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

机译:盐交换干预措施可减少高血压患者的盐摄入量:一项可行性随机对照试验的方案

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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. 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. 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. ISRCTN, 20910962 . Registered on 5 April 2017.
机译:高盐摄入量是高血压和心血管疾病的危险因素。减少盐的摄入量已显示可降低血压。尽管进行了人口一级的干预,包括重新制定产品和开展了提高公众意识的运动,但英国的成人食盐消费量仍超出建议。这主要是由于加工和预包装食品中消耗了盐。事实表明,鼓励个人减少盐摄入量的中度或高强度饮食建议可以有效降低血压,但缺乏适合常规常规初级保健大规模干预的干预措施的证据。该可行性试验研究了一种复杂的行为改变干预措施,旨在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。这项随机对照试验将测试减少盐摄入量的新干预措施的可行性,并评估其有效性的试验程序。我们将通过英国的一般做法招募参与者,并以2:1分配将40名高血压患者随机分配,以接受Salt Swap干预措施或控制信息传单。主要结局与进行大规模试验的标准有关。其中包括6周的随访率,干预措施的保真度和干预移动应用程序的使用。次要结果包括干预措施对所购买食品的含盐量(每100克克)的影响,通过24小时尿液样本评估的尿钠排泄量和血压。将收集试验过程的措施,定性评估将提供参与者对干预内容,减少盐饮食行为改变的障碍和促进者的参与程度的见解。如果结果表明该试验是可行的,并且有证据表明行为改变可能导致食盐减少,我们将进行一项确定性试验,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人群,而且可以应用于饮食盐摄入量超过建议值的血压正常人群。 ISRCTN,20910962。 2017年4月5日注册。

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