FindTrial
Sign In

Children's Use of the Built Environment for Physical Activity

Use of the Built Environment to Promote Physical Activity in Children.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01939405
Acronym
CUBES
Enrollment
60
Registered
2013-09-11
Start date
2013-10-31
Completion date
2015-06-30
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

Obesity, Overweight, Physical Activity, Built Environment, counseling

Brief summary

The study aims are to develop and test the feasibility of a pediatric physical activity intervention that incorporates personal information on use of the built environment, and test the intervention's preliminary efficacy at increasing physical activity. The investigators hypothesize that it will be feasible to incorporate and measure changes in empiric GIS (geographic information system), GPS (global positioning system), and accelerometer feedback in the office setting as demonstrated by: i) Completeness of GPS and accelerometer data collection (primary measure of feasibility), ii) Participation rates among adolescents in the intervention group compared to the control group, and iii) Acceptability to patients as measured by adolescent satisfaction.

Interventions

BEHAVIORALbuilt environment use counseling

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

* Adolescents ages 10-16 years * BMI \> 85th percentile for age and sex

Exclusion criteria

* Physical conditions impairing ambulation * Adolescents who do not speak English * Adolescents who have missed more than 2 scheduled doctor's appointments during the past 5 years * Adolescents who are receiving any other form of physical activity counseling/intervention at the time of enrollment

Design outcomes

Primary

MeasureTime frameDescription
Moderate to Vigorous Physical Activity (MVPA)Immediately post-interventionShort-term change in MVPA from baseline to post-intervention

Secondary

MeasureTime frameDescription
Sedentary TimeImmediately post-interventionShort-term change in sedentary (non-active) time from baseline to post-intervention, objectively measured using accelerometers
Moderate-to-Vigorous Physical Activity (MVPA)4 months from baselineLonger term change in MVPA from baseline to 3-4 months post intervention

Countries

United States

Participant flow

Participants by arm

ArmCount
Standard Physical Activity Counseling
standard pediatric physical activity counseling
30
Built Environment Use Counseling
personalized counseling on active use of the built environment built environment use counseling
30
Total60

Baseline characteristics

CharacteristicStandard Physical Activity CounselingBuilt Environment Use CounselingTotal
Age, Categorical
<=18 years
30 Participants30 Participants60 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous11.6 years
STANDARD_DEVIATION 1
12.2 years
STANDARD_DEVIATION 1.6
11.9 years
STANDARD_DEVIATION 1.4
BMI percentile94 BMI percentile
STANDARD_DEVIATION 3.9
94 BMI percentile
STANDARD_DEVIATION 3.9
94 BMI percentile
STANDARD_DEVIATION 3.9
parental education
Associates degree or College
16 Participants18 Participants34 Participants
parental education
Graduate Education
4 Participants1 Participants5 Participants
parental education
High School or less
9 Participants11 Participants20 Participants
parental education
missing
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Asian
2 Participants1 Participants3 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Black
3 Participants1 Participants4 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Hispanic
8 Participants10 Participants18 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Multi/Other
2 Participants5 Participants7 Participants
Race/Ethnicity, Customized
Race/Ethnicity
White
15 Participants13 Participants28 Participants
Region of Enrollment
United States
30 participants30 participants60 participants
Sex: Female, Male
Female
14 Participants14 Participants28 Participants
Sex: Female, Male
Male
16 Participants16 Participants32 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Moderate to Vigorous Physical Activity (MVPA)

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

Time frame: Immediately post-intervention

ArmMeasureValue (MEDIAN)
Standard Physical Activity CounselingModerate to Vigorous Physical Activity (MVPA)-1.9 minutes
Built Environment Use CounselingModerate to Vigorous Physical Activity (MVPA)1.07 minutes
Secondary

Moderate-to-Vigorous Physical Activity (MVPA)

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

Time frame: 4 months from baseline

ArmMeasureValue (MEDIAN)
Standard Physical Activity CounselingModerate-to-Vigorous Physical Activity (MVPA)0.5 minutes
Built Environment Use CounselingModerate-to-Vigorous Physical Activity (MVPA)6.3 minutes
Secondary

Sedentary Time

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

Time frame: Immediately post-intervention

ArmMeasureValue (MEDIAN)Dispersion
Standard Physical Activity CounselingSedentary Time11.1 minutesStandard Deviation 73.9
Built Environment Use CounselingSedentary Time5.8 minutesStandard Deviation 86.3
Secondary

Sedentary Time

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

Time frame: 4 months from baseline

ArmMeasureValue (MEDIAN)Dispersion
Standard Physical Activity CounselingSedentary Time-22.9 minutesStandard Deviation 75.6
Built Environment Use CounselingSedentary Time-4.4 minutesStandard Deviation 91.3

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026