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盐交换干预以降低高血压人群的盐摄入量:一项可行性随机对照试验方案。

The Salt Swap intervention to reduce salt intake in people with high blood pressure: protocol for a feasibility randomised controlled trial.

机构信息

Nuffield Department of Primary Care Health Sciences, University of Oxford Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.

Nuffield Department of Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Roosevelt Drive, Headington, Oxford, OX3 7LF, UK.

出版信息

Trials. 2019 Oct 11;20(1):584. doi: 10.1186/s13063-019-3691-y.

Abstract

BACKGROUND

High salt intake is a risk factor for hypertension and cardiovascular disease. Reducing salt intake has been shown to reduce blood pressure. Despite population-level interventions, including product reformulation and public awareness campaigns, adult salt consumption in the UK still exceeds recommendations; this is primarily due to salt consumed in processed and pre-packaged foods. Moderate or high-intensity dietary advice to encourage individuals to reduce their salt intake has been shown to be effective at reducing blood pressure, but evidence of the effectiveness of interventions that are suitable for delivery at scale in routine primary care is scarce. This feasibility trial investigates a complex behavioural change intervention to reduce dietary salt intake and blood pressure by encouraging individuals to purchase lower-salt foods when grocery shopping.

METHODS

This randomised controlled trial will test the feasibility of a novel intervention to reduce salt intake, and the trial procedures to assess its effectiveness. We will recruit participants through UK general practices and randomise 40 participants with high blood pressure, in a 2:1 allocation to receive either the Salt Swap intervention or a control information leaflet. The primary outcomes relate to the criteria for progression to a large-scale trial. These include follow-up rates at 6 weeks, fidelity of intervention delivery and use of the intervention mobile app. Secondary outcomes include the effect of the intervention on the salt content of purchased foods (grams per 100 g), urinary sodium excretion assessed through 24-hour urine samples and blood pressure. Trial process measures will be collected and qualitative assessment will provide insights into participant engagement with the intervention content and perceived barriers to and facilitators of salt reduction dietary behavioural change.

DISCUSSION

If the outcomes indicate the trial is feasible and there is evidence that behavioural change may result in salt reduction, we will proceed to a definitive trial to test the effectiveness of the intervention to lower blood pressure. If successful, this intervention approach could be applied not only to people with high blood pressure, but also to the wider population with normal blood pressure in whom dietary salt intake exceeds recommendations.

TRIAL REGISTRATION

ISRCTN, 20910962 . Registered on 5 April 2017.

摘要

背景

高盐摄入是高血压和心血管疾病的一个风险因素。减少盐的摄入量已被证明可以降低血压。尽管采取了包括产品配方改革和公众意识运动在内的人群干预措施,但英国成年人的盐摄入量仍超过建议量;这主要是由于加工和预包装食品中摄入的盐。鼓励个人减少盐摄入量的中等或高强度饮食建议已被证明可以有效降低血压,但在常规初级保健中大规模实施适合的干预措施的有效性证据很少。这项可行性试验研究了一种复杂的行为改变干预措施,通过鼓励个人在杂货店购物时购买低盐食品来减少饮食中的盐摄入量和血压。

方法

这项随机对照试验将测试减少盐摄入量的新型干预措施的可行性,以及评估其效果的试验程序。我们将通过英国的普通诊所招募参与者,并将 40 名高血压患者随机分为 2:1 分配,分别接受盐交换干预或对照信息传单。主要结果与进入大规模试验的标准有关。这些标准包括 6 周时的随访率、干预措施的实施保真度以及干预移动应用程序的使用情况。次要结果包括干预对购买食品中的盐含量(每 100 克克数)、通过 24 小时尿液样本评估的尿钠排泄以及血压的影响。将收集试验过程测量值,并进行定性评估,以了解参与者对干预内容的参与情况以及对减少盐摄入的饮食行为改变的障碍和促进因素的看法。

讨论

如果结果表明试验是可行的,并且有证据表明行为改变可能导致盐的减少,我们将进行一项确定试验,以测试降低血压的干预措施的有效性。如果成功,这种干预方法不仅可以应用于高血压患者,也可以应用于血压正常但饮食中盐摄入量超过建议量的更广泛人群。

试验注册

ISRCTN,20910962。注册于 2017 年 4 月 5 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b1bc/6787994/5bf087c0fff0/13063_2019_3691_Fig1_HTML.jpg

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