Trial Outcomes & Findings for Implementation and Evaluation of a Before School Physical Activity Program in Revere, MA (NCT NCT03805295)
NCT ID: NCT03805295
Last Updated: 2025-12-23
Results Overview
calculated from height and weight
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
188 participants
Primary outcome timeframe
Baseline, Follow-up for each session (12 weeks)
Results posted on
2025-12-23
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
85
|
|
Overall Study
COMPLETED
|
86
|
42
|
|
Overall Study
NOT COMPLETED
|
17
|
43
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
17
|
43
|
Baseline Characteristics
Implementation and Evaluation of a Before School Physical Activity Program in Revere, MA
Baseline characteristics by cohort
| Measure |
Spring 2018 Participation
n=86 Participants
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.
|
Fall 2018 Participation
n=42 Participants
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.
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
86 Participants
n=68 Participants
|
42 Participants
n=4 Participants
|
128 Participants
n=219 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
|
Age, Continuous
|
9.2 years
STANDARD_DEVIATION 2.2 • n=68 Participants
|
9.2 years
STANDARD_DEVIATION 2.2 • n=4 Participants
|
9.2 years
STANDARD_DEVIATION 2.2 • n=219 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=68 Participants
|
26 Participants
n=4 Participants
|
67 Participants
n=219 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=68 Participants
|
16 Participants
n=4 Participants
|
61 Participants
n=219 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=68 Participants
|
21 Participants
n=4 Participants
|
52 Participants
n=219 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=68 Participants
|
14 Participants
n=4 Participants
|
57 Participants
n=219 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=68 Participants
|
7 Participants
n=4 Participants
|
19 Participants
n=219 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=68 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=68 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=219 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=68 Participants
|
30 Participants
n=4 Participants
|
81 Participants
n=219 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=68 Participants
|
2 Participants
n=4 Participants
|
15 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=68 Participants
|
7 Participants
n=4 Participants
|
19 Participants
n=219 Participants
|
|
Region of Enrollment
United States
|
86 Participants
n=68 Participants
|
42 Participants
n=4 Participants
|
128 Participants
n=219 Participants
|
PRIMARY outcome
Timeframe: Baseline, Follow-up for each session (12 weeks)calculated from height and weight
Outcome measures
| Measure |
Spring 2018 Participation
n=76 Participants
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.
|
Fall 2018 Participation
n=31 Participants
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.
|
|---|---|---|
|
Change in Body Mass Index (kg/m^2)
|
0.14 kg/m^2 (BMI change)
Standard Deviation 0.63
|
0.01 kg/m^2 (BMI change)
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Baseline, Follow-up for each session (12 weeks)Executive function and attention/concentration as measured by the Flanker Task
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
Adverse Events
Spring 2018 Participation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fall 2018 Participation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place