Back to resultsFITT Exercise Counseling With Interactive Accelerometry and Physical Activity in Adolescents at Increased Risk of Early Cardiovascular Disease: A Pilot Study
Primary Purpose
Coronary Artery Disease Risk High
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BodyMedia
Sponsored by
About this trial
This is an interventional health services research trial for Coronary Artery Disease Risk High focused on measuring patients at increased risk for atherosclerosis
Eligibility Criteria
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
Sites / Locations
- Childrens Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of Care
Intervention
Arm Description
standard of care (office provider exercise counseling)
The intervention group received a personalized exercise prescription (using the FITT principles) and wore an accelerometer up to 7days/week (most waking hours) and logged their activity by regularly (3 times a week) uploading the device for a period of 3 months, use of the internet was supervised by a parent or guardian. Their activity was monitored via the online BodyMedia site on a regular basis by study personnel and feedback was provided at least once a week through email and/or phone calls
Outcomes
Primary Outcome Measures
Physical Activity
Total time (minutes) in Physical Activity in one week
Secondary Outcome Measures
Body Mass Index
Secondary hypotheses include greater improvement in body mass index (BMI) reported below.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01394705
Brief Title
FITT Exercise Counseling With Interactive Accelerometry and Physical Activity in Adolescents at Increased Risk of Early Cardiovascular Disease: A Pilot Study
Official Title
FITT Exercise Counseling With Interactive Accelerometry and Physical Activity in Adolescents at Increased Risk of Early Cardiovascular Disease: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease Risk High
Keywords
patients at increased risk for atherosclerosis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
standard of care (office provider exercise counseling)
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention group received a personalized exercise prescription (using the FITT principles) and wore an accelerometer up to 7days/week (most waking hours) and logged their activity by regularly (3 times a week) uploading the device for a period of 3 months, use of the internet was supervised by a parent or guardian. Their activity was monitored via the online BodyMedia site on a regular basis by study personnel and feedback was provided at least once a week through email and/or phone calls
Intervention Type
Device
Intervention Name(s)
BodyMedia
Intervention Description
Accelerometer
Primary Outcome Measure Information:
Title
Physical Activity
Description
Total time (minutes) in Physical Activity in one week
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Body Mass Index
Description
Secondary hypotheses include greater improvement in body mass index (BMI) reported below.
Time Frame
Baseline, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy c Curran, MS
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
FITT Exercise Counseling With Interactive Accelerometry and Physical Activity in Adolescents at Increased Risk of Early Cardiovascular Disease: A Pilot Study
We'll reach out to this number within 24 hrs