability and system-wide integration, and the role of these services in reducing health disparities.

SUBMITTER: Rising KL

PROVIDER: S-EPMC8453110 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature

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Publications

Assessing the impact of medically tailored meals and medical nutrition therapy on type 2 diabetes: Protocol for Project MiNT.

Rising Kristin L KL Kemp Mackenzie M Davidson Patricia P Hollander Judd E JE Jabbour Serge S Jutkowitz Eric E Leiby Benjamin E BE Marco Cheryl C McElwee Ian I Mills Geoffrey G Pizzi Laura L Powell Rhea E RE Chang Anna Marie AM

Contemporary clinical trials 20210724

<h4>Background</h4>Research has shown that among people with type 2 diabetes mellitus, reduction in hemoglobin A1c (HbA1c) prevents long term complications. Medically tailored meals (MTM) and telehealth-delivered medical nutrition therapy (tele-MNT) are promising strategies for patient-centered diabetes care.<h4>Objectives</h4>Project MiNT will determine whether provision of MTM with and without the addition of telehealth-delivered medical nutrition therapy improves HbA1c and is cost effective f ...[more]

PMID: 34314856

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Project description:BackgroundInability to adhere to nutritional recommendations is common and linked to worse outcomes in patients with nutrition-sensitive conditions.ObjectivesThe purpose of this study is to evaluate whether medically tailored meals (MTMs) improve outcomes in recently discharged adults with nutrition-sensitive conditions compared with usual care.Research designRemote pragmatic randomized trial.SubjectsAdults with heart failure, diabetes, or chronic kidney disease being discharged home between April 27, 2020, and June 9, 2021, from 5 hospitals within an integrated health care delivery system.MeasuresParticipants were prerandomized to 10 weeks of MTMs (with or without virtual nutritional counseling) compared with usual care. The primary outcome was all-cause hospitalization within 90 days after discharge. Exploratory outcomes included all-cause and cause-specific health care utilization and all-cause death within 90 days after discharge.ResultsA total of 1977 participants (MTMs: n=993, with 497 assigned to also receive virtual nutritional counseling; usual care: n=984) were enrolled. Compared with usual care, MTMs did not reduce all-cause hospitalization at 90 days after discharge [adjusted hazard ratio, aHR: 1.02, 95% confidence interval (CI), 0.86-1.21]. In exploratory analyses, MTMs were associated with lower mortality (aHR: 0.65, 95% CI, 0.43-0.98) and fewer hospitalizations for heart failure (aHR: 0.53, 95% CI, 0.33-0.88), but not for any emergency department visits (aHR: 0.95, 95% CI, 0.78-1.15) or diabetes-related hospitalizations (aHR: 0.75, 95% CI, 0.31-1.82). No additional benefit was observed with virtual nutritional counseling.ConclusionsProvision of MTMs after discharge did not reduce risk of all-cause hospitalization in adults with nutrition-sensitive conditions. Additional large-scale randomized controlled trials are needed to definitively determine the impact of MTMs on survival and cause-specific health care utilization in at-risk individuals.

Project description:ImportanceMedically 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.ObjectiveTo estimate 1- and 10-year potential changes in annual hospitalizations, potential changes in annual health care expenditures, and overall policy cost-effectiveness associated with national MTM coverage for US patients with diet-related disease and limited instrumental activities of daily living who have Medicaid, Medicare, or private insurance.Design, setting, and participantsIn this economic evaluation, conducted from January 2021 to February 2022, a nationally representative sample from the 2019 Medical Expenditure Panel Survey was used to create a population-level cohort policy simulation model that estimated changes in annual hospitalizations and health care expenditures associated with coverage of MTMs. Participants were 6 309 998 US adults aged 18 years or older who had Medicare, Medicaid, or private payer insurance and at least 1 diet-sensitive condition and 1 limitation in instrumental activities of daily living.InterventionsTen nutritionally tailored MTMs per week for a mean of 8 months in each year of intervention.Main outcomes and measuresThe main outcomes were total hospitalizations, program costs, health care expenditures, and net policy costs. One thousand Monte Carlo simulations for each of 10 years (2019-2028) jointly incorporated uncertainty in model inputs for effect sizes, hospitalizations, health care expenditures, and program costs.ResultsAt the 2019 baseline, an estimated 6 309 998 US adults were eligible to receive MTMs. Mean (SD) age was 68.1 (16.6) years; most were female (63.4%), were non-Hispanic White (66.7%), and had Medicare and/or Medicaid (76.5%). The most common eligibility diagnoses were cardiovascular diseases (70.6%), diabetes (44.9%), and cancer (37.2%). If all eligible individuals received MTMs, an estimated 1 594 000 hospitalizations (95% uncertainty interval [UI], 1 297 000-1 912 000) and $38.7 billion (95% UI, $24.9 billion to $53.9 billion) in health care expenditures could potentially be averted in 1 year. Program costs were $24.8 billion (95% UI, $23.1 billion to $26.8 billion), for an associated net savings of $13.6 billion (95% UI, $0.2 billion to $28.5 billion) from a health care perspective. In 2019 dollars, 10 years of the MTM intervention was anticipated to cost $298.7 billion (95% UI, $279.7 billion to $317.4 billion) and to potentially be associated with 18 257 000 averted hospitalizations (95% UI, 14 690 000-22 109 000) and reductions in health care expenditures of $484.5 billion (95% UI, $310.2 billion to $678.4 billion), for net savings of $185.1 billion (95% UI, $12.9 billion to $377.8 billion). Findings were robust in multiple sensitivity analyses.Conclusions and relevanceThe findings suggest that national implementation of MTMs for patients with diet-sensitive conditions and activity limitations could potentially be associated with approximately 1.6 million averted hospitalizations and net cost savings of $13.6 billion annually. The results may inform US state, federal, and private-payer interest in expanding insurance coverage for MTMs among patients with diet-related chronic illness.

Project description:BackgroundFood insecurity, defined as inconsistent food access owing to cost, leads to poor health.ObjectiveTo test whether a medically tailored meal delivery program improved dietary quality in individuals with type 2 diabetes and food insecurity.DesignRandomized cross-over clinical trial.ParticipantsForty-four adults with diabetes, hemoglobin A1c > 8.0%, and food insecurity (defined as at least one positive item on the two-item "Hunger Vital Sign").InterventionIn the Community Servings: Food as Medicine for Diabetes cross-over clinical trial (NCT02426138), conducted from June 2015 to July 2017, we randomly assigned the order of "on-meals" (home delivery of 10 meals/week for 12 weeks delivered by Community Servings, a non-profit organization) and "off-meals" (12 weeks usual care and a Choose MyPlate healthy eating brochure) periods.Main measuresThe primary outcome was Healthy Eating Index 2010 score (HEI), assessed by three 24-h food recalls in both periods. Higher HEI score (range 0-100; clinically significant difference 5) represents better dietary quality. Secondary outcomes included food insecurity and self-reported hypoglycemia.Key resultsMean "on-meal" HEI score was 71.3 (SD 7.5) while mean "off-meal" HEI score was 39.9 (SD 7.8) (difference 31.4 points, p < 0.0001). Participants experienced improvements in almost all sub-categories of HEI score, with increased consumption of vegetables, fruits, and whole grains and decreased solid fats, alcohol, and added sugar consumption. Participants also reported lower food insecurity (42% "on-meal" vs. 62% "off-meal," p = 0.047), less hypoglycemia (47% "on-meal" vs. 64% "off-meal," p = 0.03), and fewer days where mental health interfered with quality of life (5.65 vs. 9.59 days out of 30, p = 0.03).ConclusionsFor food-insecure individuals with diabetes, medically tailored meals improved dietary quality and food insecurity and reduced hypoglycemia. Longer-term studies should evaluate effects on diabetes control (e.g., hemoglobin A1c) and patient-reported outcomes (e.g., well-being).

Dataset Information

Assessing the impact of medically tailored meals and medical nutrition therapy on type 2 diabetes: Protocol for Project MiNT.

Background

Objectives

Methods

Publications

Assessing the impact of medically tailored meals and medical nutrition therapy on type 2 diabetes: Protocol for Project MiNT.

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