ACtivity Trackers to ImproVe Blood Pressure: a Pilot Study
Phase: NA
Conditions: Hypertension, Cardiovascular Risk Factor, Physical Activity, Chronic Kidney Diseases
Sponsor: University of California, San Francisco

 
 
Cover letter  
 
Title:   Physical Activity Trackers to improve Blood Pressure (PAT-
BP) 
Last date of update:  11/9/2020  
NCT 03325426 
 
 

 
 
 
1 
BACKGROUND 
AND OVERVIEW 
OF CLINICAL 
STUDIES 
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.5,6,7,8 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.9 
Supervised walking appeared to provide some benefit in individuals with type II diabetes, 
but overall compliance was poor.9,10 Interview of adolescents and young adults with 
chronic illnesses has shown preference for the use of electronic devices and online tools 
for disease management.11,12 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. FitBits© have been previously validated in clinical studies for the accuracy of 
step count.13 

 
 
PROTOCOL SYNOPSIS 
 
TITLE 
Physical Activity Trackers to Blood Pressure (PAT-BP) 
SPONSOR 
NIH 
FUNDING 
ORGANIZATION 
NHLBI 
NUMBER OF SITES 
1 
RATIONALE 
The rationale for this study is to determine whether use of physical 
activity trackers (Fitbits) helps improving patient self-awareness of 
their fitness level and enhance healthy lifestyle changes that may 
lead to lower blood pressure. The potential benefits (increased 
walking on a daily basis and awareness of own fitness level) 
outweigh the risks in this study (anxiety about step count, minimal 
risk of loss of confidentiality). 
STUDY DESIGN 
This is a pilot randomized controlled trial. 
We will recruit 75 adolescents and young adults at UCSF. Patients 
included for study will be between ages 8-30 receiving anti- 
hypertensive therapy at the time of recruitment or have elevated BP 
> 120 mm Hg or > 95th percentile for age/sex/height if < 18 years 
of age.14,15 
Study intervention. Daily use of physical activity tracker coupled 
with biweekly provider telemonitoring and feedback (via secure 
email, phone call, or text) will be compared to usual care (daily use 
of physical activity tracker with biweekly feedback for the latter 6 
months of the study). The study intervention will last 6 months for 
patients in the usual care group and 12 months for patients in the 
intervention group. Physical activity and data will be reviewed by 
telemonitoring on a biweekly basis by study personnel. Patients will 
receive feedback on their progress from study personnel via patient- 
preferred communication modalities (secure e-mail, phone call, or 
text) biweekly. If daily step count is below desired goal (as per age- 
appropriate references),16 patients will be provided with ideas on 
how to increase physical activity level/step counts (e.g. parking 
further from their destination and walking, taking stairs instead of 
elevator). 
OBJECTIVES 
To determine feasibility of a randomized controlled trial testing 
to effect of physical activity trackers on blood pressure levels. 
 
To determine potential effect sizes from the use of physical 
activity trackers on change in blood pressure. 
NUMBER OF 
SUBJECTS 
75 

 
 
 
SUBJECT 
SELECTION 
CRITERIA 
Inclusion Criteria: 
Patients included for study will be 
• Male or female between ages 8-30 receiving anti-hypertensive 
therapy at the time of recruitment. Wewill target patients with 
DM, non-dialysis requiring CKD, or kidney transplant, but 
will not exclude patients with other etiologies of hypertension 
who are deemed eligible (such as fibromuscular dysplasia). 
• Only patients with phones compatible for wireless device data 
transmission will be eligible. Wireless sync between Fitbit 
monitors and online account (provided by Fitbit which 
securely stores step count) will be set-up in clinic, and only 
patients who consent to grant study personnel access to home 
monitoring data will be enrolled. 
• Written informed consent (and assent when applicable) 
obtained from subject or subject’s legal representative and 
ability for subject to comply with the requirements of the 
study. 
Exclusion Criteria: We will exclude patients with a history of 
decompensated congestive heart failure, pregnancy, cognitive 
impairment (and therefore inability to self-manage disease), non- 
ambulatory patients who are unable to perform physical activity, 
patients with BP >180/110 mm Hg, prisoners, patients with any 
contraindication to use or wear of home activity tracker (such as 
allergy to activity tracker band), or presence of any co-morbidity 
that would preclude physical activity (such as moderate or severe 
cerebral palsy).  
 
TEST PRODUCT, 
DOSE, AND ROUTE 
OF 
ADMINISTRATION 
1.1 
Fitbit (to be worn on the wrist). 
Up to 75 eligible patients will be randomly assigned to Fitbit or usual 
care treatment groups in a 2:1 ratio using a randomization scheme 
developed by the study data management provider. Due to the 
objectives of the study, the identity of test and control treatments will 
be known to investigators, patients. 
CONTROL ARM 
Usual care is defined as routine clinical care for the first 6 months of 
the study and wearing a Fitbit for the last 6 months of the study. 

 
 
 
STATISTICS 
Primary Analysis Plan 
The primary feasibility outcomes will be tallied using simple 
proportions and descriptive statistics. Chi-square and other tests will 
be used to characterize participants who did and did not enroll. To 
examine differences in clinical outcomes, intention-to-treat analysis 
will be performed. Change in mean office systolic BP between 3 and 
12 months, compared across usual care vs. intervention arms will be 
evaluated using t-tests and mixed linear models with an interaction 
term between time and randomization arm to evaluate change in 
office BPs at various time intervals both between groups and within-
subjects. 

 
Protocol 1.4Confidential 
 
 
 
 
APPENDIX 1. EXAMPLE OF SCHEDULE OF STUDY VISITS 
 
VISIT 1 
(Day/Week/Month #)a 
VISIT 2 
(Day/Week/Month #)a 
VISIT 3 
(Day/Week/Month #)a 
VISIT 4 
(Day/Week/Month #)a 
VISIT 5 
(Day/Week/Month #) 
Informed Consent 
X 
Medical History 
X 
Complete Physical Exam 
X 
X 
Abbreviated Physical Exam 
X 
X 
X 
Height 
X 
X 
X 
X 
X 
Weight 
X 
X 
X 
X 
X 
Randomization 
X 
Quality of Health Surveyb 
X 
X 
X 
Initiate Subject Diary 
X 
Subject Diary Review 
X 
X 
X 
X 
Adverse Experiences 
X 
X 
X 
X 
X 
a 
2 day 
b 
The Quality of Health Survey may be administered over the phone or email if needed. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Version Date: March 7, 2019 
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Protocol 1.4Confidential 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Version #: 
Version Date: Date 
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