Trial Outcomes & Findings for Be a Champion! Comprehensive School Physical Activity Program (NCT NCT02465372)

Results Overview

Physical activity measured using an accelerometer at baseline and one-year follow-up (spring 2015 and spring 2016).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

599 participants

Primary outcome timeframe

baseline and one-year follow-up

Results posted on

2018-11-14

Participant Flow

Unit of analysis: Schools

Participant milestones

Participant milestones
Measure	CSPAP Schools in this arm will receive the Comprehensive School Physical Activity Program training. CSPAP: Comprehensive School Physical Activity Program.	Control Standard practice.
Overall Study STARTED	349 3	250 2
Overall Study COMPLETED	227 3	153 2
Overall Study NOT COMPLETED	122 0	97 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Be a Champion! Comprehensive School Physical Activity Program

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CSPAP n=227 Participants Schools in this arm will receive the Comprehensive School Physical Activity Program training. CSPAP: Comprehensive School Physical Activity Program.	Control n=153 Participants Standard practice.	Total n=380 Participants Total of all reporting groups
Age, Categorical <=18 years	227 Participants n=5 Participants	153 Participants n=7 Participants	380 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	127 Participants n=5 Participants	75 Participants n=7 Participants	202 Participants n=5 Participants
Sex: Female, Male Male	100 Participants n=5 Participants	78 Participants n=7 Participants	178 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and one-year follow-up

Physical activity measured using an accelerometer at baseline and one-year follow-up (spring 2015 and spring 2016).

Outcome measures

Outcome measures
Measure	CSPAP n=227 Participants Schools in this arm will receive the Comprehensive School Physical Activity Program training. CSPAP: Comprehensive School Physical Activity Program.	Control n=153 Participants Standard practice.
Change in Youth Physical Activity baseline	32.13 minutes/day Standard Deviation 16.91	36.47 minutes/day Standard Deviation 16.33
Change in Youth Physical Activity one-year follow-up	33.16 minutes/day Standard Deviation 16.70	36.50 minutes/day Standard Deviation 16.69

SECONDARY outcome

Timeframe: Up to nine months.

Implementation monitoring to determine feasibility of the program as indicated by the percentage of planned tasks achieved with full fidelity and as determined by the number who, a) assembled an implementation team, b) completed all trainings, c) completed self-assessments, d) developed action plans, and e) executed at least one component of their action plans.

Outcome measures

Outcome measures
Measure	CSPAP n=3 Schools Schools in this arm will receive the Comprehensive School Physical Activity Program training. CSPAP: Comprehensive School Physical Activity Program.	Control n=2 Schools Standard practice.
Feasibility of the Be a Champion! Program	3 schools	2 schools

SECONDARY outcome

Timeframe: Up to nine months.

Number of schools that indicated BAC was acceptable, based upon qualitative and quantitative feedback from principals, classroom teachers, and implementation teams.

Outcome measures

Outcome measures
Measure	CSPAP n=3 Schools Schools in this arm will receive the Comprehensive School Physical Activity Program training. CSPAP: Comprehensive School Physical Activity Program.	Control n=2 Schools Standard practice.
Acceptability of the Be a Champion! Program	3 number of schools	2 number of schools

Adverse Events

CSPAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Dr. Justin Moore

Wake Forest University Health Sciences

Phone: 336-716-3702

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place