NCT01939405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2013

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

October 2, 2017

Completed
Last Updated

October 2, 2017

Status Verified

August 1, 2017

Enrollment Period

1.6 years

First QC Date

September 3, 2013

Results QC Date

March 21, 2017

Last Update Submit

August 31, 2017

Conditions

ObesityOverweight

Keywords

ObesityOverweightPhysical ActivityBuilt Environmentcounseling

Outcome Measures

Primary Outcomes (1)

  • Moderate to Vigorous Physical Activity (MVPA)

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

    Immediately post-intervention

Secondary Outcomes (3)

  • Moderate-to-Vigorous Physical Activity (MVPA)

    4 months from baseline

  • Sedentary Time

    Immediately post-intervention

  • Sedentary Time

    4 months from baseline

Study Arms (2)

standard physical activity counseling

NO INTERVENTION

built environment use counseling

EXPERIMENTAL

personalized counseling on active use of the built environment

Behavioral: built environment use counseling

Interventions

built environment use counselingBEHAVIORAL
built environment use counseling

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital Revere HealthCare Center

Revere, Massachusetts, 02151, United States

Location

Related Publications (1)

  • Oreskovic NM, Winickoff JP, Perrin JM, Robinson AI, Goodman E. A Multimodal Counseling-Based Adolescent Physical Activity Intervention. J Adolesc Health. 2016 Sep;59(3):332-337. doi: 10.1016/j.jadohealth.2016.03.012. Epub 2016 May 24.

    PMID: 27235377DERIVED

MeSH Terms

Conditions

ObesityOverweightMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Limitations and Caveats

Small sample size, single office setting, short term (4 months) follow-up, multi-component intervention including financial incentives and text messages.

Results Point of Contact

Title
Dr. Nicolas Oreskovic
Organization
MGH
noreskovic@mgh.harvard.edu
6177260593

Study Officials

  • Nicolas M Oreskovic, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

September 3, 2013

First Posted

September 11, 2013

Study Start

October 1, 2013

Primary Completion

May 1, 2015

Study Completion

June 1, 2015

Last Updated

October 2, 2017

Results First Posted

October 2, 2017

Record last verified: 2017-08

Locations

US(1)