Effect of Healthy Family Program on Population Blood Pressure

NCT ID: NCT06427096

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 8000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-23
• Study Completion Date: 2025-12-27

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.

Conditions

Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Multifaceted intervention

Intervention Type: BEHAVIORAL

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.

Usual care

Residents in this group will receive usual lifestyle and health care management.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

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

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

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Heart Health Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Cai, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Xin Du, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Craig S Anderson, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Science and Technology for Brain-Inspired Intelligence

Chao Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Locations

Ruyang County People's Hospital

Luoyang, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yanna Song

Role: CONTACT

songyanna@RRH.onaliyun.com

+86 17839372777

Rong Han

Role: CONTACT

hanrong@hhresearch.cn

+86 13910669903

Facility Contacts

Yanna Song

Role: primary

songyanna@RRH.onaliyun.com

17839372777

References

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.

Reference Type: DERIVED

PMID: 39884452 (View on PubMed)

Other Identifiers

HFP2024

Identifier Type: -

Identifier Source: org_study_id