Congenital Heart Disease Physical Activity Lifestyle Study V.2
NCT ID: NCT06003023
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
144 participants
INTERVENTIONAL
2023-07-18
2027-06-30
Brief Summary
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Detailed Description
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The CHD-PAL intervention is informed by the Theory of Planned Behavior (TPB) which has been used as a framework for lifestyle interventions, including among adults with heart failure and adolescents. Additionally, the CHD-PAL intervention implements goal-setting (or developing action plans) and self-monitoring, both of which are key for enacting the behavior within the TPB.
Investigators will randomize (1:1) 144 AYAs (ages 15-25) with moderate and complex CHD who spend \<=30 minutes/day in moderate to vigorous physical activity (MVPA) to 1 of 2 arms: CHD-PAL or attention control (Control). Both arms will receive a Fitbit® and a tailored exercise prescription. Those in CHD-PAL will also receive a 20-week videoconferencing-administered intervention that includes 9, 20 to 30-minute sessions designed to increase positive attitudes towards, subjective norms for, and perceived control for engaging in physical activity. Self-monitoring and goal-setting will also be encouraged to help enact behavior change. Controls will receive the same number/frequency of videoconferencing contacts to discuss the Fitbit and exercise prescription, as well as general healthy living, without addressing the TPB hypothesized mechanisms. Controls will also not be directed to self-monitor or engage in goal-setting. All participants will receive text messages from interventionists to either reinforce session content and inquire about progress towards goals (CHD-PAL) or to remind participants to wear the Fitbit (Control). Randomization will be stratified by gender and age using randomly varying block sizes of 4 to 6. MVPA, as measured with a research-grade accelerometer, will be assessed at baseline (T1), post-intervention (T3; 20 weeks after baseline), interim follow-up (T4; 20 weeks post-intervention), and follow-up (T5; 40 weeks post-intervention). TPB mechanisms will be similarly assessed, with the addition of an interim assessment during the intervention (T2; 10 weeks after baseline). Cardiorespiratory fitness (peak volume of oxygen consumption (VO2) and metabolic equivalent (METs)), as assessed via stress testing, will be measured at T1 and T3 as exploratory secondary outcomes.
The primary aim is to determine the efficacy of the CHD-PAL intervention on change in time spent in moderate to vigorous physical activity (MVPA) for AYAs with moderate and complex CHD. The secondary aim is to explore change in the TPB mechanisms and their relevance to change in MVPA. The tertiary aim is exploring the impact of CHD-PAL on cardiorespiratory fitness.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
15 Years
25 Years
ALL
No
Sponsors
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National Institute of Nursing Research (NINR)
NIH
Jamie Jackson
OTHER
Responsible Party
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Jamie Jackson
Principal Investigator
Principal Investigators
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Jamie L Jackson, PhD
Role: PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital
Locations
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Nationwide Children's Hospital
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00002759
Identifier Type: -
Identifier Source: org_study_id
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