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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 | Clinical Trials | Clareo Health

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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

NCT01394705•Boston Children's Hospital

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

13 - 21 years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (1)

Childrens Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

June 1, 2011

Primary Completion Date

August 1, 2017

Completion Date

September 1, 2017

Last Updated

May 29, 2019

Enrollment

ACTUAL participants

Conditions

Coronary Artery Disease Risk High

Interventions

BodyMedia

DEVICE

Use of Mechanical Left ventricuLar Unloading in Complex Higher-risk Indicated Procedures

NCT07380217

High-risk PCICoronary Artery Disease Risk High

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 29, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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