xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06003023</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00002759</org_study_id>
      <secondary_id>R01NR020423</secondary_id>
      <nct_id>NCT06003023</nct_id>
    </id_info>
    <brief_title>Congenital Heart Disease Physical Activity Lifestyle Study V.2</brief_title>
    <acronym>CHD-PALS V2</acronym>
    <official_title>Establishing Efficacy for the Congenital Heart Disease Physical Activity Lifestyle Intervention</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jamie Jackson</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Nursing Research (NINR)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Nationwide Children's Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The Congenital Heart Disease Physical Activity Lifestyle Intervention Study (CHD-PALS) V.2&#xD;
        seeks to determine the efficacy of a lifestyle intervention program for adolescents and young&#xD;
        adults (AYAs) with congenital heart disease (CHD). This trial was adapted from the original&#xD;
        CHD-PAL trial to continue improving cardiovascular outcomes for transition-aged CHD&#xD;
        survivors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Current estimates indicate more than 2 million individuals in the United States have CHD. CHD&#xD;
        survivors are now living well into adulthood, including those with moderate and complex forms&#xD;
        of CHD, who previously did not survive childhood. However, adult CHD survivors are now&#xD;
        encountering cardiovascular comorbidities, such as coronary disease and hypertension, costing&#xD;
        more than $3.16 billion annually in hospitalizations and resulting in premature death. The&#xD;
        benefits of physical activity for preventing coronary artery disease and other cardiac&#xD;
        comorbidities are well-known. For CHD survivors, the benefits of physical activity for&#xD;
        preventing morbidity and premature mortality have also been emphasized. Despite strong&#xD;
        evidence for physical activity preventing and treating acquired cardiovascular comorbidities&#xD;
        among CHD survivors, adolescents and young adults (AYAs) with CHD do not meet recommended&#xD;
        activity levels. The CHD-PAL intervention aims to provide individualized guidance on safe&#xD;
        forms of physical activity that is delivered by trained allied health interventionists.&#xD;
  &#xD;
        The CHD-PAL intervention is informed by the Theory of Planned Behavior (TPB) which has been&#xD;
        used as a framework for lifestyle interventions, including among adults with heart failure&#xD;
        and adolescents. Additionally, the CHD-PAL intervention implements goal-setting (or&#xD;
        developing action plans) and self-monitoring, both of which are key for enacting the behavior&#xD;
        within the TPB.&#xD;
  &#xD;
        Investigators will randomize (1:1) 144 AYAs (ages 15-25) with moderate and complex CHD who&#xD;
        spend &lt;=30 minutes/day in moderate to vigorous physical activity (MVPA) to 1 of 2 arms:&#xD;
        CHD-PAL or attention control (Control). Both arms will receive a Fitbit® and a tailored&#xD;
        exercise prescription. Those in CHD-PAL will also receive a 20-week&#xD;
        videoconferencing-administered intervention that includes 9, 20 to 30-minute sessions&#xD;
        designed to increase positive attitudes towards, subjective norms for, and perceived control&#xD;
        for engaging in physical activity. Self-monitoring and goal-setting will also be encouraged&#xD;
        to help enact behavior change. Controls will receive the same number/frequency of&#xD;
        videoconferencing contacts to discuss the Fitbit and exercise prescription, as well as&#xD;
        general healthy living, without addressing the TPB hypothesized mechanisms. Controls will&#xD;
        also not be directed to self-monitor or engage in goal-setting. All participants will receive&#xD;
        text messages from interventionists to either reinforce session content and inquire about&#xD;
        progress towards goals (CHD-PAL) or to remind participants to wear the Fitbit (Control).&#xD;
        Randomization will be stratified by gender and age using randomly varying block sizes of 4 to&#xD;
        6. MVPA, as measured with a research-grade accelerometer, will be assessed at baseline (T1),&#xD;
        post-intervention (T3; 20 weeks after baseline), interim follow-up (T4; 20 weeks&#xD;
        post-intervention), and follow-up (T5; 40 weeks post-intervention). TPB mechanisms will be&#xD;
        similarly assessed, with the addition of an interim assessment during the intervention (T2;&#xD;
        10 weeks after baseline). Cardiorespiratory fitness (peak volume of oxygen consumption (VO2)&#xD;
        and metabolic equivalent (METs)), as assessed via stress testing, will be measured at T1 and&#xD;
        T3 as exploratory secondary outcomes.&#xD;
  &#xD;
        The primary aim is to determine the efficacy of the CHD-PAL intervention on change in time&#xD;
        spent in moderate to vigorous physical activity (MVPA) for AYAs with moderate and complex&#xD;
        CHD. The secondary aim is to explore change in the TPB mechanisms and their relevance to&#xD;
        change in MVPA. The tertiary aim is exploring the impact of CHD-PAL on cardiorespiratory&#xD;
        fitness.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 18, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Study includes 2 possible conditions to which participants are randomized: (1) Control: Fitbit + tailored exercise prescription + information on living well with CHD (2) Fitbit + tailored exercise prescription + theory-driven health coaching sessions.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Group assignment will be generated through the data capture system (REDCap) in which the randomization scheme was developed by the study statistician. Investigator, research assistants, coaches (interventionists), and participants do not know which condition a participant is in until after Phase 2 consent.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Moderate to Vigorous Physical Activity (MVPA)</measure>
      <time_frame>Baseline to Weeks 20, 40, and 80</time_frame>
      <description>Number of minutes spent in moderate to vigorous physical activity as measured by an accelerometer.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Physical Activity Enjoyment/Engagement Scale (Attitudes)</measure>
      <time_frame>Baseline to Weeks 10, 20, 40, and 80</time_frame>
      <description>18-item measure of enjoyment and dislike of physical activity in which the participant currently engages. Each item is rated on a 7-point Likert scale with a positive attitude (e.g., I enjoy it) and negative attitude (e.g., I hate it) towards physical activity on each end.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Affective Attitudes for Physical Activity Scale (Attitudes)</measure>
      <time_frame>Baseline to Weeks 10, 20, 40, and 80</time_frame>
      <description>4-item measure of affective physical activity attitudes using bipolar adjectives on a 7-point Likert scale (i.e., enjoyable-unenjoyable, boring-interesting, pleasant-unpleasant, stressful-relaxing).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical Activity Norms Measure (Social Norms)</measure>
      <time_frame>Baseline to Weeks 10, 20, 40, and 80</time_frame>
      <description>5-item measure of perceptions of subjective norms of physical activity (e.g. &quot;Members of my family think I should be physically active regularly&quot;). An additional item was added to assess norms of cardiologist. Original item wording of &quot;during my free time on most days&quot; was changed to &quot;regularly.&quot; Participants are presented with a 5-point Likert scale ranging from &quot;Strongly disagree&quot; to &quot;Strongly agree.&quot; One item (&quot;Compared to others of your age and sex, mark how active you are.&quot;) is measured on a 5-point Likert scale ranging from &quot;Much less active&quot; to &quot;Much more active.&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Family and Partner Support for Physical Activity Engagement Measure (Social Norms)</measure>
      <time_frame>Baseline to Weeks 10, 20, 40, and 80</time_frame>
      <description>39-item measure asking participants to indicate &quot;None,&quot; &quot;Rarely,&quot; &quot;A few times,&quot; Often,&quot; &quot;Very often,&quot; and &quot;Does not apply,&quot; when rating the extent to which family (i.e., parents, siblings) and friends provided support for physical activity in different contexts within the past 3 months. This measure has been modified to include items for partners.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived Control for Physical Activity Engagement Measure (Perceived Control)</measure>
      <time_frame>Baseline to Weeks 10, 20, 40, and 80</time_frame>
      <description>5-item measure of perceived control for engaging in regular physical activity. Wording was adapted to use &quot;physical activity&quot; instead of &quot;exercise&quot;. Each item is rated on a 7-point Likert scale with a negative perception of control (e.g., Very little control) and positive perception of control (e.g., Complete control) of physical activity engagement on each end.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exercise Confidence Survey (Perceived Control)</measure>
      <time_frame>Baseline to Weeks 10, 20, 40, and 80</time_frame>
      <description>12-item questionnaire assessing health-related self-efficacy in adjusting physical activity behaviors. The original questionnaire has items for self-efficacy in diet behaviors, which have been removed for the purpose of this study. Wording has also been modified to reflect &quot;physical activity&quot;/&quot;physically active&quot; language. Items are measured on a 5-point Likert scale from &quot;I know I cannot&quot; to &quot;I know I can&quot; with an additional option of &quot;Does not apply.&quot;</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Cardiorespiratory Fitness-Volume of Oxygen Consumption (Peak VO2)</measure>
      <time_frame>Baseline to Week 20</time_frame>
      <description>Peak VO2 is the highest value of oxygen consumption during an exercise stress test and is widely used as an indicator of cardiorespiratory fitness. Peak VO2 will be measured at baseline and post-intervention to examine the impact of CHD-PAL on change in biological markers of cardiovascular health.</description>
    </other_outcome>
    <other_outcome>
      <measure>Cardiorespiratory Fitness- Metabolic Equivalents (METs)</measure>
      <time_frame>Baseline to Week 20</time_frame>
      <description>MET scores, or metabolic equivalents, represent the amount of oxygen consumed at rest or during activity. It is a simple, practical way to express the energy cost of different physical activities. METs, as assessed during the exercise stress test, will be measured at baseline and post-intervention to examine the impact of CHD-PAL on change in biological markers of cardiovascular health. METs are calculated by: ([miles per hour x 26.8 x 0.1] + [grade/100 x 1.8 x miles per hour x 26.8] + 3.5)/3.5 and the highest MET achieved during the stress test will be abstracted.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">144</enrollment>
    <condition>Heart Defects, Congenital</condition>
    <condition>Cardiovascular Disease Other</condition>
    <arm_group>
      <arm_group_label>Living Well with Congenital Heart Disease (LIV-CHD) Intervention</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In LIV-CHD, participants will receive a Fitbit and a tailored exercise prescription, as devised from their baseline exercise stress test results. They will also meet with a health coach for 9 virtual sessions over a period of 20 weeks. The content will focus on how to use the Fitbit along with health education pertinent to living a healthy lifestyle (e.g., sleep hygiene, stress management). Goal-setting and other cognitive behavioral strategies for health behavior change will not be discussed in this arm. Participants in the attention control arm will also receive text messages reminding them to wear their Fitbit.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In CHD-PAL, participants will receive a Fitbit and a tailored exercise prescription, as devised from their baseline exercise stress test results. They will also meet with a health coach for 9 virtual sessions over a period of 20 weeks. The content will focus on cognitive behavioral strategies, grounded in the Theory of Planned Behavior, to increase physical activity and healthy living. Participants in the intervention arm will also receive text motivational messages relevant to session content, as well as reminders to wear their Fitbit.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Physical Activity Monitoring</intervention_name>
      <description>A physical activity monitor (Fitbit) will be provided to participants in both arms.</description>
      <arm_group_label>Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) Intervention</arm_group_label>
      <arm_group_label>Living Well with Congenital Heart Disease (LIV-CHD) Intervention</arm_group_label>
      <other_name>Fitbit</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Tailored Exercise Prescription</intervention_name>
      <description>Participants in both arms will receive the results of their exercise stress test, which includes information on the duration, frequency, and intensity of their physical activity.</description>
      <arm_group_label>Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) Intervention</arm_group_label>
      <arm_group_label>Living Well with Congenital Heart Disease (LIV-CHD) Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Healthy Lifestyle Education</intervention_name>
      <description>Participants in both arms will receive information on healthy living, including topics such as physical activity, sleep, stress management, and diet.</description>
      <arm_group_label>Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) Intervention</arm_group_label>
      <arm_group_label>Living Well with Congenital Heart Disease (LIV-CHD) Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Physical Activity Lifestyle Intervention Informed by the Theory of Planned Behavior</intervention_name>
      <description>Participants randomized to the CHD-PAL arm will receive coaching to: 1) change attitudes towards physical activity; 2) increase perceptions of other people's approval of physical activity; 3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance and will be accompanied by goal-setting.</description>
      <arm_group_label>Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) Intervention</arm_group_label>
      <other_name>CHD-PAL</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Between the ages of 15-25 years&#xD;
  &#xD;
            -  Diagnosed with moderate or complex structural CHD&#xD;
  &#xD;
            -  Actively receiving care from a cardiologist at Nationwide Children's Hospital (NCH) or&#xD;
               Ohio State University (OSU)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to speak and read proficiently in English&#xD;
  &#xD;
            -  Have a diagnosis of a genetic syndrome that impacts multiple organ systems&#xD;
  &#xD;
            -  Have cognitive impairments that would interfere with completing study measures&#xD;
  &#xD;
            -  Have been engaged in a formal exercise program within the past 6 months,&#xD;
  &#xD;
            -  Have participated in the intervention arm of the previous CHD-PAL Study&#xD;
  &#xD;
            -  Have undergone open-heart surgery or had a valve replacement in the last 3 months&#xD;
  &#xD;
            -  Are unable to complete an exercise stress test using a treadmill&#xD;
  &#xD;
            -  Are pregnant&#xD;
  &#xD;
            -  Are prohibited to engage in at least moderate levels of physical activity by their&#xD;
               cardiologist&#xD;
  &#xD;
            -  Engage in &gt;30 minutes of moderate-to-vigorous physical activity per day, on average&#xD;
               per accelerometer&#xD;
  &#xD;
            -  Have contraindications for exercise based on an exercise stress test (e.g.,&#xD;
               exercise-induced arrhythmias or evidence of cardiac ischemia)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jamie L Jackson, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Nationwide Children's Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jamie L Jackson, PhD</last_name>
      <phone>6147223585</phone>
      <email>jamie.jackson2@nationwidechildrens.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jessica Bowman, MS</last_name>
      <phone>6143553499</phone>
      <email>jessica.bowman2@nationwidechildrens.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Nationwide Children's Hospital</name>
        <address>
          <city>Columbus</city>
          <state>Ohio</state>
          <zip>43205</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jamie L Jackson, PhD</last_name>
        <phone>614-722-3585</phone>
        <email>jamie.jackson2@nationwidechildrens.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
      <investigator_full_name>Jamie Jackson</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>congenital heart disease</keyword>
    <keyword>physical activity</keyword>
    <keyword>adolescents</keyword>
    <keyword>young adults</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiovascular Diseases</mesh_term>
      <mesh_term>Heart Diseases</mesh_term>
      <mesh_term>Heart Defects, Congenital</mesh_term>
      <mesh_term>Congenital Abnormalities</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06003023
  org study id: STUDY00002759
  secondary id: R01NR020423
  nct id: NCT06003023
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The Congenital Heart Disease Physical Activity Lifestyle Intervention Study (CHD-PALS) V.2
        seeks to determine the efficacy of a lifestyle intervention program for adolescents and young
        adults (AYAs) with congenital heart disease (CHD). This trial was adapted from the original
        CHD-PAL trial to continue improving cardiovascular outcomes for transition-aged CHD
        survivors.
  Current estimates indicate more than 2 million individuals in the United States have CHD. CHD
        survivors are now living well into adulthood, including those with moderate and complex forms
        of CHD, who previously did not survive childhood. However, adult CHD survivors are now
        encountering cardiovascular comorbidities, such as coronary disease and hypertension, costing
        more than $3.16 billion annually in hospitalizations and resulting in premature death. The
        benefits of physical activity for preventing coronary artery disease and other cardiac
        comorbidities are well-known. For CHD survivors, the benefits of physical activity for
        preventing morbidity and premature mortality have also been emphasized. Despite strong
        evidence for physical activity preventing and treating acquired cardiovascular comorbidities
        among CHD survivors, adolescents and young adults (AYAs) with CHD do not meet recommended
        activity levels. The CHD-PAL intervention aims to provide individualized guidance on safe
        forms of physical activity that is delivered by trained allied health interventionists.
  
        The CHD-PAL intervention is informed by the Theory of Planned Behavior (TPB) which has been
        used as a framework for lifestyle interventions, including among adults with heart failure
        and adolescents. Additionally, the CHD-PAL intervention implements goal-setting (or
        developing action plans) and self-monitoring, both of which are key for enacting the behavior
        within the TPB.
  
        Investigators will randomize (1:1) 144 AYAs (ages 15-25) with moderate and complex CHD who
        spend <=30 minutes/day in moderate to vigorous physical activity (MVPA) to 1 of 2 arms:
        CHD-PAL or attention control (Control). Both arms will receive a Fitbit® and a tailored
        exercise prescription. Those in CHD-PAL will also receive a 20-week
        videoconferencing-administered intervention that includes 9, 20 to 30-minute sessions
        designed to increase positive attitudes towards, subjective norms for, and perceived control
        for engaging in physical activity. Self-monitoring and goal-setting will also be encouraged
        to help enact behavior change. Controls will receive the same number/frequency of
        videoconferencing contacts to discuss the Fitbit and exercise prescription, as well as
        general healthy living, without addressing the TPB hypothesized mechanisms. Controls will
        also not be directed to self-monitor or engage in goal-setting. All participants will receive
        text messages from interventionists to either reinforce session content and inquire about
        progress towards goals (CHD-PAL) or to remind participants to wear the Fitbit (Control).
        Randomization will be stratified by gender and age using randomly varying block sizes of 4 to
        6. MVPA, as measured with a research-grade accelerometer, will be assessed at baseline (T1),
        post-intervention (T3; 20 weeks after baseline), interim follow-up (T4; 20 weeks
        post-intervention), and follow-up (T5; 40 weeks post-intervention). TPB mechanisms will be
        similarly assessed, with the addition of an interim assessment during the intervention (T2;
        10 weeks after baseline). Cardiorespiratory fitness (peak volume of oxygen consumption (VO2)
        and metabolic equivalent (METs)), as assessed via stress testing, will be measured at T1 and
        T3 as exploratory secondary outcomes.
  
        The primary aim is to determine the efficacy of the CHD-PAL intervention on change in time
        spent in moderate to vigorous physical activity (MVPA) for AYAs with moderate and complex
        CHD. The secondary aim is to explore change in the TPB mechanisms and their relevance to
        change in MVPA. The tertiary aim is exploring the impact of CHD-PAL on cardiorespiratory
        fitness.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Study includes 2 possible conditions to which participants are randomized: (1) Control: Fitbit + tailored exercise prescription + information on living well with CHD (2) Fitbit + tailored exercise prescription + theory-driven health coaching sessions.
  primary purpose: Prevention
  masking: None (Open Label)
  masking description: Group assignment will be generated through the data capture system (REDCap) in which the randomization scheme was developed by the study statistician. Investigator, research assistants, coaches (interventionists), and participants do not know which condition a participant is in until after Phase 2 consent.
  measure: Moderate to Vigorous Physical Activity (MVPA)
  time frame: Baseline to Weeks 20, 40, and 80
  description: Number of minutes spent in moderate to vigorous physical activity as measured by an accelerometer.
  measure: Physical Activity Enjoyment/Engagement Scale (Attitudes)
  time frame: Baseline to Weeks 10, 20, 40, and 80
  description: 18-item measure of enjoyment and dislike of physical activity in which the participant currently engages. Each item is rated on a 7-point Likert scale with a positive attitude (e.g., I enjoy it) and negative attitude (e.g., I hate it) towards physical activity on each end.
  measure: Affective Attitudes for Physical Activity Scale (Attitudes)
  time frame: Baseline to Weeks 10, 20, 40, and 80
  description: 4-item measure of affective physical activity attitudes using bipolar adjectives on a 7-point Likert scale (i.e., enjoyable-unenjoyable, boring-interesting, pleasant-unpleasant, stressful-relaxing).
  measure: Physical Activity Norms Measure (Social Norms)
  time frame: Baseline to Weeks 10, 20, 40, and 80
  description: 5-item measure of perceptions of subjective norms of physical activity (e.g. "Members of my family think I should be physically active regularly"). An additional item was added to assess norms of cardiologist. Original item wording of "during my free time on most days" was changed to "regularly." Participants are presented with a 5-point Likert scale ranging from "Strongly disagree" to "Strongly agree." One item ("Compared to others of your age and sex, mark how active you are.") is measured on a 5-point Likert scale ranging from "Much less active" to "Much more active."
  measure: Family and Partner Support for Physical Activity Engagement Measure (Social Norms)
  time frame: Baseline to Weeks 10, 20, 40, and 80
  description: 39-item measure asking participants to indicate "None," "Rarely," "A few times," Often," "Very often," and "Does not apply," when rating the extent to which family (i.e., parents, siblings) and friends provided support for physical activity in different contexts within the past 3 months. This measure has been modified to include items for partners.
  measure: Perceived Control for Physical Activity Engagement Measure (Perceived Control)
  time frame: Baseline to Weeks 10, 20, 40, and 80
  description: 5-item measure of perceived control for engaging in regular physical activity. Wording was adapted to use "physical activity" instead of "exercise". Each item is rated on a 7-point Likert scale with a negative perception of control (e.g., Very little control) and positive perception of control (e.g., Complete control) of physical activity engagement on each end.
  measure: Exercise Confidence Survey (Perceived Control)
  time frame: Baseline to Weeks 10, 20, 40, and 80
  description: 12-item questionnaire assessing health-related self-efficacy in adjusting physical activity behaviors. The original questionnaire has items for self-efficacy in diet behaviors, which have been removed for the purpose of this study. Wording has also been modified to reflect "physical activity"/"physically active" language. Items are measured on a 5-point Likert scale from "I know I cannot" to "I know I can" with an additional option of "Does not apply."
  measure: Cardiorespiratory Fitness-Volume of Oxygen Consumption (Peak VO2)
  time frame: Baseline to Week 20
  description: Peak VO2 is the highest value of oxygen consumption during an exercise stress test and is widely used as an indicator of cardiorespiratory fitness. Peak VO2 will be measured at baseline and post-intervention to examine the impact of CHD-PAL on change in biological markers of cardiovascular health.
  measure: Cardiorespiratory Fitness- Metabolic Equivalents (METs)
  time frame: Baseline to Week 20
  description: MET scores, or metabolic equivalents, represent the amount of oxygen consumed at rest or during activity. It is a simple, practical way to express the energy cost of different physical activities. METs, as assessed during the exercise stress test, will be measured at baseline and post-intervention to examine the impact of CHD-PAL on change in biological markers of cardiovascular health. METs are calculated by: ([miles per hour x 26.8 x 0.1] + [grade/100 x 1.8 x miles per hour x 26.8] + 3.5)/3.5 and the highest MET achieved during the stress test will be abstracted.
  arm group label: Living Well with Congenital Heart Disease (LIV-CHD) Intervention
  arm group type: Active Comparator
  description: In LIV-CHD, participants will receive a Fitbit and a tailored exercise prescription, as devised from their baseline exercise stress test results. They will also meet with a health coach for 9 virtual sessions over a period of 20 weeks. The content will focus on how to use the Fitbit along with health education pertinent to living a healthy lifestyle (e.g., sleep hygiene, stress management). Goal-setting and other cognitive behavioral strategies for health behavior change will not be discussed in this arm. Participants in the attention control arm will also receive text messages reminding them to wear their Fitbit.
  arm group label: Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) Intervention
  arm group type: Experimental
  description: In CHD-PAL, participants will receive a Fitbit and a tailored exercise prescription, as devised from their baseline exercise stress test results. They will also meet with a health coach for 9 virtual sessions over a period of 20 weeks. The content will focus on cognitive behavioral strategies, grounded in the Theory of Planned Behavior, to increase physical activity and healthy living. Participants in the intervention arm will also receive text motivational messages relevant to session content, as well as reminders to wear their Fitbit.
  intervention type: Behavioral
  intervention name: Physical Activity Monitoring
  description: A physical activity monitor (Fitbit) will be provided to participants in both arms.
  arm group label: Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) Intervention
  arm group label: Living Well with Congenital Heart Disease (LIV-CHD) Intervention
  other name: Fitbit
  intervention type: Behavioral
  intervention name: Tailored Exercise Prescription
  description: Participants in both arms will receive the results of their exercise stress test, which includes information on the duration, frequency, and intensity of their physical activity.
  arm group label: Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) Intervention
  arm group label: Living Well with Congenital Heart Disease (LIV-CHD) Intervention
  intervention type: Behavioral
  intervention name: Healthy Lifestyle Education
  description: Participants in both arms will receive information on healthy living, including topics such as physical activity, sleep, stress management, and diet.
  arm group label: Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) Intervention
  arm group label: Living Well with Congenital Heart Disease (LIV-CHD) Intervention
  intervention type: Behavioral
  intervention name: Physical Activity Lifestyle Intervention Informed by the Theory of Planned Behavior
  description: Participants randomized to the CHD-PAL arm will receive coaching to: 1) change attitudes towards physical activity; 2) increase perceptions of other people's approval of physical activity; 3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance and will be accompanied by goal-setting.
  arm group label: Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) Intervention
  other name: CHD-PAL
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 25 Years
  healthy volunteers: No
  last name: Jamie L Jackson, PhD
  role: Principal Investigator
  affiliation: Nationwide Children's Hospital
  last name: Jamie L Jackson, PhD
  phone: 6147223585
  email: jamie.jackson2@nationwidechildrens.org
  last name: Jessica Bowman, MS
  phone: 6143553499
  email: jessica.bowman2@nationwidechildrens.org
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: Nationwide Children's Hospital
  investigator full name: Jamie Jackson
  investigator title: Principal Investigator
  mesh term: Cardiovascular Diseases
  mesh term: Heart Diseases
  mesh term: Heart Defects, Congenital
  mesh term: Congenital Abnormalities
  sharing ipd: No