HypertensionNCT07698509
Virtual Lifestyle Medicine Group Visits for High Blood Pressure
A study testing Lifestyle Medicine Virtual group in people with Hypertension, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to learn whether virtual Lifestyle medicine shared medical appointments (LMSMAs) can help people better manage their blood pressure and improve their overall health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Lifestyle Medicine Virtual group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2026to 7 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current diagnosis of hypertension (ICD codes I10.0-I14.0 billed within the last 5 years Essential HTN, Essential HTN, Primary HTN)
- Currently receives care at a UTPhysicians; Last seen by a PCP at Victory location within the last 1 year.
- Able to participate in a virtual format
- Willingness to participate and engage in home blood pressure monitoring
Who cannot join
- Unstable cardiovascular disease (recent Myocardial Infarction (MI), unstable angina, decompensated HF)
- Advanced Chronic kidney disease (CKD) (eGFR < 30) without nephrology co-management
- Active cancer treatment
- Severe cognitive impairment (unable to engage)
- Uncontrolled psychiatric illness (e.g., active psychosis)
- Resistant hypertension (requiring> 3 medications at maximum doses)
- Unable to participate in English class format
- Unstable internet or lack of smartphone
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Puja B Gandhi, MD, MPH, DipABLM, (713) 500-6714, Puja.Gandhi@uth.tmc.edu
Natalia Williams, (713) 486-3844, Natalia.Williams@uth.tmc.edu
About this study
Official title: A Scalable, Lifestyle Medicine Intervention for Hypertension Using Virtual Group Shared Medical Appointments
The purpose of this study is to learn whether virtual Lifestyle medicine shared medical appointments (LMSMAs) can help people better manage their blood pressure and improve their overall health.
- Conditions
- Hypertension
- Being tested
- Lifestyle Medicine Virtual group, Usual Care Group
- Keywords
- high blood pressure, Lifestyle medicine shared medical appointments (LMSMAs)
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Medicine Virtual groupBehavioural
Participants will be given a home BP monitor upon enrollment and the group will engage in twice monthly virtual shared medical appointments (vSMAs) for 4 visits. Prior to each visit, participants will be asked to complete home BP monitoring (twice in the morning and twice in the evening for 3 days before visit), with readings reviewed during visits and medications adjusted as clinically indicated. Participants will complete four sessions over an 8-week period, with one session type offered in each 2 week block.
Usual Care GroupBehavioural
Participants will be given a home BP monitor upon enrollment and will be instructed by phone and with an electronic health record (EHR) portal message on proper technique for home BP readings. Participants will continue to have follow-up visits with their PCP as clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Medicine Virtual Group Visit Program plus usual medical care | Experimental | Not described Receives: Behavioral: Lifestyle Medicine Virtual group; Behavioral: Usual Care Group |
| Usual medical care only | Active comparator | Not described Receives: Behavioral: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diastolic blood pressure readings
Measured: 2-4 weeks after randomization,6 months after randomization
Change in systolic blood pressure readings
Measured: 2-4 weeks after randomization,6 months after randomization
Secondary outcomes (5)
Percentage of eligible participants who agree to participate
Measured: end of study (6 months after randomization)
Number of primary care physicians (PCPs) whose patients are included in the program
Measured: end of study (6 months after randomization)
Median number of sessions attended by each participant
Measured: end of study (6 months after randomization)
Adherence as assessed by the number of of blood pressure (BP) readings submitted between each session
Measured: end of study (6 months after randomization)
Adherence to home BP monitoring as assessed by the number of of home BP sessions submitted between each session
Measured: end of study (6 months after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start3 Aug 2026 (estimated)
- Primary completion3 Jan 2027 (estimated)
- Study completion7 Feb 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.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Puja Bharat Gandhi, The University of Texas Health Science Center, Houston
- Investigators
- Puja B Gandhi, MD, MPH, DipABLM, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698509
- Sponsor's protocol ID
- HSC-MS-26-0577
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Scalable, Lifestyle Medicine Intervention for Hypertension Using Virtual Group Shared Medical Appointments
- ClinicalTrials.gov ID
- NCT07698509
- Acronym / sponsor ID
- HSC-MS-26-0577
- Conditions
- Hypertension
- Keywords
- high blood pressure, Lifestyle medicine shared medical appointments (LMSMAs)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 3 Aug 2026 (estimated)
- Primary completion
- 3 Jan 2027 (estimated)
- Study completion
- 7 Feb 2027 (estimated)
- First posted
- 13 Jul 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.
The purpose of this study is to learn whether virtual Lifestyle medicine shared medical appointments (LMSMAs) can help people better manage their blood pressure and improve their overall health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Medicine Virtual Group Visit Program plus usual medical care | Experimental | Behavioral: Lifestyle Medicine Virtual group, Behavioral: Usual Care Group |
| Usual medical care only | Active comparator | Behavioral: Usual Care Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current diagnosis of hypertension (ICD codes I10.0-I14.0 billed within the last 5 years Essential HTN, Essential HTN, Primary HTN)
- Currently receives care at a UTPhysicians; Last seen by a PCP at Victory location within the last 1 year.
- Able to participate in a virtual format
- Willingness to participate and engage in home blood pressure monitoring
Key exclusion criteria (8 listed)
- Unstable cardiovascular disease (recent Myocardial Infarction (MI), unstable angina, decompensated HF)
- Advanced Chronic kidney disease (CKD) (eGFR < 30) without nephrology co-management
- Active cancer treatment
- Severe cognitive impairment (unable to engage)
- Uncontrolled psychiatric illness (e.g., active psychosis)
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 Medicine Virtual groupParticipants will be given a home BP monitor upon enrollment and the group will engage in twice monthly virtual shared medical appointments (vSMAs) for 4 visits. Prior to each visit, participants will be asked to complete home BP monitoring (twice in the morning and twice in the evening for 3 days before visit), with readings reviewed during visits and medications adjusted as clinically indicated. Participants will complete four sessions over an 8-week period, with one session type offered in each 2 week block. | Behavioural | Lifestyle Medicine Virtual Group Visit Program plus usual medical care |
| Usual Care GroupParticipants will be given a home BP monitor upon enrollment and will be instructed by phone and with an electronic health record (EHR) portal message on proper technique for home BP readings. Participants will continue to have follow-up visits with their PCP as clinically indicated. | Behavioural | Lifestyle Medicine Virtual Group Visit Program plus usual medical care, Usual medical care only |
Primary outcome
Change in diastolic blood pressure readings
Time frame: 2-4 weeks after randomization,6 months after randomization
Change in systolic blood pressure readings
Time frame: 2-4 weeks after randomization,6 months after randomization
5 secondary outcomes
Percentage of eligible participants who agree to participate
Time frame: end of study (6 months after randomization)
Number of primary care physicians (PCPs) whose patients are included in the program
Time frame: end of study (6 months after randomization)
Median number of sessions attended by each participant
Time frame: end of study (6 months after randomization)
Adherence as assessed by the number of of blood pressure (BP) readings submitted between each session
Time frame: end of study (6 months after randomization)
Adherence to home BP monitoring as assessed by the number of of home BP sessions submitted between each session
Time frame: end of study (6 months after randomization)
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 13 Jul 2026.
- 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.
Puja B Gandhi, MD, MPH, DipABLM principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Medicine Virtual group in people with Hypertension, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 8 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 13 Jul 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 United States. 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?
Contact Puja B Gandhi, MD, MPH, DipABLM ((713) 500-6714, Puja.Gandhi@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in diastolic blood pressure readings (time frame: 2-4 weeks after randomization,6 months after randomization). 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 13 Jul 2026.