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NCT04135859 · ClinicalTrials.gov registry record · NA
Young Adult Congenital Heart Disease Physical Activity Lifestyle Study (YACHD-PALS)
A NA study, sponsored by Jamie Jackson.
- Completed
- Registry status
- NA
- Development phase
- 36
- Enrollment target
NCT04135859 is a NA study that has completed, run by Jamie Jackson. The registered enrollment target is 36 participants.
The verdict
NCT04135859, a NA study, has completed, sponsored by Jamie Jackson.
- COMPLETED
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
Study Summary
This study will adapt a physical activity lifestyle intervention to 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. 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. 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.
Interventions
- BEHAVIORAL Physical Activity Monitoring
- BEHAVIORAL Physical Activity Lifestyle Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2019-03-14 |
| Est. Completion | 2022-02-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04135859
The ClinicalTrials.gov registry entry for NCT04135859 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jamie Jackson, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Physical Activity Monitoring is the first listed.
NCT04135859 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04135859 about?
NCT04135859 is a clinical study titled "Young Adult Congenital Heart Disease Physical Activity Lifestyle Study (YACHD-PALS)". This study will adapt a physical activity lifestyle intervention to 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...
What is the current status of trial NCT04135859?
This trial is currently completed. It is a NA study. The enrollment target is 36 participants. The study started on 2019-03-14. Estimated completion is 2022-02-09.
What interventions are being tested in trial NCT04135859?
The interventions under investigation include: Physical Activity Monitoring (BEHAVIORAL), Physical Activity Lifestyle Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT04135859?
This trial is sponsored by Jamie Jackson, which has 3 total clinical trials registered on ClinicalTrials.gov.
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