Blood PressureNCT06427096
Effect of Healthy Family Program on Population Blood Pressure
A study testing Multifaceted intervention in people with Blood Pressure and Public Health, run by Heart Health Research Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Public Health
- What is being tested?
- Multifaceted intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,001 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2024to 28 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
- At least one family member can use the smartphone to upload BP values.
- 40-80 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.
Who cannot join
- Any family member participated in the other hypertension-related programs;
- Inappropriate for the study decided by the healthy family instructor.
- 3.Inclusion and Exclusion Criteria for the Family Member
- 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;
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- Diagnosed of secondary hypertension;
- Having birth plans in the next six months, pregnant or lactating women;
- Other ineligible circumstances judged by the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Healthy Family Program on Population Blood Pressure: A 1:1 Parallel Design, Multi-Center Cluster Randomized Trial
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.
Read the 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 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.
- Conditions
- Blood Pressure, Public Health
- Being tested
- Multifaceted intervention
- Keywords
- cluster randomized trial, blood pressure, family intervention, China
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifaceted interventionBehavioural
The multifaceted interventions is comprised of the following components:
- To establish a BP management team led by family health instructor. The team members also include family leaders and village doctors.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multifaceted intervention |
| Usual care | No intervention | Residents in this group will receive usual lifestyle and health care management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
The changes of systolic blood pressure from baseline to 12 months
The systolic blood pressure changes from baseline to 12 months, reported as the difference between intervention and control group.
Measured: 12 months
The changes of diastolic blood pressure from baseline to 6 months
The diastolic blood pressure changes from baseline to 6 months, reported as the difference between intervention and control group.
Measured: 6 months
The proportion of participants with SBP<130 or DBP<80 mmHg at 6 months
The proportion of participants with SBP<130 or DBP<80 mmHg at 6 months
Measured: 6 months
The proportion of participants with antihypertensive therapy at 6 months
The proportion of participants with antihypertensive therapy at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start23 May 2024
- Primary completion12 Feb 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8,001 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart Health Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Major Project
- Responsible party
- Sponsor
- Investigators
- Jun Cai, MD, Principal investigator, Beijing Anzhen HospitalXin Du, MD, Principal investigator, Beijing Anzhen HospitalCraig S Anderson, MD, Principal investigator, Institute of Science and Technology for Brain-Inspired IntelligenceChao Jiang, MD, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427096
- Sponsor's protocol ID
- HFP2024
- Status last verified
- Mar 2026
- First submitted
- 18 May 2024
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Du X, Jiang C, Tang Y, Han R, Song Y, Wang C, Lin X, Yi Y, Rodgers A, Dong J, Ma C, Anderson CS, Cai J. A Coordinated Community- and Family-Based Intervention to Control Blood Pressure in Rural China: A Cluster-Randomized Trial. J Am Coll Cardiol. 2026 Aug 10:S0735-1097(26)07372-9. doi: 10.1016/j.jacc.2026.07.045. Online ahead of print.
PubMed 42644782Tang 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.
PubMed 39884452
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Healthy Family Program on Population Blood Pressure: A 1:1 Parallel Design, Multi-Center Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06427096
- Acronym / sponsor ID
- HFP2024
- Conditions
- Blood Pressure, Public Health
- Keywords
- cluster randomized trial, blood pressure, family intervention, China
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,001 participants (actual)
- Lead sponsor
- Heart Health Research CenterUniversity, hospital or other
- Collaborators
- National Science and Technology Major Project
- Study start
- 23 May 2024 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifaceted intervention | Experimental | Behavioral: Multifaceted interventionResidents 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. |
| Usual care | No intervention | –Residents in this group will receive usual lifestyle and health care management. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
- At least one family member can use the smartphone to upload BP values.
- 40-80 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.
Key exclusion criteria (9 listed)
- Any family member participated in the other hypertension-related programs;
- Inappropriate for the study decided by the healthy family instructor.
- 3.Inclusion and Exclusion Criteria for the Family Member
- Significant cognitive dysfunction;
- With advanced tumor, dialysis, or other serious diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifaceted interventionThe 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. | Behavioural | Multifaceted intervention |
Primary outcome
The changes of systolic blood pressure from baseline to 6 months
Time frame: 6 months
The systolic blood pressure changes from baseline to 6 months for all villagers, reported as the difference between intervention and control group.
4 secondary outcomes
The changes of systolic blood pressure from baseline to 12 months
Time frame: 12 months
The changes of diastolic blood pressure from baseline to 6 months
Time frame: 6 months
The proportion of participants with SBP<130 or DBP<80 mmHg at 6 months
Time frame: 6 months
The proportion of participants with antihypertensive therapy at 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Derived from this study: PubMed 42644782Du X, Jiang C, Tang Y, Han R, Song Y, Wang C, Lin X, Yi Y, Rodgers A, Dong J, Ma C, Anderson CS, Cai J. A Coordinated Community- and Family-Based Intervention to Control Blood Pressure in Rural China: A Cluster-Randomized Trial. J Am Coll Cardiol. 2026 Aug 10:S0735-1097(26)07372-9. doi: 10.1016/j.jacc.2026.07.045. Online ahead of print.
- Derived from this study: PubMed 39884452Tang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Cai, MD principal investigator
Beijing Anzhen Hospital
Xin Du, MD principal investigator
Beijing Anzhen Hospital
Craig S Anderson, MD principal investigator
Institute of Science and Technology for Brain-Inspired Intelligence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifaceted intervention in people with Blood Pressure and Public Health, run by Heart Health Research Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of systolic blood pressure from baseline to 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06427096, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.