Chronic Kidney Diseases
Conditions
Keywords
chronic kidney disease, CKD
Brief summary
The goal of this is to test the efficacy of a 12-week physical activity intervention in 64 adolescents with CKD.
Detailed description
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.
Interventions
BEHAVIORALIncrease Physical Activity
Behavioral interventions to improve physical activity
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Masking description
Principal investigator and Clinical Care providers will be masked to intervention. Research Coordinator will not be masked
Intervention model description
A computerized random number generated by the Way to Health platform will assign children to 1 of 16 study conditions for a 12-week intervention period. The study conditions differ with respect to: personalized exercise plan(on vs off), step goals (ramp-up vs fixed), financial incentive (on vs off), and personalized feedback (on vs off). Our design includes one constant: all participants need to self-monitor their physical activity by wearing the FitBit to allow for daily capture of moderate to vigourous physical activity and step counts. The intervention period is therefore designed to test the effectiveness of 4 components, each with two levels, using a factorial design.
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
For adolescent participants: 1. Males or females age 13 - 18 years 2. Diagnosis of CKD stage II - V not yet on dialysis or with a transplant 3. English proficiency 4. Parental/guardian permission (informed consent), and if applicable, child assent For caregiver participants: 1. Parent/legal guardian of an enrolled adolescent participant 2. English proficiency
Exclusion criteria
For adolescent participants: 1. Pregnant or lactating 2. Non-ambulatory 3. Have high physical activity at baseline (\>45 min/day of MVPA) 4. Provide \<2 days of physical activity data during the run-in period 5. Have a condition, such as heart or lung disease, that preclude safely engaging in physical activity 6. Have received a solid organ transplant 7. Have limited English proficiency 8. Are on dialysis 9. In the opinion of the investigator, are unable to comply with the requirements of the study protocol or are unsuitable for the study for any reason For caregivers participants: 1\. Limited English proficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in time spent in moderate to vigorous physical activity (minutes/day) | pre 12 week intervention and post 12 week intervention | Change in time spent in moderate to vigorous physical activity measured by Fitbit over the course of 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| moderate to vigorous physical activity at 6 months | 6 months | measure moderate to vigorous physical activity by Fitbit 3 months after completion of 12 week intervention |
| PROMIS Anxiety | pre 12 week intervention and post 12 week intervention | 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. |
| PROMIS Depressive Symptoms | pre 12 week intervention and post 12 week intervention | 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. |
| PROMIS Positive Affect | pre 12 week intervention and post 12 week intervention | 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. |
| PROMIS Anger | pre 12 week intervention and post 12 week intervention | 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. |
| Participant feedback | at the end of the 12 week intervention | At completion of 12 week intervention, participants will complete an exit survey to collect feedback about the participant's experience. This is not scored. |
| Change in hand grip strength (age and sex based z-scores) | pre 12-week intervention and post 12-week intervention | 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. |
| PROMIS Fatigue | pre 12 week intervention and post 12 week intervention | 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. |
| PROMIS Sleep Disturbance | pre 12 week intervention and post 12 week intervention | 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. |
| PROMIS Sleep-Related Impairment | pre 12 week intervention and post 12 week intervention | 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. |
| PROMIS Life Satisfaction | pre 12 week intervention and post 12 week intervention | 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. |
| PROMIS Psychological Stress Experiences | pre 12 week intervention and post 12 week intervention | 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. |
Countries
United States
Contacts
Primary ContactJillian LoGuidice, BS
Backup ContactAmy Kogon, MD MPH
Outcome results
None listed