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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DK134847-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed step goal only | Experimental | This intervention designed to test if fixed step goals improve physical activity participation. |
|
| Fixed step goal with feedback | Experimental | This intervention designed to test if fixed step goals and/or daily feed back improve physical activity participation. |
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| Fixed step goal with financial incentives | Experimental | This intervention designed to test if fixed step goals and/or financial incentives improve physical activity participation. |
|
| Fixed step goal with financial incentive and feedback | Experimental | This intervention designed to test if fixed step goals and/or financial incentives and/or daily feedback improve physical activity participation. |
|
| Ramped Step goals | Experimental | This intervention designed to test if ramped step goals improve physical activity participation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Increase Physical Activity | Behavioral | Behavioral interventions to improve physical activity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change 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 | pre 12 week intervention and post 12 week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at the end of the 12 week intervention |
| moderate to vigorous physical activity at 6 months |
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Inclusion criteria:
For adolescent participants:
For caregiver participants:
Exclusion Criteria:
For adolescent participants:
For caregivers participants:
1. Limited English proficiency
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jillian LoGuidice, BS | Contact | 267-425-4541 | loguidicej@chop.edu | |
| Amy Kogon, MD MPH | Contact | 215 590 2449 | kogona@chop.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amy Kogon, MD MPH | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27755284 | Background | Mitchell JA, Dowda M, Pate RR, Kordas K, Froberg K, Sardinha LB, Kolle E, Page A. Physical Activity and Pediatric Obesity: A Quantile Regression Analysis. Med Sci Sports Exerc. 2017 Mar;49(3):466-473. doi: 10.1249/MSS.0000000000001129. | |
| 26684326 | Background | Clark SL, Denburg MR, Furth SL. Physical activity and screen time in adolescents in the chronic kidney disease in children (CKiD) cohort. Pediatr Nephrol. 2016 May;31(5):801-8. doi: 10.1007/s00467-015-3287-z. Epub 2015 Dec 18. |
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All demographic (without PHI), summary data from clinical tests, survey data, processed summary of physical activity, and summary data from the participant feedback will be shared. The investigators will provide the approved Institutional Review Board (IRB) study protocol and the Management Operating Procedures (MOPs). The sample case report forms and surveys used in the study will be made available. The data dictionary for the project will also be shared. The software versions used in the collection and processing of data will be preserved. Source codes in STATA format used to process data for data cleaning purposes will be preserved and made available.
Shared data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 10 years after the end of the funding period.
Data shall be made available to authorized Arcus users without access restrictions.
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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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.
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Principal investigator and Clinical Care providers will be masked to intervention. Research Coordinator will not be masked
| Ramped step goals with feedback | Experimental | This intervention designed to test if ramped step goals and/or daily feedback improve physical activity participation. |
|
| Ramped step goal with financial incentive | Experimental | This intervention designed to test if ramped step goals and/or financial incentive improve physical activity participation. |
|
| Ramped step goal with financial incentive and feedback | Experimental | This intervention designed to test if ramped step goals and/or financial incentive and/or daily feedback improve physical activity participation. |
|
| Personalized plan with fixed step goal | Experimental | This intervention designed to test if personalized exercise plan and/or fixed step goal improves physical activity participation. |
|
| Personalized plan with fixed step goal and feedback | Experimental | This intervention designed to test if personalized exercise plan and/or fixed step goal and/or daily feedback improves physical activity participation. |
|
| Personalized plan with fixed step goal and financial incentive | Experimental | This intervention designed to test if personalized exercise plan and/or fixed step goal and/or financial incentive improves physical activity participation. |
|
| Personalized plan with fixed step goal and financial incentive and feedback | Experimental | This intervention designed to test if personalized exercise plan and/or fixed step goal and/or financial incentive and/or daily feedback improves physical activity participation. |
|
| Personalized plan with ramped step goal | Experimental | This intervention designed to test if personalized exercise plan and/or fixed step goal improves physical activity participation. |
|
| Personalized plan with ramped step goal and feedback | Experimental | This intervention designed to test if personalized exercise plan and/or fixed step goal and/or daily feedback improves physical activity participation. |
|
| Personalized plan with ramped step goal and financial incentive | Experimental | This intervention designed to test if personalized exercise plan and/or fixed step goal and/or financial incentive improves physical activity participation. |
|
| Personalized plan with ramped step goal and financial incentive and feedback | Experimental | This intervention designed to test if personalized exercise plan and/or fixed step goal and/or financial incentive and/or daily feedback improves physical activity participation. |
|
measure moderate to vigorous physical activity by Fitbit 3 months after completion of 12 week intervention |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | pre 12 week intervention and post 12 week intervention |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |