Chronic Kidney DiseasesPACKDNCT06624358
Physical Activity in CKD
A study testing Increase Physical Activity in people with Chronic Kidney Diseases, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The goal of this is to test the efficacy of a 12-week physical activity intervention in 64 adolescents with CKD. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Increase Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- For adolescent participants:
- Males or females age 13 - 18 years
- Diagnosis of CKD stage II - V not yet on dialysis or with a transplant
- English proficiency
- Parental/guardian permission (informed consent), and if applicable, child assent
- For caregiver participants:
- Parent/legal guardian of an enrolled adolescent participant
- English proficiency
Who cannot join
- For adolescent participants:
- Pregnant or lactating
- Non-ambulatory
- Have high physical activity at baseline (>45 min/day of MVPA)
- Provide <2 days of physical activity data during the run-in period
- Have a condition, such as heart or lung disease, that preclude safely engaging in physical activity
Show all 12Show fewer
- Have received a solid organ transplant
- Have limited English proficiency
- Are on dialysis
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Jill LoGuidice, 267-425-4541, loguidicej@chop.edu
Amy Kogon, MD, MPH, 215-590-2449, kogona@chop.edu
About this study
Official title: Physical Activity in Adolescents With Chronic Kidney Disease
The goal of this is to test the efficacy of a 12-week physical activity intervention in 64 adolescents with CKD.
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Increase Physical Activity
- Keywords
- chronic kidney disease, CKD
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increase Physical ActivityBehavioural
Behavioral interventions to improve physical activity
| Study group | Role | What they receive |
|---|---|---|
| Fixed step goal only | Experimental | This intervention designed to test if fixed step goals improve physical activity participation. Receives: Behavioral: Increase Physical Activity |
| Fixed step goal with feedback | Experimental | This intervention designed to test if fixed step goals and/or daily feed back improve physical activity participation. Receives: Behavioral: Increase Physical Activity |
| Fixed step goal with financial incentives | Experimental | This intervention designed to test if fixed step goals and/or financial incentives improve physical activity participation. Receives: Behavioral: Increase Physical Activity |
| 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. Receives: Behavioral: Increase Physical Activity |
| Ramped Step goals | Experimental | This intervention designed to test if ramped step goals improve physical activity participation. Receives: Behavioral: Increase Physical Activity |
| Ramped step goals with feedback | Experimental | This intervention designed to test if ramped step goals and/or daily feedback improve physical activity participation. Receives: Behavioral: Increase Physical Activity |
| Ramped step goal with financial incentive | Experimental | This intervention designed to test if ramped step goals and/or financial incentive improve physical activity participation. Receives: Behavioral: Increase Physical Activity |
| 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. Receives: Behavioral: Increase Physical Activity |
| 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. Receives: Behavioral: Increase Physical Activity |
| 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. Receives: Behavioral: Increase Physical Activity |
| 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. Receives: Behavioral: Increase Physical Activity |
| 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. Receives: Behavioral: Increase Physical Activity |
| 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. Receives: Behavioral: Increase Physical Activity |
| 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. Receives: Behavioral: Increase Physical Activity |
| 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. Receives: Behavioral: Increase Physical Activity |
| 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. Receives: Behavioral: Increase Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: pre 12 week intervention and post 12 week intervention
Secondary outcomes (12)
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.
Measured: 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
Measured: 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.
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.
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.
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.
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.
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.
Measured: 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.
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.
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.
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.
Measured: pre 12 week intervention and post 12 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start30 Sep 2025
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (72)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Kogon, MD MPH, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624358
- Sponsor's protocol ID
- 23-020727
- Other IDs
- 1K23DK134847-01A1
- Acronym
- PACKD
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 27755284Clark 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.
PubMed 26684326Fedele DA, Cushing CC, Fritz A, Amaro CM, Ortega A. Mobile Health Interventions for Improving Health Outcomes in Youth: A Meta-analysis. JAMA Pediatr. 2017 May 1;171(5):461-469. doi: 10.1001/jamapediatrics.2017.0042.
PubMed 28319239Rose T, Barker M, Maria Jacob C, Morrison L, Lawrence W, Strommer S, Vogel C, Woods-Townsend K, Farrell D, Inskip H, Baird J. A Systematic Review of Digital Interventions for Improving the Diet and Physical Activity Behaviors of Adolescents. J Adolesc Health. 2017 Dec;61(6):669-677. doi: 10.1016/j.jadohealth.2017.05.024. Epub 2017 Aug 16.
PubMed 28822682Groothoff JW, Gruppen MP, Offringa M, Hutten J, Lilien MR, Van De Kar NJ, Wolff ED, Davin JC, Heymans HS. Mortality and causes of death of end-stage renal disease in children: a Dutch cohort study. Kidney Int. 2002 Feb;61(2):621-9. doi: 10.1046/j.1523-1755.2002.00156.x.
PubMed 11849405McDonald SP, Craig JC; Australian and New Zealand Paediatric Nephrology Association. Long-term survival of children with end-stage renal disease. N Engl J Med. 2004 Jun 24;350(26):2654-62. doi: 10.1056/NEJMoa031643.
PubMed 15215481Mitsnefes MM, Laskin BL, Dahhou M, Zhang X, Foster BJ. Mortality risk among children initially treated with dialysis for end-stage kidney disease, 1990-2010. JAMA. 2013 May 8;309(18):1921-9. doi: 10.1001/jama.2013.4208.
PubMed 23645144Laskin BL, Mitsnefes MM, Dahhou M, Zhang X, Foster BJ. The mortality risk with graft function has decreased among children receiving a first kidney transplant in the United States. Kidney Int. 2015 Mar;87(3):575-83. doi: 10.1038/ki.2014.342. Epub 2014 Oct 15.
PubMed 25317931Parekh RS, Carroll CE, Wolfe RA, Port FK. Cardiovascular mortality in children and young adults with end-stage kidney disease. J Pediatr. 2002 Aug;141(2):191-7. doi: 10.1067/mpd.2002.125910.
PubMed 12183713Brady TM, Townsend K, Schneider MF, Cox C, Kimball T, Madueme P, Warady B, Furth S, Mitsnefes M. Cystatin C and Cardiac Measures in Children and Adolescents With CKD. Am J Kidney Dis. 2017 Feb;69(2):247-256. doi: 10.1053/j.ajkd.2016.08.036. Epub 2016 Nov 14.
PubMed 27856090Lalan S, Jiang S, Ng DK, Kupferman F, Warady BA, Furth S, Mitsnefes MM. Cardiometabolic Risk Factors, Metabolic Syndrome, and Chronic Kidney Disease Progression in Children. J Pediatr. 2018 Nov;202:163-170. doi: 10.1016/j.jpeds.2018.06.007. Epub 2018 Jul 2.
PubMed 30041938Brady TM, Schneider MF, Flynn JT, Cox C, Samuels J, Saland J, White CT, Furth S, Warady BA, Mitsnefes M. Carotid intima-media thickness in children with CKD: results from the CKiD study. Clin J Am Soc Nephrol. 2012 Dec;7(12):1930-7. doi: 10.2215/CJN.03130312. Epub 2012 Sep 13.
PubMed 22977209Mitsnefes M, Flynn J, Cohn S, Samuels J, Blydt-Hansen T, Saland J, Kimball T, Furth S, Warady B; CKiD Study Group. Masked hypertension associates with left ventricular hypertrophy in children with CKD. J Am Soc Nephrol. 2010 Jan;21(1):137-44. doi: 10.1681/ASN.2009060609. Epub 2009 Nov 16.
PubMed 19917781Khandelwal P, Murugan V, Hari S, Lakshmy R, Sinha A, Hari P, Bagga A. Dyslipidemia, carotid intima-media thickness and endothelial dysfunction in children with chronic kidney disease. Pediatr Nephrol. 2016 Aug;31(8):1313-20. doi: 10.1007/s00467-016-3350-4. Epub 2016 Feb 26.
PubMed 26921213Lai HL, Kartal J, Mitsnefes M. Hyperinsulinemia in pediatric patients with chronic kidney disease: the role of tumor necrosis factor-alpha. Pediatr Nephrol. 2007 Oct;22(10):1751-6. doi: 10.1007/s00467-007-0533-z. Epub 2007 Jun 1.
PubMed 17541791
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity in Adolescents With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06624358
- Acronym / sponsor ID
- PACKD / 23-020727
- Conditions
- Chronic Kidney Diseases
- Keywords
- chronic kidney disease, CKD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 16
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fixed step goal only | Experimental | Behavioral: Increase Physical ActivityThis intervention designed to test if fixed step goals improve physical activity participation. |
| Fixed step goal with feedback | Experimental | Behavioral: Increase Physical ActivityThis intervention designed to test if fixed step goals and/or daily feed back improve physical activity participation. |
| Fixed step goal with financial incentives | Experimental | Behavioral: Increase Physical ActivityThis 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 | Behavioral: Increase Physical ActivityThis intervention designed to test if fixed step goals and/or financial incentives and/or daily feedback improve physical activity participation. |
| Ramped Step goals | Experimental | Behavioral: Increase Physical ActivityThis intervention designed to test if ramped step goals improve physical activity participation. |
| Ramped step goals with feedback | Experimental | Behavioral: Increase Physical ActivityThis intervention designed to test if ramped step goals and/or daily feedback improve physical activity participation. |
| Ramped step goal with financial incentive | Experimental | Behavioral: Increase Physical ActivityThis 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 | Behavioral: Increase Physical ActivityThis 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 | Behavioral: Increase Physical ActivityThis 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 | Behavioral: Increase Physical ActivityThis 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 | Behavioral: Increase Physical ActivityThis 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 | Behavioral: Increase Physical ActivityThis 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 | Behavioral: Increase Physical ActivityThis 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 | Behavioral: Increase Physical ActivityThis 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 | Behavioral: Increase Physical ActivityThis 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 | Behavioral: Increase Physical ActivityThis 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Males or females age 13 - 18 years
- Diagnosis of CKD stage II - V not yet on dialysis or with a transplant
- English proficiency
- Parental/guardian permission (informed consent), and if applicable, child assent
- Parent/legal guardian of an enrolled adolescent participant
Key exclusion criteria (12 listed)
- Pregnant or lactating
- Non-ambulatory
- Have high physical activity at baseline (>45 min/day of MVPA)
- Provide <2 days of physical activity data during the run-in period
- Have a condition, such as heart or lung disease, that preclude safely engaging in physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increase Physical ActivityBehavioral interventions to improve physical activity | Behavioural | Fixed step goal only, Fixed step goal with feedback, Fixed step goal with financial incentive and feedback, Fixed step goal with financial incentives, Personalized plan with fixed step goal, Personalized plan with fixed step goal and feedback, Personalized plan with fixed step goal and financial incentive, Personalized plan with fixed step goal and financial incentive and feedback, Personalized plan with ramped step goal, Personalized plan with ramped step goal and feedback, Personalized plan with ramped step goal and financial incentive, Personalized plan with ramped step goal and financial incentive and feedback, Ramped Step goals, Ramped step goal with financial incentive, Ramped step goal with financial incentive and feedback, Ramped step goals with feedback |
Primary outcome
Change in time spent in moderate to vigorous physical activity (minutes/day)
Time frame: 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
12 secondary outcomes
Participant feedback
Time frame: at the end of the 12 week intervention
moderate to vigorous physical activity at 6 months
Time frame: 6 months
PROMIS Anxiety
Time frame: pre 12 week intervention and post 12 week intervention
PROMIS Depressive Symptoms
Time frame: pre 12 week intervention and post 12 week intervention
PROMIS Positive Affect
Time frame: pre 12 week intervention and post 12 week intervention
PROMIS Anger
Time frame: pre 12 week intervention and post 12 week intervention
PROMIS Psychological Stress Experiences
Time frame: pre 12 week intervention and post 12 week intervention
Change in hand grip strength (age and sex based z-scores)
Time frame: pre 12-week intervention and post 12-week intervention
PROMIS Fatigue
Time frame: pre 12 week intervention and post 12 week intervention
PROMIS Sleep Disturbance
Time frame: pre 12 week intervention and post 12 week intervention
PROMIS Sleep-Related Impairment
Time frame: pre 12 week intervention and post 12 week intervention
PROMIS Life Satisfaction
Time frame: pre 12 week intervention and post 12 week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 27755284Mitchell 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.
- Background: PubMed 26684326Clark 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.
- Background: PubMed 28319239Fedele DA, Cushing CC, Fritz A, Amaro CM, Ortega A. Mobile Health Interventions for Improving Health Outcomes in Youth: A Meta-analysis. JAMA Pediatr. 2017 May 1;171(5):461-469. doi: 10.1001/jamapediatrics.2017.0042.
- Background: PubMed 28822682Rose T, Barker M, Maria Jacob C, Morrison L, Lawrence W, Strommer S, Vogel C, Woods-Townsend K, Farrell D, Inskip H, Baird J. A Systematic Review of Digital Interventions for Improving the Diet and Physical Activity Behaviors of Adolescents. J Adolesc Health. 2017 Dec;61(6):669-677. doi: 10.1016/j.jadohealth.2017.05.024. Epub 2017 Aug 16.
- Background: PubMed 11849405Groothoff JW, Gruppen MP, Offringa M, Hutten J, Lilien MR, Van De Kar NJ, Wolff ED, Davin JC, Heymans HS. Mortality and causes of death of end-stage renal disease in children: a Dutch cohort study. Kidney Int. 2002 Feb;61(2):621-9. doi: 10.1046/j.1523-1755.2002.00156.x.
- Background: PubMed 15215481McDonald SP, Craig JC; Australian and New Zealand Paediatric Nephrology Association. Long-term survival of children with end-stage renal disease. N Engl J Med. 2004 Jun 24;350(26):2654-62. doi: 10.1056/NEJMoa031643.
- Background: PubMed 23645144Mitsnefes MM, Laskin BL, Dahhou M, Zhang X, Foster BJ. Mortality risk among children initially treated with dialysis for end-stage kidney disease, 1990-2010. JAMA. 2013 May 8;309(18):1921-9. doi: 10.1001/jama.2013.4208.
- Background: PubMed 25317931Laskin BL, Mitsnefes MM, Dahhou M, Zhang X, Foster BJ. The mortality risk with graft function has decreased among children receiving a first kidney transplant in the United States. Kidney Int. 2015 Mar;87(3):575-83. doi: 10.1038/ki.2014.342. Epub 2014 Oct 15.
- Background: PubMed 12183713Parekh RS, Carroll CE, Wolfe RA, Port FK. Cardiovascular mortality in children and young adults with end-stage kidney disease. J Pediatr. 2002 Aug;141(2):191-7. doi: 10.1067/mpd.2002.125910.
- Background: PubMed 27856090Brady TM, Townsend K, Schneider MF, Cox C, Kimball T, Madueme P, Warady B, Furth S, Mitsnefes M. Cystatin C and Cardiac Measures in Children and Adolescents With CKD. Am J Kidney Dis. 2017 Feb;69(2):247-256. doi: 10.1053/j.ajkd.2016.08.036. Epub 2016 Nov 14.
- Background: PubMed 30041938Lalan S, Jiang S, Ng DK, Kupferman F, Warady BA, Furth S, Mitsnefes MM. Cardiometabolic Risk Factors, Metabolic Syndrome, and Chronic Kidney Disease Progression in Children. J Pediatr. 2018 Nov;202:163-170. doi: 10.1016/j.jpeds.2018.06.007. Epub 2018 Jul 2.
- Background: PubMed 22977209Brady TM, Schneider MF, Flynn JT, Cox C, Samuels J, Saland J, White CT, Furth S, Warady BA, Mitsnefes M. Carotid intima-media thickness in children with CKD: results from the CKiD study. Clin J Am Soc Nephrol. 2012 Dec;7(12):1930-7. doi: 10.2215/CJN.03130312. Epub 2012 Sep 13.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy Kogon, MD MPH principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increase Physical Activity in people with Chronic Kidney Diseases, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jillian LoGuidice, BS (267-425-4541, loguidicej@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in time spent in moderate to vigorous physical activity (minutes/day) (time frame: pre 12 week intervention and post 12 week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06624358, which also lists 72 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.