Blood pressure control program in China
| ISRCTN | ISRCTN48365507 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48365507 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/12/2017
- Registration date
- 20/01/2018
- Last edited
- 19/01/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
38, Xueyuan Road, Haidian District
Beijing
100191
China
Study information
| Study design | Community-based non-randomized controlled intervention program |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A community-based non-randomized controlled intervention program for blood pressure control in China |
| Study objectives | 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(s) | Institutional Review Board of Peking University Health Science Center, 01/01/2007 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2007 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 18,528 |
| Key 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 |
| Key exclusion criteria | Unable to sign the written informed consent |
| Date of first enrolment | 01/06/2007 |
| Date of final enrolment | 01/10/2007 |
Locations
Countries of recruitment
- China
Study participating centres
200000
China
200000
China
Sponsor information
Government
B15, Fuxing Road
Beijing
100862
China
| Phone | +86 (0)10 58881800 |
|---|---|
| program@most.cn | |
"ROR" |
https://ror.org/027s68j25 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 19/03/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | 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. |
