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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01394705
First Posted: July 14, 2011
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tracy Curran, Boston Children's Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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 Tracy Curran, Boston Children's Hospital:

Primary Outcome Measures:
  • Increase Physical Activity [ Time Frame: 3 months ]
    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 ]
    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.


Enrollment: 38
Study Start Date: June 2011
Study Completion Date: September 2017
Primary Completion Date: August 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

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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): 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
First Submitted: June 14, 2011
First Posted: July 14, 2011
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by Tracy Curran, 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