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OpenTrials
Completed

NCT Number: NCT01394705

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.

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Key information

Conditions

Coronary Artery Disease Risk High

Age range

13 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Childrens Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • Ages 13-21 years
  • Reporting an average of less than 60 minutes per day of moderate to vigorous exercise most (5) days of the week.
  • Regular access to the internet with the capacity to download the device
  • Commitment on the part of a parent to supervise internet access as part of this protocol

Exclusion criteria

  • Unable to exercise based on physician recommendations or medical conditions
  • Unable/unwilling to complete requirements of the research study including consent and assent.
  • Not proficient in English

Treatment and study plan

BodyMedia

Device

Accelerometer

Primary outcomes

  1. Physical Activity

    Time frame: Baseline, 3 months

    Total time (minutes) in Physical Activity in one week

Secondary outcomes

  1. Body Mass Index

    Time frame: Baseline, 3 months

    Secondary hypotheses include greater improvement in body mass index (BMI) reported below.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jul 14, 2011
Registry last updated
May 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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