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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33112424 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups. |
| FG001 | 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). 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. Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Three withdrawn participants (2 from Fitbit + Coaching Sessions arm and 1 from Fitbit Only arm) are excluded from the baseline analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Two participants in the Fitbit + Coaching group had missing MVPA data | Posted | Mean | Standard Deviation | Average change in minutes per day | From baseline to follow-up (approximately 22 weeks). |
|
Randomization to follow-up (approximately 22 weeks)
An adverse event is an unanticipated change in cardiovascular, musculoskeletal, or emotional symptoms that are (1) concerning to the participant and (2) results in seeking medical attention, if cardiovascular or musculoskeletal in nature. Any condition that is present at the time that the participant is screened will be considered as baseline and not reported as an adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ankle sprain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Severity: Moderate Relatedness: Unrelated Expectedness: Unexpected |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Jackson, Ph.D. | Nationwide Children's Hospital | 614-722-3585 | jamie.jackson2@nationwidechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2021 | Jan 30, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 13, 2021 | Feb 24, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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Study includes 2 possible conditions to which participants are randomized: (1) Fitbit only and (2) Fitbit + coaching sessions.
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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.
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| Physical Activity Monitoring | Behavioral | A physical activity monitor (Fitbit) will be provided to both groups. |
|
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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). |
| Did not complete stress test |
|
| Did not wear accelerometer and did not complete stress test |
|
| BG001 |
| 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). 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. Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| MVPA | Mean | Standard Deviation | Average min/day |
|
| Sedentary Behavior | Mean | Standard Deviation | Average min/day |
|
| VO2Peak | Mean | Standard Deviation | mL/kg/min |
|
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). 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. Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups. |
|
|
|
| Secondary | Sedentary Behavior | Baseline to follow-up change in number of minutes spent being sedentary as measured by an accelerometer. | Three participants in the Fitbit + Coaching group had missing data for sedentary behavior | Posted | Mean | Standard Deviation | Average change in minutes per day | From baseline to follow-up (approximately 22 weeks). |
|
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|
|
| Secondary | Exercise Tolerance | Baseline to follow-up change in maximal oxygen utilization during physical activity as measured by VO2peak during an exercise stress test. | Three participants from the Fitbit Only group and four participants from the Fitbit + Coaching Sessions group had missing data for VO2peak. | Posted | Mean | Standard Deviation | Average change in mL/kg/min | From baseline to follow-up (approximately 22 weeks). |
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|
| 0 |
| 19 |
| 0 |
| 19 |
| 1 |
| 19 |
| EG001 | 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). 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. Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups. | 0 | 17 | 0 | 17 | 0 | 17 |
|
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| D000013 |
| Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |