Activity Trackers for Improving BP

Hypertension Clinical Trial

Official title:

ACtivity Trackers to ImproVe Blood Pressure: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03325426
• Other study ID #: 16-18605
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: January 1, 2021

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 30 Years

Eligibility

Inclusion Criteria:

• ages 8-30 receiving anti-hypertensive therapy at the time of recruitment.

• diabetes, non-dialysis requiring chronic kidney disease, kidney transplant, or other etiologies of hypertension

• have phones compatible for wireless device (FitBits©) data transmission

Exclusion Criteria:

• history of decompensated congestive heart failure

• pregnant

• cognitive impairment

• unable to perform physical activity

• BP >180/110 mm Hg

• prisoners

• contraindication to use or wear of home activity tracker (such as allergy to activity tracker band)

• presence of any co-morbidity that would preclude physical activity

• actively using physical activity tracking devices prior to the study will be excluded.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Chronic Kidney Diseases
• Hypertension
• Kidney Diseases
• Physical Activity
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: JAMA. 2014 May 7;311(17):1809. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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/ — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Between baseline and month 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	Between baseline and month 6
Secondary	Number of Participants Retained	Rate of study participant retention	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.	Months 0-12