Congenital Heart Disease Physical Activity Lifestyle Study

Not Applicable

Completed

Conditions: Cardiovascular Disease Other
Physical Activity

Interventions: Behavioral: Physical Activity Monitoring
Behavioral: Physical Activity Lifestyle Intervention

Registration Number: NCT03335475

Lead Sponsor: Jamie Jackson

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fitbit Only	Physical Activity Monitoring	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).
Fitbit + Coaching Sessions	Physical Activity Lifestyle Intervention	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).
Fitbit + Coaching Sessions	Physical Activity Monitoring	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).

Primary Outcome Measures

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

Secondary Outcome Measures

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