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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | No physical activity tracker or feedback x 6 months, then crossover to physical activity tracker x 6 months | |
| Physical activity tracker | Experimental | Physical activity tracker x 12 months (6 months with study feedback and 6 months without) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FitBit | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Between baseline and month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Retained | Rate of study participant retention | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elaine Ku | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24529535 | Background | Cohen DL, Huan Y, Townsend RR. Home blood pressure monitoring in CKD. Am J Kidney Dis. 2014 May;63(5):835-42. doi: 10.1053/j.ajkd.2013.12.015. Epub 2014 Feb 12. | |
| 17765133 | Background | Logan AG, McIsaac WJ, Tisler A, Irvine MJ, Saunders A, Dunai A, Rizo CA, Feig DS, Hamill M, Trudel M, Cafazzo JA. Mobile phone-based remote patient monitoring system for management of hypertension in diabetic patients. Am J Hypertens. 2007 Sep;20(9):942-8. doi: 10.1016/j.amjhyper.2007.03.020. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Six months of usual care without a device, followed by crossover to use of the physical activity tracker |
| FG001 | Physical Activity Tracker | FitBit: Daily use of physical activity tracker coupled with biweekly provider telemonitoring and feedback for 12 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care Arm | Usual care x 6 months, then crossover to physical activity tracker x 6 months |
| BG001 | Intervention Arm | Physical activity tracker x 12 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | mmHg | Between baseline and month 12 |
|
Participants were followed during participation in the study for 1 year
All-cause mortality Serious adverse events include hospitalizations related to the intervention and/or death
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care Arm (mo. 0-6) | Usual care for months 0-6 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elaine Ku | UCSF | 415-502-7760 | elaine.ku@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 9, 2020 | Apr 5, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D009043 | Motor Activity |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
| D051437 | Renal Insufficiency |
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|
| Months 0-12 |
| 21115879 | Background | Agarwal R, Bills JE, Hecht TJ, Light RP. Role of home blood pressure monitoring in overcoming therapeutic inertia and improving hypertension control: a systematic review and meta-analysis. Hypertension. 2011 Jan;57(1):29-38. doi: 10.1161/HYPERTENSIONAHA.110.160911. Epub 2010 Nov 29. |
| 22439158 | Background | Uhlig K, Balk EM, Patel K, Ip S, Kitsios GD, Obadan NO, Haynes SM, Stefan M, Rao M, Kong Win Chang L, Gaylor J, Iovin RC. Self-Measured Blood Pressure Monitoring: Comparative Effectiveness [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Jan. Report No.: 12-EHC002-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK84604/ |
| 22422539 | Background | Akber A, Portale AA, Johansen KL. Pedometer-assessed physical activity in children and young adults with CKD. Clin J Am Soc Nephrol. 2012 May;7(5):720-6. doi: 10.2215/CJN.06330611. Epub 2012 Mar 15. |
| 25092645 | Background | Mohammed J, Deda L, Clarson CL, Stein RI, Cuerden MS, Mahmud FH. Assessment of habitual physical activity in adolescents with type 1 diabetes. Can J Diabetes. 2014 Aug;38(4):250-5. doi: 10.1016/j.jcjd.2014.05.010. |
| 24648129 | Background | Akber A, Portale AA, Johansen KL. Use of pedometers to increase physical activity among children and adolescents with chronic kidney disease. Pediatr Nephrol. 2014 Aug;29(8):1395-402. doi: 10.1007/s00467-014-2787-6. Epub 2014 Mar 20. |
| 20980426 | Background | Negri C, Bacchi E, Morgante S, Soave D, Marques A, Menghini E, Muggeo M, Bonora E, Moghetti P. Supervised walking groups to increase physical activity in type 2 diabetic patients. Diabetes Care. 2010 Nov;33(11):2333-5. doi: 10.2337/dc10-0877. |
| 23740658 | Background | Applebaum MA, Lawson EF, von Scheven E. Perception of transition readiness and preferences for use of technology in transition programs: teens' ideas for the future. Int J Adolesc Med Health. 2013;25(2):119-25. doi: 10.1515/ijamh-2013-0019. |
| 22089460 | Background | Ting TV, Kudalkar D, Nelson S, Cortina S, Pendl J, Budhani S, Neville J, Taylor J, Huggins J, Drotar D, Brunner HI. Usefulness of cellular text messaging for improving adherence among adolescents and young adults with systemic lupus erythematosus. J Rheumatol. 2012 Jan;39(1):174-9. doi: 10.3899/jrheum.110771. Epub 2011 Nov 15. |
| 24268570 | Background | Takacs J, Pollock CL, Guenther JR, Bahar M, Napier C, Hunt MA. Validation of the Fitbit One activity monitor device during treadmill walking. J Sci Med Sport. 2014 Sep;17(5):496-500. doi: 10.1016/j.jsams.2013.10.241. Epub 2013 Oct 31. |
| 24352797 | Background | James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, LeFevre ML, MacKenzie TD, Ogedegbe O, Smith SC Jr, Svetkey LP, Taler SJ, Townsend RR, Wright JT Jr, Narva AS, Ortiz E. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014 Feb 5;311(5):507-20. doi: 10.1001/jama.2013.284427. |
| 15193909 | Background | Tudor-Locke C, Pangrazi RP, Corbin CB, Rutherford WJ, Vincent SD, Raustorp A, Tomson LM, Cuddihy TF. BMI-referenced standards for recommended pedometer-determined steps/day in children. Prev Med. 2004 Jun;38(6):857-64. doi: 10.1016/j.ypmed.2003.12.018. |
| 15699287 | Background | Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ. Recommendations for blood pressure measurement in humans and experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Circulation. 2005 Feb 8;111(5):697-716. doi: 10.1161/01.CIR.0000154900.76284.F6. |
| 24591341 | Background | Flynn JT, Daniels SR, Hayman LL, Maahs DM, McCrindle BW, Mitsnefes M, Zachariah JP, Urbina EM; American Heart Association Atherosclerosis, Hypertension and Obesity in Youth Committee of the Council on Cardiovascular Disease in the Young. Update: ambulatory blood pressure monitoring in children and adolescents: a scientific statement from the American Heart Association. Hypertension. 2014 May;63(5):1116-35. doi: 10.1161/HYP.0000000000000007. Epub 2014 Mar 3. No abstract available. |
| 38503990 | Derived | Bicki AC, Seth D, McCulloch CE, Lin F, Ku E. Use of activity trackers to improve blood pressure in young people at risk for cardiovascular disease: a pilot randomized controlled trial. Pediatr Nephrol. 2024 Aug;39(8):2467-2474. doi: 10.1007/s00467-024-06340-6. Epub 2024 Mar 19. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Estimated glomerular filtration rate | Mean | Standard Deviation | mL/min/1.73 m^2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Participants Retained | Rate of study participant retention | Posted | Count of Participants | Participants | Months 0-12 |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | Z-score | Months 0-12 |
|
|
|
| Primary | 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 | Posted | Mean | 95% Confidence Interval | mmHg | Between baseline and month 6 |
|
|
|
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Usual Care Arm (mo. 6-12) | Crossover to use of physical activity tracker for control participants from months 6-12 | 0 | 21 | 0 | 21 | 0 | 21 |
| EG002 | Intervention Arm | Use of physical activity tracker x 12 months | 0 | 42 | 0 | 42 | 0 | 42 |
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| D007674 |
| Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |