HypertensionNCT03969056
AI Activity Study in Patients With Elevated Blood Pressure
A study testing Artificial Intelligence (AI) Activity and 10,000 steps in people with Hypertension, run by University of California, San Francisco at 1 site in United States.
Trial summary
In this pilot RCT, a total of 40 adults with hypertension will be randomized to either an artificial intelligence (AI) physical activity intervention group or an active control group with a 1 to 1 ratio after completing a 2-week run-in period and 4-week training. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Artificial Intelligence (AI) Activity and 10,000 steps
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2020to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥18 years
- systolic blood pressure between 130 mmHg to 180 mmHg or/and diastolic blood *pressure between 80 to 100 mmHg in a research office
- speaking and reading English
- being physically inactive at work or during leisure time and willing to be physically active
- having an iPhone 8 or newer or an Android Lollipop or newer
Who cannot join
- self-reported diagnosis of coronary heart disease, medical condition or other physical problem necessitating special attention in an exercise program (e.g., cancer, eating disorder, uncontrolled diabetes)
- current participation in a lifestyle modification program or research study
- self-report of being currently pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94118
About this study
Official title: Applying Artificial Intelligence to a Physical Activity Intervention in Patients With Elevated Blood Pressure- a Pilot Randomized Controlled Trial
In this pilot RCT, a total of 40 adults with hypertension will be randomized to either an artificial intelligence (AI) physical activity intervention group or an active control group with a 1 to 1 ratio after completing a 2-week run-in period and 4-week training. The AI intervention group will receive an automated and personalized daily step goal intervention involving a sophisticated activity analytics algorithm using advanced statistics and machine learning, while the active control group will receive a standardized and fixed 10,000 daily steps goal. Both groups will receive an identical smartphone app (app content differs between the two groups) and ActiGraph GT9X Link to assess objectively measured physical activity (primary outcome) during the study period.
- Conditions
- Hypertension
- Being tested
- Artificial Intelligence (AI) Activity, 10,000 steps
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence (AI) ActivityBehavioural
The intervention provides participants with an automated and personalized daily step goal intervention involving a sophisticated activity analytics algorithm using advanced statistics and machine learning.
10,000 stepsBehavioural
The intervention provides participants with an automated daily 10,000 step goal intervention
| Study group | Role | What they receive |
|---|---|---|
| Artificial Intelligence (AI) Activity group | Experimental | Participants in this group receive an AI based intervention (automated and personalized daily step goal intervention involving a sophisticated activity analytics algorithm using advanced statistics and machine learning and message) Receives: Behavioral: Artificial Intelligence (AI) Activity |
| Control group | Active comparator | Participants in this group receive a standardized and fixed 10,000 daily steps goal intervention. Receives: Behavioral: 10,000 steps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in weekly daily average steps
measured by ActiGraph GT9X Link]
Measured: Baseline (run-in period), 4 week-test period, and 3-month intervention period
Duration (minutes) of moderate to vigorous intensity physical activity (MVPA) per day
measured by ActiGraph GT9X Link]
Measured: Baseline (run-in period), 4 week-test period, and 3-month intervention period
Secondary outcomes (6)
Changes in Systolic blood pressure (SBP)
Measured: Baseline (run-in period), 4 week-test period, and 3-month intervention period
Changes in diastolic blood pressure (DBP)
Measured: Baseline (run-in period), 4 week-test period, and 3-month intervention period
aortic stiffness
measured by SphigmoCor XCEL system
Measured: Baseline (run-in period), 4 week-test period, and 3-month intervention period
sodium intake
as measured in 24-hour urine samples
Measured: Baseline (run-in period), 4 week-test period, and 3-month intervention period
Changes in weight
Measured: Baseline (run-in period), 4 week-test period, and 3-month intervention period
Changes in Body Mass Index (BMI)
using weight and height to calculate
Measured: Baseline (run-in period), 4 week-test period, and 3-month intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start6 Feb 2020
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Why it stopped: Due to the COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoshimi Fukuoka, PhD, RN, FAAN, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969056
- Sponsor's protocol ID
- 18-26452
- Status last verified
- Dec 2023
- First submitted
- 20 May 2019
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Artificial Intelligence to a Physical Activity Intervention in Patients With Elevated Blood Pressure- a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03969056
- Acronym / sponsor ID
- 18-26452
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the COVID-19 pandemic
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 31 May 2019 (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.
In this pilot RCT, a total of 40 adults with hypertension will be randomized to either an artificial intelligence (AI) physical activity intervention group or an active control group with a 1 to 1 ratio after completing a 2-week run-in period and 4-week training. The AI intervention group will receive an automated and personalized daily step goal intervention involving a sophisticated activity analytics algorithm using advanced statistics and machine learning, while the active control group will receive a standardized and fixed 10,000 daily steps goal. Both groups will receive an identical smartphone app (app content differs between the two groups) and ActiGraph GT9X Link to assess objectively measured physical activity (primary outcome) during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artificial Intelligence (AI) Activity group | Experimental | Behavioral: Artificial Intelligence (AI) ActivityParticipants in this group receive an AI based intervention (automated and personalized daily step goal intervention involving a sophisticated activity analytics algorithm using advanced statistics and machine learning and message) |
| Control group | Active comparator | Behavioral: 10,000 stepsParticipants in this group receive a standardized and fixed 10,000 daily steps goal intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥18 years
- systolic blood pressure between 130 mmHg to 180 mmHg or/and diastolic blood *pressure between 80 to 100 mmHg in a research office
- speaking and reading English
- being physically inactive at work or during leisure time and willing to be physically active
- having an iPhone 8 or newer or an Android Lollipop or newer
Key exclusion criteria (3 listed)
- self-reported diagnosis of coronary heart disease, medical condition or other physical problem necessitating special attention in an exercise program (e.g., cancer, eating disorder, uncontrolled diabetes)
- current participation in a lifestyle modification program or research study
- self-report of being currently pregnant.
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 |
|---|---|---|
| Artificial Intelligence (AI) ActivityThe intervention provides participants with an automated and personalized daily step goal intervention involving a sophisticated activity analytics algorithm using advanced statistics and machine learning. | Behavioural | Artificial Intelligence (AI) Activity group |
| 10,000 stepsThe intervention provides participants with an automated daily 10,000 step goal intervention | Behavioural | Control group |
Primary outcome
Changes in weekly daily average steps
Time frame: Baseline (run-in period), 4 week-test period, and 3-month intervention period
measured by ActiGraph GT9X Link]
Duration (minutes) of moderate to vigorous intensity physical activity (MVPA) per day
Time frame: Baseline (run-in period), 4 week-test period, and 3-month intervention period
measured by ActiGraph GT9X Link]
6 secondary outcomes
Changes in Systolic blood pressure (SBP)
Time frame: Baseline (run-in period), 4 week-test period, and 3-month intervention period
Changes in diastolic blood pressure (DBP)
Time frame: Baseline (run-in period), 4 week-test period, and 3-month intervention period
aortic stiffness
Time frame: Baseline (run-in period), 4 week-test period, and 3-month intervention period
sodium intake
Time frame: Baseline (run-in period), 4 week-test period, and 3-month intervention period
Changes in weight
Time frame: Baseline (run-in period), 4 week-test period, and 3-month intervention period
Changes in Body Mass Index (BMI)
Time frame: Baseline (run-in period), 4 week-test period, and 3-month intervention period
Results and safety
The study was stopped early (reason given: Due to the COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yoshimi Fukuoka, PhD, RN, FAAN principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence (AI) Activity and 10,000 steps in people with Hypertension, run by University of California, San Francisco at 1 site in United States.
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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Due to the COVID-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in weekly daily average steps (time frame: Baseline (run-in period), 4 week-test period, and 3-month intervention period). The study lists 2 primary outcomes in all. 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 20 Dec 2023.