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Physical ActivityNCT07342543

Guided Physical Activity Counseling for Hypertension in Primary Care

A study testing Physical activity counseling in people with Physical Activity and Hypertension, run by University of California, San Diego.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this study is to create easy-to-read physical activity reports and counseling guides for primary care doctors. These tools will use activity data collected over time from wearable fitness trackers. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Physical Activity, Hypertension, Prehypertension
What is being tested?
Physical activity counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
No sites listed yet
Study dates
1 Oct 2026to 1 Jan 2031
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Currently work for UC San Diego Health, with a primary appointment in one of the eight primary care clinics
  • Conduct ambulatory care visits for blood pressure management with at least 20 patients with a diagnosis of pre- or stage 1 hypertension
  • Have received a diagnosis of pre- or stage 1 hypertension, and/or having SBP 120-139, DBP <89
  • be receiving care from one of the enrolled providers
  • be currently engaging in <150 minutes/week of at least moderate intensity exercise (see below)
  • be between age 18 and 80 years
  • not currently taking anti-hypertensive medication
  • able to read, speak, and understand English.

Who cannot join

  • planning to leave UCSD Health in the next 18 months
  • participated in the co-design workshops to design the PACE system
  • being unwilling to be randomized to one of the three conditions.
  • any condition that would contraindicate unsupervised exercise as determined by their provider, such as severe cardiovascular or pulmonary disease limiting exercise tolerance
  • plans to change healthcare providers within the next two months
  • planned surgery or procedure that could impact mobility within the next five months
  • pregnancy.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Britta Larsen, PhD contact

858-534-8429

blarsen@health.ucsd.edu

About this study

The goal of this study is to create easy-to-read physical activity reports and counseling guides for primary care doctors. These tools will use activity data collected over time from wearable fitness trackers. The study will also test how helpful and easy the system is for doctors when talking with patients who have high blood pressure. This approach uses technology that already exists and helps solve problems that make it hard to use in medical care. It also has the potential to reach many people and be low-cost for clinics to use.

Read the detailed description

There is robust evidence that adopting regular moderate-to-vigorous physical activity (MVPA) can improve blood pressure and reduce CVD risk in patients with hypertension. Accordingly, MVPA counseling is considered first line treatment for patients with pre- and stage 1 hypertension, though rates of counseling in ambulatory care visits for hypertension management remain low. Some health systems have begun incorporating data from wearable activity trackers (e.g., Fitbits) into electronic health records (EHR) to facilitate MVPA counseling, but it is unclear whether sharing these data with providers will change ambulatory care visits or patient behavior. Clinicians have reported myriad barriers to incorporating this technology into clinical care, including that reviewing data takes too much time, is not standardized, takes expertise they do not have, and there is often too much data to be useful. In addition to summarized data, providers may need guidance in how to interpret it, use evidence-based counseling practices, and suggest behavior change strategies based on patients' unique barriers. In the current proposal, investigators will conduct a 3-arm randomized trial to test the efficacy of an expert software system to interpret data from wearables for providers and generate tailored counseling scripts for them incorporating evidence-based communication strategies for primary care. The study team will recruit N=30 primary care providers from UC San Diego primary care clinics and N=300 of their patients with pre- and stage 1 hypertension (PS1H). All patients will receive a wearable Fitbit activity tracker to wear in the 4-6 weeks preceding an ambulatory care visit for PS1H management. Providers will be randomized to receive 1) algorithm-driven counseling guides in EHR with summarize data and tailored counseling scripts based on patient activity levels and barriers (intervention), 2) only summarized data from wearables integrated into EHR (comparison), or 3) no access to patient Fitbit data (control). Patients will continue to wear trackers continuously for 3 months following their ambulatory care visit, and will take at-home blood pressure readings monthly. Investigators hypothesize that patients whose providers are randomized to receive the expert system summary reports will show greater increases in MVPA following ambulatory care visits than those whose providers receive only summarized data and patients in the control group. The study team will also evaluate effects of the counseling guides on blood pressure, doctor-patient communication, and clinical workflow by using time stamps in EHR to estimate visit length. Investigators will also evaluate provider satisfaction with the system through questionnaires and interviews. This study will advance intervention science by creating an intervention tool for providers that has potential for low-cost implementation across a wide range of clinical settings. This will capitalize on the rich data that are increasingly generated by consumer wearables in clinical populations while addressing critical barriers to incorporating this data into clinical care.

Being tested
Physical activity counseling
Keywords
primary care, physical activity counseling, fitness tracker, physical activity, prehypertension, stage 1 hypertension
Medical subject headings
Motor Activity, Hypertension, Prehypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical activity counselingBehavioural

    The personalized data system will use physical activity data from Fitbits to create summary system reports that will guide brief discussions between providers and patients regarding PA during clinic visits. To facilitate discussion, tailored guides for providers randomly assigned to the Intervention Arm will include each of the following elements: a) a visual summary of mean weekly minutes of MVPA over the past 4-6 weeks, b) whether they are meeting clinical guidelines of 150 minutes/week, c) whether their minutes are increasing, decreasing, or generally remaining the same, d) a script for performance feedback, e) questions tailored to whether the patient is increasing or decreasing their activity, f) a script to discuss an appropriate BCT through the lens of shared decision making, and g) a prompt to review the plan. The plan summary will be incorporated in the patient's after visit summary.

Study groups in NCT07342543
Study groupRoleWhat they receive
Physical Activity Counseling GuideExperimentalProviders randomized to this group will provide physical activity counseling to patients based on their wearable fitness tracker data. Counseling will be guided by an online tool that synthesizes the patient's unique data and provides effective counseling prompts based on the data.
Receives: Behavioral: Physical activity counseling
Standard of careNo interventionProviders randomized to this group will provide patients with the standard of care for physical activity counseling.
Comparison: Fitbit Data OnlyNo interventionProviders randomly assigned to this group will have access to patients' Fitbit data but will not be provided with activity counseling prompts.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Physical Activity Minutes Measured by Fitbit

    Change in physical activity minutes measured by wrist-worn Fitbits in patients who that are assigned to providers receiving the PACE Guides during ambulatory care visits (intervention group) compared to those seeing providers in the comparison or control groups.

    Measured: 4 months

Secondary outcomes (20)
  1. Height in centimeters

    Height in cm

    Measured: Recorded at ambulatory care visit (4-6 weeks post-enrollment)

  2. Medication Use

    Use and dose of medications per medical record

    Measured: 4 months

  3. Blood Pressure (at-home)

    Patients will be sent an Omron M10-IT blood pressure cuff for monthly at-home readings. They will be provided with detailed instructions and a link to an AHA video demonstrating proper measurement. Participants will measure BP twice, one minute apart, in a seated position after 5 minutes of rest. They will be instructed to measure at the same time of day each month, and to avoid caffeine or physical activity immediately before measurement. Readings will be shared via Bluetooth and recorded in a log.

    Measured: 4 months

  4. Demographics (Patient)

    Age, race, ethnicity, education, income, marital status

    Measured: Enrollment

  5. Rate Your Plate

    a 24-item tool capturing information regarding fat intake, animal and dairy protein, fruit, vegetables, whole grains, snacks, and sweets.

    Measured: 4 months

  6. Social Support for Exercise (SSE)

    Questionnaire measuring social support specifically in relation to exercise with three subscales (friends, family, rewards/punishments)

    Measured: 4 months

  7. Self-Efficacy for Physical Activity (SE)

    Questionnaire measuring confidence to become physically active across diverse contexts

    Measured: 4 months

  8. Center for Epidemiologic Studies Depression Scale (CES-D)

    20-item self reported questionnaire designed to measure depressive symptoms, with higher scores indicating possible depression

    Measured: 4 months

  9. Perceived Stress Scale (PSS)

    A 10-item scale used to assess stress levels with higher scores indicating greater perceived stress

    Measured: 4 months

  10. Pittsburgh Sleep Quality Index

    Questionnaire used to measure sleep quality

    Measured: 4 months

  11. After-visit Questionnaire

    Assesses which topics were discussed during provider visit, including physical activity, goals, behavior change techniques, wearable tracker data, etc.

    Measured: immediately following ambulatory care visit in clinic (4-6 weeks post-enrollment)

  12. Communication and Shared Decision Making

    the CollaboRATE questionnaire measuring patient experience of care, plus the facilitation subscale of the Perceived Involvement in Care scale

    Measured: immediately following ambulatory care visit in clinic (4-6 weeks post enrollment)

  13. Fitbit Adherence

    % of days Fitbit worn, % of days Fitbit synced within 5 days

    Measured: 4 months

  14. Clinical Workflow

    Timestamped user access logs in Epic to approximate visit lengths to assess if using the physical activity counseling guides impacts total visit timed

    Measured: 2 months

  15. Consumer Satisfaction Questionnaire (Provider)

    Assess overall satisfaction/acceptability and suggestions for improvement (intervention arm only)

    Measured: 18-36 months post-enrollment

  16. Follow-up Interview (Provider)

    A brief 20-minute interview to share experiences with the physical activity counseling guides (intervention arm) or summarized wearable data (comparison arm), and give suggestions for increased efficacy and usability

    Measured: 18-36 months post-enrollment

  17. Demographics (Provider)

    Age, sex, provider type/degree, specialty, years in clinical practice

    Measured: At enrollment

  18. Weight in kg

    Weight measured in kilograms

    Measured: Recorded at ambulatory care visit (4-6 weeks post-enrollment)

  19. Resting blood pressure in clinic

    Blood pressure in mm Hg as measured in clinic

    Measured: Recorded at ambulatory care visit (4-6 weeks post-enrollment)

  20. Medication adherence

    Medication Adherence Report Scale (MARS-5) is a 5-item questionnaire to assess self-reported adherence to medical regimens with higher scores indicating better adherence

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion1 Sep 2030 (estimated)
  4. Study completion1 Jan 2031 (estimated)

Resources

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07342543
Sponsor's protocol ID
811759
Status last verified
Jan 2026
First submitted
12 Jan 2026
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All quantitative data produced in the course of the project will be preserved and shared. Transcripts from stakeholder interviews will be shared only in the event that they give permission for the entire transcript to be shared; otherwise, summaries and codebooks will be shared.

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity counseling in people with Physical Activity and Hypertension, run by University of California, San Diego.

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 8 inclusion and 7 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 15 Jan 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 Britta Larsen, PhD (858-534-8429, blarsen@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Physical Activity Minutes Measured by Fitbit (time frame: 4 months). 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 15 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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