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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BodyMedia | Device | Accelerometer |
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| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity | Total time (minutes) in Physical Activity in one week | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | Secondary hypotheses include greater improvement in body mass index (BMI) reported below. | Baseline, 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tracy c Curran, MS | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital | Boston | Massachusetts | 02115 | United States |
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38 completed study, 21 randomized to each group, 2 lost to follow-up in each group with an N of 19 in each group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | BodyMedia: Accelerometer |
| FG001 | Intervention | BodyMedia: Accelerometer |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 25, 2011 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | BodyMedia: Accelerometer |
| BG001 | Intervention | BodyMedia: Accelerometer |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Physical Activity | Total time (minutes) in Physical Activity in one week | Posted | Median | Full Range | minutes per week | Baseline, 3 months |
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| Secondary | Body Mass Index | Secondary hypotheses include greater improvement in body mass index (BMI) reported below. | Posted | Median | Full Range | BMI (kg/m2) | Baseline, 3 months |
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Study participant data was collected for 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care | BodyMedia: Accelerometer | 0 | 21 | 0 | 21 | 0 | 21 |
| EG001 | Intervention | BodyMedia: Accelerometer | 0 | 21 | 0 | 21 | 0 | 21 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tracy Curran | Boston Children's Hospial | 617355-5445 | tracy.curran@cardio.chboston.org |
| May 1, 2019 |
| Prot_SAP_000.pdf |
| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Superiority |
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