The George Institute for Global Health, Faculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia.
The George Institute for Global Health, Faculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia.
Contemp Clin Trials. 2023 Sep;132:107307. doi: 10.1016/j.cct.2023.107307. Epub 2023 Jul 28.
'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.
This study will test the efficacy of an MTM program in Australia among participants with type 2 diabetes (T2D) and hyperglycemia, who experience difficulties accessing and eating nutritious food.
This study will be a two-arm parallel trial (goal n = 212) with individuals randomized in a 1:1 ratio to a MTM intervention group or a control group (106 per arm). Over 26 weeks, the intervention group will be prescribed 20 MTM per fortnight and up to 3 sessions with an accredited dietitian. Controls will continue with their usual care. The primary outcome is glycated hemoglobin (HbA1c, %) and secondary outcomes include differences in blood pressure, blood lipids and weight, all measured at 26 weeks. Process and economic data will be analyzed to assess the feasibility, acceptability, scalability, and cost-effectiveness of the intervention. Recruitment commenced in the first quarter of 2023, with analyses and results anticipated to be available by March 2025.
Few randomized controlled trials have assessed the impact of MTM on clinical outcomes. This Australian-first trial will generate robust data to inform the case for sustained, large-scale implementation of MTM to improve the management of T2D among vulnerable populations.
ACTRN12622000852752.
Version 1.1, July 2023.
“食物即药物”策略旨在将基于食物的营养干预措施纳入医疗保健系统，越来越受到医疗保健提供者和政策制定者的关注。“量身定制的医疗膳食”（MTM）就是这样一种干预措施，它涉及医疗保健提供者为预防或管理慢性病而向个人开出补贴、预制膳食的“处方”，并结合营养教育。
本研究将在澳大利亚 2 型糖尿病（T2D）和高血糖患者中测试 MTM 方案的疗效，这些患者在获得和食用营养食品方面存在困难。
这将是一项两臂平行试验（目标 n=212），将参与者以 1:1 的比例随机分配到 MTM 干预组或对照组（每组 106 人）。在 26 周内，干预组将每两周开 20 份 MTM，并最多接受 3 次认证营养师的咨询。对照组将继续接受常规护理。主要结局指标为糖化血红蛋白（HbA1c，%），次要结局指标包括血压、血脂和体重的差异，所有指标均在 26 周时测量。将分析过程和经济数据，以评估干预措施的可行性、可接受性、可扩展性和成本效益。招募工作于 2023 年第一季度开始，预计 2025 年 3 月可获得分析结果。
很少有随机对照试验评估 MTM 对临床结局的影响。这项澳大利亚首例试验将提供有力的数据，为在弱势人群中持续、大规模实施 MTM 以改善 2 型糖尿病管理提供依据。
ACTRN12622000852752。
第 1.1 版，2023 年 7 月。
