Launching a salt substitute to reduce blood pressure at the population level: a cluster randomized stepped wedge trial in Peru

Trials

J Jaime Miranda⁴  Katherine A Sacksteder³  María K Cárdenas⁵  Robert H Gilman²  Francisco Diez-Canseco⁵  Antonio Bernabe-Ortiz¹ 

[1] School of Public Health and Administration, Universidad Peruana Cayetano Heredia, Av. Honorio Delgado 430, Ingenieria, Lima 31, Peru;Área de Investigación y Desarrollo, Asociación Benéfica PRISMA, Carlos Gonzales 251, Maranga, Lima 32, Peru;Department of International Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, 615 N Wolfe Street, Baltimore, MD, USA;Department of Medicine, School of Medicine, Universidad Peruana Cayetano Heredia, Av. Honorio Delgado 430, Ingenieria, Lima 31, Peru;CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Av. Armendariz 497, Miraflores, Lima 18, Peru

关键词: Trial;    Sodium-restricted diet;    Potassium chloride;    Peru;    Operations research;    Hypertension;    Blood pressure;   

Others  :  807196
DOI  :  10.1186/1745-6215-15-93

 received in 2013-10-21, accepted in 2014-03-05,  发布年份 2014

【 摘 要 】

Background

Controlling hypertension rates and maintaining normal blood pressure, particularly in resource-constrained settings, represent ongoing challenges of effective and affordable implementation in health care. One of the strategies being largely advocated to improve high blood pressure calls for salt reduction strategies. This study aims to estimate the impact of a population-level intervention based on sodium reduction and potassium increase – in practice, introducing a low-sodium, high-potassium salt substitute – on adult blood pressure levels.

Methods/Design

The proposed implementation research study includes two components: Phase 1, an exploratory component, and Phase 2, an intervention component. The exploratory component involves a triangle taste test and a formative research study designed to gain an understanding of the best implementation methods. Phase 2 involves a pragmatic stepped wedge trial design where the intervention will be progressively implemented in several clusters starting the intervention randomly at different times. In addition, we will evaluate the implementation strategy using a cost-effectiveness analysis.

Discussion

This is the first project in a Latin-American setting to implement a salt substitution intervention at the population level to tackle high blood pressure. Data generated and lessons learnt from this study will provide a strong platform to address potential interventions applicable to other similar low- and middle-income settings.

Trial registration

This study is registered in ClinicalTrials.gov NCT01960972.

【 授权许可】

   
2014 Bernabe-Ortiz et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Anand SS, Yusuf S: Stemming the global tsunami of cardiovascular disease. Lancet 2011, 377:529-532.
• [2]Yusuf S, Reddy S, Ounpuu S, Anand S: Global burden of cardiovascular diseases: part I: general considerations, the epidemiologic transition, risk factors, and impact of urbanization. Circulation 2001, 104:2746-2753.
• [3]Yusuf S, Ounpuu S: Tackling the growing global burden of atherosclerotic cardiovascular diseases. Eur J Cardiovasc Prev Rehabil 2003, 10:236-239.
• [4]World Health Organization: Global Status Report on Noncommunicable Diseases 2010. Geneva: World Health Organization; 2011.
• [5]Beaglehole R, Bonita R, Horton R, Adams C, Alleyne G, Asaria P, Baugh V, Bekedam H, Billo N, Casswell S, Cecchini M, Colagiuri R, Colagiuri S, Collins T, Ebrahim S, Engelgau M, Galea G, Gaziano T, Geneau R, Haines A, Hospedales J, Jha P, Keeling A, Leeder S, Lincoln P, McKee M, Mackay J, Magnusson R, Moodie R, Mwatsama M, Lancet NCD Action Group; NCD Alliance, et al.: Priority actions for the non-communicable disease crisis. Lancet 2011, 377:1438-1447.
• [6]Committee on the Consequences of Sodium Reduction in Populations: Sodium Intake in Populations. In Assessment of Evidence. Washington, DC: Institute of Medicine of the National Academies; 2013.
• [7]Henney JE, Taylor CL: Boon CS (Eds): Strategies to Reduce Sodium Intake in the United States. Committee on Strategies to Reduce Sodium Intake; Institute of Medicine. Washington DC: National Academies Press; 2010.
• [8]Lewington S, Clarke R, Qizilbash N, Peto R, Collins R: Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 1903–1913, 2002:360.
• [9]Aburto NJ, Ziolkovska A, Hooper L, Elliott P, Cappuccio FP, Meerpohl JJ: Effect of lower sodium intake on health: systematic review and meta-analyses. BMJ 2013, 346:f1326.
• [10]He FJ, Li J, Macgregor GA: Effect of longer-term modest salt reduction on blood pressure. Cochrane Database Syst Rev 2013., 4CD004937
• [11]Taylor RS, Ashton KE, Moxham T, Hooper L, Ebrahim S: Reduced dietary salt for the prevention of cardiovascular disease. Cochrane Database Syst Rev 2011., 7CD009217
• [12]Iestra JA, Kromhout D, van der Schouw YT, Grobbee DE, Boshuizen HC, van Staveren WA: Effect size estimates of lifestyle and dietary changes on all-cause mortality in coronary artery disease patients: a systematic review. Circulation 2005, 112:924-934.
• [13]Geleijnse JM, Kok FJ, Grobbee DE: Blood pressure response to changes in sodium and potassium intake: a metaregression analysis of randomised trials. J Hum Hypertens 2003, 17:471-480.
• [14]Hooper L, Bartlett C, Davey Smith G, Ebrahim S: Systematic review of long term effects of advice to reduce dietary salt in adults. BMJ 2002, 325:628.
• [15]Mitka M, IOM report: Evidence fails to support guidelines for dietary salt reduction. JAMA 2013, 309:2535-2536.
• [16]Zhao X, Ke L, Li S, Li N, Yan LL, Ba S, He F, Neal B, Wu Y: Effects on Blood Pressure of a Low-Sodium, High Potassium Salt Substitute Among Tibetan Chinese: A Randomized Controlled Trial. In World Congress of Cardiology Scientific Sessions. American Heart Association: Dallas, TX; 2010.
• [17]Zhou B, Wang HL, Wang WL, Wu XM, Fu LY, Shi JP: Long-term effects of salt substitution on blood pressure in a rural north Chinese population. J Hum Hypertens 2013, 27:427-433.
• [18]World Health Organization: Guideline: Sodium Intake for Adults and Children. In World Health Organization. Geneva: WHO; 2012.
• [19]DeSimone JA, Beauchamp GK, Drewnowski A, Johnson GH: Sodium in the food supply: challenges and opportunities. Nutr Rev 2013, 71:52-59.
• [20]Liem DG, Miremadi F, Keast RS: Reducing sodium in foods: the effect on flavor. Nutrients 2011, 3:694-711.
• [21]Saavedra-Garcia L, Bernabe-Ortiz A, Diez-Canseco F, Miranda J: Get the facts: Do we know how much is the average salt intake and what are its sources? Rev Peru Med Exp Salud Publica 2014. In Press
• [22]Hawkes C, Webster J: National approaches to monitoring population salt intake: a trade-off between accuracy and practicality? PLoS One 2012, 7:e46727.
• [23]Brown CA, Lilford RJ: The stepped wedge trial design: a systematic review. BMC Med Res Methodol 2006, 6:54. BioMed Central Full Text
• [24]Bi J: Sensory Discrimination Tests and Measurements: Statistical Principles, Procedures and Tables. Iowa: Blackwell Publishing Ltd; 2006.
• [25]Meilgaard M, Civille GV, Carr BT: Sensory Evaluation Techniques. 3rd edition. NY: CRC Press; 1999.
• [26]WHO STEPwise approach to Surveillance (STEPS): STEPS Manual. In STEPS Manual[http://www.who.int/chp/steps/manual/en/index.html webcite]
• [27]Campbell MK, Piaggio G, Elbourne DR, Altman DG: CONSORT 2010 statement: extension to cluster randomised trials. BMJ 2012, 345:e5661.
• [28]Miranda JJ, Bernabe-Ortiz A, Smeeth L, Gilman RH, Checkley W: Addressing geographical variation in the progression of non-communicable diseases in Peru: the CRONICAS cohort study protocol. BMJ Open 2012, 2:e000610.
• [29]Miranda JJ, Gilman RH, Smeeth L: Differences in cardiovascular risk factors in rural, urban and rural-to-urban migrants in Peru. Heart 2011, 97:787-796.
• [30]Hussey MA, Hughes JP: Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials 2007, 28:182-191.
• [31]Hughes JP, Goldenberg RL, Wilfert CM, Valentine M, Mwinga KG, Guay LA, Mimiro F, Stringer JSA: Design of the HIV Prevention Trials Network (HPTN) Protocol 054: A Cluster Randomized Crossover Trial to Evaluate Combined Access to Nevirapine in Developing Countries. Technical Report 195. Washington: University of Washington, Department of Biostatistics; 2003.
• [32]Mason R, Nottingham S: Sensory Evaluation Manual. Queensland: The University of Queensland; 2002.
• [33]Glaser BG: Doing Grounded Theory: Issues and Discussions. Mill Valley: CSP; 1998.
• [34]Strauss AL, Corbin J: Basics of Qualitative Research: Grounded Theory Procedures and Techniques. 2nd edition. Thousand Oaks: CSP; 1998.
• [35]Fitzmaurice GM, Laird NM, Ware JH: Applied Longitudinal Analysis. 2nd edition. New Jersey: Wiley; 2011.
• [36]Hardin JW, Hill JM: Generalized Estimating Equations. Chapman & Hall/CRC: Florida; 2002.
• [37]WHO: CHOosing Interventions that are Cost Effective. WHO-CHOICE[http://www.who.int/choice/description/en/ webcite]
• [38]Musgrove P, Fox-Rushby J: Disease Control Priorities in Developing Countries. Washington: Oxford University Press and The World Bank; 2006.
• [39]Suhrcke M, Boluarte TA, Niessen L: A systematic review of economic evaluations of interventions to tackle cardiovascular disease in low- and middle-income countries. BMC Public Health 2012, 12:2. BioMed Central Full Text
• [40]Pan American Health and Education Foundation: Former Minister of Health of Peru Honored for Work Combating Iodine Deficiency Disorders in Latin America. [http://www.pahef.org/en/ourwork/46/137-former-minister-of-health-of-peru-honored-for-work-combating-iodine-deficiency-disorders-in-latin-america.html webcite]
• [41]Geleijnse JM, Witteman JC, Bak AA, den Breeijen JH, Grobbee DE: Reduction in blood pressure with a low sodium, high potassium, high magnesium salt in older subjects with mild to moderate hypertension. BMJ 1994, 309:436-440.
• [42]Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha D, Obarzanek E, Conlin PR, Miller ER, Simons-Morton DG, Karanja N, Lin PH, DASH-Sodium Collaborative Research Group: Effects on blood pressure of reduced dietary sodium and the Dietary Approaches to Stop Hypertension (DASH) diet. DASH-Sodium Collaborative Research Group. N Engl J Med 2001, 344:3-10.
• [43]Cook NR, Cutler JA, Obarzanek E, Buring JE, Rexrode KM, Kumanyika SK, Appel LJ, Whelton PK: Long term effects of dietary sodium reduction on cardiovascular disease outcomes: observational follow-up of the trials of hypertension prevention (TOHP). BMJ 2007, 334:885-888.
• [44]Whelton PK, Buring J, Borhani NO, Cohen JD, Cook N, Cutler JA, Kiley JE, Kuller LH, Satterfield S, Sacks FM, Taylor JO, Trials of Hypertension Prevention (TOHP) Collaborative Research Group: The effect of potassium supplementation in persons with a high-normal blood pressure. Results from phase I of the Trials of Hypertension Prevention (TOHP). Trials of Hypertension Prevention (TOHP) Collaborative Research Group. Ann Epidemiol 1995, 5:85-95.
• [45]Whelton PK, He J, Cutler JA, Brancati FL, Appel LJ, Follmann D, Klag MJ: Effects of oral potassium on blood pressure. Meta-analysis of randomized controlled clinical trials. JAMA 1997, 277:1624-1632.
• [46]Dickinson HO, Nicolson DJ, Campbell F, Beyer FR, Mason J: Potassium supplementation for the management of primary hypertension in adults. Cochrane Database Syst Rev 2006., 3CD004641
• [47]He FJ, MacGregor GA: A comprehensive review on salt and health and current experience of worldwide salt reduction programmes. J Hum Hypertens 2009, 23:363-384.
• [48]China Salt Substitute Study Collaborative Group: Salt substitution: a low-cost strategy for blood pressure control among rural Chinese. A randomized, controlled trial. J Hypertens 2007, 25:2011-2018.
• [49]Murray CJ, Lauer JA, Hutubessy RC, Niessen L, Tomijima N, Rodgers A, Lawes CM, Evans DB: Effectiveness and costs of interventions to lower systolic blood pressure and cholesterol: a global and regional analysis on reduction of cardiovascular-disease risk. Lancet 2003, 361:717-725.
• [50]Pearson TA, Bazzarre TL, Daniels SR, Fair JM, Fortmann SP, Franklin BA, Goldstein LB, Hong Y, Mensah GA, Sallis JF Jr, Smith S Jr, Stone NJ, Taubert KA, American Heart Association Expert Panel on Population and Prevention Science: American Heart Association guide for improving cardiovascular health at the community level: a statement for public health practitioners, healthcare providers, and health policy makers from the American Heart Association Expert Panel on Population and Prevention Science. Circulation 2003, 107:645-651.