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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
June 14, 2011
July 14, 2011
November 17, 2017
June 2011
August 2017   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01394705 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
FITT Exercise Counseling With Interactive Accelerometry and Physical Activity in Adolescents at Increased Risk of Early Cardiovascular Disease: A Pilot Study
FITT Exercise Counseling With Interactive Accelerometry and Physical Activity in Adolescents at Increased Risk of Early Cardiovascular Disease: A Pilot Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Coronary Artery Disease Risk High
Device: BodyMedia
Accelerometer
  • Experimental: Standard of Care
    Intervention: Device: BodyMedia
  • Experimental: Intervention
    Intervention: Device: BodyMedia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
September 2017
August 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
13 Years to 21 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01394705
P00000416
Yes
Not Provided
Not Provided
Tracy Curran, Boston Children's Hospital
Boston Children’s Hospital
Not Provided
Principal Investigator: Tracy c Curran, MS Children's Hospital Medical Center, Cincinnati
Boston Children’s Hospital
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP