Clinical trial NCT01259700: High Cardiovascular Risk Management and Salt Reduction in Rural Villages in China
Official title: China Rural Health Initiative: High Cardiovascular Risk Management and Salt Reduction in Rural Villages in China -- Two Parallel Large Cluster Randomized Controlled Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: High blood pressure
Primary care
Cardiovascular disease prevention
Salt reduction
Lead sponsor: The George Institute for Global Health, China
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-12-14
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cardiovascular disease is the leading cause of death in China. At the village level, strategies for the control of cardiovascular disease are mostly absent. National clinical guidelines for the management of hypertension and cardiovascular disease are rarely disseminated to, or implemented by, the village primary care providers. Salt reduction has greater potential in rural China than almost anywhere else in the world. Very high levels of salt consumption, very little use of processed food and most dietary salt deriving from home cooking makes the removal of salt from the diet easier, cheaper and more worthwhile than in almost any other setting. The two large-scale cluster-randomized controlled trials proposed here will precisely and reliably define the effect of two highly plausible intervention strategies on important clinical outcomes. The evidence provided by the project will form the basis for policy setting that has the potential to greatly reduce the occurrence of vascular disease in rural China and take an important step towards balancing the rural urban divide in health and healthcare.


Eligibility criteria: Inclusion Criteria:

* Physician-diagnosed history of coronary heart disease, ischemic stroke, or hemorrhagic stroke, or
* Older age (50 years or older for men; 60 years or older for women) and having physician-diagnosed Type I or Type II diabetes
* Older age (50 years or older for men; 60 years or older for women) and systolic blood pressure 160 mmHg (note that for simplicity, diastolic blood pressure is not included in the criteria)

Exclusion Criteria:

* none

Primary outcomes:
measure: Mean systematic blood pressure level
timeFrame: October 2010 - December 2012
measure: 24 hour urinary sodium
timeFrame: October -December 2012
Secondary outcomes:
measure: 24 hour urinary potassium
timeFrame: October-December 2012
measure: Urinary sodium:potassium ratio
timeFrame: October-December 2012
measure: Receiving regular primary care
timeFrame: October 2010 -December 2012
measure: Taking anti-hypertensive medications
timeFrame: October 2010 -December 2012
measure: Taking aspirin
timeFrame: October 2010 -December 2012
measure: Receiving therapeutic lifestyle recommendations from village doctors
timeFrame: Oct 2010 - Dec 2012
Other outcomes:
measure: Knowledge, attitude and behaviour relating to salt consumption
timeFrame: October-December 2012
measure: Awareness, treatment, and control of hypertension
timeFrame: October 2010 - December 2012
Locations:
city: Shijiazhuang
country: China
facility: Hebei Province Center for Disease Prevention and Control ,China
state: Hebei
city: Shenyang
country: China
facility: The First Hospital Of China Medical University
state: Liaoning
city: Yinchuan
country: China
facility: Ningxia Medical University School of Public Health
state: Ningxia
city: Changzhi
country: China
facility: Changzhi Medical College, China
state: Shanxi
city: Xi'an
country: China
facility: The Xi'an Jiaotong University School of Public Health
state: Shanxi
Study officials:
affiliation: The George Institute for Global Health, China
name: Yangfeng Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.
citation: Jardine MJ, Li N, Ninomiya T, Feng X, Zhang J, Shi J, Zhang Y, Zhang R, Zhang J, Hao J, Perkovic V, Heerspink HL, Wu Y, Yan LL, Neal B. Dietary Sodium Reduction Reduces Albuminuria: A Cluster Randomized Trial. J Ren Nutr. 2019 Jul;29(4):276-284. doi: 10.1053/j.jrn.2018.10.009. Epub 2018 Dec 24.
citation: Li N, Yan LL, Niu W, Yao C, Feng X, Zhang J, Shi J, Zhang Y, Zhang R, Hao Z, Chu H, Zhang J, Li X, Pan J, Li Z, Sun J, Zhou B, Zhao Y, Yu Y, Engelgau M, Labarthe D, Ma J, MacMahon S, Elliott P, Wu Y, Neal B. The Effects of a Community-Based Sodium Reduction Program in Rural China - A Cluster-Randomized Trial. PLoS One. 2016 Dec 9;11(12):e0166620. doi: 10.1371/journal.pone.0166620. eCollection 2016.
citation: Wang X, Li X, Vaartjes I, Neal B, Bots ML, Hoes AW, Wu Y. Does education level affect the efficacy of a community based salt reduction program? - A post-hoc analysis of the China Rural Health Initiative Sodium Reduction Study (CRHI-SRS). BMC Public Health. 2016 Aug 11;16(1):759. doi: 10.1186/s12889-016-3454-6.
citation: Zhang J, Wu T, Chu H, Feng X, Shi J, Zhang R, Zhang Y, Zhang J, Li N, Yan L, Niu W, Wu Y. Salt intake belief, knowledge, and behavior: a cross-sectional study of older rural Chinese adults. Medicine (Baltimore). 2016 Aug;95(31):e4404. doi: 10.1097/MD.0000000000004404.
citation: Yan LL, Fang W, Delong E, Neal B, Peterson ED, Huang Y, Sun N, Yao C, Li X, MacMahon S, Wu Y. Population impact of a high cardiovascular risk management program delivered by village doctors in rural China: design and rationale of a large, cluster-randomized controlled trial. BMC Public Health. 2014 Apr 11;14:345. doi: 10.1186/1471-2458-14-345.