HypertensionNCT07265193
The Workplace-Based Hypertension Management Program
A study testing Workplace-based Multicomponent Hypertension Management Program and Routine workplace health education and management according to current guidelines. in people with Hypertension, run by Guangxi Medical University at 1 site in China.
Trial summary
This study aims to evaluate the effectiveness of a workplace-based, multicomponent hypertension management program for newly diagnosed patients. Investigators will recruit 512 participants (256 pairs) from the Kailuan Study in Tangshan, China. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Workplace-based Multicomponent Hypertension Management Program and Routine workplace health education and management according to current guidelines.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 1 siteChina
- Study dates
- Jan 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18-60 years
- Newly diagnosed hypertension (per 2024 Chinese hypertension guideline criteria)
- Employed in Kailuan Group workplace settings
- Able to provide informed consent
Who cannot join
- Severe cardiovascular or renal disease at baseline
- Psychiatric disorders affecting compliance
- Pregnant or lactating women
- Participation in other intervention trials
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Yan-Feng Zhou
Nanning, Guangxi, 530021
Yan-Feng Zhou, 15927422928, yanfengzhou_h@163.com
About this study
Official title: The Workplace-Based, Multicomponent Hypertension Management Program in Patients Aged 18-60 Years: A Randomized Controlled Trial
This study aims to evaluate the effectiveness of a workplace-based, multicomponent hypertension management program for newly diagnosed patients. Investigators will recruit 512 participants (256 pairs) from the Kailuan Study in Tangshan, China. Participants will be randomly assigned to receive a Workplace-based Multicomponent Hypertension Management Program or Standard Workplace Health Management. The primary objective is to assess improvements in blood pressure control and hypertension-related health behaviors.
Read the detailed description
Hypertension is a major public health issue worldwide, and workplace settings represent a critical intervention opportunity for middle-aged populations. Nudge theory provides a cost-effective and behaviorally informed approach to promote sustainable health behaviors. This randomized controlled trial (RCT) will explore mechanisms of health behavior promotion, evaluate the effectiveness of a nudge-based workplace health management strategy, and contribute to evidence-based hypertension prevention and control in China.
- Conditions
- Hypertension
- Being tested
- Workplace-based Multicomponent Hypertension Management Program, Routine workplace health education and management according to current guidelines.
- Keywords
- Hypertension, workplace health, behavioral intervention, randomized controlled trial, Kailuan study
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Workplace-based Multicomponent Hypertension Management ProgramBehavioural
Multicomponent strategies, including default scheduling of BP monitoring and counseling sessions, personalized reminders via workplace digital systems, social comparison feedback using anonymized peer data, small incentives and commitment devices.
Routine workplace health education and management according to current guidelines.Other
Routine workplace health education and management according to current guidelines, including routine health education, standard hypertension counseling, and usual workplace health services.
| Study group | Role | What they receive |
|---|---|---|
| Standard Workplace Health Management | Active comparator | Routine workplace health education and management according to current guidelines, including routine health education, standard hypertension counseling, and usual workplace health services. Receives: Other: Routine workplace health education and management according to current guidelines. |
| Workplace-based Multicomponent Hypertension Management Program | Experimental | Multicomponent strategies, including default scheduling of BP monitoring and counseling sessions, personalized reminders via workplace digital systems, social comparison feedback using anonymized peer data, small incentives and commitment devices. Receives: Behavioral: Workplace-based Multicomponent Hypertension Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic and diastolic blood pressure
Change in systolic and diastolic blood pressure from baseline to 12 months
Measured: up to 12 months
Secondary outcomes (3)
Changes in hypertension-related health behaviors
Changes in hypertension-related health behaviors (dietary intake, physical activity, medication adherence) at 12 months
Measured: up to 12 months
Change in body mass index (BMI)
Change in body mass index (BMI) at 12 months
Measured: up to 12 months
Work productivity and quality of life scores
Work productivity and quality of life scores (e.g., the European Quality of Life-5 Dimensions) at 12 months
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 512 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan-Feng Zhou, Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265193
- Sponsor's protocol ID
- 82404393
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be available upon reasonable request after publication of main trial results.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Workplace-Based, Multicomponent Hypertension Management Program in Patients Aged 18-60 Years: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07265193
- Acronym / sponsor ID
- 82404393
- Conditions
- Hypertension
- Keywords
- Hypertension, workplace health, behavioral intervention, randomized controlled trial, Kailuan study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 512 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 4 Dec 2025 (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 study aims to evaluate the effectiveness of a workplace-based, multicomponent hypertension management program for newly diagnosed patients. Investigators will recruit 512 participants (256 pairs) from the Kailuan Study in Tangshan, China. Participants will be randomly assigned to receive a Workplace-based Multicomponent Hypertension Management Program or Standard Workplace Health Management. The primary objective is to assess improvements in blood pressure control and hypertension-related health behaviors.
Detailed description
Hypertension is a major public health issue worldwide, and workplace settings represent a critical intervention opportunity for middle-aged populations. Nudge theory provides a cost-effective and behaviorally informed approach to promote sustainable health behaviors. This randomized controlled trial (RCT) will explore mechanisms of health behavior promotion, evaluate the effectiveness of a nudge-based workplace health management strategy, and contribute to evidence-based hypertension prevention and control in China.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Workplace Health Management | Active comparator | Other: Routine workplace health education and management according to current guidelines.Routine workplace health education and management according to current guidelines, including routine health education, standard hypertension counseling, and usual workplace health services. |
| Workplace-based Multicomponent Hypertension Management Program | Experimental | Behavioral: Workplace-based Multicomponent Hypertension Management ProgramMulticomponent strategies, including default scheduling of BP monitoring and counseling sessions, personalized reminders via workplace digital systems, social comparison feedback using anonymized peer data, small incentives and commitment devices. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 18-60 years
- Newly diagnosed hypertension (per 2024 Chinese hypertension guideline criteria)
- Employed in Kailuan Group workplace settings
- Able to provide informed consent
Key exclusion criteria (4 listed)
- Severe cardiovascular or renal disease at baseline
- Psychiatric disorders affecting compliance
- Pregnant or lactating women
- Participation in other intervention trials
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 |
|---|---|---|
| Workplace-based Multicomponent Hypertension Management ProgramMulticomponent strategies, including default scheduling of BP monitoring and counseling sessions, personalized reminders via workplace digital systems, social comparison feedback using anonymized peer data, small incentives and commitment devices. | Behavioural | Workplace-based Multicomponent Hypertension Management Program |
| Routine workplace health education and management according to current guidelines.Routine workplace health education and management according to current guidelines, including routine health education, standard hypertension counseling, and usual workplace health services. | Other | Standard Workplace Health Management |
Primary outcome
Change in systolic and diastolic blood pressure
Time frame: up to 12 months
Change in systolic and diastolic blood pressure from baseline to 12 months
3 secondary outcomes
Changes in hypertension-related health behaviors
Time frame: up to 12 months
Change in body mass index (BMI)
Time frame: up to 12 months
Work productivity and quality of life scores
Time frame: up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be available upon reasonable request after publication of main trial results.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Workplace-based Multicomponent Hypertension Management Program and Routine workplace health education and management according to current guidelines. in people with Hypertension, run by Guangxi Medical University 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 4 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic and diastolic blood pressure (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2025.