Physical Activity in CKD

NCT ID: NCT06624358

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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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

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators
Principal investigator and Clinical Care providers will be masked to intervention. Research Coordinator will not be masked

Study Groups

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Fixed step goal only

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

Group Type EXPERIMENTAL

Increase Physical Activity

Intervention Type BEHAVIORAL

Behavioral interventions to improve physical activity

Fixed step goal with feedback

This intervention designed to test if fixed step goals and/or daily feed back improve physical activity participation.

Group Type EXPERIMENTAL

Increase Physical Activity

Intervention Type BEHAVIORAL

Behavioral interventions to improve physical activity

Fixed step goal with financial incentives

This intervention designed to test if fixed step goals and/or financial incentives improve physical activity participation.

Group Type EXPERIMENTAL

Increase Physical Activity

Intervention Type BEHAVIORAL

Behavioral interventions to improve physical activity

Fixed step goal with financial incentive and feedback

This intervention designed to test if fixed step goals and/or financial incentives and/or daily feedback improve physical activity participation.

Group Type EXPERIMENTAL

Increase Physical Activity

Intervention Type BEHAVIORAL

Behavioral interventions to improve physical activity

Ramped Step goals

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

Group Type EXPERIMENTAL

Increase Physical Activity

Intervention Type BEHAVIORAL

Behavioral interventions to improve physical activity

Ramped step goals with feedback

This intervention designed to test if ramped step goals and/or daily feedback improve physical activity participation.

Group Type EXPERIMENTAL

Increase Physical Activity

Intervention Type BEHAVIORAL

Behavioral interventions to improve physical activity

Ramped step goal with financial incentive

This intervention designed to test if ramped step goals and/or financial incentive improve physical activity participation.

Group Type EXPERIMENTAL

Increase Physical Activity

Intervention Type BEHAVIORAL

Behavioral interventions to improve physical activity

Ramped step goal with financial incentive and feedback

This intervention designed to test if ramped step goals and/or financial incentive and/or daily feedback improve physical activity participation.

Group Type EXPERIMENTAL

Increase Physical Activity

Intervention Type BEHAVIORAL

Behavioral interventions to improve physical activity

Personalized plan with fixed step goal

This intervention designed to test if personalized exercise plan and/or fixed step goal improves physical activity participation.

Group Type EXPERIMENTAL

Increase Physical Activity

Intervention Type BEHAVIORAL

Behavioral interventions to improve physical activity

Personalized plan with fixed step goal and feedback

This intervention designed to test if personalized exercise plan and/or fixed step goal and/or daily feedback improves physical activity participation.

Group Type EXPERIMENTAL

Increase Physical Activity

Intervention Type BEHAVIORAL

Behavioral interventions to improve physical activity

Personalized plan with fixed step goal and financial incentive

This intervention designed to test if personalized exercise plan and/or fixed step goal and/or financial incentive improves physical activity participation.

Group Type EXPERIMENTAL

Increase Physical Activity

Intervention Type BEHAVIORAL

Behavioral interventions to improve physical activity

Personalized plan with fixed step goal and financial incentive and feedback

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.

Group Type EXPERIMENTAL

Increase Physical Activity

Intervention Type BEHAVIORAL

Behavioral interventions to improve physical activity

Personalized plan with ramped step goal

This intervention designed to test if personalized exercise plan and/or fixed step goal improves physical activity participation.

Group Type EXPERIMENTAL

Increase Physical Activity

Intervention Type BEHAVIORAL

Behavioral interventions to improve physical activity

Personalized plan with ramped step goal and feedback

This intervention designed to test if personalized exercise plan and/or fixed step goal and/or daily feedback improves physical activity participation.

Group Type EXPERIMENTAL

Increase Physical Activity

Intervention Type BEHAVIORAL

Behavioral interventions to improve physical activity

Personalized plan with ramped step goal and financial incentive

This intervention designed to test if personalized exercise plan and/or fixed step goal and/or financial incentive improves physical activity participation.

Group Type EXPERIMENTAL

Increase Physical Activity

Intervention Type BEHAVIORAL

Behavioral interventions to improve physical activity

Personalized plan with ramped step goal and financial incentive and feedback

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.

Group Type EXPERIMENTAL

Increase Physical Activity

Intervention Type BEHAVIORAL

Behavioral interventions to improve physical activity

Interventions

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Increase Physical Activity

Behavioral interventions to improve physical activity

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy Kogon, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jillian LoGuidice, BS

Role: CONTACT

267-425-4541

Amy Kogon, MD MPH

Role: CONTACT

215 590 2449

Facility Contacts

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Jill LoGuidice

Role: primary

267-425-4541

Amy Kogon, MD, MPH

Role: backup

215-590-2449

References

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1K23DK134847-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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23-020727

Identifier Type: -

Identifier Source: org_study_id

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