Congenital Heart Disease Physical Activity Lifestyle Study

Study Overview
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Brief Summary
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This study will adapt a physical activity lifestyle intervention to adolescent and emerging adult congenital heart disease (CHD) survivors with the primary goal of increasing physical activity levels. The study will be split into 2 phases. In Phase 1, participants will be asked to complete questionnaires, wear an accelerometer around the waist for 7 days, and undergo an exercise stress test. The accelerometer and exercise stress test will be used to determine whether participants are eligible to be randomized for the intervention study. For adolescent participants, a parent will be asked to complete questionnaires at baseline as well. In Phase 2, participants will be randomized to one of two conditions: 1) receiving a physical activity tracker (a Fitbit) or 2) receiving a Fitbit AND engaging in videoconferencing sessions with a physical activity coach. During Phase 2, participants will also be asked to complete 3 assessments (weeks 9 and 22, and a 6-month follow-up). The week 9 assessment will consist of completing questionnaires and wearing an accelerometer for 7 days. Week 22 will be similar to week 9 with the addition of a final exercise stress test. The 6-month follow-up will mirror the week 9 assessment. For adolescent participants, the same parent will be asked to complete questionnaires at the final assessment as well. Participants who are randomized to the videoconferencing condition will be asked to meet with a physical activity coach 8 times over the course of 20 weeks. Coaches will help participants to (1) change attitudes toward physical activity, (2) increase perception of others' approval of physical activity (e.g., family members, peers), and (3) increase participants' perceived control by troubleshooting barriers and increasing efficacy for physical activity. Coaches will use the Fitbit to facilitate self-monitoring and goal setting. Participants in the intervention arm will be asked to participate in a focus group at the conclusion of the study to share their experiences.

Official Title
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Congenital Heart Disease Physical Activity Lifestyle Study

Conditions
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Cardiovascular Disease Other, Physical Activity

Intervention / Treatment
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* Behavioral: Physical Activity Lifestyle Intervention
* Behavioral: Physical Activity Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the ages of 15-18 (if 18, must be in high school and/or still living at home) Are diagnosed with moderate or complex structural congenital heart disease Live within 120 miles of Nationwide Children's Hospital Exclusion Criteria: Do no speak or write proficiently in English Have cognitive impairments that would interfere with the completion of study procedures Are diagnosed with a genetic syndrome (e.g., Downs, Marfans) Have been engaged in a formal exercise program within the past 6 months Underwent open-heart surgery or have had a transcatheter valve replacement in the last 3 months Are otherwise prohibited by their cardiologist to engage in at least moderate levels of physical activity Are unable to complete a treadmill-based exercise stress test Are currently pregnant Have contraindications for exercise based on an exercise stress test (e.g., exercise-induced arrhythmias or evidence of cardiac ischemia) >60 min/day of moderate-to-vigorous physical activity per the accelerometer Do not have internet access or a device for videoconferencing with a PA coach

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study includes 2 possible conditions to which participants are randomized: (1) Fitbit only and (2) Fitbit + coaching sessions.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fitbit Only<br>In the Fitbit Only arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, and a Fitbit. They will undergo a 9 week (interim) and a 22 week assessment (follow-up). | Behavioral: Physical Activity Monitoring<br>* A physical activity monitor (Fitbit) will be provided to both groups.<br>* Other names: Fitbit;|
| Experimental: Fitbit + Coaching Sessions<br>In the Fitbit + Coaching Sessions arm, participant will receive their exercise prescription, as devised from their baseline exercise stress test results, a Fitbit, and will have 8 sessions with a coach (interventionist) over the course of 20 weeks. They will undergo a 9 week (interim) and a 22 week assessment (follow-up). | Behavioral: Physical Activity Lifestyle Intervention<br>* Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.<br>Behavioral: Physical Activity Monitoring<br>* A physical activity monitor (Fitbit) will be provided to both groups.<br>* Other names: Fitbit;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate to Vigorous Physical Activity (MVPA) | Baseline to follow-up change in number of minutes spent in moderate to vigorous physical activity as measured by an accelerometer | From baseline to follow-up (approximately 22 weeks). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedentary Behavior | Baseline to follow-up change in number of minutes spent being sedentary as measured by an accelerometer. | From baseline to follow-up (approximately 22 weeks). | 
| Exercise Tolerance | Baseline to follow-up change in maximal oxygen utilization during physical activity as measured by VO2peak during an exercise stress test. | From baseline to follow-up (approximately 22 weeks). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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congenital heart disease, physical activity