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Activity Trackers for Improving BP

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Completed

Conditions

Chronic Kidney Diseases
Hypertension
Physical Activity
Cardiovascular Risk Factor

Treatments

Device: FitBit

Study type

Interventional

Funder types

Other

Identifiers

NCT03325426
16-18605

Details and patient eligibility

About

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.

Full 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.

Enrollment

63 patients

Sex

All

Ages

8 to 30 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

63 participants in 2 patient groups

Usual care
No Intervention group
Description:
No physical activity tracker or feedback x 6 months, then crossover to physical activity tracker x 6 months
Physical activity tracker
Experimental group
Description:
Physical activity tracker x 12 months (6 months with study feedback and 6 months without)
Treatment:
Device: FitBit

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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