Cardiovascular Risk Factor, Chronic Kidney Diseases, Hypertension, Physical Activity
Conditions
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.
Interventions
DEVICEFitBit
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
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 30 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Office Systolic BP | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Retained | Months 0-12 | Rate of study participant retention |
| Change in Weight (Z-score) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Arm Usual care x 6 months, then crossover to physical activity tracker x 6 months | 21 |
| Intervention Arm Physical activity tracker x 12 months | 42 |
| Total | 63 |
Baseline characteristics
| Characteristic | Usual Care Arm | Intervention Arm | Total |
|---|---|---|---|
| Age, Continuous | 18.0 years STANDARD_DEVIATION 4.4 | 17.6 years STANDARD_DEVIATION 3.9 | 17.7 years STANDARD_DEVIATION 4 |
| Estimated glomerular filtration rate | 81 mL/min/1.73 m^2 STANDARD_DEVIATION 35 | 81 mL/min/1.73 m^2 STANDARD_DEVIATION 25 | 81 mL/min/1.73 m^2 STANDARD_DEVIATION 28 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 19 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 23 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 21 participants | 42 participants | 63 participants |
| Sex: Female, Male Female | 12 Participants | 15 Participants | 27 Participants |
| Sex: Female, Male Male | 9 Participants | 27 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 | 0 / 42 |
| other Total, other adverse events | 0 / 21 | 0 / 21 | 0 / 42 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 | 0 / 42 |
Outcome results
Primary
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.
Time frame: Between baseline and month 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Change in Mean Office Systolic BP | 0.3 mmHg |
| Physical Activity Tracker | Change in Mean Office Systolic BP | -4 mmHg |
Primary
Change in Mean Office Systolic BP
Change in mean systolic BP using blood pressure data points collected between baseline and month 6 to provide an average change over time
Time frame: Between baseline and month 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Change in Mean Office Systolic BP | 3.0 mmHg |
| Physical Activity Tracker | Change in Mean Office Systolic BP | -2.3 mmHg |
Secondary
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.
Time frame: Months 0-12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Change in Weight (Z-score) | -0.20 Z-score |
| Physical Activity Tracker | Change in Weight (Z-score) | -0.06 Z-score |
Secondary
Number of Participants Retained
Rate of study participant retention
Time frame: Months 0-12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants Retained | 11 Participants |
| Physical Activity Tracker | Number of Participants Retained | 18 Participants |