Guided Physical Activity Counseling for Hypertension in Primary Care

Sponsor
University of California, San Diego
Study ID
NCT07342543
Status
Not Yet Recruiting

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Conditions

  • Hypertension
  • Hypertension Grade I, Subgroup "Borderline" (WHO)
  • Physical Activity
  • Prehypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Physical activity counseling — BEHAVIORAL
    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 Details

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.

Key Dates

First listed
Jan 15, 2026
Start date
Oct 1, 2026
Status verified
Jan 2026
Primary completion
Sep 1, 2030
Completion
Jan 1, 2031

Study Design

Enrollment
330 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Physical Activity Counseling Guide
    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.
  • No Intervention: Standard of care
    Providers randomized to this group will provide patients with the standard of care for physical activity counseling.
  • No Intervention: Comparison: Fitbit Data Only
    Providers randomly assigned to this group will have access to patients' Fitbit data but will not be provided with activity counseling prompts.

Primary Outcome Measure

Change in Physical Activity Minutes Measured by Fitbit [ Time Frame: 4 months ]

Central Contacts

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