Activity Trackers for Improving BP

Study Overview
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Brief Summary
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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
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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.

Official Title
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ACtivity Trackers to ImproVe Blood Pressure: a Pilot Study

Conditions
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Hypertension, Cardiovascular Risk Factor, Physical Activity, Chronic Kidney Diseases

Intervention / Treatment
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* Device: FitBit


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>No physical activity tracker or feedback x 6 months, then crossover to physical activity tracker x 6 months | |
| Experimental: Physical activity tracker<br>Physical activity tracker x 12 months (6 months with study feedback and 6 months without) | Device: FitBit<br>* 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<br>* Other names: physical activity tracker;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Retained | Rate of study participant retention | Months 0-12 | 
| 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 |