Guided Physical Activity Counseling for Hypertension in Primary Care

NCT07342543 | Not Yet Recruiting

• 1 other identifier: 811759
• Study Type: interventional
• Target: 330
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (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.

  4 months

Secondary Outcomes (20)

• Height in centimeters

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

• Medication Use

  4 months

• Blood Pressure (at-home)

  4 months

• Demographics (Patient)

  Enrollment

• Rate Your Plate

  4 months

Study Arms (3)

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.

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.

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.

Physical Activity Counseling Guide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of California, San Diego: lead

MeSH Terms

Conditions

Motor Activity; Hypertension; Prehypertension

Condition Hierarchy (Ancestors)

Behavior; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Britta Larsen, PhD

CONTACT

858-534-8429; blarsen@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 15, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): January 1, 2031
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.