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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01394705 |
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Date of registration:
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14/06/2011 |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01394705 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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Countries of recruitment
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United States
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Contacts
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Name:
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Tracy c Curran, MS |
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Address:
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Telephone:
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617-355-5445 |
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Email:
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tracy.curran@cardio.chboston.org |
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Affiliation:
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Name:
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Tracy C Curran, MS |
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Address:
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Telephone:
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617-355-5445 |
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Email:
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tracy.curran@cardio.chboston.org |
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Affiliation:
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Name:
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Tracy c Curran, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital Medical Center, Cincinnati |
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Key inclusion & exclusion criteria
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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
Age minimum:
13 Years
Age maximum:
21 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coronary Artery Disease Risk High
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Intervention(s)
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Device: BodyMedia
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Primary Outcome(s)
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Increase Physical Activity
[Time Frame: 3 months]
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Secondary Outcome(s)
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Improve risk factors
[Time Frame: 3 months]
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Secondary ID(s)
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P00000416
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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