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

Physical Activity Lifestyle Intervention for Young Adults With Congenital Heart Disease

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Cardiovascular Disease Other
• Intervention / Treatment: Behavioral: Physical Activity Monitoring; Behavioral: Physical Activity Lifestyle Intervention

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Fitbit
Experimental: Fitbit + 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 Monitoring; A physical activity monitor (Fitbit) will be provided to both groups.; Other Names: Fitbit; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderate to Vigorous Physical Activity (MVPA)	Baseline to follow-up change in number of minutes spent in moderate to vigorous physical activity as measured by an accelerometer	From baseline to follow-up (approximately 22 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedentary Behavior	Baseline to follow-up change in number of minutes spent being sedentary as measured by an accelerometer.	From baseline to follow-up (approximately 22 weeks).
Exercise Tolerance	Baseline to follow-up change in maximal oxygen utilization during physical activity as measured by VO2peak during an exercise stress test.	From baseline to follow-up (approximately 22 weeks).

Collaborators and Investigators

• Sponsor: Jamie Jackson

Publications and helpful links

General Publications

• Williams CA, Wadey C, Pieles G, Stuart G, Taylor RS, Long L. Physical activity interventions for people with congenital heart disease. Cochrane Database Syst Rev. 2020 Oct 28;10(10):CD013400. doi: 10.1002/14651858.CD013400.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2019
• Primary Completion (Actual): February 9, 2022
• Study Completion (Actual): February 9, 2022

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; congenital heart disease
• Additional Relevant MeSH Terms: Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Cardiovascular Diseases; Heart Defects, Congenital
• Other Study ID Numbers: IRB1600717

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No