FITT Exercise Counseling With Interactive Accelerometry and Physical Activity in Adolescents at Increased Risk of Early Cardiovascular Disease: A Pilot Study

Coronary Artery Disease Risk High Clinical Trial

Official title:

FITT Exercise Counseling With Interactive Accelerometry and Physical Activity in Adolescents at Increased Risk of Early Cardiovascular Disease: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394705
• Other study ID #: P00000416
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: September 2017

Study information

• Verified date: May 2019
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Artery Disease Risk High
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• BodyMedia
Accelerometer

Locations

Country	Name	City	State
United States	Childrens Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity	Total time (minutes) in Physical Activity in one week	Baseline, 3 months
Secondary	Body Mass Index	Secondary hypotheses include greater improvement in body mass index (BMI) reported below.	Baseline, 3 months