An interventional study of FitBit in Hypertension, Cardiovascular Risk Factor and Physical Activity, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 8 Years to 30 Years. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention
Among 33 studies in Hypertension by University of California, San Francisco — 5 open to participants now, 7 under way, none of them phase 3. Hypertension · University of California, San Francisco.
Among the 33 studies in Hypertension by University of California, San Francisco, this one is the 26th largest by enrollment of the 32 interventional ones that give a count, is one of 4 that started in 2017, is one of 28 with no phase, and was the 14th registered.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
Browse Hypertension studies →5 of the 33 studies in Hypertension by University of California, San Francisco are open now, in 2 countries. Recruiting first, the newest first:
University of California, San Francisco · Sites in United States
Ages 18+
University of California, San Francisco · Sites in United States
Ages 40+
University of California, San Francisco · Sites in United States
Ages 60+
University of California, San Francisco · Sites in United States
Ages 18+
University of California, San Francisco · Sites in Kenya
Ages 40+
By country, each count listing its studies:
Of the 564 Hypertension studies recruiting now, 266 (47%) set no upper age limit and 200 (35%) stop at 75 or younger; 40 take children under 18; 138 take healthy volunteers.
This study: 8 Years to 30 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
33 studies; the count open now beside each. This study's row is marked.
First in 1986; this study’s year is marked. 4 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 63 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.
Median enrollment 463 across the 32 interventional studies, 150 across the 1 observational. Of the 25 that completed or were terminated, 8 (32%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
4 of the studies in Hypertension by University of California, San Francisco that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04715568University of California, San FranciscoSecondhand Tobacco Smoke and Cardiovascular Disease | 2026-12-31 |
| NCT07469995University of California, San FranciscoThe Effect of Grocery Support Dose on Food Insecurity and Disease Control Among Covered California Members With Diabetes or Hypertension | 2027-04-30 |
| NCT07910773University of California, San FranciscoGuiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial | 2027-06 |
| NCT06871462University of California, San FranciscoImplementation Strategies for Self-Measured Blood Pressure Monitoring in Racially and Ethnically Diverse Populations | 2027-11-01 |
Among the 33 studies in Hypertension by University of California, San Francisco, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The study aims to determine if use of physical activity trackers coupled with provider feedback will increase awareness of young adults of their physical fitness and improve blood pressure levels. The goal of this pilot study is feasibility, with a secondary goal of examining potential effect sizes for planning purposes for a larger randomized controlled trial.
Increasing physical activity levels may improve cardiovascular health and BP levels in young individuals, especially if such strategies promote healthy lifestyles. Physical activity is currently recommended for adults CV health, but physical activity levels are known to be low in populations with diabetes or chronic kidney disease. One prior study of the use of pedometers (not associated with wireless technology or provider feedback) in children with CKD did not significantly improve physical activity levels. Supervised walking appeared to provide some benefit in individuals with type II diabetes, but overall compliance was poor. Interview of adolescents and young adults with chronic illnesses has shown preference for the use of electronic devices and online tools for disease management.Thus, use of sophisticated electronic devices such as FitBits© (wireless pedometers worn on the wrist that sync with cell phones) may improve disease control by engaging young patients in self-monitoring of their own health and lifestyle behaviors. This pilot study aims to determine if use of FitBits© coupled with provider feedback will increase awareness of young adults of their physical fitness and improve blood pressure levels.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No physical activity tracker or feedback x 6 months, then crossover to physical activity tracker x 6 months
Physical activity tracker x 12 months (6 months with study feedback and 6 months without)
Device: FitBit
Daily use of physical activity tracker coupled with biweekly provider telemonitoring and feedback for 6 months and then additionally without feedback for an additional 6 months
Also known as: physical activity tracker
Change in Mean Office Systolic BP
Change in mean systolic BP is modeled using all blood pressure data points collected between baseline and month 12 to provide an average change over time, accounting for repeated values from patients using a mixed linear regression approach.
Time frame: Between baseline and month 12
Change in Mean Office Systolic BP
Change in mean systolic BP using blood pressure data points collected between baseline and month 6 to provide an average change over time
Time frame: Between baseline and month 6
Number of Participants Retained
Rate of study participant retention
Time frame: Months 0-12
Change in Weight (Z-score)
Weights were measured in clinic using a standardized scale. Z score of 0 represents the population mean. A z-score of +1.96 represents the 95th percentile of weight and -1.96 represents the 5th percentile of weight. Change in weight (z-score) is modeled using all weight data points collected between baseline and month 12 to provide an average change over time accounting for repeated values from patients using a mixed linear regression approach.
Time frame: Months 0-12
| Milestone | Usual Care | Physical Activity Tracker |
|---|---|---|
| Started | 21 | 42 |
| Completed | 11 | 18 |
| Not completed | 10 | 24 |
Change in mean systolic BP is modeled using all blood pressure data points collected between baseline and month 12 to provide an average change over time, accounting for repeated values from patients using a mixed linear regression approach.
| mmHg | Usual Care | Physical Activity Tracker |
|---|---|---|
| Change in Mean Office Systolic BP | 0.3 (-10 to 10) | -4 (-14 to 6) |
Rate of study participant retention
| Participants | Usual Care Arm | Intervention Arm |
|---|---|---|
| Number of Participants Retained | 11 | 18 |
Weights were measured in clinic using a standardized scale. Z score of 0 represents the population mean. A z-score of +1.96 represents the 95th percentile of weight and -1.96 represents the 5th percentile of weight. Change in weight (z-score) is modeled using all weight data points collected between baseline and month 12 to provide an average change over time accounting for repeated values from patients using a mixed linear regression approach.
| Z-score | Usual Care | Physical Activity Tracker |
|---|---|---|
| Change in Weight (Z-score) | -0.20 (-0.34 to -0.07) | -0.06 (-0.17 to 0.05) |
Change in mean systolic BP using blood pressure data points collected between baseline and month 6 to provide an average change over time
| mmHg | Usual Care | Physical Activity Tracker |
|---|---|---|
| Change in Mean Office Systolic BP | 3.0 (-2.5 to 8.4) | -2.3 (-6.5 to 1.8) |
Collected over Participants were followed during participation in the study for 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care Arm (mo. 0-6) | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Usual Care Arm (mo. 6-12) | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Intervention Arm | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Age, Continuous(years) | Usual Care Arm | Intervention Arm | Total |
|---|---|---|---|
| Mean | 18.0 ± 4.4 | 17.6 ± 3.9 | 17.7 ± 4.0 |
| Sex: Female, Male(Participants) | Usual Care Arm | Intervention Arm | Total |
|---|---|---|---|
| Female | 12 | 15 | 27 |
| Male | 9 | 27 | 36 |
| Ethnicity (NIH/OMB)(Participants) | Usual Care Arm | Intervention Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 11 | 19 | 30 |
| Not Hispanic or Latino | 10 | 23 | 33 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Usual Care Arm | Intervention Arm | Total |
|---|---|---|---|
| United States | 21 | 42 | 63 |
| Estimated glomerular filtration rate(mL/min/1.73 m^2) | Usual Care Arm | Intervention Arm | Total |
|---|---|---|---|
| Mean | 81 ± 35 | 81 ± 25 | 81 ± 28 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2017 to primary completion in Jan 2021, 43 months.
Results were first posted in Jul 2022, 1 year 6 months after primary completion.
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 43 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 completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco →