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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL103841 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The study aims are to develop and test the feasibility of a pediatric physical activity intervention that incorporates personal information on use of the built environment, and test the intervention's preliminary efficacy at increasing physical activity. The investigators hypothesize that it will be feasible to incorporate and measure changes in empiric GIS (geographic information system), GPS (global positioning system), and accelerometer feedback in the office setting as demonstrated by: i) Completeness of GPS and accelerometer data collection (primary measure of feasibility), ii) Participation rates among adolescents in the intervention group compared to the control group, and iii) Acceptability to patients as measured by adolescent satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard physical activity counseling | No Intervention | ||
| built environment use counseling | Experimental | personalized counseling on active use of the built environment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| built environment use counseling | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Moderate to Vigorous Physical Activity (MVPA) | Short-term change in MVPA from baseline to post-intervention | Immediately post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Moderate-to-Vigorous Physical Activity (MVPA) | Longer term change in MVPA from baseline to 3-4 months post intervention | 4 months from baseline |
| Sedentary Time | Short-term change in sedentary (non-active) time from baseline to post-intervention, objectively measured using accelerometers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas M Oreskovic, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Revere HealthCare Center | Revere | Massachusetts | 02151 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27235377 | Derived | Oreskovic NM, Winickoff JP, Perrin JM, Robinson AI, Goodman E. A Multimodal Counseling-Based Adolescent Physical Activity Intervention. J Adolesc Health. 2016 Sep;59(3):332-337. doi: 10.1016/j.jadohealth.2016.03.012. Epub 2016 May 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Physical Activity Counseling | standard pedatric physical activity counseling |
| FG001 | Built Environment Use Counseling | personalized counseling on active use of the built environment built environment use counseling |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Physical Activity Counseling | standard pediatric physical activity counseling |
| BG001 | Built Environment Use Counseling | personalized counseling on active use of the built environment built environment use counseling |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Moderate to Vigorous Physical Activity (MVPA) | Short-term change in MVPA from baseline to post-intervention | Posted | Median | Inter-Quartile Range | minutes | Immediately post-intervention |
|
|
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The meaning of "0" Total Number of Participants at Risk (e.g., "All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events) were not monitored/assessed.
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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 Physical Activity Counseling | standard pedatric physical activity counseling |
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Small sample size, single office setting, short term (4 months) follow-up, multi-component intervention including financial incentives and text messages.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nicolas Oreskovic | MGH | 6177260593 | noreskovic@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Immediately post-intervention |
| Sedentary Time | Longer-term change in sedentary (non-active) time from baseline to 3-4 months post-intervention, objectively measured using accelerometers. | 4 months from baseline |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI percentile | Mean | Standard Deviation | BMI percentile |
|
| parental education | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Moderate-to-Vigorous Physical Activity (MVPA) | Longer term change in MVPA from baseline to 3-4 months post intervention | Posted | Median | Inter-Quartile Range | minutes | 4 months from baseline |
|
|
|
| Secondary | Sedentary Time | Short-term change in sedentary (non-active) time from baseline to post-intervention, objectively measured using accelerometers | Posted | Median | Standard Deviation | minutes | Immediately post-intervention |
|
|
|
| Secondary | Sedentary Time | Longer-term change in sedentary (non-active) time from baseline to 3-4 months post-intervention, objectively measured using accelerometers. | Posted | Median | Standard Deviation | minutes | 4 months from baseline |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Built Environment Use Counseling | personalized counseling on active use of the built environment built environment use counseling | 0 | 0 | 0 | 0 | 0 | 0 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |