Establishing Efficacy for the Congenital Heart Disease Physical Activity Lifestyle Intervention
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 25
Healthy Volunteers: f
View:
• 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)
Locations
United States
Ohio
Nationwide Children's Hospital
RECRUITING
Columbus
Contact Information
Primary
Jamie L Jackson, PhD
jamie.jackson2@nationwidechildrens.org
6147223585
Backup
Jessica Bowman, MS
jessica.bowman2@nationwidechildrens.org
6143553499
Time Frame
Start Date: 2023-07-18
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 144
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Nursing Research (NINR)
Leads: Jamie Jackson