Activity Trackers for Improving BP

Not Applicable

Completed

• Conditions: Physical Activity; Hypertension; Cardiovascular Risk Factor; Chronic Kidney Diseases
• Interventions: Device: FitBit

• Registration Number: NCT03325426
• Lead Sponsor: University of California, San Francisco

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.

Detailed 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.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2017-10-25
• Study First Posted: 2017-10-30
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Results First Submitted: 2022-04-08
• Results First Submitted QC: 2022-07-07
• Results First Posted: 2022-07-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical activity tracker	FitBit	Physical activity tracker x 12 months (6 months with study feedback and 6 months without)

Primary Outcome Measures

Name	Time	Method
Change in Mean Office Systolic BP	Between baseline and month 6	Change in mean systolic BP using blood pressure data points collected between baseline and month 6 to provide an average change over time

Secondary Outcome Measures

Name	Time	Method
Change in Weight (Z-score)	Months 0-12	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.
Number of Participants Retained	Months 0-12	Rate of study participant retention

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States