Congenital Heart Disease Physical Activity Lifestyle Study
Condition: Cardiovascular Disease Other; Physical Activity
MeSH terms: Cardiovascular Diseases; Heart Diseases; Heart Defects, Congenital
Study type: Interventional

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.
    


Intervention name(s): Physical Activity Lifestyle Intervention; Physical Activity Monitoring
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; A physical activity monitor (Fitbit) will be provided to both groups.
Other intervention name(s): Fitbit
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)
Primary purpose: Prevention
Keywords: congenital heart disease; physical activity