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OpenTrials
Completed

NCT Number: NCT03325426

Activity Trackers for Improving BP

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.

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Key information

Conditions

Hypertension Behavior Cardiovascular Diseases Cardiovascular Risk Factor Chronic Disease Chronic Kidney Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Physical Activity Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

8 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fitbit

Device

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

Other names: physical activity tracker

Primary outcomes

  1. Change in Mean Office Systolic BP

    Time frame: Between baseline and month 12

    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.

  2. Change in Mean Office Systolic BP

    Time frame: 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 outcomes

  1. Number of Participants Retained

    Time frame: Months 0-12

    Rate of study participant retention

  2. Change in Weight (Z-score)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

ACtivity Trackers to ImproVe Blood Pressure: a Pilot Study

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Oct 30, 2017
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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