A Novel Just-in-Time Contextual Mobile App Intervention to Reduce Sodium Intake in Hypertension: Protocol and Rationale for a Randomized Controlled Trial (LowSalt4Life Trial)
A Novel Just-in-Time Contextual Mobile App Intervention to Reduce Sodium Intake in Hypertension: Protocol and Rationale for a Randomized Controlled Trial (LowSalt4Life Trial)
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DOI：
10.2196/11282
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发表时间：
2018-12-01
影响因子：
1.7
通讯作者：
Hummel, Scott L.
中科院分区：
文献类型：
--
作者：
Dorsch, Michael P.;An, Lawrence C.;Hummel, Scott L.
背景：在美国，高钠摄入量是一个重大的公共健康问题。减少钠摄入量的干预措施可以降低血压，改善心血管结果。餐馆和杂货店是干预的主要目标，美国人平均饮食中约77%的钠摄入量来自加工食品和餐馆食品。目的：本研究提出，在杂货店和餐馆推广低钠替代品的移动应用程序干预将减少饮食中的钠摄入量，并在低钠饮食后提高高血压患者的信心。方法：在这项单中心、前瞻性、开放标签的研究中，患者将被随机分配到移动应用程序或常规护理8周。我们将以1：1的方式按性别分层随机选择50名确诊为高血压并接受降压治疗至少3个月的患者(年龄18岁)。研究对象将在8周内接受手机应用LowSalt4Life或通常的饮食建议。LowSalt4Life基于杂货店和餐馆的即时上下文定制消息提供多方面的干预。主要终点是估计的24小时尿钠排泄量的变化。次要结果包括食物频率问卷中钠含量的变化，对遵循低钠饮食的信心，尿氯和肌酐试纸，以及血压。结果：该项目于2016年5月至2018年4月获得资助。这项试验目前正在招募患者。到目前为止，所需的50名患者中已有26人入选。结果将于2019年春季公布。结论：这项随机对照试验将通过一种新的移动APP 8周干预来测试即时上下文定制消息对高血压患者尿钠排泄的疗效。我们将解决高血压患者护理方面的一个关键证据缺口。如果有效，这种干预措施可以扩大规模，以评估对高血压患者血压和心血管事件的影响。
Background: High sodium intake is a significant public health problem in the United States. Interventions that lower sodium intake can decrease blood pressure and improve cardiovascular outcomes. Restaurants and grocery stores are prime targets for intervention with about 77% of all sodium intake in the average US diet coming from processed and restaurant foods.Objective: This study proposes that a mobile app intervention that promotes low-sodium alternatives at grocery stores and restaurants will reduce dietary intake of sodium and improve confidence following a low-sodium diet in hypertension.Methods: In this single-center, prospective, open-label study, patients will be randomized to a mobile app or usual care for 8 weeks. We will randomize 50 patients (age>18 years) diagnosed with hypertension and on antihypertensive therapy for at least 3 months in a 1: 1 manner stratified by gender. Study subjects will receive the mobile app, LowSalt4Life, or usual dietary advice for 8 weeks. LowSalt4Life provides a multifaceted intervention based on just-in-time contextual tailored messages at grocery stores and restaurants. The primary endpoint is the change in the estimated 24-hour urinary excretion of sodium from spot urine. Secondary outcomes include change in the sodium content of the food frequency questionnaire, confidence in following a low-sodium diet, urine chloride and creatinine dipsticks, and blood pressure.Results: The project was funded in May 2016 until April 2018. This trial is currently enrolling patients. To date, 26 of the 50 patients needed have been enrolled. Results will be available in the Spring of 2019.Conclusions: This randomized controlled trial will test the efficacy of just-in-time contextual tailored messages through a novel mobile app 8-week intervention on urinary sodium excretion in patients with hypertension. We will address a critical evidence gap in the care of patients with hypertension. If effective, this intervention could be scaled to assess effects on blood pressure and cardiovascular events in hypertension.