Physical Activity in CKD (PACKD)

Children's Hospital of Philadelphia (CHOP)

Status: Enrolling

Conditions: Chronic Kidney Diseases

Treatments: Behavioral: Increase Physical Activity

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06624358

23-020727

1K23DK134847-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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100 participants in 16 patient groups

Fixed step goal only

Experimental group

Description:

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

Treatment:

Behavioral: Increase Physical Activity

Fixed step goal with feedback

Experimental group

Description:

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

Treatment:

Behavioral: Increase Physical Activity

Fixed step goal with financial incentives

Experimental group

Description:

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

Treatment:

Behavioral: Increase Physical Activity

Fixed step goal with financial incentive and feedback

Experimental group

Description:

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

Treatment:

Behavioral: Increase Physical Activity

Ramped Step goals

Experimental group

Description:

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

Treatment:

Behavioral: Increase Physical Activity

Ramped step goals with feedback

Experimental group

Description:

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

Treatment:

Behavioral: Increase Physical Activity

Ramped step goal with financial incentive

Experimental group

Description:

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

Treatment:

Behavioral: Increase Physical Activity

Ramped step goal with financial incentive and feedback

Experimental group

Description:

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

Treatment:

Behavioral: Increase Physical Activity

Personalized plan with fixed step goal

Experimental group

Description:

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

Treatment:

Behavioral: Increase Physical Activity

Personalized plan with fixed step goal and feedback

Experimental group

Description:

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

Treatment:

Behavioral: Increase Physical Activity

Personalized plan with fixed step goal and financial incentive

Experimental group

Description:

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

Treatment:

Behavioral: Increase Physical Activity

Personalized plan with fixed step goal and financial incentive and feedback

Experimental group

Description:

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.

Treatment:

Behavioral: Increase Physical Activity

Personalized plan with ramped step goal

Experimental group

Description:

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

Treatment:

Behavioral: Increase Physical Activity

Personalized plan with ramped step goal and feedback

Experimental group

Description:

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

Treatment:

Behavioral: Increase Physical Activity

Personalized plan with ramped step goal and financial incentive

Experimental group

Description:

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

Treatment:

Behavioral: Increase Physical Activity

Personalized plan with ramped step goal and financial incentive and feedback

Experimental group

Description:

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.

Treatment:

Behavioral: Increase Physical Activity