Congenital Heart Disease Physical Activity Lifestyle Study V.2

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Jamie Jackson
Study ID
NCT06003023
Status
Recruiting
Apply to this trial

Conditions

  • Cardiovascular Disease Other
  • Heart Defects, Congenital

Eligibility Criteria

Sex
ALL
Age
15 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Physical Activity Monitoring — BEHAVIORAL
    A physical activity monitor (Fitbit) will be provided to participants in both arms.
  • Tailored Exercise Prescription — BEHAVIORAL
    Participants in both arms will receive the results of their exercise stress test, which includes information on the duration, frequency, and intensity of their physical activity.
  • Healthy Lifestyle Education — BEHAVIORAL
    Participants in both arms will receive information on healthy living, including topics such as physical activity, sleep, stress management, and diet.
  • Physical Activity Lifestyle Intervention Informed by the Theory of Planned Behavior — BEHAVIORAL
    Participants randomized to the CHD-PAL arm will receive coaching to: 1) change attitudes towards physical activity; 2) increase perceptions of other people's approval of physical activity; 3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance and will be accompanied by goal-setting.

Study Details

The Congenital Heart Disease Physical Activity Lifestyle Intervention Study (CHD-PALS) V.2 seeks to determine the efficacy of a lifestyle intervention program for adolescents and young adults (AYAs) with congenital heart disease (CHD). This trial was adapted from the original CHD-PAL trial to continue improving cardiovascular outcomes for transition-aged CHD survivors.

Key Dates

Start date
Jul 18, 2023
Status verified
May 2026
Primary completion
Jul 30, 2027
Completion
Jul 30, 2027

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Living Well with Congenital Heart Disease (LIV-CHD) Intervention
    In LIV-CHD, participants will receive a Fitbit and a tailored exercise prescription, as devised from their baseline exercise stress test results. They will also meet with a health coach for 9 virtual sessions over a period of 20 weeks. The content will focus on how to use the Fitbit along with health education pertinent to living a healthy lifestyle (e.g., sleep hygiene, stress management). Goal-setting and other cognitive behavioral strategies for health behavior change will not be discussed in this arm. Participants in the attention control arm will also receive text messages reminding them to wear their Fitbit.
  • Experimental: Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) Intervention
    In CHD-PAL, participants will receive a Fitbit and a tailored exercise prescription, as devised from their baseline exercise stress test results. They will also meet with a health coach for 9 virtual sessions over a period of 20 weeks. The content will focus on cognitive behavioral strategies, grounded in the Theory of Planned Behavior, to increase physical activity and healthy living. Participants in the intervention arm will also receive text motivational messages relevant to session content, as well as reminders to wear their Fitbit.

Primary Outcome Measure

Moderate to Vigorous Physical Activity (MVPA) [ Time Frame: Baseline to Weeks 20, 40, and 80 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43205
Jamie L Jackson, PhD
[email protected]
6147223585

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By research site
Nationwide Children's Hospital· Columbus, OH

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