通过 "吃得好"(一种处方农产品补贴)解决糖尿病患者和面临粮食不安全风险者健康饮食的成本障碍:1 型混合效果-实施实用随机对照试验的研究方案。

IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
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引用次数: 0

摘要

背景:面临食物无保障风险的糖尿病患者在健康饮食方面面临成本障碍,因此健康状况较差。需要制定人群健康管理策略,以改善现实世界卫生系统环境中的食品安全状况。我们试图测试处方农产品计划 "吃得好 "对心脏代谢健康和医疗保健利用率的影响。我们还将评估自动化平权推广策略的实施情况:我们将从美国东南部的一个综合学术医疗系统招募约 2400 名患者,作为双臂平行混合型 1 型实用随机对照试验的一部分。有食物不安全风险、近期血红蛋白 A1c 读数的糖尿病患者将有资格参加。干预组接受 "吃得好 "项目,该项目提供一张借记卡,卡内有 80 美元(每月增加),有效期为 12 个月,可用于在杂货零售商处购买新鲜、冷冻或罐装水果和蔬菜。对照组则没有。两组均获得了糖尿病营养和自我管理材料的教育资源,以及现有护理管理资源的信息。采用意向治疗分析法,主要结果包括入组后 12 个月内的血红蛋白 A1C 水平和急诊就诊率。还将收集覆盖率和忠实度数据,以评估实施情况:讨论:解决粮食不安全问题,尤其是那些心脏代谢风险较高的人群的粮食不安全问题,对于公平、有效的人口健康管理至关重要。务实性试验为了解 "吃得好 "及类似方法在现实环境中的有效性和实施情况提供了重要依据:注册:ClinicalTrials.gov Identifier:NCT05896644;临床试验注册日期:2023-06-09。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Addressing cost barriers to healthy eating with Eat Well, a prescription produce subsidy, for patients with diabetes and at risk for food insecurity: Study protocol for a type 1 hybrid effectiveness-implementation pragmatic randomized controlled trial

Background

Patients with diabetes at risk of food insecurity face cost barriers to healthy eating and, as a result, poor health outcomes. Population health management strategies are needed to improve food security in real-world health system settings. We seek to test the effect of a prescription produce program, ‘Eat Well’ on cardiometabolic health and healthcare utilization. We will also assess the implementation of an automated, affirmative outreach strategy.

Methods

We will recruit approximately 2400 patients from an integrated academic health system in the southeastern United States as part of a two-arm parallel hybrid type 1 pragmatic randomized controlled trial. Patients with diabetes, at risk for food insecurity, and a recent hemoglobin A1c reading will be eligible to participate. The intervention arm receives, ‘Eat Well’, which provides a debit card with $80 (added monthly) for 12 months valid for fresh, frozen, or canned fruits and vegetables across grocery retailers. The control arm does not. Both arms receive educational resources with diabetes nutrition and self-management materials, and information on existing care management resources. Using an intent-to-treat analysis, primary outcomes include hemoglobin A1C levels and emergency department visits in the 12 months following enrollment. Reach and fidelity data will be collected to assess implementation.

Discussion

Addressing food insecurity, particularly among those at heightened cardiometabolic risk, is critical to equitable and effective population health management. Pragmatic trials provide important insights into the effectiveness and implementation of ‘Eat Well’ and approaches like it in real-world settings.

Registration

ClinicalTrials.gov Identifier: NCT05896644; Clinical Trial Registration Date: 2023-06-09.

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来源期刊
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.
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