Hypertension (HTN)NCT07492290
Empirical Study on Lifestyle Intervention for Elderly Hypertensive Patients in Community Based on TTM Theory
A study testing Lifestyle medicine in people with Hypertension (HTN) and Age More 60yr, run by Qu Shen.
Trial summary
This study intervention is based on TTM theory and implements lifestyle interventions, including nutritious diet, regular exercise, social support, sleep optimization, avoidance of addictive substances, and stress management. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Hypertension (HTN), Age More 60yr
- What is being tested?
- Lifestyle medicine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 30 Dec 2026
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients whose blood pressure measurements taken at community hospitals meet the hypertension criteria outlined in the Chinese Guidelines for the Prevention and Treatment of Hypertension (2024 revision);
- Aged 60-75 years old;
- Have certain abilities in reading, comprehension, and communication;
- Able to use a smartphone;
- In the pre-conscious/conscious/preparatory stage.
- Volunteer to participate in this study and sign the informed consent form.
Who cannot join
- Exclude those with a history of severe heart, brain, kidney diseases or cancer;
- Patients who currently have or have previously had mental disorders;
- Patients who are currently participating in other research projects.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study intervention is based on TTM theory and implements lifestyle interventions, including nutritious diet, regular exercise, social support, sleep optimization, avoidance of addictive substances, and stress management. Through various means such as training, guidance, and motivation, motivation is formed, goals are determined, and habits are strengthened, ultimately leading to the development of a healthy lifestyle, control of blood pressure indicators, and improvement of quality of life and cognitive function. The intervention period is a total of 3 weeks, on line.
- Conditions
- Hypertension (HTN), Age More 60yr
- Being tested
- Lifestyle medicine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle medicineBehavioural
Lifestyle medicine includes Nutrition , Physical Activity , Stress Management, Restorative Sleep , Social Connectedness, Avoidance of Risky Substances .
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle medicine | Experimental | Not described Receives: Behavioral: Lifestyle medicine |
| Routine health education | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
Measured: Baseline, the end of treatment at 3 weeks, and after 3 months
Patient quality of life (SF-36)
Measured: Baseline, the end of treatment at 3 weeks, and after 3 months
Secondary outcomes (2)
Patient cognitive function (AD8)
Measured: Baseline, the end of treatment at 3 weeks, and after 3 months
Patients' lifestyle (HPLP Ⅱ)
Measured: Baseline, the end of treatment at 3 weeks, and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qu Shen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qu Shen, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492290
- Sponsor's protocol ID
- XDYX202509K38
- Status last verified
- Mar 2026
- First submitted
- 4 Dec 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empirical Study on Lifestyle Intervention for Elderly Hypertensive Patients in Community Based on TTM Theory
- ClinicalTrials.gov ID
- NCT07492290
- Acronym / sponsor ID
- XDYX202509K38
- Conditions
- Hypertension (HTN), Age More 60yr
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Qu ShenUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 25 Mar 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.
This study intervention is based on TTM theory and implements lifestyle interventions, including nutritious diet, regular exercise, social support, sleep optimization, avoidance of addictive substances, and stress management. Through various means such as training, guidance, and motivation, motivation is formed, goals are determined, and habits are strengthened, ultimately leading to the development of a healthy lifestyle, control of blood pressure indicators, and improvement of quality of life and cognitive function. The intervention period is a total of 3 weeks, on line.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle medicine | Experimental | Behavioral: Lifestyle medicine |
| Routine health education | No intervention | – |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients whose blood pressure measurements taken at community hospitals meet the hypertension criteria outlined in the Chinese Guidelines for the Prevention and Treatment of Hypertension (2024 revision);
- Aged 60-75 years old;
- Have certain abilities in reading, comprehension, and communication;
- Able to use a smartphone;
- In the pre-conscious/conscious/preparatory stage.
Key exclusion criteria (3 listed)
- Exclude those with a history of severe heart, brain, kidney diseases or cancer;
- Patients who currently have or have previously had mental disorders;
- Patients who are currently participating in other research projects.
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 |
|---|---|---|
| Lifestyle medicineLifestyle medicine includes Nutrition , Physical Activity , Stress Management, Restorative Sleep , Social Connectedness, Avoidance of Risky Substances . | Behavioural | Lifestyle medicine |
Primary outcome
blood pressure
Time frame: Baseline, the end of treatment at 3 weeks, and after 3 months
Patient quality of life (SF-36)
Time frame: Baseline, the end of treatment at 3 weeks, and after 3 months
2 secondary outcomes
Patient cognitive function (AD8)
Time frame: Baseline, the end of treatment at 3 weeks, and after 3 months
Patients' lifestyle (HPLP Ⅱ)
Time frame: Baseline, the end of treatment at 3 weeks, and after 3 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 25 Mar 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle medicine in people with Hypertension (HTN) and Age More 60yr, run by Qu Shen.
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 6 inclusion and 3 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 25 Mar 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?
Contact Lu Zhang (+8618750236498, zhangluuz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure (time frame: Baseline, the end of treatment at 3 weeks, and after 3 months). 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 25 Mar 2026.