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

NCT01394705 | Completed Results DMC

• 1 other identifier: P00000416
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease Risk High

Keywords

patients at increased risk for atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Physical Activity

  Total time (minutes) in Physical Activity in one week

  Baseline, 3 months

Secondary Outcomes (1)

• Body Mass Index

  Baseline, 3 months

Study Arms (2)

Standard of Care

NO INTERVENTION

standard of care (office provider exercise counseling)

Intervention

EXPERIMENTAL

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

Device: BodyMedia

Interventions

BodyMedia DEVICE

Accelerometer

Intervention

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Childrens Hospital

Boston, Massachusetts, 02115, United States

Location

Results Point of Contact

• Title: Tracy Curran
• Organization: Boston Children's Hospial

tracy.curran@cardio.chboston.org

617355-5445

Study Officials

• Tracy c Curran, MS

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Exercise Physiologist

Study Record Dates

• First Submitted: June 14, 2011
• First Posted: July 14, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: May 29, 2019
• Results First Posted: May 29, 2019

Record last verified: 2019-05

Locations

US (1)