High Cardiovascular Risk Management and Salt Reduction in Rural Villages in China

NCT01259700 | Completed DMC

• 2 other identifiers: Pro00025963HHSN268200900027C
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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.

Conditions

Cardiovascular Disease

Keywords

High blood pressure; Primary care; Cardiovascular disease prevention; Salt reduction

Outcome Measures

Primary Outcomes (2)

• Mean systematic blood pressure level

  October 2010 - December 2012

• 24 hour urinary sodium

  October -December 2012

Secondary Outcomes (6)

• 24 hour urinary potassium

  October-December 2012

• Urinary sodium:potassium ratio

  October-December 2012

• Receiving regular primary care

  October 2010 -December 2012

• Taking anti-hypertensive medications

  October 2010 -December 2012

• Taking aspirin

  October 2010 -December 2012

Other Outcomes (2)

• Knowledge, attitude and behaviour relating to salt consumption

  October-December 2012

• Awareness, treatment, and control of hypertension

  October 2010 - December 2012

Study Arms (4)

High risk management

EXPERIMENTAL

Behavioral: High-risk patient standardized management package

Salt reduction

EXPERIMENTAL

Behavioral: Community based salt reduction program

high risk management and salt reduction

EXPERIMENTAL

Behavioral: High-risk patient standardized management package; Behavioral: Community based salt reduction program

Usual care

NO INTERVENTION

Interventions

High-risk patient standardized management package BEHAVIORAL

A primary-care based high cardiovascular risk management package delivered by village doctors

Also known as: high risk management

High risk management; high risk management and salt reduction

Community based salt reduction program BEHAVIORAL

A community-based salt reduction program delivered mainly by community health educators

Also known as: Salt reduction

Salt reduction; high risk management and salt reduction

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• none

Sponsors & Collaborators

• The George Institute for Global Health, China: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (5)

Hebei Province Center for Disease Prevention and Control ,China

Shijiazhuang, Hebei, China

Location

The First Hospital Of China Medical University

Shenyang, Liaoning, China

Location

Ningxia Medical University School of Public Health

Yinchuan, Ningxia, China

Location

Changzhi Medical College, China

Changzhi, Shanxi, China

Location

The Xi'an Jiaotong University School of Public Health

Xi’an, Shanxi, China

Location

Related Publications (7)

• Chen S, Yan LL, Feng X, Zhang J, Zhang Y, Zhang R, Zhou B, Wu Y. Population-wide impact of a pragmatic program to identify and manage individuals at high-risk of cardiovascular disease: a cluster randomized trial in 120 villages from Northern China. Front Cardiovasc Med. 2024 May 24;11:1372298. doi: 10.3389/fcvm.2024.1372298. eCollection 2024.

  PMID: 38854653 DERIVED

• 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.

  PMID: 34164803 DERIVED

• 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.

  PMID: 30591358 DERIVED

• 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.

  PMID: 27935977 DERIVED

• 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.

  PMID: 27515930 DERIVED

• 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.

  PMID: 27495056 DERIVED

• 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.

  PMID: 24721435 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Yangfeng Wu, PhD

  The George Institute for Global Health, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 14, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2014
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

CN (5)