Cardiovascular Disease OtherCHD-PALSNCT03335475
Congenital Heart Disease Physical Activity Lifestyle Study
A study testing Physical Activity Lifestyle Intervention and Physical Activity Monitoring in people with Cardiovascular Disease Other and Physical Activity, run by Jamie Jackson at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Cardiovascular Disease Other, Physical Activity
- What is being tested?
- Physical Activity Lifestyle Intervention and Physical Activity Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2017to 7 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between the ages of 15-18 (if 18, must be in high school and/or still living at home)
- Are diagnosed with moderate or complex structural congenital heart disease
- Live within 120 miles of Nationwide Children's Hospital
Who cannot join
- 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
Show all 11Show fewer
- 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)
- >60 min/day of moderate-to-vigorous physical activity per the accelerometer
- Do not have internet access or a device for videoconferencing with a PA coach
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
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
- Being tested
- Physical Activity Lifestyle Intervention, Physical Activity Monitoring
- Keywords
- congenital heart disease, physical activity
- Medical subject headings
- Motor Activity, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity Lifestyle InterventionBehavioural
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 MonitoringBehavioural
Also called Fitbit
A physical activity monitor (Fitbit) will be provided to both groups.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Physical Activity Monitoring |
| Fitbit + Coaching Sessions | Experimental | 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). Receives: Behavioral: Physical Activity Lifestyle Intervention; Behavioral: Physical Activity Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline to follow-up (approximately 22 weeks).
Secondary outcomes (2)
Sedentary Behavior
Baseline to follow-up change in number of minutes spent being sedentary as measured by an accelerometer.
Measured: 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.
Measured: From baseline to follow-up (approximately 22 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start7 Nov 2017
- Primary completion7 Apr 2021
- Study completion7 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Disease OtherStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study includes 2 possible conditions to which participants are randomized: (1) Fitbit only and (2) Fitbit + coaching sessions.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jamie Jackson
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Jamie Jackson, Nationwide Children's Hospital
- Investigators
- Jamie L Jackson, PhD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335475
- Sponsor's protocol ID
- IRB16-00717
- Other IDs
- K23HL127224
- Acronym
- CHD-PALS
- Status last verified
- May 2023
- First submitted
- 3 Nov 2017
- Last updated
- 3 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34951444
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Congenital Heart Disease Physical Activity Lifestyle Study
- ClinicalTrials.gov ID
- NCT03335475
- Acronym / sponsor ID
- CHD-PALS / IRB16-00717
- Conditions
- Cardiovascular Disease Other, Physical Activity
- Keywords
- congenital heart disease, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jamie JacksonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 7 Apr 2021 (actual)
- Study completion
- 7 Apr 2021 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Posted 2 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study includes 2 possible conditions to which participants are randomized: (1) Fitbit only and (2) Fitbit + coaching sessions.
| Arm | Type | Receives |
|---|---|---|
| Fitbit Only | Active comparator | Behavioral: Physical Activity MonitoringIn 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). |
| Fitbit + Coaching Sessions | Experimental | Behavioral: Physical Activity Lifestyle Intervention, Behavioral: Physical Activity MonitoringIn 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). |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Between the ages of 15-18 (if 18, must be in high school and/or still living at home)
- Are diagnosed with moderate or complex structural congenital heart disease
- Live within 120 miles of Nationwide Children's Hospital
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity Lifestyle InterventionCoaches 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. | Behavioural | Fitbit + Coaching Sessions |
| Physical Activity MonitoringAlso: FitbitA physical activity monitor (Fitbit) will be provided to both groups. | Behavioural | Fitbit + Coaching Sessions, Fitbit Only |
Primary outcome
Moderate to Vigorous Physical Activity (MVPA)
Time frame: From baseline to follow-up (approximately 22 weeks).
Baseline to follow-up change in number of minutes spent in moderate to vigorous physical activity as measured by an accelerometer
2 secondary outcomes
Sedentary Behavior
Time frame: From baseline to follow-up (approximately 22 weeks).
Exercise Tolerance
Time frame: From baseline to follow-up (approximately 22 weeks).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34951444Jackson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie L Jackson, PhD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Lifestyle Intervention and Physical Activity Monitoring in people with Cardiovascular Disease Other and Physical Activity, run by Jamie Jackson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate to Vigorous Physical Activity (MVPA) (time frame: From baseline to follow-up (approximately 22 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03335475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.