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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Physical Activity, Hypertension, Prehypertension, Hypertension Grade I, Subgroup "Borderline" (WHO)
- 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 group | Role | What they receive |
|---|---|---|
| Physical Activity Counseling Guide | Experimental | Providers 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 care | No intervention | Providers randomized to this group will provide patients with the standard of care for physical activity counseling. |
| Comparison: Fitbit Data Only | No intervention | Providers 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.
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)
Height in centimeters
Height in cm
Measured: Recorded at ambulatory care visit (4-6 weeks post-enrollment)
Medication Use
Use and dose of medications per medical record
Measured: 4 months
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
Demographics (Patient)
Age, race, ethnicity, education, income, marital status
Measured: Enrollment
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
Social Support for Exercise (SSE)
Questionnaire measuring social support specifically in relation to exercise with three subscales (friends, family, rewards/punishments)
Measured: 4 months
Self-Efficacy for Physical Activity (SE)
Questionnaire measuring confidence to become physically active across diverse contexts
Measured: 4 months
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
Perceived Stress Scale (PSS)
A 10-item scale used to assess stress levels with higher scores indicating greater perceived stress
Measured: 4 months
Pittsburgh Sleep Quality Index
Questionnaire used to measure sleep quality
Measured: 4 months
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)
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)
Fitbit Adherence
% of days Fitbit worn, % of days Fitbit synced within 5 days
Measured: 4 months
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
Consumer Satisfaction Questionnaire (Provider)
Assess overall satisfaction/acceptability and suggestions for improvement (intervention arm only)
Measured: 18-36 months post-enrollment
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
Demographics (Provider)
Age, sex, provider type/degree, specialty, years in clinical practice
Measured: At enrollment
Weight in kg
Weight measured in kilograms
Measured: Recorded at ambulatory care visit (4-6 weeks post-enrollment)
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)
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.
- First posted15 Jan 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Britta Larsen, University of California, San Diego
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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Physical Activity Counseling for Hypertension in Primary Care
- ClinicalTrials.gov ID
- NCT07342543
- Acronym / sponsor ID
- 811759
- Conditions
- Physical Activity, Hypertension, Prehypertension, Hypertension Grade I, Subgroup "Borderline" (WHO)
- Keywords
- primary care, physical activity counseling, fitness tracker, physical activity, prehypertension, stage 1 hypertension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 15 Jan 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 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Counseling Guide | Experimental | Behavioral: Physical activity counselingProviders 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. |
| Standard of care | No intervention | –Providers randomized to this group will provide patients with the standard of care for physical activity counseling. |
| Comparison: Fitbit Data Only | No intervention | –Providers randomly assigned to this group will have access to patients' Fitbit data but will not be provided with activity counseling prompts. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Physical activity counselingThe 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. | Behavioural | Physical Activity Counseling Guide |
Primary outcome
Change in Physical Activity Minutes Measured by Fitbit
Time frame: 4 months
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.
20 secondary outcomes
Height in centimeters
Time frame: Recorded at ambulatory care visit (4-6 weeks post-enrollment)
Medication Use
Time frame: 4 months
Blood Pressure (at-home)
Time frame: 4 months
Demographics (Patient)
Time frame: Enrollment
Rate Your Plate
Time frame: 4 months
Social Support for Exercise (SSE)
Time frame: 4 months
Self-Efficacy for Physical Activity (SE)
Time frame: 4 months
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 4 months
Perceived Stress Scale (PSS)
Time frame: 4 months
Pittsburgh Sleep Quality Index
Time frame: 4 months
After-visit Questionnaire
Time frame: immediately following ambulatory care visit in clinic (4-6 weeks post-enrollment)
Communication and Shared Decision Making
Time frame: immediately following ambulatory care visit in clinic (4-6 weeks post enrollment)
Fitbit Adherence
Time frame: 4 months
Clinical Workflow
Time frame: 2 months
Consumer Satisfaction Questionnaire (Provider)
Time frame: 18-36 months post-enrollment
Follow-up Interview (Provider)
Time frame: 18-36 months post-enrollment
Demographics (Provider)
Time frame: At enrollment
Weight in kg
Time frame: Recorded at ambulatory care visit (4-6 weeks post-enrollment)
Resting blood pressure in clinic
Time frame: Recorded at ambulatory care visit (4-6 weeks post-enrollment)
Medication adherence
Time frame: 4 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 15 Jan 2026.
- Individual participant dataSharing planned: 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.
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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 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.