Effects of Environmental Opportunities and Barriers on Physical Activity, Fitness, and Health in Hispanic Children in Wisconsin

December 9, 2013 updated by: University of Wisconsin, Madison
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Our primary hypothesis is that the disparity between a community's potential for physical activity and nutrition, and the realized fitness and health of its children, can be attributed to specific environmental and social factors. "Built environment" studies to date have measured potential for physical activity but have not looked at how social factors mediate an individual's activity within a particular environment. The unique aspect of this proposal is the development of a model that explains how physical, social, cultural, and nutritional SEM layers interact to create gaps between potential and realized physical activity. This project will utilize novel technologies to:

  1. identify and analyze characteristics of the social and built environment that inhibit or enhance physical activity and healthy nutrition;
  2. determine the direction and extent of influence of these variables on children's activity, nutrition, and health;
  3. gather ideas from students, parents, and school staff to inform a potential health campaign to reduce and prevent obesity in the community.

To address these goals and demonstrate a causal relationship between physical activity and the social-nutritional factors within a built environment, the following specific objectives/aims are being addressed:

Specific Aim 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.

Specific Aim 2: Assess the impact of children's social environment on movement and nutrition choices within the built environment.

Specific Aim 3: Conduct a quantitative assessment of children's fitness, obesity, and indicators of metabolic health.

Specific Aim 4: Develop a quantitative model from Specific Aims 1-3 that describes the causal relationships among children's physical health, community "healthfulness," and other mediating factors such as attitudes, perceptions, and behavior.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
214

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee and Madison, Wisconsin, United States, 53204
        • United Community Center/Bruce Guadalupe Community School and Cherokee Middle School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Middle - school age children in grades 5-8

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. The child is not in academic attendance at the BGCS in Grades 5-8 or at Cherokeed Middle School grades 6-8
  2. The child and parent or legal guardian is not able to provide assent and/or consent.

  3. The child is able to not able to understand instructions for study-related activities and comply

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 9/2010 to 3/5/13

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assess the impact of children's social environment on movement and nutrition choices within the built environment.
Time Frame: 9/2013-3/5/2013
Data collection is a three step process to analyze the built environment to determine its suitability for walking, bicycling, or other non-motorized means between children's homes, schools, and other common neighborhood destinations. This analysis does not involve direct interaction with or data collection from the students or the parents/legal guardian but will use the children's addresses, zip codes, and the data collected via GPS for Part 1 of this aim.
9/2013-3/5/2013

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Conduct a quantitative assessment of children's fitness, obesity, and indicators of metabolic health.
Time Frame: 9/2013 -03-5/2013
This aim provides a quantitative assessment of adiposity, cardiovascular fitness, and insulin sensitivity (metabolic factors tied to diabetes risk). These data will be correlated with the physical and nutritional environment.
9/2013 -03-5/2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aaron Carrel, MD, UW - Madison - Department of Pediatrics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M-2010-1159

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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