Executive Function, Fitness, Overweight and Obesity, Physical Activity, Quality of Life
Conditions
Brief summary
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.
Interventions
OTHERBOKS Program
12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session.
Sponsors
American Council on Exercise
BOKS
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
* Enrolled in the BOKS program * Participating school * Age 5-14
Exclusion criteria
* No valid consent * Not enrolled in BOKS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (kg/m^2) | Baseline, Follow-up for each session (12 weeks) | calculated from height and weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Executive Function | Baseline, Follow-up for each session (12 weeks) | Executive function and attention/concentration as measured by the Flanker Task |
| Change in Quality of Life PedsQL | Baseline, Follow-up for each session (12 weeks) | Measured by PedsQL, a validated measure of pediatric self-rated quality of life with higher score indicating higher quality of life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 86 |
| 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. | 42 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 17 | 43 |
Baseline characteristics
| Characteristic | Spring 2018 Participation | Fall 2018 Participation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 86 Participants | 42 Participants | 128 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 9.2 years STANDARD_DEVIATION 2.2 | 9.2 years STANDARD_DEVIATION 2.2 | 9.2 years STANDARD_DEVIATION 2.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants | 21 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 14 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants | 7 Participants | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 13 Participants | 2 Participants | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 7 Participants | 19 Participants |
| Race (NIH/OMB) White | 51 Participants | 30 Participants | 81 Participants |
| Region of Enrollment United States | 86 Participants | 42 Participants | 128 Participants |
| Sex: Female, Male Female | 41 Participants | 26 Participants | 67 Participants |
| Sex: Female, Male Male | 45 Participants | 16 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 0 / 42 |
| other Total, other adverse events | 0 / 86 | 0 / 42 |
| serious Total, serious adverse events | 0 / 86 | 0 / 42 |
Outcome results
Primary
Change in Body Mass Index (kg/m^2)
calculated from height and weight
Time frame: Baseline, Follow-up for each session (12 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spring 2018 Participation | Change in Body Mass Index (kg/m^2) | 0.14 kg/m^2 (BMI change) | Standard Deviation 0.63 |
| Fall 2018 Participation | Change in Body Mass Index (kg/m^2) | 0.01 kg/m^2 (BMI change) | Standard Deviation 0.7 |
Secondary
Change in Executive Function
Executive function and attention/concentration as measured by the Flanker Task
Time frame: Baseline, Follow-up for each session (12 weeks)
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.
Time frame: Baseline, Follow-up for each session (12 weeks)