Recruiting

Observational Study

Sponsor:

Jamie Jackson

Code:

NCT06003023

Conditions

Heart Defects, Congenital

Cardiovascular Disease Other

Eligibility Criteria

Sex: All

Age: 15 - 25

Healthy Volunteers: Not accepted

Interventions

Physical Activity Monitoring

Tailored Exercise Prescription

Healthy Lifestyle Education

Physical Activity Lifestyle Intervention Informed by the Theory of Planned Behavior

Study Details

Brief 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

Study ID

NCT06003023

Start date

Jul 18, 2023

Status verified date

May, 2026

Completion date

Jul 30, 2027

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 25

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Between the ages of 15-25 years
  • Diagnosed with moderate or complex structural CHD
  • Actively receiving care from a cardiologist at Nationwide Children's Hospital (NCH) or Ohio State University (OSU)

Exclusion Criteria:

  • Unable to speak and read proficiently in English
  • Have a diagnosis of a genetic syndrome that impacts multiple organ systems
  • Have cognitive impairments that would interfere with completing study measures
  • Have been engaged in a formal exercise program within the past 6 months,
  • Have participated in the intervention arm of the previous CHD-PAL Study
  • Have undergone open-heart surgery or had a valve replacement in the last 3 months
  • Are unable to complete an exercise stress test using a treadmill
  • Are pregnant
  • Are prohibited to engage in at least moderate levels of physical activity by their cardiologist
  • Engage in >30 minutes of moderate-to-vigorous physical activity per day, on average per accelerometer
  • Have contraindications for exercise based on an exercise stress test (e.g., exercise-induced arrhythmias or evidence of cardiac ischemia)

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Living Well with Congenital Heart Disease (LIV-CHD) Intervention

In LIV-CHD, participants will receive a Fitbit and a tailored exercise prescription, as devised from their baseline exercise stress test results. They will also meet with a health coach for 9 virtual sessions over a period of 20 weeks. The content will focus on how to use the Fitbit along with health education pertinent to living a healthy lifestyle (e.g., sleep hygiene, stress management). Goal-setting and other cognitive behavioral strategies for health behavior change will not be discussed in this arm. Participants in the attention control arm will also receive text messages reminding them to wear their Fitbit.

experimental: Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) Intervention

In CHD-PAL, participants will receive a Fitbit and a tailored exercise prescription, as devised from their baseline exercise stress test results. They will also meet with a health coach for 9 virtual sessions over a period of 20 weeks. The content will focus on cognitive behavioral strategies, grounded in the Theory of Planned Behavior, to increase physical activity and healthy living. Participants in the intervention arm will also receive text motivational messages relevant to session content, as well as reminders to wear their Fitbit.

Interventions

Physical Activity Monitoring

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

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.

Healthy Lifestyle Education

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

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.

Primary outcome measure

  • Moderate to Vigorous Physical Activity (MVPA) [ Time Frame: Baseline to Weeks 20, 40, and 80 ]

Central Contacts and Locations

Central contacts

Jamie L Jackson, PhD

6147223585jamie.jackson2@nationwidechildrens.org

Ruri Famelia, PhD

6143553499ruri.famelia@nationwidechildrens.org

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Jamie L Jackson, PhD

6147223585jamie.jackson2@nationwidechildrens.org

More Information

Sponsor

Jamie Jackson

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

  • congenital heart disease
  • physical activity
  • adolescents
  • young adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jamie Jackson on 2026-06-01.