Effect of Healthy Family Program on Population Blood Pressure

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06427096
• Other study ID #: HFP2024
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2024
• Est. completion date: August 2025

Study information

• Verified date: June 2024
• Source: Heart Health Research Center
• Contact: Yanna Song
• Phone: +86 17839372777
• Email: songyanna[@]RRH.onaliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 adopting a low-sodium diet, managing weight, participating in physical exercise, monitoring blood pressure, and undergoing antihypertensive treatment. These efforts will be led by healthy family 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.

Description:

This cluster-randomized control trial aims to randomly allocate 80 villages in Ruyan County to either receive a multifaceted intervention led by family healthy 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 healthy family 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: August 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

1. Village screening:

The suitable villages were initially screened according to the statistical information of the number of villages and households in Ruyang County.

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 exclusion criteria of family members and willing to participate in this study;

2. At least one family member can use the smartphone to upload BP values.

Exclusion Criteria:

1. Any family member participated in the other hypertension-related programs;

2. Inappropriate for the study decided by the healthy family instructor.

3.Inclusion and Exclusion Criteria for the Family Member

Inclusion Criteria:

1. 40-80 years old, regardless of BP level and antihypertensive treatment;

2. No travel plan for more than 1 month during the study period;

3. Written or fingerprinted informed consent form.

Exclusion Criteria:

1. Significant cognitive dysfunction;

2. With advanced tumor, dialysis, or other serious diseases;

3. Lying in bed for a long time or unable to take care of themselves;

4. Diagnosed of secondary hypertension;

5. Having birth plans in the next six months, pregnant or lactating women;

6. Other ineligible circumstances judged by the investigators.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Behavioral:
• Multifaceted intervention
The multifaceted interventions is comprised of the following components: To establish a BP management team led by healthy family instructor. The team members also include family leaders and village doctors. To conduct multifaceted intervention, which includes low-sodium diet, weight management, physical exercise, BP monitoring and antihypertensive treatment.

Locations

Country	Name	City	State
China	Ruyang County People's Hospital	Luoyang	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Heart Health Research Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	The changes of diastolic blood pressure from baseline to 6 months	The diastolic blood pressure changes from baseline to 6 months, reported as the difference between intervention and control group.	6 months
Secondary	The percentage of blood pressure =130/80mmHg	The percentage of blood pressure =130/80mmHg at 6 months, reported as the difference between intervention and control group.	6 months
Secondary	The percentage of hypertensive participants receiving antihypertensive treatment	The percentage of hypertensive participants receiving antihypertensive treatment at 6 months, reported as the difference between intervention and control group.	6 months
Secondary	The percentage of hypertensive participants achieving blood pressure goal	The percentage of hypertensive participants who achieved blood pressure goal <130/80mmHg at 6 months, reported as the difference between intervention and control group.	6 months
Secondary	The weight changes	The weight changes from baseline to 6 months, reported as the difference between intervention and control group.	6 months
Secondary	The major cardiovascular events	The incidence of major cardiovascular events including nonfatal stroke, nonfatal myocardial infarction, hospitalization for heart failure, and cardiovascular death within 6 months, reported as the difference between intervention and control group.	6 months