N/A N=42 Randomized Health Services Research

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

Bottom Line

View on ClinicalTrials.gov: NCT01394705 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Physical Activity — 457; 443; 364; 279 minutes per week — p=.65

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: BodyMedia (Device)
Age: Pediatric, Adult · 13+ yrs
Sex: All
Sponsor: Boston Children's Hospital
Primary completion: Aug 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Physical Activity	457; 443; 364; 279	.65
SECONDARY Body Mass Index	30; 33; 30; 32	0.76

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 Criteria

Inclusion Criteria

Patients at increased risk of atherosclerosis based on lipid profiles (Total Cholesterol > 199 mg/dL, High Density Lipoprotein 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

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Data sourced from ClinicalTrials.gov (NCT01394705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.