Obesity, Diabetes, Nutrition, Physical HealthNCT01180972
Effects of Environmental Opportunities and Barriers on Physical Activity, Fitness, and Health in Hispanic Children in Wisconsin
An observational study of Obesity, Diabetes, Nutrition, Physical Health, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes, Nutrition, Physical Health
- How many people
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Middle - school age children in grades 5-8
Who may be able to join
- 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
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
United Community Center/Bruce Guadalupe Community School and Cherokee Middle School
Milwaukee and Madison, Wisconsin, 53204
About this study
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.
Read the 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:
- identify and analyze characteristics of the social and built environment that inhibit or enhance physical activity and healthy nutrition;
- determine the direction and extent of influence of these variables on children's activity, nutrition, and health;
- 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.
- Keywords
- Obesity, diabetes, hispanic, physical activity, nutrition
- Medical subject headings
- Obesity, Diabetes Mellitus, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- How does the built environment influence children's physical activity, access to healthy food, and individual health and fitness?
- Do these relationships vary spatially (e.g., across and within neighborhoods)?
Measured: 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.
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.
Measured: 9/2013-3/5/2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, Diabetes, Nutrition, Physical HealthStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron Carrel, MD, Principal investigator, UW - Madison - Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180972
- Sponsor's protocol ID
- M-2010-1159
- Status last verified
- Oct 2012
- First submitted
- 11 Aug 2010
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Environmental Opportunities and Barriers on Physical Activity, Fitness, and Health in Hispanic Children in Wisconsin
- ClinicalTrials.gov ID
- NCT01180972
- Acronym / sponsor ID
- M-2010-1159
- Keywords
- Obesity, diabetes, hispanic, physical activity, nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- identify and analyze characteristics of the social and built environment that inhibit or enhance physical activity and healthy nutrition;
- determine the direction and extent of influence of these variables on children's activity, nutrition, and health;
- 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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Middle - school age children in grades 5-8
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)?
1 secondary outcome
Assess the impact of children's social environment on movement and nutrition choices within the built environment.
Time frame: 9/2013-3/5/2013
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Carrel, MD principal investigator
UW - Madison - Department of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Diabetes, Nutrition, Physical Health, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2013.