A pragmatic randomized controlled trial assessing the impact of medically tailored meals and medical nutrition therapy via telehealth among patients with poorly controlled diabetes

一项实用的随机对照试验，评估通过远程医疗进行医学定制膳食和医学营养治疗对控制不佳的糖尿病患者的影响

• 批准号: 10439452
• 负责人: Kristin Laura Rising
• 金额: $ 63.29万
• 依托单位: THOMAS JEFFERSON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-18 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10439452
• 关键词: Address; African American; African American population; American; Behavior; Cause of Death; Chronic Disease; Client satisfaction; Clinical; Clinical Trials; Collaborations; Communities; Cost Analysis; Counseling; Data; Decision Making; Diabetes Mellitus; Diet; Diet and Nutrition; Disadvantaged; Disease Management; Disparity; Food; Food Access; Food Services; Glycosylated hemoglobin A; Goals; Health; Health Care Costs; Health Food; Health system; Healthcare Systems; High Prevalence; Improve Access; Individual; Intervention; Low income; Measures; Medical; Medical Nutrition Therapy; Medicine; Modeling; Non-Insulin-Dependent Diabetes Mellitus; Nonprofit Organizations; Outcome; Patient-Focused Outcomes; Patients; Persons; Pilot Projects; Provider; Public Health; Quality of life; Randomized; Randomized, Controlled Trials; Recommendation; Research; Research Personnel; Schedule; Self Care; Self Efficacy; Services; Structure; System; Telemedicine; Testing; Therapeutic Intervention; Treatment Failure; Visit; Weight; Work; arm; care costs; care delivery; comparison intervention; cost effectiveness; disparity reduction; effectiveness evaluation; efficacy evaluation; evidence base; experience; glycemic control; health care service utilization; high risk; improved; improved outcome; innovation; interest; novel; nutrition; nutrition education; outcome disparities; patient oriented; patient population; patient responsibilities; patient-level barriers; precision nutrition; primary outcome; programs; randomized trial; routine practice; secondary outcome; success; telehealth; treatment arm; treatment as usual; uptake

PROJECT SUMMARY Despite the availability of evidence-based guidance and treatments, many patients with diabetes mellitus (DM) do not achieve optimal glycemic control. In prior work, patients with DM identified primary needs of improved access to food and nutrition education. Several innovative models for food services have emerged to address patient needs for improved healthy food access. Currently, select non-profit organizations across the U.S. deliver millions of medically-tailored meals (MTM) to patients with chronic illnesses, based on the premise that food can be as helpful as medicine in improving patient outcomes. While a handful of pilot studies have demonstrated success of MTM in reducing healthcare utilization and hemoglobin A1c (HbA1c) among patients with DM, no randomized trials have assessed the sustained impact of MTM on long-term outcomes for patients with DM. Similarly, individual studies of medical nutrition therapy (MNT), which includes individualized nutrition education and counseling, have shown benefit for improving DM outcomes. However, uptake of MNT across health systems has historically been extremely limited because of patient logistical barriers to attending the in- person visits. MNT delivered by telehealth (tele-MNT) has potential to overcome these barriers. Our goal is to evaluate the effect of MTM, with and without additional tele-MNT, on outcomes for patients with poorly controlled type 2 DM. We will conduct a pragmatic randomized controlled trial with patients who have poorly controlled DM. Outcomes of interest include change in HbA1c, cost effectiveness, weight, diabetes self- efficacy, self-care, diabetes quality of life, and patient satisfaction. We will assess the efficacy of 1) MTM and 2) MTM + tele-MNT compared to usual care in reducing HbA1c at 3, 6 (primary outcome) and 12 months and the cost effectiveness of each intervention compared to usual care up to 12 months. We will also explore patient perspectives regarding experiences with MTM and MTM + tele-MNT to gain a better understanding of potential factors contributing to treatment failure and success within each group. The proposed research is innovative because it develops and tests a novel tele-MNT intervention tailored to recipients of MTM, provides a comprehensive solution to patient-identified nutrition needs, includes complete utilization data provided by the HealthShare Exchange, and leverages a unique health system and community group partnership to improve sustainability and scalability. Study results will inform 1) provider and payor decisions regarding offering and covering these services; 2) how services should be structured for scalability; and 3) integration of these services into the larger care delivery system to reduce DM disparities.

项目总结

项目成果

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

• DOI: 10.1016/j.cct.2021.106511
• 发表时间: 2021-09
• 期刊: Contemporary clinical trials
• 影响因子: 2.2
• 作者: Rising KL;Kemp M;Davidson P;Hollander JE;Jabbour S;Jutkowitz E;Leiby BE;Marco C;McElwee I;Mills G;Pizzi L;Powell RE;Chang AM
• 通讯作者: Chang AM