Activity Trackers for Improving BP

NCT03325426 | Completed Results FDA Device

• 1 other identifier: 16-18605
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Cardiovascular Risk Factor; Physical Activity; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Number of Participants Retained

  Months 0-12

• Change in Weight (Z-score)

  Months 0-12

Study Arms (2)

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)

Device: FitBit

Interventions

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

Also known as: physical activity tracker

Physical activity tracker

Eligibility Criteria

• Age: 8 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (16)

• 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.

  PMID: 24529535 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.

  PMID: 17765133 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.

  PMID: 21115879 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/

  PMID: 22439158 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.

  PMID: 22422539 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.

  PMID: 25092645 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.

  PMID: 24648129 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.

  PMID: 20980426 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.

  PMID: 23740658 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.

  PMID: 22089460 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.

  PMID: 24268570 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.

  PMID: 24352797 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.

  PMID: 15193909 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.

  PMID: 15699287 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.

  PMID: 24591341 BACKGROUND

• 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.

  PMID: 38503990 DERIVED

MeSH Terms

Conditions

Hypertension; Motor Activity; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Elaine Ku
• Organization: UCSF

elaine.ku@ucsf.edu

415-502-7760

Study Officials

• Elaine Ku

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: October 30, 2017
• Study Start: June 1, 2017
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: April 2, 2024
• Results First Posted: July 14, 2022

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)