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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 10, 20, 40, and 80
Awards & highlights
CHD-PALS V2 Trial 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.Check my eligibility
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.See study design
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.
CHD-PALS V2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a moderate or complex heart defect.
Select...
I am between 15 and 25 years old.
CHD-PALS V2 Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Moderate to Vigorous Physical Activity (MVPA)
Secondary outcome measures
Affective Attitudes for Physical Activity Scale (Attitudes)
Exercise Confidence Survey (Perceived Control)
Family and Partner Support for Physical Activity Engagement Measure (Social Norms)
+3 moreOther outcome measures
Cardiorespiratory Fitness- Metabolic Equivalents (METs)
Cardiorespiratory Fitness-Volume of Oxygen Consumption (Peak VO2)
CHD-PALS V2 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
Healthy Lifestyle Education
2020
N/A
~530
Physical Activity Monitoring
2018
N/A
~150
Find a Location
Who is running the clinical trial?
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,417 Total Patients Enrolled
Jamie JacksonLead Sponsor
2 Previous Clinical Trials
96 Total Patients Enrolled
Jamie L Jackson, PhDPrincipal InvestigatorNationwide Children's Hospital
1 Previous Clinical Trials
60 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals below the age of seventy eligible to participate in this experiment?
"The age range for this research study is between 15 and 25 years old."
Answered by AI
Are there still openings to participate in this medical experiment?
"As per the latest information available on clinicaltrials.gov, this trial has an open call for participants. The original posting date was July 18th 2023 and it went through its last edit in August 23rd 2023."
Answered by AI
May I join this research endeavor?
"To be considered for this research, individuals must possess a congenital heart defect and measure within the 15-25 age range. A total of 144 participants will have their enrollment accepted."
Answered by AI
To what extent is this clinical trial being utilized to treat people?
"Affirmative. Clinicaltrials.gov discloses that this clinical trial, posted on July 18th 2023 and last updated August 23rd of the same year, is currently recruiting patients. A total of 144 people are necessary for enrolment at 1 site."
Answered by AI
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