Congenital Heart Disease Physical Activity Lifestyle Study V.2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-25
SponsorJamie Jackson
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Physical Activity Monitoring
BehavioralA physical activity monitor (Fitbit) will be provided to participants in both arms.
Tailored Exercise Prescription
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: Living Well with Congenital Heart Disease (LIV-CHD) InterventionActive comparator 3 interventions
Group B: Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) InterventionExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Moderate to Vigorous Physical Activity (MVPA)
Number of minutes spent in moderate to vigorous physical activity as measured by an accelerometer.
Time frame
Baseline to Weeks 20, 40, and 80Secondary outcomes
1
Physical Activity Enjoyment/Engagement Scale (Attitudes)
18-item measure of enjoyment and dislike of physical activity in which the participant currently engages. Each item is rated on a 7-point Likert scale with a positive attitude (e.g., I enjoy it) and negative attitude (e.g., I hate it) towards physical activity on each end.
Time frame
Baseline to Weeks 10, 20, 40, and 802
Affective Attitudes for Physical Activity Scale (Attitudes)
4-item measure of affective physical activity attitudes using bipolar adjectives on a 7-point Likert scale (i.e., enjoyable-unenjoyable, boring-interesting, pleasant-unpleasant, stressful-relaxing).
Time frame
Baseline to Weeks 10, 20, 40, and 803
Physical Activity Norms Measure (Social Norms)
5-item measure of perceptions of subjective norms of physical activity (e.g. "Members of my family think I should be physically active regularly"). An additional item was added to assess norms of cardiologist. Original item wording of "during my free time on most days" was changed to "regularly." Participants are presented with a 5-point Likert scale ranging from "Strongly disagree" to "Strongly agree." One item ("Compared to others of your age and sex, mark how active you are.") is measured on a 5-point Likert scale ranging from "Much less active" to "Much more active."
Time frame
Baseline to Weeks 10, 20, 40, and 804
Family and Partner Support for Physical Activity Engagement Measure (Social Norms)
39-item measure asking participants to indicate "None," "Rarely," "A few times," Often," "Very often," and "Does not apply," when rating the extent to which family (i.e., parents, siblings) and friends provided support for physical activity in different contexts within the past 3 months. This measure has been modified to include items for partners.
Time frame
Baseline to Weeks 10, 20, 40, and 80Other outcomes
1
Cardiorespiratory Fitness-Volume of Oxygen Consumption (Peak VO2)
Peak VO2 is the highest value of oxygen consumption during an exercise stress test and is widely used as an indicator of cardiorespiratory fitness. Peak VO2 will be measured at baseline and post-intervention to examine the impact of CHD-PAL on change in biological markers of cardiovascular health.
Time frame
Baseline to Week 202
Cardiorespiratory Fitness- Metabolic Equivalents (METs)
MET scores, or metabolic equivalents, represent the amount of oxygen consumed at rest or during activity. It is a simple, practical way to express the energy cost of different physical activities. METs, as assessed during the exercise stress test, will be measured at baseline and post-intervention to examine the impact of CHD-PAL on change in biological markers of cardiovascular health. METs are calculated by: (\[miles per hour x 26.8 x 0.1\] + \[grade/100 x 1.8 x miles per hour x 26.8\] + 3.5)/3.5 and the highest MET achieved during the stress test will be abstracted.
Time frame
Baseline to Week 20Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jamie Jackson
Lead sponsor
Nationwide Children's Hospital
Sponsor institution
National Institute of Nursing Research (NINR)
Collaborator
Source ClinicalTrials.gov