An interventional study of Physical activity counseling in Physical Activity, Hypertension and Prehypertension, sponsored by University of California, San Diego. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Prevention
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.
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 330 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.
Compared within Hypertension, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Inclusion Criteria for Providers:
Inclusion Criteria for Patients:
Exclusion Criteria for Providers:
Exclusion Criteria for Patients:
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.
Behavioral: Physical activity counseling
Providers randomized to this group will provide patients with the standard of care for physical activity counseling.
Providers randomly assigned to this group will have access to patients' Fitbit data but will not be provided with activity counseling prompts.
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.
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.
Time frame: 4 months
Height in centimeters
Height in cm
Time frame: Recorded at ambulatory care visit (4-6 weeks post-enrollment)
Medication Use
Use and dose of medications per medical record
Time frame: 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.
Time frame: 4 months
Demographics (Patient)
Age, race, ethnicity, education, income, marital status
Time frame: Enrollment
Rate Your Plate
a 24-item tool capturing information regarding fat intake, animal and dairy protein, fruit, vegetables, whole grains, snacks, and sweets.
Time frame: 4 months
Social Support for Exercise (SSE)
Questionnaire measuring social support specifically in relation to exercise with three subscales (friends, family, rewards/punishments)
Time frame: 4 months
Self-Efficacy for Physical Activity (SE)
Questionnaire measuring confidence to become physically active across diverse contexts
Time frame: 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
Time frame: 4 months
Perceived Stress Scale (PSS)
A 10-item scale used to assess stress levels with higher scores indicating greater perceived stress
Time frame: 4 months
Pittsburgh Sleep Quality Index
Questionnaire used to measure sleep quality
Time frame: 4 months
After-visit Questionnaire
Assesses which topics were discussed during provider visit, including physical activity, goals, behavior change techniques, wearable tracker data, etc.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2 months
Consumer Satisfaction Questionnaire (Provider)
Assess overall satisfaction/acceptability and suggestions for improvement (intervention arm only)
Time frame: 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
Time frame: 18-36 months post-enrollment
Demographics (Provider)
Age, sex, provider type/degree, specialty, years in clinical practice
Time frame: At enrollment
Weight in kg
Weight measured in kilograms
Time frame: Recorded at ambulatory care visit (4-6 weeks post-enrollment)
Resting blood pressure in clinic
Blood pressure in mm Hg as measured in clinic
Time frame: 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
Time frame: 4 months
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Shared data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 7 years after the end of the funding period.
Access criteria: The Larsen USCD data provides metadata, persistent identifiers and long-term access. This repository is supported by USCD and dataset(s) are available through a request process directly with the PI, Dr. Larsen.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Sep 2030, 47 months later.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 47 months is above that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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