An interventional study of Physical Activity Lifestyle Intervention and Physical Activity Monitoring in Cardiovascular Disease Other and Physical Activity, sponsored by Jamie Jackson. Completed at 1 site in United States. Open to participants aged 15 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-05-03.
Sponsored by Jamie Jackson · Not applicable, Interventional, and Prevention
Among 356 studies in Heart Defects, Congenital with a site in United States — 66 open to participants now, 87 under way, 4 of them phase 3. Heart Defects, Congenital · United States.
Among the 356 studies in Heart Defects, Congenital with a site in United States, this one is the 79th largest by enrollment of the 184 interventional ones that give a count, is one of 21 that started in 2017, is one of 111 with no phase, and was the 210th registered.
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
Browse Heart Defects, Congenital studies →66 of the 356 studies in Heart Defects, Congenital with a site in United States are open now. Recruiting first, the newest first:
University of Nebraska · Sites in United States
Ages 1 mo–3 yrs
Le Bonheur Children's Hospital · Sites in United States
Ages 0 mo–12 mo
Carelon Research · Sites in United States
Ages 18+
Carelon Research · Sites in United States
Ages 18+
The Cleveland Clinic · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 154 Heart Defects, Congenital studies recruiting now, 67 (44%) set no upper age limit and 79 (51%) stop at 75 or younger; 110 take children under 18; 25 take healthy volunteers.
This study: 15 Years to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
356 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 22 · Phase 2 33 · Phase 3 25 · Phase 4 9
First in 1980; this study’s year is marked. 21 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 60 is close to the median of 60 across 507 interventional studies indexed under Heart Defects, Congenital.
Median enrollment 50 across the 184 interventional studies, 72 across the 167 observational. Of the 240 that completed or were terminated, 62 (26%) have results posted.
This tab as a report to print or save as PDF → With an account.
31 of 356 have an industry lead sponsor. The 10 most frequent:
Jamie Jackson is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Jamie Jackson has 3 studies filed under Heart Defects, Congenital — fewer than ten, so there is no comparison to draw.
30 of the studies in Heart Defects, Congenital with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04216927Phase 3Children's Hospital Medical Center, CincinnatiNO During CPB in Neonates to Reduce Risk of AKI | 2027-06-30 |
| NCT05077774Medtronic CardiovascularHarmony TPV Post-Approval Study | 2026-11 |
| NCT05687292Boston Children's HospitalApplication of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery in Children | 2026-11-18 |
| NCT07559253University of Wisconsin, MadisonImplementation of an Accessible Healthcare Model (ACHD STRONG): Comparing Nurse and Physician Lead Healthcare Transition Education in a RE-AIM Framework | 2026-11-30 |
| NCT04236479Catherine BollardMesenchymal Stromal Cells for Infants With Congenital Heart Disease (MedCaP) | 2026-12 |
Among the 356 studies in Heart Defects, Congenital with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 507 interventional studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Jamie Jackson is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Compared within Heart Defects, Congenital, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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).
Behavioral: Physical Activity Lifestyle Intervention · Behavioral: Physical Activity Monitoring
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.
Also known as: Fitbit
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
Time frame: From baseline to follow-up (approximately 22 weeks).
Sedentary Behavior
Baseline to follow-up change in number of minutes spent being sedentary as measured by an accelerometer.
Time frame: 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.
Time frame: From baseline to follow-up (approximately 22 weeks).
| Milestone | Fitbit Only | Fitbit + Coaching Sessions |
|---|---|---|
| Started | 29 | 31 |
| Completed | 25 | 30 |
| Not completed | 4 | 1 |
| Withdrew: Did not wear accelerometer | 4 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 |
Baseline to follow-up change in number of minutes spent in moderate to vigorous physical activity as measured by an accelerometer
| average minutes per day | Fitbit Only | Fitbit + Coaching Sessions |
|---|---|---|
| Moderate to Vigorous Physical Activity (MVPA) | -1.9 ± 12.4 | 3.4 ± 22.8 |
Baseline to follow-up change in number of minutes spent being sedentary as measured by an accelerometer.
| average minutes per day | Fitbit Only | Fitbit + Coaching Sessions |
|---|---|---|
| Sedentary Behavior | -7.2 ± 146.9 | -33.6 ± 109.9 |
Baseline to follow-up change in maximal oxygen utilization during physical activity as measured by VO2peak during an exercise stress test.
| mL/kg/min | Fitbit Only | Fitbit + Coaching Sessions |
|---|---|---|
| Exercise Tolerance | -1.72 ± 3.23 | -0.57 ± 3.11 |
Collected over Randomization to follow-up (approximately 22 weeks). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fitbit Only | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Fitbit + Coaching Sessions | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Age, Continuous(years) | Fitbit Only | Fitbit + Coaching Sessions | Total |
|---|---|---|---|
| Mean | 15.9 ± 0.9 | 16.7 ± 1.0 | 16.3 ± 1.0 |
| Sex: Female, Male(Participants) | Fitbit Only | Fitbit + Coaching Sessions | Total |
|---|---|---|---|
| Female | 15 | 13 | 28 |
| Male | 14 | 18 | 32 |
| Ethnicity (NIH/OMB)(Participants) | Fitbit Only | Fitbit + Coaching Sessions | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 28 | 30 | 58 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Fitbit Only | Fitbit + Coaching Sessions | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 2 | 5 |
| White | 24 | 28 | 52 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 1 | 1 | 2 |
| MVPA(average minutes per day) | Fitbit Only | Fitbit + Coaching Sessions | Total |
|---|---|---|---|
| Mean | 19.0 ± 10.8 | 20.5 ± 13.9 | 19.8 ± 12.4 |
| Sedentary Behavior(average minutes per day) | Fitbit Only | Fitbit + Coaching Sessions | Total |
|---|---|---|---|
| Mean | 557.7 ± 106.0 | 578.9 ± 105.3 | 568.7 ± 105.3 |
| VO2Peak(mL/kg/min) | Fitbit Only | Fitbit + Coaching Sessions | Total |
|---|---|---|---|
| Mean | 37.7 ± 9.2 | 37.6 ± 10.0 | 37.6 ± 9.5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2017 to primary completion in Apr 2021, 41 months.
Results were first posted in Mar 2023, 1 year 10 months after primary completion.
Of 205 non-industry interventional studies with no phase under Heart Defects, Congenital, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's 41 months is above that.
Counting every sponsor, half of 223 studies reached it within 34 months; a quarter within 17 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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