The Salt Swap intervention to reduce salt intake in people with high blood pressure: protocol for a feasibility randomised controlled trial.
Adolescent
Adult
Aged
Aged, 80 and over
Blood Pressure
Choice Behavior
Consumer Behavior
Diet, Sodium-Restricted
England
Feasibility Studies
Female
Health Knowledge, Attitudes, Practice
Humans
Hypertension
/ diet therapy
Male
Middle Aged
Mobile Applications
Motivation
Patient Education as Topic
Randomized Controlled Trials as Topic
Risk Reduction Behavior
Sodium Chloride, Dietary
/ adverse effects
Treatment Outcome
Young Adult
Behaviour change
Blood pressure
Food purchasing
Salt intake
Urinary sodium
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
11 Oct 2019
11 Oct 2019
Historique:
received:
07
05
2019
accepted:
30
08
2019
entrez:
13
10
2019
pubmed:
13
10
2019
medline:
24
3
2020
Statut:
epublish
Résumé
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.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
ISRCTN, 20910962 . Registered on 5 April 2017.
Identifiants
pubmed: 31604477
doi: 10.1186/s13063-019-3691-y
pii: 10.1186/s13063-019-3691-y
pmc: PMC6787994
doi:
Substances chimiques
Sodium Chloride, Dietary
0
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
584Subventions
Organisme : British Heart Foundation
ID : FS/16/34/3221
Pays : United Kingdom
Organisme : Wellcome Trust
ID : 211182/Z/18/Z
Pays : United Kingdom
Organisme : National Institute for Health Research
ID : NF-SI-0617-10064
Organisme : British Heart Foundation
ID : 006/PSS/CORE/2016/OXFORD
Pays : United Kingdom
Organisme : NIHR CLAHRC Thames Valley
ID : IS CLA 01131006
Organisme : Biomedical Research Centre Oxford
ID : IS BRC 121520008
Organisme : British Heart Foundation
ID : FS/16/34/32211
Pays : United Kingdom
Organisme : National Institute for Health Research
ID : NF-SI-0617-10060
Références
BMJ. 2002 Sep 21;325(7365):628
pubmed: 12242173
BMC Med Res Methodol. 2013 Sep 18;13:117
pubmed: 24047204
Eur J Prev Cardiol. 2017 Sep;24(13):1435-1444
pubmed: 28631933
BMJ. 2004 May 1;328(7447):1054
pubmed: 15082472
BMJ Open. 2014 Apr 14;4(4):e004549
pubmed: 24732242
Int J Behav Nutr Phys Act. 2016 Dec 7;13(1):127
pubmed: 27927218
Nutrition. 2017 Jan;33:343-347
pubmed: 27742102
Lancet. 2012 Dec 15;380(9859):2224-60
pubmed: 23245609
Transl Behav Med. 2018 Mar 1;8(2):212-224
pubmed: 29381786
Lancet. 2016 Oct 8;388(10053):1659-1724
pubmed: 27733284
JAMA. 1989 Oct 6;262(13):1801-7
pubmed: 2778913
Implement Sci. 2012 Apr 24;7:38
pubmed: 22531013
Proc Nutr Soc. 2003 Aug;62(3):583-9
pubmed: 14692593
BMC Fam Pract. 2013 May 12;14:59
pubmed: 23663789
N Engl J Med. 2001 Jan 4;344(1):3-10
pubmed: 11136953
Lancet. 2002 Nov 2;360(9343):1347-60
pubmed: 12423980
Arch Intern Med. 1997 Mar 24;157(6):657-67
pubmed: 9080920
Cochrane Database Syst Rev. 2013 Mar 28;(3):CD002128
pubmed: 23543514
Cochrane Database Syst Rev. 2004;(1):CD003656
pubmed: 14974027
Implement Sci. 2011 Apr 23;6:42
pubmed: 21513547
BMJ. 1996 May 18;312(7041):1249-53
pubmed: 8634612
Lancet. 2016 Oct 8;388(10053):1459-1544
pubmed: 27733281
Cochrane Database Syst Rev. 2007 Apr 18;(2):CD004148
pubmed: 17443541
Am J Clin Nutr. 2018 Jun 1;107(6):1004-1016
pubmed: 29868912
Cochrane Database Syst Rev. 2013 May 31;(5):CD000165
pubmed: 23728631