制定处方以改善澳大利亚成人2型糖尿病患者的健康状况：一项随机对照试验方案

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-04-15 DOI:10.1016/j.cct.2025.107915

Kimberly Glover , Megan Gow , Kathy Trieu , Liping Huang , Kristy K. Law , Bruce Neal , Jencia Wong , Ted Wu , Stephen Twigg , Amanda Gauld , Maria Constantino , Margaret McGill , Stephanie Noonan , David Simmons , Ian D. Caterson , Dariush Mozaffarian , Claudia Nau , Jing Li , Gian Luca Di Tanna , Vincent Wong , Jason H.Y. Wu

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引用次数: 0

摘要

“食物就是药”项目，如农产品处方（PRx），旨在将基于食物的营养项目整合到医疗保健中，以预防、管理和治疗与饮食有关的疾病，特别是那些经历粮食不安全的人。然而，PRx对澳大利亚健康指标的影响从未在随机试验中进行过测试。目的研究PRx对澳大利亚患有高血糖和食物不安全和/或经济困难的成人2型糖尿病患者血糖控制和其他健康指标的影响。方法采用平行设计随机对照试验，将n = 224名受试者随机（1:1）分为PRx组和常规治疗组。在26周的时间里，干预组每周将收到水果、蔬菜、全谷物和坚果，并与认证营养师进行多达3次的会谈。控制组将接受常规护理。主要结果是干预组和对照组在26周内平均HbA1c的变化。次要结局包括26周时血压、体重、血脂、食物和营养不安全、个人报告的结局测量、药物使用和饮食质量的组间差异。评估实施结果将包括可行性、可接受性、可扩展性和成本效益。这项澳大利亚首个PRx试验将为干预措施提供新颖和严格的数据，这些干预措施可能是可行的，可以改善健康和健康公平作为澳大利亚医疗保健系统的一部分。我们预计PRx将导致临床上有意义的HbA1c降低，有助于改善2型糖尿病和食品不安全成人的健康公平和长期健康益处。

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Produce prescription to improve health among adults with type 2 diabetes in Australia: Protocol for a randomised controlled trial

Background

‘Food is medicine’ programs such as Produce Prescription (PRx) aim to integrate food-based nutrition programs into healthcare, for the prevention, management and treatment of diet-related diseases, typically for those experiencing food insecurity. However, the impact of PRx on health indicators in Australia has never been tested in a randomised trial.

Objectives

To determine the effect of PRx on blood glucose control and other health indicators in adults with type 2 diabetes experiencing hyperglycaemia and food insecurity and/or financial hardship in Australia.

Methods

Using a parallel design randomised controlled trial, n = 224 participants will be randomised (1:1) to PRx or usual care. Over 26 weeks, the intervention group will receive a weekly delivery of fruits, vegetables, wholegrains and nuts, and up to 3 sessions with an accredited dietitian. Controls will receive usual care. The primary outcome is change in mean HbA1c over 26 weeks, comparing the intervention and control group. Secondary outcomes include between-group differences at 26 weeks in change in blood pressure, body weight, blood lipids, food and nutrition insecurity, person-reported outcome measures, medication use, and diet quality. Implementation outcomes assessed will include feasibility, acceptability, scalability and cost effectiveness.

Discussion

This Australia-first PRx trial will provide novel and rigorous data for an intervention that may be feasible to improve health and health equity as part of the Australian healthcare system. We anticipate PRx will lead to a clinically meaningful reduction in HbA1c, contribute to improved health equity and long-term health benefits for adults with type 2 diabetes and food insecurity.

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.