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

NCT04135859 | Completed Results DMC

• 1 other identifier: IRB1600717
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease Other; Physical Activity

Keywords

congenital heart disease; physical activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Sedentary Behavior

  From baseline to follow-up (approximately 22 weeks).

• Exercise Tolerance

  From baseline to follow-up (approximately 22 weeks).

Study Arms (2)

Fitbit Only

ACTIVE COMPARATOR

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

Fitbit + Coaching Sessions

EXPERIMENTAL

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; Behavioral: Physical Activity Monitoring

Interventions

Physical Activity Lifestyle Intervention BEHAVIORAL

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.

Fitbit + Coaching Sessions

Physical Activity Monitoring BEHAVIORAL

A physical activity monitor (Fitbit) will be provided to both groups.

Also known as: Fitbit

Fitbit + Coaching Sessions; Fitbit Only

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 18-25 (if 18, must no longer be in high school and no longer living at home)
• Are diagnosed with moderate or complex structural congenital heart disease
• Live within 120 miles of Nationwide Children's Hospital

You may not qualify if:

• Do no speak or write proficiently in English
• Have cognitive impairments that would interfere with the completion of study procedures
• Are diagnosed with a genetic syndrome (e.g., Downs, Marfans)
• Have been engaged in a formal exercise program within the past 6 months
• Underwent open-heart surgery or have had a transcatheter valve replacement in the last 3 months
• Are otherwise prohibited by their cardiologist to engage in at least moderate levels of physical activity
• Are unable to complete a treadmill-based exercise stress test
• Are currently pregnant
• Have contraindications for exercise based on an exercise stress test (e.g., exercise-induced arrhythmias or evidence of cardiac ischemia)
• \>150 min/weekday of moderate-to-vigorous physical activity per the accelerometer
• Do not have access or a device for videoconferencing with the coach

Sponsors & Collaborators

• Jamie Jackson: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

• 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.

  PMID: 33112424 DERIVED

MeSH Terms

Conditions

Motor Activity; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Behavior; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Jamie Jackson, Ph.D.
• Organization: Nationwide Children's Hospital

jamie.jackson2@nationwidechildrens.org

614-722-3585

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Study includes 2 possible conditions to which participants are randomized: (1) Fitbit only and (2) Fitbit + coaching sessions.

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 23, 2019
• Study Start: March 14, 2019
• Primary Completion: February 9, 2022
• Study Completion: February 9, 2022
• Last Updated: September 19, 2024
• Results First Posted: November 15, 2023

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)