Condition category
Circulatory System
Date applied
23/12/2017
Date assigned
20/01/2018
Last edited
19/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The disease burden of hypertension (high blood pressure) in China has been increased rapidly, and long-term effective prevention strategies are needed to prevent and control hypertension in China. This is a 2-year community-based study in two communities in Shanghai, China with the support of the local government. The aim of this study is to find out whether a community-based comprehensive intervention strategy of blood pressure control is effective.

Who can participate?
People aged 35 to 74 living in two selected communities in China

What does the study involve?
All participants in the intervention community receive comprehensive interventions, including health education and lifestyle interventions, including reducing intakes of dietary sodium, decreasing body weight, and increasing physical activity. In addition, the hypertensive patients in the intervention community are managed with hypertensive drug treatment to control blood pressure and followed up by the community physicians regularly. Participants in control community do not receive any intervention provided by the investigators of this study.

What are the possible benefits and risks of participating?
The participants would not have any direct benefit from the study, but the study may contribute to the prevention and control of blood pressure in China. When the participants had physical examinations, they may feel uncomfortable. For example, sphygmomanometer cuff inflation for blood pressure measurement may cause discomfort. In addition, the participants may feel short-term discomfort when blood is drawn. There is a small possibility of infection, excessive bleeding, clotting or fainting. If the participants are injured as a result of participating in this study, medical treatment is provided by the researchers.

Where is the study run from?
1. Bansongyuan Community (China)
2. Nanjing East Road Community (China)

When is the study starting and how long is it expected to run for?
May 2007 to December 2010

Who is funding the study?
National Science and Technology Support Projects for the Eleventh Five-Year Plan of China

Who is the main contact?
Dr Tao Wu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tao Wu

ORCID ID

Contact details

38
Xueyuan Road
Haidian District
Beijing
100191
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A community-based non-randomized controlled intervention program for blood pressure control in China

Acronym

Study hypothesis

The community-based comprehensive intervention strategy of blood pressure control is more effective in the intervention group compared to the control group without interventions.

Ethics approval

Institutional Review Board of Peking University Health Science Center, 01/01/2007

Study design

Community-based non-randomized controlled intervention program

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Hypertension

Intervention

The study was a non-randomized controlled intervention program, and two well-organized communities, in which the population was relatively stable and health records of the participants were accessible, were selected as our survey sites.

All participants in the intervention community received health education to improve hypertension-related knowledge. Lifestyle interventions including reducing intakes of dietary sodium, decreasing body weight, and increasing physical activity were offered to all participants in the intervention community. Whole community fitness program was launched in the intervention community to encourage residents to participate in physical exercise. Also, cardiovascular and cerebrovascular diseases specialists provided on-site counseling and guidance on healthy lifestyle. In addition, the hypertensive patients in the intervention community were managed to have hypertensive drug treatment to control blood pressure and followed up by the community physicians regularly. Participants in control community did not receive any intervention provided by the investigators of this project. The total duration of the intervention and follow-up was 2 years.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Systolic blood pressure, measured by trained staff using a conventional mercury sphygmomanometer and appropriately sized cuffs after a 5-minute rest in the seated position, at baseline and the endpoint of the study

Secondary outcome measures

Diastolic blood pressure, measured by trained staff using a conventional mercury sphygmomanometer and appropriately sized cuffs after a 5-minute rest in the seated position, at baseline and the endpoint of the study

Overall trial start date

01/05/2007

Overall trial end date

31/12/2010

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 35 to 74 years
2. With local registered residence
3. Living in the community for more than five years
4 Being able to sign the written informed consent

Participant type

All

Age group

Adult

Gender

Both

Target number of participants

18,528

Participant exclusion criteria

Unable to sign the written informed consent

Recruitment start date

01/06/2007

Recruitment end date

01/10/2007

Locations

Countries of recruitment

China

Trial participating centre

Bansongyuan Community
Shanghai
200000
China

Trial participating centre

Nanjing East Road Community
Shanghai
200000
China

Sponsor information

Organisation

Ministry of Science and Technology of the People's Republic of China

Sponsor details

B15
Fuxing Road
Beijing
100862
China
+86 (0)10 58881800
program@most.cn

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

National Science and Technology Support Projects for the Eleventh Five-Year Plan of China (grant number 2006BA101A01)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available. The decision was attained by all parties involved in the study. The dataset is kept by specialized data analysts under the supervision of principal investigators of the study.

Intention to publish date

19/03/2018

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes