ObesityNCT00853814
Increasing Youth Physical Activity: Neighborhood Environment Influences
A study testing Access to sedentary behaviors in people with Obesity and Overweight, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
Increased access to highly reinforcing sedentary behaviors in the home such as TV and computers are associated with overweight in youth. Reducing these behaviors reduces overweight and prevents increases in overweight in youth who are at risk, likely by increasing physical activity and/or reducing energy intake. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Access to sedentary behaviors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Sep 2011
- Phase
- Interventional
- 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
Who may be able to join
- Parent and child must wear an accelerometer and record their sedentary behaviors
- Youth must engage in at least 24 h/week of time in sedentary behaviors
- Youth should have no dietary or activity restrictions
- Youth and parents should have no psychopathology that would limit participation
- No contraindications to physical activity in either the parent or adolescent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University at Buffalo
Buffalo, New York, 14220
Denise Feda, Ph.D., 716-829-3400, dmfeda@buffalo.edu
About this study
Increased access to highly reinforcing sedentary behaviors in the home such as TV and computers are associated with overweight in youth. Reducing these behaviors reduces overweight and prevents increases in overweight in youth who are at risk, likely by increasing physical activity and/or reducing energy intake. Reducing access to highly reinforcing sedentary activities frees-up time and youth must choose to reallocate their time between engaging in other, less reinforcing sedentary activities or physical activity. Neighborhood environments that provide easy access to reinforcing physical activities such as those at parks may result in greater increases in physical activity when access to highly reinforcing home sedentary behaviors is reduced. The investigators have found in 3 data sets of youth ranging in age from 4 to 16 years that the proportion of park and recreation area to residential area within ½ mile of the child's home parcel (park and recreation index) independently predicted the physical activity of youth. The investigators also found that increases in physical activity when access to sedentary behaviors were reduced for 3 weeks was related to park area within ½ mile of the child's home. The aim of this study is to decrease access to home sedentary behaviors for 4 months and determine if changes in physical activity habits are related to access to parks and recreation areas in the neighborhood environment. The investigators propose to study 128 sedentary overweight male and female 12-14 year-old youth recruited from parcels within Erie County, New York that have a high or low park and recreation index. Groups will be matched on racial/ethnic distribution and socioeconomic status. Subjects living at low and high park access parcels will then be equally randomized to groups that reduce targeted sedentary behavior (TV, computer use) time by 50% using TV Allowance devices placed on each TV/monitor in the home or a control group that has the same experimental experiences including TV Allowance devices placed on each TV/monitor, but programmed to not limit access to targeted sedentary behavior. Subjects will wear both accelerometers and wrist-watch-type global positioning systems to determine changes in the duration and intensity of physical activity in various parcel types, including parks. The investigators hypothesize differential responses in physical activity and the utilization of parks for physical activity. The group of youth that live at parcels with high access to parks and that incur a 50% reduction in sedentary behavior will have greater increases in physical activity, number of visits to parks and will accrue greater physical activity at parks than youth in the other 3 treatment groups. The investigators hypothesize that the alterations in physical activity will be mediated by parent modeling of physical activity and individual differences in the motivation to be physically active. The investigators hypothesize that there will be a main effect of reduction in access to sedentary behaviors on energy and fat intake and percent overweight.
- Conditions
- Obesity, Overweight
- Being tested
- Access to sedentary behaviors
- Keywords
- adolescence, obesity, physical activity, built environment, neighborhood environment, children, youth, increasing physical activity, changing dietary intake, reducing zBMI
- Medical subject headings
- Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to sedentary behaviorsBehavioural
Access to sedentary behaviors: Reduced access - reduce access to sedentary behaviors by 50% using TV Allowance technology. Usual access - monitoring only, no change in access to sedentary behaviors. Access to neighborhood parks: High access - large amount of park land very near to the child's home. Low access - little to no park land near the child's home.
| Study group | Role | What they receive |
|---|---|---|
| Reduced access to sedentary behaviors, High park access | Experimental | Not described Receives: Behavioral: Access to sedentary behaviors |
| Usual access to sedentary behaviors, High park access | Experimental | Not described Receives: Behavioral: Access to sedentary behaviors |
| Reduced access to sedentary behaviors, Low park access | Experimental | Not described Receives: Behavioral: Access to sedentary behaviors |
| Usual access to sedentary behaviors, Low park access | Experimental | Not described Receives: Behavioral: Access to sedentary behaviors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Measured: 10 weeks
Secondary outcomes (3)
Physical activity in parks
Measured: 10 weeks
Dietary intake
Measured: 10 weeks
BMI percentile
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startSep 2007
- Primary completionSep 2010 (estimated)
- Study completionSep 2011 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- James N Roemmich, Ph.D., Principal investigator, University at BuffaloSamina Raja, Ph.D., Principal investigator, University at BuffaloLeonard H Epstein, Ph.D., Principal investigator, University at BuffaloLi Yin, Ph.D., Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853814
- Sponsor's protocol ID
- R01HD055270
- Other IDs
- 5R01HD055270-02, 5R01HD055270-03
- Status last verified
- Feb 2009
- First submitted
- 26 Feb 2009
- Last updated
- 2 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Youth Physical Activity: Neighborhood Environment Influences
- ClinicalTrials.gov ID
- NCT00853814
- Acronym / sponsor ID
- R01HD055270
- Conditions
- Obesity, Overweight
- Keywords
- adolescence, obesity, physical activity, built environment, neighborhood environment, children, youth, increasing physical activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Sep 2007
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 2 Mar 2009 (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.
Increased access to highly reinforcing sedentary behaviors in the home such as TV and computers are associated with overweight in youth. Reducing these behaviors reduces overweight and prevents increases in overweight in youth who are at risk, likely by increasing physical activity and/or reducing energy intake. Reducing access to highly reinforcing sedentary activities frees-up time and youth must choose to reallocate their time between engaging in other, less reinforcing sedentary activities or physical activity. Neighborhood environments that provide easy access to reinforcing physical activities such as those at parks may result in greater increases in physical activity when access to highly reinforcing home sedentary behaviors is reduced. The investigators have found in 3 data sets of youth ranging in age from 4 to 16 years that the proportion of park and recreation area to residential area within ½ mile of the child's home parcel (park and recreation index) independently predicted the physical activity of youth. The investigators also found that increases in physical activity when access to sedentary behaviors were reduced for 3 weeks was related to park area within ½ mile of the child's home. The aim of this study is to decrease access to home sedentary behaviors for 4 months and determine if changes in physical activity habits are related to access to parks and recreation areas in the neighborhood environment. The investigators propose to study 128 sedentary overweight male and female 12-14 year-old youth recruited from parcels within Erie County, New York that have a high or low park and recreation index. Groups will be matched on racial/ethnic distribution and socioeconomic status. Subjects living at low and high park access parcels will then be equally randomized to groups that reduce targeted sedentary behavior (TV, computer use) time by 50% using TV Allowance devices placed on each TV/monitor in the home or a control group that has the same experimental experiences including TV Allowance devices placed on each TV/monitor, but programmed to not limit access to targeted sedentary behavior. Subjects will wear both accelerometers and wrist-watch-type global positioning systems to determine changes in the duration and intensity of physical activity in various parcel types, including parks. The investigators hypothesize differential responses in physical activity and the utilization of parks for physical activity. The group of youth that live at parcels with high access to parks and that incur a 50% reduction in sedentary behavior will have greater increases in physical activity, number of visits to parks and will accrue greater physical activity at parks than youth in the other 3 treatment groups. The investigators hypothesize that the alterations in physical activity will be mediated by parent modeling of physical activity and individual differences in the motivation to be physically active. The investigators hypothesize that there will be a main effect of reduction in access to sedentary behaviors on energy and fat intake and percent overweight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Reduced access to sedentary behaviors, High park access | Experimental | Behavioral: Access to sedentary behaviors |
| Usual access to sedentary behaviors, High park access | Experimental | Behavioral: Access to sedentary behaviors |
| Reduced access to sedentary behaviors, Low park access | Experimental | Behavioral: Access to sedentary behaviors |
| Usual access to sedentary behaviors, Low park access | Experimental | Behavioral: Access to sedentary behaviors |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Parent and child must wear an accelerometer and record their sedentary behaviors
- Youth must engage in at least 24 h/week of time in sedentary behaviors
- Youth should have no dietary or activity restrictions
- Youth and parents should have no psychopathology that would limit participation
- No contraindications to physical activity in either the parent or adolescent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access to sedentary behaviorsAccess to sedentary behaviors: Reduced access - reduce access to sedentary behaviors by 50% using TV Allowance technology. Usual access - monitoring only, no change in access to sedentary behaviors. Access to neighborhood parks: High access - large amount of park land very near to the child's home. Low access - little to no park land near the child's home. | Behavioural | Reduced access to sedentary behaviors, High park access, Reduced access to sedentary behaviors, Low park access, Usual access to sedentary behaviors, High park access, Usual access to sedentary behaviors, Low park access |
Primary outcome
Physical activity
Time frame: 10 weeks
3 secondary outcomes
Physical activity in parks
Time frame: 10 weeks
Dietary intake
Time frame: 10 weeks
BMI percentile
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2009.
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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.
James N Roemmich, Ph.D. principal investigator
University at Buffalo
Samina Raja, Ph.D. principal investigator
University at Buffalo
Leonard H Epstein, Ph.D. principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to sedentary behaviors in people with Obesity and Overweight, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 5 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 2 Mar 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James N Roemmich, Ph.D. (716-829-3400, roemmich@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: 10 weeks). 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 2 Mar 2009.