MedTrace Logo

Congenital Heart Disease Physical Activity Lifestyle Study V.2

NCT06003023 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2025-04-04

No results posted yet for this study

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.

Conditions

  • Heart Defects, Congenital
  • Cardiovascular Disease Other

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.

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • Jamie Jackson

    lead OTHER

Principal Investigators

  • Jamie L Jackson, PhD · Nationwide Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-18
Primary Completion
2026-04-01
Completion
2027-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06003023 on ClinicalTrials.gov