NCT06624358

Brief Summary

The goal of this is to test the efficacy of a 12-week physical activity intervention in 64 adolescents with CKD.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
32mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Sep 2025Dec 2028

First Submitted

Initial submission to the registry

October 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
12 months until next milestone

Study Start

First participant enrolled

September 30, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

October 2, 2025

Status Verified

October 1, 2025

Enrollment Period

2.7 years

First QC Date

October 1, 2024

Last Update Submit

October 1, 2025

Conditions

Chronic Kidney Diseases

Keywords

chronic kidney diseaseCKD

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (12)

  • Participant feedback

    at the end of the 12 week intervention

  • moderate to vigorous physical activity at 6 months

    6 months

  • PROMIS Anxiety

    pre 12 week intervention and post 12 week intervention

  • PROMIS Depressive Symptoms

    pre 12 week intervention and post 12 week intervention

  • PROMIS Positive Affect

    pre 12 week intervention and post 12 week intervention

  • +7 more secondary outcomes

Study Arms (16)

Fixed step goal only

EXPERIMENTAL

This intervention designed to test if fixed step goals improve physical activity participation.

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.

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.

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.

Behavioral: Increase Physical Activity

Ramped Step goals

EXPERIMENTAL

This intervention designed to test if ramped step goals improve physical activity participation.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Behavioral: Increase Physical Activity

Interventions

Increase Physical ActivityBEHAVIORAL

Behavioral interventions to improve physical activity

Fixed step goal onlyFixed step goal with feedbackFixed step goal with financial incentive and feedbackFixed step goal with financial incentivesPersonalized plan with fixed step goalPersonalized plan with fixed step goal and feedbackPersonalized plan with fixed step goal and financial incentivePersonalized plan with fixed step goal and financial incentive and feedbackPersonalized plan with ramped step goalPersonalized plan with ramped step goal and feedbackPersonalized plan with ramped step goal and financial incentivePersonalized plan with ramped step goal and financial incentive and feedbackRamped Step goalsRamped step goal with financial incentiveRamped step goal with financial incentive and feedbackRamped step goals with feedback

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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:
  • \. Limited English proficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (72)

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MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Amy Kogon, MD MPH

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jillian LoGuidice, BS

CONTACT

267-425-4541loguidicej@chop.edu

Amy Kogon, MD MPH

CONTACT

215 590 2449kogona@chop.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Masking Details
Principal investigator and Clinical Care providers will be masked to intervention. Research Coordinator will not be masked
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 3, 2024

Study Start

September 30, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

October 2, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

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 Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
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.
Access Criteria
Data shall be made available to authorized Arcus users without access restrictions.

Locations

US(1)