Clinical trial NCT03325426: Activity Trackers for Improving BP
Official title: ACtivity Trackers to ImproVe Blood Pressure: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Cardiovascular Risk Factor
Physical Activity
Chronic Kidney Diseases
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 63
Sex: ALL
Minimum age (years): 8
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Mean Office Systolic BP
timeFrame: Between baseline and month 12
measure: Change in Mean Office Systolic BP
timeFrame: Between baseline and month 6
Secondary outcomes:
measure: Number of Participants Retained
timeFrame: Months 0-12
measure: Change in Weight (Z-score)
timeFrame: Months 0-12
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Elaine Ku
role: PRINCIPAL_INVESTIGATOR
References:
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