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Behavioural Intervention

Lifestyle Program for Congenital Heart Disease (CHD-PALS V2 Trial)

N/A

Recruiting

Led By Jamie L Jackson, PhD

Research Sponsored by Jamie Jackson

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with moderate or complex structural CHD

Between the ages of 15-25 years

Must not have

Underwent open-heart surgery or had a valve replacement in the last 3 months

Diagnosis of a genetic syndrome that impacts multiple organ systems

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to weeks 10, 20, 40, and 80

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the effectiveness of a lifestyle program to improve outcomes for teens & young adults with congenital heart disease. #CHD #AYA

Who is the study for?

This trial is for young people aged 15-25 with moderate to complex congenital heart disease, who are patients at Nationwide Children's Hospital or Ohio State University. They must be able to speak and read English well, not have had recent major heart surgery, and can't already be very physically active or in another exercise program.

What is being tested?

The study tests a lifestyle program that includes education on healthy living, monitoring physical activity levels, personalized exercise plans, and interventions based on the Theory of Planned Behavior to improve cardiovascular health in adolescents and young adults with congenital heart disease.

What are the potential side effects?

Since this trial involves non-medical interventions like education and exercise prescriptions rather than drugs or medical procedures, side effects may include typical risks associated with starting a new physical activity routine such as muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a moderate or complex heart defect.

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I am between 15 and 25 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had open-heart surgery or valve replacement in the last 3 months.

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I have a genetic condition that affects multiple organs.

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I do not have cognitive issues that would prevent me from participating in study tasks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to weeks 10, 20, 40, and 80

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to weeks 10, 20, 40, and 80

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 10, 20, 40, and 80 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Moderate to Vigorous Physical Activity (MVPA)

Secondary study objectives

Affective Attitudes for Physical Activity Scale (Attitudes)

Exercise Confidence Survey (Perceived Control)

Family and Partner Support for Physical Activity Engagement Measure (Social Norms)

+3 more

Other study objectives

Cardiorespiratory Fitness- Metabolic Equivalents (METs)

Cardiorespiratory Fitness-Volume of Oxygen Consumption (Peak VO2)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) InterventionExperimental Treatment4 Interventions

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.

Group II: Living Well with Congenital Heart Disease (LIV-CHD) InterventionActive Control3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Physical Activity Monitoring

2018

N/A

~150

Healthy Lifestyle Education

2020

N/A

~530