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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 currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Children's Hospital Boston
Sponsor:
Information provided by (Responsible Party):
Tracy Curran, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01394705
First received: June 14, 2011
Last updated: July 30, 2013
Last verified: July 2013

June 14, 2011
July 30, 2013
June 2011
May 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01394705 on ClinicalTrials.gov Archive Site
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.
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Coronary Artery Disease Risk High
Device: BodyMedia
Accelerometer
Experimental: Standard of Care
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.
 
Recruiting
60
December 2014
May 2014   (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
Both
13 Years to 21 Years
Yes
Contact: Tracy C Curran, MS 617-355-5445 tracy.curran@cardio.chboston.org
United States
 
NCT01394705
P00000416
Yes
Tracy Curran, Children's Hospital Boston
Children's Hospital Boston
Not Provided
Principal Investigator: Tracy c Curran, MS Children's Hospital Medical Center, Cincinnati
Children's Hospital Boston
July 2013

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