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

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Public Health
• Intervention / Treatment: Behavioral: Multifaceted intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 8001
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Luoyang, Henan, China
      • Ruyang County People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Residents in this group will receive usual lifestyle and health care management.
Experimental: 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.	Behavioral: Multifaceted intervention; The multifaceted interventions is comprised of the following components: To establish a BP management team led by family health instructor. The team members also include family leaders and village doctors.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
The proportion of participants with antihypertensive therapy at 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	The proportion of participants with SBP<130 or DBP<80 mmHg at 6 months	6 months

Collaborators and Investigators

• Sponsor: Heart Health Research Center
• Collaborators: National Science and Technology Major Project
• Investigators: Principal Investigator: Jun Cai, MD, Beijing Anzhen Hospital; Principal Investigator: Xin Du, MD, Beijing Anzhen Hospital; Principal Investigator: Craig S Anderson, MD, Institute of Science and Technology for Brain-Inspired Intelligence; Principal Investigator: Chao Jiang, MD, Beijing Anzhen Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2024
• Primary Completion (Actual): February 12, 2025
• Study Completion (Actual): July 28, 2025

Study Registration Dates

• First Submitted: May 18, 2024
• First Submitted That Met QC Criteria: May 18, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: China; blood pressure; family intervention; cluster randomized trial
• Other Study ID Numbers: HFP2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No