PrehypertensionNCT07880990
Behaviour Change Wheel Intervention to Promote Healthy Behaviors in Adults With Prehypertension
A study testing Behaviour Change Wheel-Based Health-Promoting Behavior Intervention and Routine Health Education in people with Prehypertension, run by Fujian Medical University Union Hospital.
Trial summary
Prehypertension is an important risk factor for developing hypertension and cardiovascular disease. Promoting healthy lifestyle behaviors among young and middle-aged adults with prehypertension may help reduce the risk of progression to hypertension. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Prehypertension
- What is being tested?
- Behaviour Change Wheel-Based Health-Promoting Behavior Intervention and Routine Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Dec 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-59 years; (2) meeting the diagnostic criteria for prehypertension specified in the 2024 Chinese Guidelines for Clinical Practice in Hypertension; (3) having primary prehypertension; (4) providing informed consent and voluntarily participating in the study; (5) having normal verbal expression and communication abilities; and (6) having no history of antihypertensive medication use.
Who cannot join
- comorbid neurological and psychiatric diseases (epilepsy, Parkinson's disease, Alzheimer's disease, other dementia, depression or anxiety disorders, etc.); (2) severe heart, brain or kidney complications and definite target organ damage; (3) pregnant or lactating women.
About this study
Official title: An Intervention Study on Health-Promoting Behaviors Among Young and Middle-Aged Adults With Prehypertension Based on the Behaviour Change Wheel Theory
Prehypertension is an important risk factor for developing hypertension and cardiovascular disease. Promoting healthy lifestyle behaviors among young and middle-aged adults with prehypertension may help reduce the risk of progression to hypertension.
This study aims to evaluate the effectiveness of an intervention based on the Behaviour Change Wheel (BCW) framework in improving health-promoting behaviors among young and middle-aged adults with prehypertension. The intervention will be designed to address factors influencing health behaviors and support participants in adopting healthier lifestyles.
The study will assess changes in health-promoting behaviors and related health outcomes before and after the intervention to determine whether the BCW-based intervention can improve lifestyle management in this population.
- Conditions
- Prehypertension
- Being tested
- Behaviour Change Wheel-Based Health-Promoting Behavior Intervention, Routine Health Education
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behaviour Change Wheel-Based Health-Promoting Behavior InterventionBehavioural
The intervention is based on the Behaviour Change Wheel (BCW) framework and aims to improve health-promoting behaviors among young and middle-aged adults with prehypertension. The intervention will be tailored to participants' needs and barriers to behavior change and will focus on promoting healthy eating, regular physical activity, stress management, health responsibility, interpersonal relationships, and personal health awareness. Intervention strategies may include health education, individualized behavioral guidance, goal setting, regular follow-up, and feedback on behavioral progress. The intervention is designed to support sustainable lifestyle changes and improve the management of prehypertension.
Routine Health EducationBehavioural
Participants will receive routine health education for prehypertension management according to the usual care provided.
| Study group | Role | What they receive |
|---|---|---|
| BCW-Based Intervention Group | Experimental | Participants will receive a health-promoting behavior intervention based on the Behaviour Change Wheel (BCW) framework to improve lifestyle behaviors and support hypertension prevention. Receives: Behavioral: Behaviour Change Wheel-Based Health-Promoting Behavior Intervention |
| Usual Care Control Group | Active comparator | Participants will receive routine health education and usual care for prehypertension management. Receives: Behavioral: Routine Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: Before the intervention, at the end of the 3-month intervention, and 3 months after the end of the intervention
Incidence of Hypertension
Measured: Before the intervention, at the end of the 3-month intervention, and 3 months after the end of the intervention
Secondary outcomes (5)
Health promoting behaviors
HPLP-Ⅱ questionnaire score
Measured: Before the intervention, at the end of the 3-month intervention, and 3 months after the end of the intervention
Self management ability
The Prehypertension self-management health Behavior Assessment questionnaire score
Measured: Before the intervention, at the end of the 3-month intervention, and 3 months after the end of the intervention
Social support
SSRS score
Measured: Before the intervention, at the end of the 3-month intervention, and 3 months after the end of the intervention
Self-efficacy
SEMCD6 score
Measured: Before the intervention, at the end of the 3-month intervention, and 3 months after the end of the intervention
Sleep quality
PSQI score
Measured: Before the intervention, at the end of the 3-month intervention, and 3 months after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehypertensionStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- 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
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880990
- Sponsor's protocol ID
- 2025KY632-01
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention Study on Health-Promoting Behaviors Among Young and Middle-Aged Adults With Prehypertension Based on the Behaviour Change Wheel Theory
- ClinicalTrials.gov ID
- NCT07880990
- Acronym / sponsor ID
- 2025KY632-01
- Conditions
- Prehypertension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Oct 2026 (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.
Prehypertension is an important risk factor for developing hypertension and cardiovascular disease. Promoting healthy lifestyle behaviors among young and middle-aged adults with prehypertension may help reduce the risk of progression to hypertension.
This study aims to evaluate the effectiveness of an intervention based on the Behaviour Change Wheel (BCW) framework in improving health-promoting behaviors among young and middle-aged adults with prehypertension. The intervention will be designed to address factors influencing health behaviors and support participants in adopting healthier lifestyles.
The study will assess changes in health-promoting behaviors and related health outcomes before and after the intervention to determine whether the BCW-based intervention can improve lifestyle management in this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCW-Based Intervention Group | Experimental | Behavioral: Behaviour Change Wheel-Based Health-Promoting Behavior InterventionParticipants will receive a health-promoting behavior intervention based on the Behaviour Change Wheel (BCW) framework to improve lifestyle behaviors and support hypertension prevention. |
| Usual Care Control Group | Active comparator | Behavioral: Routine Health EducationParticipants will receive routine health education and usual care for prehypertension management. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Aged 18-59 years; (2) meeting the diagnostic criteria for prehypertension specified in the 2024 Chinese Guidelines for Clinical Practice in Hypertension; (3) having primary prehypertension; (4) providing informed consent and voluntarily participating in the study; (5) having normal verbal expression and communication abilities; and (6) having no history of antihypertensive medication use.
Key exclusion criteria (1 listed)
- comorbid neurological and psychiatric diseases (epilepsy, Parkinson's disease, Alzheimer's disease, other dementia, depression or anxiety disorders, etc.); (2) severe heart, brain or kidney complications and definite target organ damage; (3) pregnant or lactating women.
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 |
|---|---|---|
| Behaviour Change Wheel-Based Health-Promoting Behavior InterventionThe intervention is based on the Behaviour Change Wheel (BCW) framework and aims to improve health-promoting behaviors among young and middle-aged adults with prehypertension. The intervention will be tailored to participants' needs and barriers to behavior change and will focus on promoting healthy eating, regular physical activity, stress management, health responsibility, interpersonal relationships, and personal health awareness. Intervention strategies may include health education, individualized behavioral guidance, goal setting, regular follow-up, and feedback on behavioral progress. The intervention is designed to support sustainable lifestyle changes and improve the management of prehypertension. | Behavioural | BCW-Based Intervention Group |
| Routine Health EducationParticipants will receive routine health education for prehypertension management according to the usual care provided. | Behavioural | Usual Care Control Group |
Primary outcome
Blood pressure
Time frame: Before the intervention, at the end of the 3-month intervention, and 3 months after the end of the intervention
Incidence of Hypertension
Time frame: Before the intervention, at the end of the 3-month intervention, and 3 months after the end of the intervention
5 secondary outcomes
Health promoting behaviors
Time frame: Before the intervention, at the end of the 3-month intervention, and 3 months after the end of the intervention
Self management ability
Time frame: Before the intervention, at the end of the 3-month intervention, and 3 months after the end of the intervention
Social support
Time frame: Before the intervention, at the end of the 3-month intervention, and 3 months after the end of the intervention
Self-efficacy
Time frame: Before the intervention, at the end of the 3-month intervention, and 3 months after the end of the intervention
Sleep quality
Time frame: Before the intervention, at the end of the 3-month intervention, and 3 months after the end of the intervention
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 19 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Behaviour Change Wheel-Based Health-Promoting Behavior Intervention and Routine Health Education in people with Prehypertension, run by Fujian Medical University Union Hospital.
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 1 inclusion and 1 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 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Blood pressure (time frame: Before the intervention, at the end of the 3-month intervention, and 3 months after the end of the intervention). The study lists 2 primary outcomes in all. 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 19 Oct 2026.