Clark Jeanne M, Maw May Thu Thu, Pettway Kathy, Chander Geetanjali, Elias Susan, Zisow-McClean Sam, Maruthur Nisa M, Greer Raquel C
Division of General Internal Medicine, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Johns Hopkins Brancati Center for the Advancement of Community Care, Baltimore, MD, USA.
J Gen Intern Med. 2024 Dec 13. doi: 10.1007/s11606-024-09248-x.
Adults with type 2 diabetes (T2DM) and adverse social determinants of health experience barriers to healthful eating, and achieve poorer glycemic control and clinical outcomes.
To examine the impact of medically tailored meals (MTM) with medical nutrition therapy (MNT) on clinical outcomes among adults with DM.
Pilot randomized controlled trial.
English-speaking adults with DM and hemoglobin A1c (A1c) levels > 8% insured by Maryland Medicaid plans.
The treatment group received home delivery of 12 medically tailored, frozen meals and a fresh produce bag weekly for 3 months, and individual calls with a registered dietitian monthly for 6 months in addition to usual care. The control group received usual care. Outcomes were change from baseline to 6 months in A1c (primary), body mass index (BMI), blood pressure, food insecurity, and diabetes-related quality of life, knowledge, and self-efficacy (secondary).
We randomized 74 adults; 77% completed data collection. The mean age was 48 years, 40% were male, 77% were Black, and the mean A1c was 10.3%. Eighty-six percent of meals were delivered, and on average 4.8 nutrition visits were completed. At 6 months, both groups had similar improvements in A1c (- 0.7 vs. - 0.6%); the control group reported more favorable changes in diabetes medications. Changes in systolic blood pressure and BMI at 6 months did not differ between groups. Diabetes-related quality of life, knowledge, and self-efficacy improved modestly, but not differently by group. Food insecurity decreased significantly from baseline to 3 months in the intervention (53 to 17%) compared to control (48 to 44%; p < 0.05), which lessened but remained significant at 6 months.
Recruitment and retention of an at-risk group of adults with DM was feasible. Intervention uptake was good but did not improve clinical outcomes. More comprehensive and clinically integrated interventions are likely needed to achieve significant clinical benefits.
NCT04034511.
患有2型糖尿病（T2DM）且存在不良健康社会决定因素的成年人在健康饮食方面存在障碍，血糖控制和临床结局较差。
研究医学定制餐（MTM）联合医学营养治疗（MNT）对糖尿病成年患者临床结局的影响。
试点随机对照试验。
由马里兰州医疗补助计划承保、英语流利、患有糖尿病且糖化血红蛋白（A1c）水平>8%的成年人。
治疗组除接受常规护理外，还每周在家中收到12份医学定制的冷冻餐和一个新鲜农产品袋，持续3个月，并在6个月内每月与注册营养师进行单独通话。对照组接受常规护理。结局指标为从基线到6个月时A1c（主要指标）、体重指数（BMI）、血压、粮食不安全状况以及糖尿病相关生活质量、知识和自我效能的变化（次要指标）。
我们将74名成年人随机分组；77%完成了数据收集。平均年龄为48岁，40%为男性，77%为黑人，平均A1c为10.3%。86%的餐食已送达，平均完成了4.8次营养咨询。在6个月时，两组的A1c改善情况相似（-0.7%对-0.6%）；对照组报告糖尿病药物方面有更有利的变化。6个月时收缩压和BMI的变化在两组间无差异。糖尿病相关生活质量、知识和自我效能有适度改善，但两组间无差异。与对照组（从48%降至44%；p<0.05）相比，干预组的粮食不安全状况从基线到3个月时显著下降（从53%降至17%），在6个月时有所减轻但仍显著。
招募和留住糖尿病高危成年人群是可行的。干预措施的接受度良好，但未改善临床结局。可能需要更全面且临床整合的干预措施才能取得显著的临床益处。
NCT04034511。
