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

NCT ID: NCT01259700

Last Updated: 2016-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High risk management

Group Type EXPERIMENTAL

High-risk patient standardized management package

Intervention Type BEHAVIORAL

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

Salt reduction

Group Type EXPERIMENTAL

Community based salt reduction program

Intervention Type BEHAVIORAL

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

high risk management and salt reduction

Group Type EXPERIMENTAL

High-risk patient standardized management package

Intervention Type BEHAVIORAL

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

Community based salt reduction program

Intervention Type BEHAVIORAL

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

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High-risk patient standardized management package

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

Intervention Type BEHAVIORAL

Community based salt reduction program

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

high risk management Salt reduction

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

The George Institute for Global Health, China

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yangfeng Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

The George Institute for Global Health, China

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hebei Province Center for Disease Prevention and Control ,China

Shijiazhuang, Hebei, China

Site Status

The First Hospital Of China Medical University

Shenyang, Liaoning, China

Site Status

Ningxia Medical University School of Public Health

Yinchuan, Ningxia, China

Site Status

Changzhi Medical College, China

Changzhi, Shanxi, China

Site Status

The Xi'an Jiaotong University School of Public Health

Xi’an, Shanxi, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38854653 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34164803 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30591358 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27935977 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27515930 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27495056 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24721435 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HHSN268200900027C

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00025963

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Low Sodium Cooking Study
NCT03481322 COMPLETED NA
Dietary Salt Intake and Vascular Function
NCT00590512 COMPLETED EARLY_PHASE1
Blood Pressure Reduction in Heart Failure
NCT01255475 COMPLETED PHASE2/PHASE3
Clarifying Optimal Sodium Intake Project
NCT02738736 COMPLETED PHASE2