- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07698509
Virtual Lifestyle Medicine Group Visits for High Blood Pressure
July 6, 2026 updated by: Puja Bharat Gandhi, The University of Texas Health Science Center, Houston
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Puja B Gandhi, MD, MPH, DipABLM
- Phone Number: (713) 500-6714
- Email: Puja.Gandhi@uth.tmc.edu
Study Contact Backup
- Name: Natalia Williams
- Phone Number: (713) 486-3844
- Email: Natalia.Williams@uth.tmc.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
-
Contact:
- Puja B Gandhi, MD, MPH, DipABLM
- Phone Number: (713) 500-6714
- Email: Puja.Gandhi@uth.tmc.edu
-
Contact:
- Natalia Williams
- Phone Number: (713) 486-3844
- Email: Natalia.Williams@uth.tmc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lifestyle Medicine Virtual Group Visit Program plus usual medical care
|
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.
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.
|
|
Active Comparator: Usual medical care only
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in diastolic blood pressure readings
Time Frame: 2-4 weeks after randomization,6 months after randomization
|
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
|
2-4 weeks after randomization,6 months after randomization
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of eligible participants who agree to participate
Time Frame: end of study (6 months after randomization)
|
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)
|
end of study (6 months after randomization)
|
|
Median number of sessions attended by each participant
Time Frame: end of study (6 months after randomization)
|
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)
|
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)
|
end of study (6 months after randomization)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Puja B Gandhi, MD, MPH, DipABLM, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 3, 2026
Primary Completion (Estimated)
January 3, 2027
Study Completion (Estimated)
February 7, 2027
Study Registration Dates
First Submitted
July 6, 2026
First Submitted That Met QC Criteria
July 6, 2026
First Posted (Actual)
July 13, 2026
Study Record Updates
Last Update Posted (Actual)
July 13, 2026
Last Update Submitted That Met QC Criteria
July 6, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-MS-26-0577
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
Franz Rischard, DOAcceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway...Not yet recruitingPulmonary Hypertension | Pulmonary Arterial Hypertension (PAH)United States
-
BackBeat Medical IncNot yet recruitingHypertension, Systolic | Hypertension (HTN) | Heart Failure With Preserved Ejection Fraction (HFpEFGeorgia
-
Abant Izzet Baysal UniversityNot yet recruitingPRIMARY HYPERTENSIONTurkey (Türkiye)
-
SingHealth PolyclinicsNanyang PolytechnicEnrolling by invitationHypertension,EssentialSingapore
-
Hacettepe UniversityBozok UniversityCompletedHypertension | Arterial Hypertension | Systemic HypertensionTurkey (Türkiye)
-
Xuanwu Hospital, BeijingNot yet recruiting
-
Shenzhen Salubris Pharmaceuticals Co., Ltd.Not yet recruiting
-
Instituto de Cardiologia do Rio Grande do SulCompletedHypertension (HTN) | Hypertension ArterialBrazil
Clinical Trials on Lifestyle Medicine Virtual group
-
MaineHealthEnrolling by invitation
-
Chinese University of Hong KongRecruiting
-
University of California, Los AngelesHealth Resources and Services Administration (HRSA)Not yet recruitingStress | Autism | Cardiovascular (CV) Risk | Adverse Childhood Experience
-
Chinese University of Hong KongNot yet recruiting
-
Chinese University of Hong KongUniversity of Melbourne; University of Western SydneyUnknown
-
Chinese University of Hong KongThe University of Hong Kong; The Hong Kong Polytechnic University; University... and other collaboratorsUnknown
-
Scripps Center for Integrative MedicineUnknown
-
Northern Ontario School of MedicineRecruitingHeart Diseases | Hypertension | Obesity | Diabetes | High CholesterolCanada
-
Chinese University of Hong KongNot yet recruiting
-
Chinese University of Hong KongUnknown