NCT01180972

Brief Summary

This is a pilot community-based research study to examine the effects of specific environmental and social factors on physical activity, fitness, and health of middle school Hispanic children living in an inner-city community.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

December 10, 2013

Status Verified

October 1, 2012

Enrollment Period

2.6 years

First QC Date

August 11, 2010

Last Update Submit

December 9, 2013

Conditions

Keywords

Obesity, diabetes, hispanic, physical activity, nutrition

Outcome Measures

Primary Outcomes (1)

  • Assess the built environment for energy requirements of movement, nutrition options, suitability for outdoor physical activity, and for children's actual physical activity and energy expenditure within those environments.

    Assess the built environment for energy requirements of movement, nutrition options, suitability for outdoor physical activity, and for children's actual physical activity and energy expenditure within those environments. To address this specific aim, we attempt to answer these 2 questions through direct participation from the students and then indirectly through a geographic analysis of the area of interest: 1. How does the built environment influence children's physical activity, access to healthy food, and individual health and fitness? 2. Do these relationships vary spatially (e.g., across and within neighborhoods)?

    9/2010 to 3/5/13

Secondary Outcomes (1)

  • Assess the impact of children's social environment on movement and nutrition choices within the built environment.

    9/2013-3/5/2013

Other Outcomes (1)

  • Conduct a quantitative assessment of children's fitness, obesity, and indicators of metabolic health.

    9/2013 -03-5/2013

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Middle - school age children in grades 5-8

You may qualify if:

  • The child is in academic attendance at the BGCS in Grades 5-8 and Cherokee Middle School in Grades 6-8.
  • The child and parent or legal guardian is able to provide assent and/or consent.
  • The child is able to understand instructions for study-related activities and comply

You may not qualify if:

  • The child is not in academic attendance at the BGCS in Grades 5-8 or at Cherokeed Middle School grades 6-8
  • The child and parent or legal guardian is not able to provide assent and/or consent.
  • The child is able to not able to understand instructions for study-related activities and comply

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United Community Center/Bruce Guadalupe Community School and Cherokee Middle School

Milwaukee and Madison, Wisconsin, 53204, United States

Location

MeSH Terms

Conditions

ObesityDiabetes MellitusMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Aaron Carrel, MD

    UW - Madison - Department of Pediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2010

First Posted

August 13, 2010

Study Start

August 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

December 10, 2013

Record last verified: 2012-10

Locations