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

China Rural Health Initiative: High Cardiovascular Risk Management and Salt Reduction in Rural Villages in China -- Two Parallel Large Cluster Randomized Controlled Trials

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01259700
Enrollment
120
Registered
2010-12-14
Start date
2010-12-31
Completion date
2014-06-30
Last updated
2016-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

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

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.

Interventions

BEHAVIORALHigh-risk patient standardized management package

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

BEHAVIORALCommunity based salt reduction program

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

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
The George Institute for Global Health, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
24 hour urinary sodiumOctober -December 2012
Mean systematic blood pressure levelOctober 2010 - December 2012

Secondary

MeasureTime frame
Receiving therapeutic lifestyle recommendations from village doctorsOct 2010 - Dec 2012
24 hour urinary potassiumOctober-December 2012
Urinary sodium:potassium ratioOctober-December 2012
Receiving regular primary careOctober 2010 -December 2012
Taking anti-hypertensive medicationsOctober 2010 -December 2012
Taking aspirinOctober 2010 -December 2012

Other

MeasureTime frame
Knowledge, attitude and behaviour relating to salt consumptionOctober-December 2012
Awareness, treatment, and control of hypertensionOctober 2010 - December 2012

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026