Effect of Healthy Family Program on Population Blood Pressure: A 1:1 Parallel Design, Multi-Center Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8,001
- 试验地点
- 2
- 主要终点
- The changes of systolic blood pressure from baseline to 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Village screening:
- •Villages were eligible for inclusion if they had ≥200 permanent households, with ≥60 households comprising ≥2 family members.
- •Inclusion and
排除标准
- •for the Family
- •Inclusion Criteria:
- •At least 2 participants between the age of 40-80 years meet the inclusion and exclusion criteria of family members and willing to participate in this study;
- •At least one family member can use the smartphone to upload BP values.
- •Exclusion Criteria:
- •Any family member participated in the other hypertension-related programs;
- •Inappropriate for the study decided by the healthy family instructor.
- •3.Inclusion and Exclusion Criteria for the Family Member
- •Inclusion Criteria:
- •40-80 years old, regardless of BP level and antihypertensive treatment;
- •No travel plan for more than 1 month during the study period;
- •Written or fingerprinted informed consent form.
- •Exclusion Criteria:
- •Significant cognitive dysfunction;
- •With advanced tumor, dialysis, or other serious diseases;
- •Lying in bed for a long time or unable to take care of themselves;
- •Diagnosed of secondary hypertension;
- •Having birth plans in the next six months, pregnant or lactating women;
- •Other ineligible circumstances judged by the investigators.
研究组 & 干预措施
Multifaceted intervention
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.
干预措施: Multifaceted intervention (Behavioral)
Usual care
Residents in this group will receive usual lifestyle and health care management.
结局指标
主要结局
The changes of systolic blood pressure from baseline to 6 months
时间窗: 6 months
The systolic blood pressure changes from baseline to 6 months for all villagers, reported as the difference between intervention and control group.
次要结局
- The changes of systolic blood pressure from baseline to 12 months(12 months)
- The changes of diastolic blood pressure from baseline to 6 months(6 months)
- The proportion of participants with antihypertensive therapy at 6 months(6 months)
- The proportion of participants with SBP<130 or DBP<80 mmHg at 6 months(6 months)