Cardiovascular DiseasesTAAG2NCT00046631
Community Characteristics and Physical Activity Among Adolescent Girls - Ancillary to TAAG
An observational study of Cardiovascular Diseases and Heart Diseases, run by RAND at 6 sites in United States.
Trial summary
To investigate the role of community characteristics in physical activity levels of adolescent girls. Read more about this study
- Who is it for?
- Ages 11 to 14 years, women only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- How many people
- 1,556 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2002to Jul 2007
- 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 11 to 14 years
- Women only
- No healthy volunteers
- Child
No eligibility criteria
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Maryland
Baltimore, Maryland
University of South Carolina
Columbia, South Carolina
University of Minnesota
Minneapolis, Minnesota
Tulane
New Orleans, Louisiana
San Diego State University
San Diego, California
University of Arizona
Tucson, Arizona
About this study
Official title: Community Characteristics and Physical Activity Among Adolescent Girls
To investigate the role of community characteristics in physical activity levels of adolescent girls.
Read the detailed description
BACKGROUND:
The NHLBI-funded multi-centered Trial of Activity for Adolescent Girls (TAAG) is a group (school)-randomized controlled intervention trial to increase physical activity among a cohort of sixth grade girls over 2.5 years.
DESIGN NARRATIVE:
Because environmental factors can influence the likelihood that a person will engage in physical activity, the study investigates the role of community characteristics in physical activity levels. The research forms an ancillary study to the NHLBI-funded multi-centered Trial of Activity for Adolescent Girls (TAAG), a group (school)-randomized controlled intervention trial to increase physical activity among a cohort of sixth grade girls over 2.5 years. The parent TAAG study will be collecting measures of physical activity using both self-report and CSA accelerometers, small monitors worn at the hip that record acceleration and deceleration of movement without the need for any reporting from the participants. Using a radius of 5 miles around each participating TAAG school and around the homes of each study participant, the investigators plan to use geographic information systems (GIS) to gather information documenting proximity of recreational facilities, street design, population density, population mix (ethnic/age distribution), crime, availability of mass transit, neighborhood socioeconomic status (SES), geographic elevations and topography and types of land use. Using hierarchical linear modeling, with girls nested within neighborhoods, while controlling for individual level factors such as race and socioeconomic status, they plan to investigate the relationship of the environment to individual physical activity. In addition, by following girls over time, they plan to investigate whether the effect of the TAAG intervention will be modified by community characteristics. This study will be unique in its scope of exploring the role of community environments in physical activity across six very different urban, suburban, and rural areas: San Diego, CA, Minneapolis, MN, Baltimore, MD, New Orleans, LA, Tucson, AZ and Columbia, SC.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Keywords
- built environment, parks, retail outlets, adolescent girls, physical activity
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adolescent girls | Chosen from 6 schools in 6 cities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
We examined the association between built environment features and physical activity
Measured: 3 years
Secondary outcomes (1)
Body Mass Index
We examined the association between built environment features and BMI
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2002 (estimated)
- Study startAug 2002
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,556 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), San Diego State University, University of Minnesota, University of North Carolina, Chapel Hill, University of South Carolina, University of Maryland, University of Arizona, Tulane University
- Responsible party
- Principal investigator, Deborah Cohen, RAND
- Investigators
- Deborah Cohen, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046631
- Sponsor's protocol ID
- 1188
- Other IDs
- R01HL071244
- Acronym
- TAAG2
- Status last verified
- Mar 2014
- First submitted
- 30 Sep 2002
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Scott MM, Cohen DA, Evenson KR, Elder J, Catellier D, Ashwood JS, Overton A. Weekend schoolyard accessibility, physical activity, and obesity: the Trial of Activity in Adolescent Girls (TAAG) study. Prev Med. 2007 May;44(5):398-403. doi: 10.1016/j.ypmed.2006.12.010. Epub 2006 Dec 29.
PubMed 17292958Cohen DA, Ashwood JS, Scott MM, Overton A, Evenson KR, Staten LK, Porter D, McKenzie TL, Catellier D. Public parks and physical activity among adolescent girls. Pediatrics. 2006 Nov;118(5):e1381-9. doi: 10.1542/peds.2006-1226.
PubMed 17079539Evenson KR, Scott MM, Cohen DA, Voorhees CC. Girls' perception of neighborhood factors on physical activity, sedentary behavior, and BMI. Obesity (Silver Spring). 2007 Feb;15(2):430-45. doi: 10.1038/oby.2007.502.
PubMed 17299117Scott MM, Evenson KR, Cohen DA, Cox CE. Comparing perceived and objectively measured access to recreational facilities as predictors of physical activity in adolescent girls. J Urban Health. 2007 May;84(3):346-59. doi: 10.1007/s11524-007-9179-1.
PubMed 17401691Dowda M, McKenzie TL, Cohen DA, Scott MM, Evenson KR, Bedimo-Rung AL, Voorhees CC, Almeida MJ. Commercial venues as supports for physical activity in adolescent girls. Prev Med. 2007 Aug-Sep;45(2-3):163-8. doi: 10.1016/j.ypmed.2007.06.001. Epub 2007 Jun 7.
PubMed 17673281
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Characteristics and Physical Activity Among Adolescent Girls
- ClinicalTrials.gov ID
- NCT00046631
- Acronym / sponsor ID
- TAAG2 / 1188
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Keywords
- built environment, parks, retail outlets, adolescent girls, physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,556 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), San Diego State University, University of Minnesota, University of North Carolina, Chapel Hill, University of South Carolina, University of Maryland, University of Arizona, Tulane University
- Study start
- Aug 2002
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 1 Oct 2002 (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.
To investigate the role of community characteristics in physical activity levels of adolescent girls.
Detailed description
BACKGROUND:
The NHLBI-funded multi-centered Trial of Activity for Adolescent Girls (TAAG) is a group (school)-randomized controlled intervention trial to increase physical activity among a cohort of sixth grade girls over 2.5 years.
DESIGN NARRATIVE:
Because environmental factors can influence the likelihood that a person will engage in physical activity, the study investigates the role of community characteristics in physical activity levels. The research forms an ancillary study to the NHLBI-funded multi-centered Trial of Activity for Adolescent Girls (TAAG), a group (school)-randomized controlled intervention trial to increase physical activity among a cohort of sixth grade girls over 2.5 years. The parent TAAG study will be collecting measures of physical activity using both self-report and CSA accelerometers, small monitors worn at the hip that record acceleration and deceleration of movement without the need for any reporting from the participants. Using a radius of 5 miles around each participating TAAG school and around the homes of each study participant, the investigators plan to use geographic information systems (GIS) to gather information documenting proximity of recreational facilities, street design, population density, population mix (ethnic/age distribution), crime, availability of mass transit, neighborhood socioeconomic status (SES), geographic elevations and topography and types of land use. Using hierarchical linear modeling, with girls nested within neighborhoods, while controlling for individual level factors such as race and socioeconomic status, they plan to investigate the relationship of the environment to individual physical activity. In addition, by following girls over time, they plan to investigate whether the effect of the TAAG intervention will be modified by community characteristics. This study will be unique in its scope of exploring the role of community environments in physical activity across six very different urban, suburban, and rural areas: San Diego, CA, Minneapolis, MN, Baltimore, MD, New Orleans, LA, Tucson, AZ and Columbia, SC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescent girls | – | –Chosen from 6 schools in 6 cities |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
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
Physical activity
Time frame: 3 years
We examined the association between built environment features and physical activity
1 secondary outcome
Body Mass Index
Time frame: 3 years
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 13 Mar 2014.
- Results publication: PubMed 17292958Scott MM, Cohen DA, Evenson KR, Elder J, Catellier D, Ashwood JS, Overton A. Weekend schoolyard accessibility, physical activity, and obesity: the Trial of Activity in Adolescent Girls (TAAG) study. Prev Med. 2007 May;44(5):398-403. doi: 10.1016/j.ypmed.2006.12.010. Epub 2006 Dec 29.
- Results publication: PubMed 17079539Cohen DA, Ashwood JS, Scott MM, Overton A, Evenson KR, Staten LK, Porter D, McKenzie TL, Catellier D. Public parks and physical activity among adolescent girls. Pediatrics. 2006 Nov;118(5):e1381-9. doi: 10.1542/peds.2006-1226.
- Results publication: PubMed 17299117Evenson KR, Scott MM, Cohen DA, Voorhees CC. Girls' perception of neighborhood factors on physical activity, sedentary behavior, and BMI. Obesity (Silver Spring). 2007 Feb;15(2):430-45. doi: 10.1038/oby.2007.502.
- Results publication: PubMed 17401691Scott MM, Evenson KR, Cohen DA, Cox CE. Comparing perceived and objectively measured access to recreational facilities as predictors of physical activity in adolescent girls. J Urban Health. 2007 May;84(3):346-59. doi: 10.1007/s11524-007-9179-1.
- Results publication: PubMed 17673281Dowda M, McKenzie TL, Cohen DA, Scott MM, Evenson KR, Bedimo-Rung AL, Voorhees CC, Almeida MJ. Commercial venues as supports for physical activity in adolescent girls. Prev Med. 2007 Aug-Sep;45(2-3):163-8. doi: 10.1016/j.ypmed.2007.06.001. Epub 2007 Jun 7.
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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.
Deborah Cohen
RAND
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by RAND at 6 sites 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?
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 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Physical activity (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00046631, which also lists 5 linked publications.
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 13 Mar 2014.