Trials Sponsors Conditions Drugs Pricing

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

BodyMediaDevice

Accelerometer

Intervention

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age13 Years - 21 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (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

Sponsors & Collaborators

Boston Children's Hospital
Otherlead

Study Sites (1)

Childrens Hospital

Boston, Massachusetts, 02115, United States

Results Point of Contact

Title: Tracy Curran
Organization: Boston Children's Hospial

Study Officials

Tracy c Curran, MS
Children's Hospital Medical Center, Cincinnati
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes
Restrictive Agreement: No

Enrollment

42 participants (actual enrollment reported by the registry).

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 2011

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Standard of Care

Intervention

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Standard of Care

Intervention

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations