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RECRUITING
NCT06003023
NA

Congenital Heart Disease Physical Activity Lifestyle Study V.2

Sponsor: Jamie Jackson

View on ClinicalTrials.gov

Summary

The Congenital Heart Disease Physical Activity Lifestyle Intervention Study (CHD-PALS) V.2 seeks to determine the efficacy of a lifestyle intervention program for adolescents and young adults (AYAs) with congenital heart disease (CHD). This trial was adapted from the original CHD-PAL trial to continue improving cardiovascular outcomes for transition-aged CHD survivors.

Official title: Establishing Efficacy for the Congenital Heart Disease Physical Activity Lifestyle Intervention

Key Details

Gender

All

Age Range

15 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2023-07-18

Completion Date

2027-06-30

Last Updated

2025-04-04

Healthy Volunteers

No

Interventions

BEHAVIORAL

Physical Activity Monitoring

A physical activity monitor (Fitbit) will be provided to participants in both arms.

BEHAVIORAL

Tailored Exercise Prescription

Participants in both arms will receive the results of their exercise stress test, which includes information on the duration, frequency, and intensity of their physical activity.

BEHAVIORAL

Healthy Lifestyle Education

Participants in both arms will receive information on healthy living, including topics such as physical activity, sleep, stress management, and diet.

BEHAVIORAL

Physical Activity Lifestyle Intervention Informed by the Theory of Planned Behavior

Participants randomized to the CHD-PAL arm will receive coaching to: 1) change attitudes towards physical activity; 2) increase perceptions of other people's approval of physical activity; 3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance and will be accompanied by goal-setting.

Locations (1)

Nationwide Children's Hospital

Columbus, Ohio, United States