Clinical trial NCT03335475: Congenital Heart Disease Physical Activity Lifestyle Study
Official title: Congenital Heart Disease Physical Activity Lifestyle Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease Other
Physical Activity
Keywords: congenital heart disease
physical activity
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-11-07
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study includes 2 possible conditions to which participants are randomized: (1) Fitbit only and (2) Fitbit + coaching sessions.
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Between the ages of 15-18 (if 18, must be in high school and/or still living at home)
2. Are diagnosed with moderate or complex structural congenital heart disease
3. Live within 120 miles of Nationwide Children's Hospital

Exclusion Criteria:

1. Do no speak or write proficiently in English
2. Have cognitive impairments that would interfere with the completion of study procedures
3. Are diagnosed with a genetic syndrome (e.g., Downs, Marfans)
4. Have been engaged in a formal exercise program within the past 6 months
5. Underwent open-heart surgery or have had a transcatheter valve replacement in the last 3 months
6. Are otherwise prohibited by their cardiologist to engage in at least moderate levels of physical activity
7. Are unable to complete a treadmill-based exercise stress test
8. Are currently pregnant
9. Have contraindications for exercise based on an exercise stress test (e.g., exercise-induced arrhythmias or evidence of cardiac ischemia)
10. \>60 min/day of moderate-to-vigorous physical activity per the accelerometer
11. Do not have internet access or a device for videoconferencing with a PA coach

Primary outcomes:
measure: Moderate to Vigorous Physical Activity (MVPA)
timeFrame: From baseline to follow-up (approximately 22 weeks).
Secondary outcomes:
measure: Sedentary Behavior
timeFrame: From baseline to follow-up (approximately 22 weeks).
measure: Exercise Tolerance
timeFrame: From baseline to follow-up (approximately 22 weeks).
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Jamie L Jackson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jackson JL, Fox KR, Rausch JR, Swenski TN, Neville SP, Marousis NC, Korth CX, Cua CL, Garg V, Vannatta K. A Randomized Clinical Trial Demonstrating Feasibility and Preliminary Efficacy of a Videoconference-Delivered Physical Activity Lifestyle Intervention Among Adolescents With a Congenital Heart Defect. Ann Behav Med. 2022 Jul 12;56(7):673-684. doi: 10.1093/abm/kaab105.