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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

  1. 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)
  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.

  1. First posted6 Feb 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionDec 2010
  4. Study completionMay 2012

Resources

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)
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

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.

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