NCT06427096

Effect of Healthy Family Program on Population Blood Pressure

Effect of Healthy Family Program on Population Blood Pressure: A 1:1 Parallel Design, Multi-Center Cluster Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8,001 (actual)
• Sponsor: Heart Health Research Center · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Blood Pressure
• Public Health

Interventions

Type	Name	Description
BEHAVIORAL	Multifaceted 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.

Timeline

• Start date: 2024-05-23
• Primary completion: 2025-02-12
• Completion: 2025-07-28
• First posted: 2024-05-23
• Last updated: 2026-03-04

Locations

1 site across 1 country: China