Trial Outcomes & Findings for Children's Use of the Built Environment for Physical Activity (NCT NCT01939405)

NCT ID: NCT01939405

Last Updated: 2017-10-02

Results Overview

Short-term change in MVPA from baseline to post-intervention

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: Immediately post-intervention
• Results posted on: 2017-10-02

Participant Flow

Participant milestones

Measure	Standard Physical Activity Counseling standard pedatric physical activity counseling	Built Environment Use Counseling personalized counseling on active use of the built environment built environment use counseling
Overall Study STARTED	30	30
Overall Study COMPLETED	27	28
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Children's Use of the Built Environment for Physical Activity

Baseline characteristics by cohort

Measure	Standard Physical Activity Counseling n=30 Participants standard pediatric physical activity counseling	Built Environment Use Counseling n=30 Participants personalized counseling on active use of the built environment built environment use counseling	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 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
Age, Continuous	11.6 years STANDARD_DEVIATION 1.0 • n=5 Participants	12.2 years STANDARD_DEVIATION 1.6 • n=7 Participants	11.9 years STANDARD_DEVIATION 1.4 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Multi/Other	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants
BMI percentile	94 BMI percentile STANDARD_DEVIATION 3.9 • n=5 Participants	94 BMI percentile STANDARD_DEVIATION 3.9 • n=7 Participants	94 BMI percentile STANDARD_DEVIATION 3.9 • n=5 Participants
parental education High School or less	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
parental education Associates degree or College	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
parental education Graduate Education	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
parental education missing	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately post-intervention

Short-term change in MVPA from baseline to post-intervention

Outcome measures

Measure	Standard Physical Activity Counseling n=27 Participants standard pedatric physical activity counseling	Built Environment Use Counseling n=28 Participants personalized counseling on active use of the built environment built environment use counseling
Moderate to Vigorous Physical Activity (MVPA)	-1.9 minutes Interval -14.1 to 3.7	1.07 minutes Interval -14.7 to 21.4

SECONDARY outcome

Timeframe: 4 months from baseline

Longer term change in MVPA from baseline to 3-4 months post intervention

Outcome measures

Measure	Standard Physical Activity Counseling n=27 Participants standard pedatric physical activity counseling	Built Environment Use Counseling n=28 Participants personalized counseling on active use of the built environment built environment use counseling
Moderate-to-Vigorous Physical Activity (MVPA)	0.5 minutes Interval -22.7 to 4.1	6.3 minutes Interval -31.1 to 11.8

SECONDARY outcome

Timeframe: Immediately post-intervention

Short-term change in sedentary (non-active) time from baseline to post-intervention, objectively measured using accelerometers

Outcome measures

Measure	Standard Physical Activity Counseling n=27 Participants standard pedatric physical activity counseling	Built Environment Use Counseling n=28 Participants personalized counseling on active use of the built environment built environment use counseling
Sedentary Time	11.1 minutes Standard Deviation 73.9	5.8 minutes Standard Deviation 86.3

SECONDARY outcome

Timeframe: 4 months from baseline

Longer-term change in sedentary (non-active) time from baseline to 3-4 months post-intervention, objectively measured using accelerometers.

Outcome measures

Measure	Standard Physical Activity Counseling n=27 Participants standard pedatric physical activity counseling	Built Environment Use Counseling n=28 Participants personalized counseling on active use of the built environment built environment use counseling
Sedentary Time	-22.9 minutes Standard Deviation 75.6	-4.4 minutes Standard Deviation 91.3

Adverse Events

Standard Physical Activity Counseling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Built Environment Use Counseling

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. Nicolas Oreskovic

MGH

Phone: 6177260593

Email: noreskovic@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place