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Activity Trackers for Improving BP

Primary Purpose

Hypertension, Cardiovascular Risk Factor, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FitBit
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension

Eligibility Criteria

8 Years - 30 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Physical activity tracker

Arm Description

No physical activity tracker or feedback x 6 months, then crossover to physical activity tracker x 6 months

Physical activity tracker x 12 months (6 months with study feedback and 6 months without)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants Retained
Rate of study participant retention
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.

Full Information

First Posted
October 25, 2017
Last Updated
July 7, 2022
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03325426
Brief Title
Activity Trackers for Improving BP
Official Title
ACtivity Trackers to ImproVe Blood Pressure: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Cardiovascular Risk Factor, Physical Activity, Chronic Kidney Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
No physical activity tracker or feedback x 6 months, then crossover to physical activity tracker x 6 months
Arm Title
Physical activity tracker
Arm Type
Experimental
Arm Description
Physical activity tracker x 12 months (6 months with study feedback and 6 months without)
Intervention Type
Device
Intervention Name(s)
FitBit
Other Intervention Name(s)
physical activity tracker
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Mean Office Systolic BP
Description
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.
Time Frame
Between baseline and month 12
Secondary Outcome Measure Information:
Title
Number of Participants Retained
Description
Rate of study participant retention
Time Frame
Months 0-12
Title
Change in Weight (Z-score)
Description
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.
Time Frame
Months 0-12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine Ku
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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24529535
Citation
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Activity Trackers for Improving BP

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