Effect of Healthy Family Program on Population Blood Pressure

NCT06427096 | Completed

• 1 other identifier: HFP2024
• Study Type: interventional
• Target: 8,001
• Locations: 1 country
• Sites: 1

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.

Conditions

Public Health; Blood Pressure

Keywords

cluster randomized trial; blood pressure; family intervention; China

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 SBP<130 or DBP<80 mmHg at 6 months

  6 months

• The proportion of participants with antihypertensive therapy at 6 months

  6 months

Study Arms (2)

Multifaceted intervention

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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

Interventions

Multifaceted intervention 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.

Multifaceted intervention

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• At least one family member can use the smartphone to upload BP values.
• Any family member participated in the other hypertension-related programs;
• Inappropriate for the study decided by the healthy family instructor.
• 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.
• 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.

Sponsors & Collaborators

• Heart Health Research Center: lead
• National Science and Technology Major Project: collaborator

Study Sites (1)

Ruyang County People's Hospital

Luoyang, Henan, China

Location

Related Publications (1)

• 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.

  PMID: 39884452 DERIVED

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2024
• First Posted: May 23, 2024
• Study Start: May 23, 2024
• Primary Completion: February 12, 2025
• Study Completion: July 28, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)