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| Name | Class |
|---|---|
| National Science and Technology Major Project | UNKNOWN |
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This is a 1:1 parallel design, multi-center, cluster-randomized control trial. A total of 80 villages in Ruyang County, Henan Province, China, will be randomly assigned to the intervention group or control group. At least 100 participants from 30-50 families in each village will be included in this study. The intervention group will engage in a variety of strategies, including educating a healthy lifestyle, adopting a low-sodium diet, managing weight, participating in physical exercise, monitoring blood pressure, and undergoing antihypertensive treatment. These efforts will be led by family health instructors from the community. The control group will receive usual care. The primary endpoint of this study is the change of systolic blood pressure from baseline to 6 months, reported as the difference between intervention and control group.
This cluster-randomized control trial aims to randomly allocate 80 villages in Ruyan County to either receive a multifaceted intervention led by family health instructors or continue with usual care. Each village will recruit around 100 individuals aged 40-80 years, with or without hypertension. In intervention villages, a blood pressure management team, headed by family health instructors and family leaders, will implement various strategies including promoting a low-sodium diet, weight management, physical exercise, blood pressure monitoring, and administering antihypertensive treatment. The intervention will span 6 months, followed by another 6-month follow-up period. The primary hypothesis posits that the mean systolic blood pressure change from baseline to 6 months will be higher in the intervention group compared to the control group. The objective of this "Health Family Program" is to evaluate the efficacy of a non-healthcare provider-led multifaceted intervention in enhancing healthy lifestyles and managing blood pressure among rural residents, regardless of their hypertension status, in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multifaceted intervention | Experimental | Residents in this group will receive multifaceted intervention including education for a healthy lifestyle, free provision of sodium substitute, weight management, physical exercise, BP monitoring, and appropriate antihypertensive treatment for individuals with hypertension. |
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| Usual care | No Intervention | Residents in this group will receive usual lifestyle and health care management. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multifaceted intervention | Behavioral | The multifaceted interventions is comprised of the following components:
|
| Measure | Description | Time Frame |
|---|---|---|
| The changes of systolic blood pressure from baseline to 6 months | The systolic blood pressure changes from baseline to 6 months for all villagers, reported as the difference between intervention and control group. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The changes of systolic blood pressure from baseline to 12 months | The systolic blood pressure changes from baseline to 12 months, reported as the difference between intervention and control group. | 12 months |
| The changes of diastolic blood pressure from baseline to 6 months |
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Village screening:
Villages were eligible for inclusion if they had ≥200 permanent households, with ≥60 households comprising ≥2 family members.
Inclusion and Exclusion Criteria for the Family
Inclusion Criteria:
Exclusion Criteria:
3.Inclusion and Exclusion Criteria for the Family Member
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Cai, MD | Beijing Anzhen Hospital | Principal Investigator |
| Xin Du, MD | Beijing Anzhen Hospital | Principal Investigator |
| Craig S Anderson, MD | Institute of Science and Technology for Brain-Inspired Intelligence | Principal Investigator |
| Chao Jiang, MD | Beijing Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruyang County People's Hospital | Luoyang | Henan | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39884452 | Derived | Tang Y, Jiang C, Guo J, Li Y, Wang C, Chu SH, Wang Z, Wu Y, Hua C, Lu Y, Zhang S, Song Y, Han R, Dong J, Ma C, Cai J, Anderson CS, Du X. Study protocol for the healthy family program on population blood pressure: A multicenter, parallel group, cluster randomized, controlled trial in rural China. Am Heart J. 2025 May;283:70-80. doi: 10.1016/j.ahj.2025.01.014. Epub 2025 Jan 28. |
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|
The diastolic blood pressure changes from baseline to 6 months, reported as the difference between intervention and control group. |
| 6 months |
| The proportion of participants with SBP<130 or DBP<80 mmHg at 6 months | The proportion of participants with SBP<130 or DBP<80 mmHg at 6 months | 6 months |
| The proportion of participants with antihypertensive therapy at 6 months | The proportion of participants with antihypertensive therapy at 6 months | 6 months |