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FITT Exercise Counseling With Interactive Accelerometry and Physical Activity in Adolescents at Increased Risk of Early Cardiovascular Disease: A Pilot Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tracy Curran, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT01394705
First received: June 14, 2011
Last updated: December 5, 2016
Last verified: December 2016
  Purpose

This pilot study seeks to compare the change in energy expenditure and fitness levels of patients seen in the Children's Hospital Preventive Cardiology program receiving standard of care provider exercise counseling to similar patients receiving Frequency, Intensity, Time, Type (FITT) exercise prescription and counseling combined with BodyMedia supported by an online interactive tool.

The investigators primary hypothesis is that this interactive technology coupled with support from a exercise specialist will increase the energy expenditure of the investigators patients over standard of care provider counseling.

The investigators Secondary hypotheses include greater improvement in measured physical fitness Peak oxygen consumption (VO2max), oxygen consumption (VO2) at anaerobic threshold (AT) and ventilation/carbon dioxide (VE/VCO2) slope, lipid profiles, blood pressure, arterial stiffness, body mass index (BMI), BMI percentile, and self-efficacy in the intervention group compared to control.


Condition Intervention
Coronary Artery Disease Risk High
Device: BodyMedia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: FITT Exercise Counseling With Interactive Accelerometry and Physical Activity in Adolescents at Increased Risk of Early Cardiovascular Disease: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Boston Children’s Hospital:

Primary Outcome Measures:
  • Increase Physical Activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Our primary hypothesis is that this interactive technology coupled with support from a exercise specialist will increase the energy expenditure of our patients over standard of care provider counseling


Secondary Outcome Measures:
  • Improve risk factors [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Secondary hypotheses include greater improvement in measured physical fitness Peak oxygen consumption (VO2max), oxygen consumption (VO2) at anaerobic threshold (AT) and ventilation/carbon dioxide (VE/VCO2) slope, lipid profiles, blood pressure, arterial stiffness, body mass index (BMI), BMI percentile, and self-efficacy in the intervention group compared to control.


Estimated Enrollment: 40
Study Start Date: June 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard of Care Device: BodyMedia
Accelerometer
Experimental: Intervention Device: BodyMedia
Accelerometer

  Eligibility

Ages Eligible for Study:   13 Years to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients at increased risk of atherosclerosis based on lipid profiles (Total Cholesterol > 199 mg/dL, High Density Lipoprotein < 40 mg/dL, LDL > 129 mg/dL, blood pressure (Systolic Blood Pressure or Diastolic Blood Pressure > 90th percentile), obesity (>85%Body Mass Index)
  2. Ages 13-21 years
  3. Reporting an average of less than 60 minutes per day of moderate to vigorous exercise most (5) days of the week.
  4. Regular access to the internet with the capacity to download the device
  5. Commitment on the part of a parent to supervise internet access as part of this protocol

Exclusion Criteria:

  1. Unable to exercise based on physician recommendations or medical conditions
  2. Unable/unwilling to complete requirements of the research study including consent and assent.
  3. Not proficient in English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394705

Locations
United States, Massachusetts
Childrens Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
Principal Investigator: Tracy c Curran, MS Children's Hospital Medical Center, Cincinnati
  More Information

Responsible Party: Tracy Curran, Clinical Exercise Physiologist, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT01394705     History of Changes
Other Study ID Numbers: P00000416 
Study First Received: June 14, 2011
Last Updated: December 5, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Children’s Hospital:
patients at increased risk for atherosclerosis

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on December 07, 2016