Healthy Family Program to Manage Blood Pressure in Rural China

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

This study is testing a new program that helps people in rural China manage their blood pressure through diet, exercise, and support to see if it works better than regular care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 8000 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Heart Health Research Center (other)
• Locations: 1 site (Luoyang, Henan)
• Trial ID: NCT06427096 on ClinicalTrials.gov

What this trial studies

This clinical trial is a cluster-randomized control trial involving 80 villages in Ruyang County, China, where villages will be assigned to either an intervention group or a control group. The intervention group will implement a multifaceted approach to blood pressure management, including dietary changes, weight management, exercise, and monitoring, led by community instructors. The study aims to evaluate the effectiveness of this program over a 6-month period, measuring changes in systolic blood pressure compared to the control group receiving usual care. Participants will include individuals aged 40-80 years, regardless of their hypertension status.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40-80 years living in Ruyang County, with or without hypertension, who can participate in family-based interventions.

Not a fit: Patients with significant cognitive dysfunction or those already involved in other hypertension-related programs may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly lower blood pressure levels in rural populations, improving overall cardiovascular health.

How similar studies have performed: Other studies have shown success with community-led health interventions for managing chronic conditions, suggesting potential for this approach.

Eligibility criteria

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.

Where this trial is running

Luoyang, Henan

• Ruyang County People's Hospital — Luoyang, Henan, China (RECRUITING)

Study contacts

• Principal investigator: Jun Cai, MD — Beijing Anzhen Hospital
• Study coordinator: Yanna Song

Conditions: Blood Pressure