Congenital Heart Disease Physical Activity Lifestyle Study

NCT ID: NCT03335475

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-07
• Study Completion Date: 2021-04-07

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.

Conditions

Cardiovascular Disease Other; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Physical Activity Monitoring

Intervention Type: BEHAVIORAL

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

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).

Group Type: EXPERIMENTAL

Physical Activity Lifestyle Intervention

Intervention Type: 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.

Physical Activity Monitoring

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Physical Activity Monitoring

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Fitbit

Eligibility Criteria

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

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Jamie Jackson

OTHER

Sponsor Role: lead

Responsible Party

Jamie Jackson

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jamie L Jackson, PhD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

References

Jackson JL, Fox KR, Rausch JR, Swenski TN, Neville SP, Marousis NC, Korth CX, Cua CL, Garg V, Vannatta K. A Randomized Clinical Trial Demonstrating Feasibility and Preliminary Efficacy of a Videoconference-Delivered Physical Activity Lifestyle Intervention Among Adolescents With a Congenital Heart Defect. Ann Behav Med. 2022 Jul 12;56(7):673-684. doi: 10.1093/abm/kaab105.

Reference Type: DERIVED

PMID: 34951444 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K23HL127224

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB16-00717

Identifier Type: -

Identifier Source: org_study_id