Clinical trial NCT06427096: Effect of Healthy Family Program on Population Blood Pressure
Official title: Effect of Healthy Family Program on Population Blood Pressure: A 1:1 Parallel Design, Multi-Center Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Pressure
Lead sponsor: Heart Health Research Center
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 8000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 adopting a low-sodium diet, managing weight, participating in physical exercise, monitoring blood pressure, and undergoing antihypertensive treatment. These efforts will be led by healthy family 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 healthy 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 healthy family 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.

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.

Primary outcomes:
measure: The changes of systolic blood pressure from baseline to 6 months
timeFrame: 6 months
Secondary outcomes:
measure: The changes of systolic blood pressure from baseline to 12 months
timeFrame: 12 months
measure: The changes of diastolic blood pressure from baseline to 6 months
timeFrame: 6 months
measure: The percentage of blood pressure ≥130/80mmHg
timeFrame: 6 months
measure: The percentage of hypertensive participants receiving antihypertensive treatment
timeFrame: 6 months
measure: The percentage of hypertensive participants achieving blood pressure goal
timeFrame: 6 months
measure: The weight changes
timeFrame: 6 months
measure: The major cardiovascular events
timeFrame: 6 months
Other outcomes:
Locations:
city: Luoyang
country: China
facility: Ruyang County People's Hospital
state: Henan
Study officials:
affiliation: Beijing Anzhen Hospital
name: Jun Cai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Anzhen Hospital
name: Xin Du, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Science and Technology for Brain-Inspired Intelligence
name: Craig S Anderson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Anzhen Hospital
name: Chao Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References: