Congenital Heart Disease Physical Activity Lifestyle Study
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 15 - 25 |
| Updated: | 12/14/2018 |
| Start Date: | October 5, 2017 |
| End Date: | April 10, 2021 |
| Contact: | Jamie L Jackson, PhD |
| Email: | jamie.jackson2@nationwidechildrens.org |
| Phone: | 6147223585 |
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.
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.
Inclusion Criteria:
1. Between the ages of 15-25
2. Are diagnosed with moderate or complex structural congenital heart disease
3. Live within 120 miles of Nationwide Children's Hospital
4. Able to complete an exercise stress test on a treadmill
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
We found this trial at
1
site
700 Childrens Drive
Columbus, Ohio 43205
Columbus, Ohio 43205
(616) 722-2000
Phone: 614-722-3585
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