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Congenital Heart Disease Physical Activity Lifestyle Study (CHD-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: NCT03335475
Recruitment Status : Active, not recruiting
First Posted : November 7, 2017
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Jamie Jackson, Nationwide Children's Hospital

Tracking Information
First Submitted Date  ICMJE November 3, 2017
First Posted Date  ICMJE November 7, 2017
Last Update Posted Date September 18, 2020
Actual Study Start Date  ICMJE November 7, 2017
Estimated Primary Completion Date April 21, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2017)
  • Sedentary behavior [ Time Frame: From baseline to follow-up (approximately 22 weeks). ]
    Number of minutes spent being sedentary as measured by an accelerometer.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Congenital Heart Disease Physical Activity Lifestyle Study
Official Title  ICMJE Congenital Heart Disease Physical Activity Lifestyle Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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 assents/consents to Phase 2. Envelopes with the conditions were prepared by the study statistician.
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Disease Other
  • Physical Activity
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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).
    Intervention: Behavioral: Physical Activity Monitoring
  • Experimental: Fitbit + Coaching Sessions
    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).
    Interventions:
    • Behavioral: Physical Activity Lifestyle Intervention
    • Behavioral: Physical Activity Monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 22, 2020)
59
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2017)
70
Estimated Study Completion Date  ICMJE April 21, 2021
Estimated Primary Completion Date April 21, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  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. >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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03335475
Other Study ID Numbers  ICMJE IRB16-00717
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jamie Jackson, Nationwide Children's Hospital
Study Sponsor  ICMJE Jamie Jackson
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jamie L Jackson, PhD Nationwide Children's Hospital
PRS Account Nationwide Children's Hospital
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP