ObesityNCT00608036
Evaluating the Relationship Between Physical Activity, Diet, Weight, and the Neighborhood Environment for Adolescents
An observational study of Obesity, run by Dr. James Sallis at 2 sites in United States.
Trial summary
Many teenagers have unhealthy eating habits and do not get enough physical activity. This study will examine whether the neighborhood in which a teenager lives affects his/her quality of life, physical activity levels, and eating habits. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 954 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2008to May 2012
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants will be selected from identified neighboorhoods in the Seattle-King County, WA and Baltimore-Washington, DC areas.
Who may be able to join
- Child is between 12 and 16 years old
- Child and parent live in identified block group
- Child and parent speak English
- Child attends middle school or high school
Who cannot join
- Child must not have a diagnosed thought disorder, suicidality, substance abuse disorder, or other psychological or medical condition that would prevent full participation in the study
- Child must not have a disability or illness that would prevent moderate intensity physical activity
- Child must not have an eating disturbance indicative of significant eating disorder pathology
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California San Diego
San Diego, California, 92093
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105
About this study
Official title: Ecological Analysis of Activity, Eating, and Weight in Adolescents
Many teenagers have unhealthy eating habits and do not get enough physical activity. This study will examine whether the neighborhood in which a teenager lives affects his/her quality of life, physical activity levels, and eating habits.
Read the detailed description
Obesity is an increasingly important health problem in the United States, particularly among adolescents. Previous studies among adults have shown that people who live in neighborhoods with good "walkability" and recreational environments have increased physical activity levels, and some studies have suggested that there is a relationship between the neighborhood food environment and eating patterns. While these concepts have been studied in adults, more research is needed on the effect of the neighborhood environment on adolescents. In this study, adolescents who live in select neighborhoods in Seattle-King County, WA and Baltimore-Washington, DC will be enrolled. Forty-eight neighborhoods in these areas will be studied, with researchers taking into account the neighborhoods' walkability levels (e.g., combination of street connectivity, residential density, land use mix, retail floor area ratio) and median income levels. Study researchers will examine and create formulas to measure walkability, pedestrian infrastructure, public recreation space, and nutrition environment quality. Researchers will also examine crime and weather patterns; psychosocial variables; parent support; and perceived neighborhood, school, and home environments. Overall, this study will evaluate the ability of a research model to explain the variation in physical activity levels, sedentary behavior, dietary patterns, and weight among adolescents, with an emphasis on neighborhood environment.
There will be no study visits for this study: participation will take place entirely through the mail, phone, or internet. Participants will include adolescents between the ages of 12 and 16 years old and their parents, all of whom live in the identified study neighborhoods. At the time of study entry, adolescents will complete a questionnaire on neighborhood and safety issues, diet, physical activity habits and places where activity occurs, grades, school policies and parental rules that affect physical activity and eating, and the support they get from people regarding healthy eating and physical activity. One parent of each adolescent will also complete a neighborhood information questionnaire. Adolescents will measure their height, weight, and waist circumference and send the measurements to study staff along with the questionnaire. Next, a 4-week period, study staff will call adolescents on three random days and collect information on their diet in the previous 24 hours. During this period, adolescents will wear an activity meter and a GPS monitor for 7 consecutive days and will mail the devices to study staff for analysis.
- Conditions
- Obesity
- Keywords
- Adolescents, Neighborhood, Walkability, Physical Activity, Quality of Life, Ecological Analysis, Dietary Patterns, Weight Status, Neighborhood Environment, Food Environment, Recreation Environment
- Medical subject headings
- Obesity, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity measured with accelerometer
Average minutes of moderate-to-vigorous physical activity per day, average minutes of sedentary time per day
Measured: Time 1
Secondary outcomes (1)
Diet measured with 24 hour dietary recall interviews
Measures of diet quality
Measured: Time 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2010
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 954 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. James Sallis
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Dr. James Sallis, University of California, San Diego
- Investigators
- James F. Sallis, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608036
- Sponsor's protocol ID
- 527
- Other IDs
- R01HL083454
- Status last verified
- Dec 2020
- First submitted
- 28 Jan 2008
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ecological Analysis of Activity, Eating, and Weight in Adolescents
- ClinicalTrials.gov ID
- NCT00608036
- Acronym / sponsor ID
- 527
- Conditions
- Obesity
- Keywords
- Adolescents, Neighborhood, Walkability, Physical Activity, Quality of Life, Ecological Analysis, Dietary Patterns, Weight Status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 954 participants (actual)
- Lead sponsor
- Dr. James SallisUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 6 Feb 2008 (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.
Many teenagers have unhealthy eating habits and do not get enough physical activity. This study will examine whether the neighborhood in which a teenager lives affects his/her quality of life, physical activity levels, and eating habits.
Detailed description
Obesity is an increasingly important health problem in the United States, particularly among adolescents. Previous studies among adults have shown that people who live in neighborhoods with good "walkability" and recreational environments have increased physical activity levels, and some studies have suggested that there is a relationship between the neighborhood food environment and eating patterns. While these concepts have been studied in adults, more research is needed on the effect of the neighborhood environment on adolescents. In this study, adolescents who live in select neighborhoods in Seattle-King County, WA and Baltimore-Washington, DC will be enrolled. Forty-eight neighborhoods in these areas will be studied, with researchers taking into account the neighborhoods' walkability levels (e.g., combination of street connectivity, residential density, land use mix, retail floor area ratio) and median income levels. Study researchers will examine and create formulas to measure walkability, pedestrian infrastructure, public recreation space, and nutrition environment quality. Researchers will also examine crime and weather patterns; psychosocial variables; parent support; and perceived neighborhood, school, and home environments. Overall, this study will evaluate the ability of a research model to explain the variation in physical activity levels, sedentary behavior, dietary patterns, and weight among adolescents, with an emphasis on neighborhood environment.
There will be no study visits for this study: participation will take place entirely through the mail, phone, or internet. Participants will include adolescents between the ages of 12 and 16 years old and their parents, all of whom live in the identified study neighborhoods. At the time of study entry, adolescents will complete a questionnaire on neighborhood and safety issues, diet, physical activity habits and places where activity occurs, grades, school policies and parental rules that affect physical activity and eating, and the support they get from people regarding healthy eating and physical activity. One parent of each adolescent will also complete a neighborhood information questionnaire. Adolescents will measure their height, weight, and waist circumference and send the measurements to study staff along with the questionnaire. Next, a 4-week period, study staff will call adolescents on three random days and collect information on their diet in the previous 24 hours. During this period, adolescents will wear an activity meter and a GPS monitor for 7 consecutive days and will mail the devices to study staff for analysis.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants will be selected from identified neighboorhoods in the Seattle-King County, WA and Baltimore-Washington, DC areas.
Key inclusion criteria (4 listed)
- Child is between 12 and 16 years old
- Child and parent live in identified block group
- Child and parent speak English
- Child attends middle school or high school
Key exclusion criteria (3 listed)
- Child must not have a diagnosed thought disorder, suicidality, substance abuse disorder, or other psychological or medical condition that would prevent full participation in the study
- Child must not have a disability or illness that would prevent moderate intensity physical activity
- Child must not have an eating disturbance indicative of significant eating disorder pathology
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 measured with accelerometer
Time frame: Time 1
Average minutes of moderate-to-vigorous physical activity per day, average minutes of sedentary time per day
1 secondary outcome
Diet measured with 24 hour dietary recall interviews
Time frame: Time 1
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 4 Dec 2020.
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Obesity
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.
James F. Sallis, PhD principal investigator
University of California, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Dr. James Sallis at 2 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?
The sponsor lists 4 inclusion and 3 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 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 measured with accelerometer (time frame: Time 1). 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 4 Dec 2020.