Effect of Healthy Family Program on Population Blood Pressure

Heart Health Research Center

Status: Enrolling

Conditions: Blood Pressure

Treatments: Behavioral: Multifaceted intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06427096

HFP2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8,000 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

8,000 participants in 2 patient groups

Multifaceted intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Multifaceted intervention

Usual care

No Intervention group

Description:

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