Blood Pressure, Public Health
Conditions
Keywords
cluster randomized trial, blood pressure, family intervention, China
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMultifaceted intervention
The multifaceted interventions is comprised of the following components: 1. To establish a BP management team led by family health instructor. The team members also include family leaders and village doctors. 2. To conduct multifaceted intervention, which includes education for a healthy lifestyle, free provision of sodium substitute, weight management, physical exercise, BP monitoring, and appropriate antihypertensive treatment for individuals with hypertension.
Sponsors
Heart Health Research Center
National Science and Technology Major Project
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Village screening: Villages were eligible for inclusion if they had ≥200 permanent households, with ≥60 households comprising ≥2 family members. 2. Inclusion and
Exclusion criteria
for the Family Inclusion Criteria: 1. At least 2 participants between the age of 40-80 years meet the inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The changes of systolic blood pressure from baseline to 6 months | 6 months | The systolic blood pressure changes from baseline to 6 months for all villagers, reported as the difference between intervention and control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The changes of systolic blood pressure from baseline to 12 months | 12 months | The systolic blood pressure changes from baseline to 12 months, reported as the difference between intervention and control group. |
| The changes of diastolic blood pressure from baseline to 6 months | 6 months | The diastolic blood pressure changes from baseline to 6 months, reported as the difference between intervention and control group. |
| The proportion of participants with SBP<130 or DBP<80 mmHg at 6 months | 6 months | The proportion of participants with SBP\<130 or DBP\<80 mmHg at 6 months |
| The proportion of participants with antihypertensive therapy at 6 months | 6 months | The proportion of participants with antihypertensive therapy at 6 months |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORJun Cai, MD
Beijing Anzhen Hospital
PRINCIPAL_INVESTIGATORXin Du, MD
Beijing Anzhen Hospital
PRINCIPAL_INVESTIGATORCraig S Anderson, MD
Institute of Science and Technology for Brain-Inspired Intelligence
PRINCIPAL_INVESTIGATORChao Jiang, MD
Beijing Anzhen Hospital
Outcome results
None listed