## Protocol Section
### Identification Module
**NCT ID:** NCT06427096

**Brief Title:** 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

#### Organization Study ID Info
**ID:** HFP2024
#### Organization
**Class:** OTHER
**Full Name:** Heart Health Research Center
### Status Module
#### Completion Date
**Date:** 2025-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Heart Health Research Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Blood Pressure

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 8000

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Residents in this group will receive multifaceted intervention including low-sodium diet, weight management, physical exercise, BP monitoring and antihypertensive treatment.

**Intervention Names:**

- Behavioral: Multifaceted intervention

**Label:** Multifaceted intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Label:** Usual care

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Multifaceted intervention

**Description:** The multifaceted interventions is comprised of the following components:

1. To establish a BP management team led by healthy family instructor. The team members also include family leaders and village doctors.
2. To conduct multifaceted intervention, which includes low-sodium diet, weight management, physical exercise, BP monitoring and antihypertensive treatment.

**Name:** Multifaceted intervention

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The systolic blood pressure changes from baseline to 6 months for all villagers, reported as the difference between intervention and control group.

**Measure:** The changes of systolic blood pressure from baseline to 6 months

**Time Frame:** 6 months

#### Secondary Outcomes

**Description:** The systolic blood pressure changes from baseline to 12 months, reported as the difference between intervention and control group.

**Measure:** The changes of systolic blood pressure from baseline to 12 months

**Time Frame:** 12 months

**Description:** The diastolic blood pressure changes from baseline to 6 months, reported as the difference between intervention and control group.

**Measure:** The changes of diastolic blood pressure from baseline to 6 months

**Time Frame:** 6 months

**Description:** The percentage of blood pressure ≥130/80mmHg at 6 months, reported as the difference between intervention and control group.

**Measure:** The percentage of blood pressure ≥130/80mmHg

**Time Frame:** 6 months

**Description:** The percentage of hypertensive participants receiving antihypertensive treatment at 6 months, reported as the difference between intervention and control group.

**Measure:** The percentage of hypertensive participants receiving antihypertensive treatment

**Time Frame:** 6 months

**Description:** The percentage of hypertensive participants who achieved blood pressure goal \<130/80mmHg at 6 months, reported as the difference between intervention and control group.

**Measure:** The percentage of hypertensive participants achieving blood pressure goal

**Time Frame:** 6 months

**Description:** The weight changes from baseline to 6 months, reported as the difference between intervention and control group.

**Measure:** The weight changes

**Time Frame:** 6 months

**Description:** The incidence of major cardiovascular events including nonfatal stroke, nonfatal myocardial infarction, hospitalization for heart failure, and cardiovascular death within 6 months, reported as the difference between intervention and control group.

**Measure:** The major cardiovascular events

**Time Frame:** 6 months

### Eligibility Module

**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.

**Maximum Age:** 80 Years

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** songyanna@RRH.onaliyun.com

**Name:** Yanna Song

**Phone:** +86 17839372777

**Role:** CONTACT

**Contact 2:**

**Email:** hanrong@hhresearch.cn

**Name:** Rong Han

**Phone:** +86 13910669903

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Beijing Anzhen Hospital

**Name:** Jun Cai, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Beijing Anzhen Hospital

**Name:** Xin Du, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Institute of Science and Technology for Brain-Inspired Intelligence

**Name:** Craig S Anderson, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 4:**

**Affiliation:** Beijing Anzhen Hospital

**Name:** Chao Jiang, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: AnAg

- Name: Antihypertensive Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4277

- Name: Antihypertensive Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
