The goal of this is to test the efficacy of a 12-week physical activity intervention in 64 adolescents with CKD.
For youth with chronic kidney disease (CKD), cardiovascular disease (CVD) is a leading cause of morbidity and early mortality. Physical activity is a well-recognized determinant of health and quality of life, but, youth with CKD are less physically active than their healthy peers. Identification of effective strategies to increase physical activity in youth with CKD is paramount to improving outcomes. The investigators will test the efficacy of a 12-week physical activity intervention in 64 adolescents with CKD. Guided by the Multiphase Optimization Strategy (MOST) framework, an optimization trial will identify intervention components that increase average daily moderate to vigorous physical activity by 15 min/day, a clinically meaningful increase. The components will be grounded in established behavioral change theories and be delivered via Way to Health, a web-based platform, to overcome barriers at the point of clinical care where time and resources are limited.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Behavioral interventions to improve physical activity
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
RECRUITINGChange in time spent in moderate to vigorous physical activity (minutes/day)
Change in time spent in moderate to vigorous physical activity measured by Fitbit over the course of 12 weeks
Time frame: pre 12 week intervention and post 12 week intervention
Participant feedback
At completion of 12 week intervention, participants will complete an exit survey to collect feedback about the participant's experience. This is not scored.
Time frame: at the end of the 12 week intervention
moderate to vigorous physical activity at 6 months
measure moderate to vigorous physical activity by Fitbit 3 months after completion of 12 week intervention
Time frame: 6 months
PROMIS Anxiety
Patient self-report of 15 items from PROMIS anxiety domain. Participants rate their experience using a five point scale ranging from never to almost always. Answers are converted to a t-score to compare to the general population. A higher PROMIS T-score represents more of the concept being measured.
Time frame: pre 12 week intervention and post 12 week intervention
PROMIS Depressive Symptoms
Patient self-report of 14 items from PROMIS anxiety domain. Participants rate their experience using a five point scale ranging from never to almost always. Answers are converted to a t-score to compare to the general population. A higher PROMIS T-score represents more of the concept being measured.
Time frame: pre 12 week intervention and post 12 week intervention
PROMIS Positive Affect
Patient self-report of 39 items from PROMIS positive affect domain. Participants rate their experience using a five point scale ranging from never to always. Answers are converted to a t-score to compare to the general population. A higher PROMIS T-score represents more of the concept being measured.
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Time frame: pre 12 week intervention and post 12 week intervention
PROMIS Anger
Patient self-report of 9 items from PROMIS anger domain. Participants rate their experience using a five point scale ranging from never to almost always. Answers are converted to a t-score to compare to the general population. A higher PROMIS T-score represents more of the concept being measured.
Time frame: pre 12 week intervention and post 12 week intervention
PROMIS Psychological Stress Experiences
Patient self-report of 19 items from PROMIS stress domain. Participants rate their experience using a five point scale ranging from never to always. Answers are converted to a t-score to compare to the general population. A higher PROMIS T-score represents more of the concept being measured.
Time frame: pre 12 week intervention and post 12 week intervention
Change in hand grip strength (age and sex based z-scores)
Change in hand grip strength measured by digital hand dynamometer as a age and sex z-score generated from normative data. Z-score is a statistical measurement that describes a values relationship to the mean of a group of values. Values above the mean have positive standard scores, while those below the mean have negative standard scores.
Time frame: pre 12-week intervention and post 12-week intervention
PROMIS Fatigue
Patient self-report of 25 items from PROMIS fatigue domain. Participants rate their experience using a five point scale ranging from never to almost always. Answers are converted to a t-score to compare to the general population. A higher PROMIS T-score represents more of the concept being measured.
Time frame: pre 12 week intervention and post 12 week intervention
PROMIS Sleep Disturbance
Patient self-report of 15 items from PROMIS sleep disturbance domain. Participants rate their experience using a five point scale ranging from never to almost always. Answers are converted to a t-score to compare to the general population. A higher PROMIS T-score represents more of the concept being measured.
Time frame: pre 12 week intervention and post 12 week intervention
PROMIS Sleep-Related Impairment
Patient self-report of 13 items from PROMIS sleep-related impairment domain. Participants rate their experience using a five point scale ranging from never to almost always. Answers are converted to a t-score to compare to the general population. A higher PROMIS T-score represents more of the concept being measured.
Time frame: pre 12 week intervention and post 12 week intervention
PROMIS Life Satisfaction
Patient self-report of 42 items from PROMIS life satisfaction domain. Participants rate their experience using a five point scale ranging from never to almost always. Answers are converted to a t-score to compare to the general population. A higher PROMIS T-score represents more of the concept being measured.
Time frame: pre 12 week intervention and post 12 week intervention