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Congenital Heart Disease Physical Activity Lifestyle Study (CHD-PALS)

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ClinicalTrials.gov Identifier: NCT03335475
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Jamie Jackson, Nationwide Children's Hospital

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.


Condition or disease Intervention/treatment Phase
Cardiovascular Disease Other Physical Activity Behavioral: Physical Activity Lifestyle Intervention Behavioral: Physical Activity Monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study includes 2 possible conditions to which participants are randomized: (1) Fitbit only and (2) Fitbit + coaching sessions.
Masking: None (Open Label)
Masking Description: Investigator, research assistants, coaches (interventionists), and participants do not know which condition a participant is in until the condition is revealed (opening an envelop with the condition listed) after the participant assents/consents to Phase 2. Envelopes with the conditions were prepared by the study statistician.
Primary Purpose: Prevention
Official Title: Congenital Heart Disease Physical Activity Lifestyle Study
Actual Study Start Date : October 5, 2017
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : April 10, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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).
Behavioral: Physical Activity Monitoring
A physical activity monitor (Fitbit) will be provided to both groups.
Other Name: Fitbit

Experimental: 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).
Behavioral: 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.

Behavioral: Physical Activity Monitoring
A physical activity monitor (Fitbit) will be provided to both groups.
Other Name: Fitbit




Primary Outcome Measures :
  1. Moderate to vigorous physical activity [ Time Frame: From baseline to follow-up (approximately 22 weeks). ]
    Number of minutes spent in moderate to vigorous physical activity as measured by an accelerometer


Secondary Outcome Measures :
  1. Sedentary behavior [ Time Frame: From baseline to follow-up (approximately 22 weeks). ]
    Number of minutes spent being sedentary as measured by an accelerometer.

  2. Exercise tolerance [ Time Frame: From baseline to follow-up (approximately 22 weeks). ]
    Maximal oxygen utilization during physical activity as measured by V02max during an exercise stress test.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Between the ages of 15-25
  2. Are diagnosed with moderate or complex structural congenital heart disease
  3. Live within 120 miles of Nationwide Children's Hospital
  4. Able to complete an exercise stress test on a treadmill

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335475


Contacts
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Contact: Jamie L Jackson, PhD 6147223585 jamie.jackson2@nationwidechildrens.org

Locations
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United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Jamie L Jackson, PhD    614-722-3585    jamie.jackson2@nationwidechildrens.org   
Sponsors and Collaborators
Jamie Jackson
Investigators
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Principal Investigator: Jamie L Jackson, PhD Nationwide Children's Hospital
  Study Documents (Full-Text)

Documents provided by Jamie Jackson, Nationwide Children's Hospital:

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Responsible Party: Jamie Jackson, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03335475     History of Changes
Other Study ID Numbers: IRB16-00717
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jamie Jackson, Nationwide Children's Hospital:
congenital heart disease
physical activity

Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities