NCT07698509

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
6mo left

Started Aug 2026

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

August 3, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2027

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 6, 2026

Last Update Submit

July 6, 2026

Conditions

Hypertension

Keywords

high blood pressureLifestyle medicine shared medical appointments (LMSMAs)

Outcome Measures

Primary Outcomes (2)

  • Change in diastolic blood pressure readings

    2-4 weeks after randomization,6 months after randomization

  • Change in systolic blood pressure readings

    2-4 weeks after randomization,6 months after randomization

Secondary Outcomes (5)

  • Percentage of eligible participants who agree to participate

    end of study (6 months after randomization)

  • Number of primary care physicians (PCPs) whose patients are included in the program

    end of study (6 months after randomization)

  • Median number of sessions attended by each participant

    end of study (6 months after randomization)

  • Adherence as assessed by the number of of blood pressure (BP) readings submitted between each session

    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

    end of study (6 months after randomization)

Study Arms (2)

Lifestyle Medicine Virtual Group Visit Program plus usual medical care

EXPERIMENTAL
Behavioral: Lifestyle Medicine Virtual groupBehavioral: Usual Care Group

Usual medical care only

ACTIVE COMPARATOR
Behavioral: Usual Care Group

Interventions

Lifestyle Medicine Virtual groupBEHAVIORAL

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.

Lifestyle Medicine Virtual Group Visit Program plus usual medical care
Usual Care GroupBEHAVIORAL

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.

Lifestyle Medicine Virtual Group Visit Program plus usual medical careUsual medical care only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Puja B Gandhi, MD, MPH, DipABLM

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Puja B Gandhi, MD, MPH, DipABLM

CONTACT

(713) 500-6714Puja.Gandhi@uth.tmc.edu

Natalia Williams

CONTACT

(713) 486-3844Natalia.Williams@uth.tmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 13, 2026

Study Start (Estimated)

August 3, 2026

Primary Completion (Estimated)

January 3, 2027

Study Completion (Estimated)

February 7, 2027

Last Updated

July 13, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)