Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.
National Institute for Health Research, Oxford Biomedical Research Centre, Oxford University Hospitals, Oxford, United Kingdom.
JMIR Mhealth Uhealth. 2021 Oct 21;9(10):e26233. doi: 10.2196/26233.
A high-salt diet is a risk factor for hypertension and cardiovascular disease; therefore, reducing dietary salt intake is a key part of prevention strategies. There are few effective salt reduction interventions suitable for delivery in the primary care setting, where the majority of the management and diagnosis of hypertension occurs.
The aim of this study is to assess the feasibility of a complex behavioral intervention to lower salt intake in people with elevated blood pressure and test the trial procedures for a randomized controlled trial to investigate the intervention's effectiveness.
This feasibility study was an unblinded, randomized controlled trial of a mobile health intervention for salt reduction versus an advice leaflet (control). The intervention was developed using the Behavior Change Wheel and comprised individualized, brief advice from a health care professional with the use of the SaltSwap app. Participants with an elevated blood pressure recorded in the clinic were recruited through primary care practices in the United Kingdom. Primary outcomes assessed the feasibility of progression to a larger trial, including follow-up attendance, fidelity of intervention delivery, and app use. Secondary outcomes were objectively assessed using changes in salt intake (measured via 24-hour urine collection), salt content of purchased foods, and blood pressure. Qualitative outcomes were assessed using the think-aloud method, and the process outcomes were evaluated.
A total of 47 participants were randomized. All progression criteria were met: follow-up attendance (45/47, 96%), intervention fidelity (25/31, 81%), and app use (27/31, 87%). There was no evidence that the intervention significantly reduced the salt content of purchased foods, salt intake, or blood pressure; however, this feasibility study was not powered to detect changes in secondary outcomes. Process and qualitative outcomes demonstrated that the trial design was feasible and the intervention was acceptable to both individuals and practitioners and positively influenced salt intake behaviors.
The intervention was acceptable and feasible to deliver within primary care; the trial procedures were practicable, and there was sufficient signal of potential efficacy to change salt intake. With some improvements to the intervention app, a larger trial to assess intervention effectiveness for reducing salt intake and blood pressure is warranted.
International Standard Randomized Controlled Trial Number (ISRCTN): 20910962; https://www.isrctn.com/ISRCTN20910962.
高盐饮食是高血压和心血管疾病的危险因素；因此，减少饮食中的盐摄入量是预防策略的关键部分。在大多数高血压的管理和诊断都发生的初级保健环境中，很少有有效的减盐干预措施适合实施。
本研究旨在评估一项降低高血压患者盐摄入量的复杂行为干预措施的可行性，并测试一项随机对照试验的试验程序，以调查该干预措施的有效性。
这是一项针对移动健康干预措施降低盐摄入量与建议传单（对照组）的非盲、随机对照可行性研究。该干预措施是使用行为改变车轮开发的，包括来自医疗保健专业人员的个性化、简短建议，并使用 SaltSwap 应用程序。通过英国的初级保健实践，从诊所记录血压升高的患者中招募参与者。主要结局评估了向更大规模试验推进的可行性，包括随访参与度、干预措施实施的保真度和应用程序使用情况。次要结局通过 24 小时尿液收集测量的盐摄入量变化、购买食品的盐含量和血压进行客观评估。使用出声思维法评估定性结局，评估过程结局。
共有 47 名参与者被随机分配。所有推进标准均得到满足：随访参与率（45/47，96%）、干预保真度（25/31，81%）和应用程序使用（27/31，87%）。没有证据表明该干预措施显著降低了购买食品的盐含量、盐摄入量或血压；然而，本可行性研究没有足够的能力检测次要结局的变化。过程和定性结果表明，试验设计是可行的，干预措施对个人和从业者都是可接受的，并对盐摄入行为产生了积极影响。
该干预措施在初级保健中实施是可行和可接受的；试验程序是可行的，并且有足够的潜在疗效信号可以改变盐摄入量。对干预应用程序进行一些改进后，有必要进行更大规模的试验来评估降低盐摄入量和血压的干预效果。
国际标准随机对照试验编号（ISRCTN）：20910962；https://www.isrctn.com/ISRCTN20910962。
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