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Young Adult Congenital Heart Disease Physical Activity Lifestyle Study (YACHD-PALS) (YACHD-PALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135859
Recruitment Status : Enrolling by invitation
First Posted : October 23, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Jamie Jackson, Nationwide Children's Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Cardiovascular Disease Other Physical Activity Behavioral: Physical Activity Lifestyle Intervention Behavioral: Physical Activity Monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study includes 2 possible conditions to which participants are randomized: (1) Fitbit only and (2) Fitbit + coaching sessions.
Masking: None (Open Label)
Masking Description: Investigator, research assistants, coaches (interventionists), and participants do not know which condition a participant is in until the condition is revealed (opening an envelope with the condition listed) after the participant consents to Phase 2. Envelopes with the conditions were prepared by the study statistician.
Primary Purpose: Prevention
Official Title: Physical Activity Lifestyle Intervention for Young Adults With Congenital Heart Disease
Actual Study Start Date : March 14, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Fitbit Only
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
A physical activity monitor (Fitbit) will be provided to both groups.
Other Name: Fitbit

Experimental: Fibit + Coaching Sessions
In the Fitbit + Coaching Sessions arm, participants 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
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.

Behavioral: Physical Activity Monitoring
A physical activity monitor (Fitbit) will be provided to both groups.
Other Name: Fitbit




Primary Outcome Measures :
  1. Moderate to vigorous physical activity [ Time Frame: From baseline to follow-up (approximately 22 weeks). ]
    Number of minutes spent in moderate to vigorous physical activity as measured by an accelerometer.


Secondary Outcome Measures :
  1. Sedentary behavior [ Time Frame: From baseline to follow-up (approximately 22 weeks). ]
    Number of minutes spent being sedentary as measured by an accelerometer.

  2. Exercise tolerance [ Time Frame: From baseline to follow-up (approximately 22 weeks). ]
    Maximal oxygen utilization during physical activity as measured by V02max during an exercise stress test.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Between the ages of 18-25 (if 18, must no longer be in high school and no longer living at home)
  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
  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. >150 min/weekday of moderate-to-vigorous physical activity per the accelerometer
  11. Do not have access or a device for videoconferencing with the coach

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135859


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Jamie Jackson
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Responsible Party: Jamie Jackson, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT04135859    
Other Study ID Numbers: IRB1600717
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jamie Jackson, Nationwide Children's Hospital:
congenital heart disease
physical activity
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases