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| Name | Class |
|---|---|
| American Council on Exercise | OTHER |
| BOKS | UNKNOWN |
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This study evaluates the implementation of the BOKS program in three schools (K-8) in Revere, MA, and its effect on participating students with regard to BMI, cognitive, and quality of life outcomes. BOKS (Build Our Kids' Success) is a before-school physical activity program that has been implemented in over 2,000 elementary and middle schools. Two sessions will be held (Spring 2018 and Winter 2018. This is a cohort study evaluating the impact of program participation on child BMI, quality of life, and executive function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spring 2018 Participation | Experimental | Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Winter-Spring 2018. They will serve as the control group in Fall 2018. |
|
| Fall 2018 Participation | Experimental | Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Fall 2018. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BOKS Program | Other | 12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass Index (kg/m^2) | calculated from height and weight | Baseline, Follow-up for each session (12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Executive Function | Executive function and attention/concentration as measured by the Flanker Task | Baseline, Follow-up for each session (12 weeks) |
| Change in Quality of Life PedsQL | Measured by PedsQL, a validated measure of pediatric self-rated quality of life with higher score indicating higher quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elsie Taveras, MD | MGH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Spring 2018 Participation | Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Winter-Spring 2018. They will serve as the control group in Fall 2018. BOKS Program: 12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session. |
| FG001 | Fall 2018 Participation | Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Fall 2018. BOKS Program: 12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Spring 2018 Participation | Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Winter-Spring 2018. They will serve as the control group in Fall 2018. BOKS Program: 12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session. |
| BG001 |
| 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 | Change in Body Mass Index (kg/m^2) | calculated from height and weight | Posted | Mean | Standard Deviation | kg/m^2 (BMI change) | Baseline, Follow-up for each session (12 weeks) |
|
12 weeks
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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 | Spring 2018 Participation | Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Winter-Spring 2018. They will serve as the control group in Fall 2018. BOKS Program: 12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rachel Whooten | Massachusetts General Hospital | 6176434585 | rwhooten@mgh.harvard.edu |
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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 | Aug 9, 2018 | Dec 19, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 14, 2018 | Dec 19, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Baseline, Follow-up for each session (12 weeks) |
| Fall 2018 Participation |
Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Fall 2018. BOKS Program: 12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Count of Participants | Participants |
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|
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| Secondary | Change in Executive Function | Executive function and attention/concentration as measured by the Flanker Task | Not Posted | Baseline, Follow-up for each session (12 weeks) | Participants |
| Secondary | Change in Quality of Life PedsQL | Measured by PedsQL, a validated measure of pediatric self-rated quality of life with higher score indicating higher quality of life. | Not Posted | Baseline, Follow-up for each session (12 weeks) | Participants |
| 0 |
| 86 |
| 0 |
| 86 |
| 0 |
| 86 |
| EG001 | Fall 2018 Participation | Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Fall 2018. BOKS Program: 12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session. | 0 | 42 | 0 | 42 | 0 | 42 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |