ObesityPhase 1/2NCT00285792
Stanford Preschool Physical Activity Project
A Phase 1/2 study testing Physical Activity in people with Obesity, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of increasing the amount of time spent in recess (outside playtime) on overall daily physical activity in Hispanic preschool age children attending full-day and half-day preschool programs. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Mar 2006
- Phase
- Phase 1/2
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Hispanic children between 3 - 5 years of age on the date of randomization. A child is defined as Hispanic if their parent/guardian identifies the child's ethnicity as "Hispanic" or "Latino", regardless of race.
Who cannot join
- Children will not be eligible if they have a condition limiting their participation in the intervention (unable to participate in routine outdoor play time at school, requiring oxygen supplementation for exertion, developmental or physical disability preventing participations in the interventions, participants who can not increase their physical activity for any reason); if they have a condition limiting participation in the assessment (parent/guardian is not able to read surveys in English or Spanish, if child is unable to wear the activity monitor); or if parent/guardian is unable to read, understand or complete informed consent in English or Spanish.
Trial locations and contacts
1 site in 1 country.
United States1 site
Roosevelt Elementary School
Redwood City, California, 94063
About this study
The purpose of this study is to examine the effects of increasing the amount of time spent in recess (outside playtime) on overall daily physical activity in Hispanic preschool age children attending full-day and half-day preschool programs. We hypothesize that increasing recess (outside playtime) by 60 minutes in participants attending full-day and 30 minutes in participants attending half-day of preschool will increase average daily physical activity during the intervention days. We also hypothesize that children will not compensate for the increased recess (outside playtime) by decreasing physical activity outside of school during the intervention days.
Read the detailed description
Childhood obesity has dramatically increased in the past two decades. The increased prevalence of obesity in Hispanic children is even more alarming. Obesity is a known risk factor for the development of a wide range of chronic diseases in both children and adults, and overweight status tends to track from childhood into adulthood. Therefore, many experts have recommended that obesity prevention should be initiated during early childhood, particularly in preschool-aged children, to prevent the excess co-morbidities associated with obesity throughout the lifespan. However, less is known about the prevention of obesity in young children.
One factor associated with the increased prevalence of overweight and obesity in children is a decrease in physical activity level and an increase in sedentary lifestyle. Even though approximately 61% of children ages 3 - 5 years of age spend a part of their day in some form of early child care program (day care centers, nursery schools, Head Start, and pre-kindergarten programs) only a few studies have been conducted to examine their daily physical activity level while they are attending preschool. Since the majority of young children spend a part of their day in a preschool setting, this setting could potential play an integral role in increasing their daily physical activity level.
Experts have recommended that in order to meet the current guidelines for daily physical activity (at least 120 minutes/day), planned and/or free playtime should be incorporated into a preschooler's daily schedule. Direct observation indicates that preschoolers spend 27 - 40% of their recess time engaged in moderate-to-vigorous physical activity. By increasing children's time in recess it is possible to increase their daily physical activity level. Therefore the purpose of this study is to examine the effects of increasing the amount of time spent in recess on overall daily physical activity in preschool age children.
Following preliminary screening, participants selected to participant in this study will undergo baseline assessment. All participants will complete two days of baseline conditioning prior to the initiation of the experimental intervention. The experimental intervention will consist of adding an additional recess period for two consecutive school days. Participants' physical activity will be monitored during the baseline conditioning and intervention days. The experimental intervention will last for one week.
- Conditions
- Obesity
- Being tested
- Physical Activity
- Keywords
- Preschool, Physical Activity
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's physical activity levels will be monitored Monday thru Friday of the experimental intervention week using the ActiGraph Accelerometer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startDec 2005
- Study completionMar 2006
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.
- More trials run by Stanford UniversityThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Investigators
- Sofiya Alhassan, Ph.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285792
- Sponsor's protocol ID
- 96534
- Status last verified
- Jul 2006
- First submitted
- 31 Jan 2006
- Last updated
- 5 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stanford Preschool Physical Activity Project
- ClinicalTrials.gov ID
- NCT00285792
- Acronym / sponsor ID
- 96534
- Conditions
- Obesity
- Keywords
- Preschool, Physical Activity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Dec 2005
- Study completion
- Mar 2006
- First posted
- 2 Feb 2006 (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.
The purpose of this study is to examine the effects of increasing the amount of time spent in recess (outside playtime) on overall daily physical activity in Hispanic preschool age children attending full-day and half-day preschool programs. We hypothesize that increasing recess (outside playtime) by 60 minutes in participants attending full-day and 30 minutes in participants attending half-day of preschool will increase average daily physical activity during the intervention days. We also hypothesize that children will not compensate for the increased recess (outside playtime) by decreasing physical activity outside of school during the intervention days.
Detailed description
Childhood obesity has dramatically increased in the past two decades. The increased prevalence of obesity in Hispanic children is even more alarming. Obesity is a known risk factor for the development of a wide range of chronic diseases in both children and adults, and overweight status tends to track from childhood into adulthood. Therefore, many experts have recommended that obesity prevention should be initiated during early childhood, particularly in preschool-aged children, to prevent the excess co-morbidities associated with obesity throughout the lifespan. However, less is known about the prevention of obesity in young children.
One factor associated with the increased prevalence of overweight and obesity in children is a decrease in physical activity level and an increase in sedentary lifestyle. Even though approximately 61% of children ages 3 - 5 years of age spend a part of their day in some form of early child care program (day care centers, nursery schools, Head Start, and pre-kindergarten programs) only a few studies have been conducted to examine their daily physical activity level while they are attending preschool. Since the majority of young children spend a part of their day in a preschool setting, this setting could potential play an integral role in increasing their daily physical activity level.
Experts have recommended that in order to meet the current guidelines for daily physical activity (at least 120 minutes/day), planned and/or free playtime should be incorporated into a preschooler's daily schedule. Direct observation indicates that preschoolers spend 27 - 40% of their recess time engaged in moderate-to-vigorous physical activity. By increasing children's time in recess it is possible to increase their daily physical activity level. Therefore the purpose of this study is to examine the effects of increasing the amount of time spent in recess on overall daily physical activity in preschool age children.
Following preliminary screening, participants selected to participant in this study will undergo baseline assessment. All participants will complete two days of baseline conditioning prior to the initiation of the experimental intervention. The experimental intervention will consist of adding an additional recess period for two consecutive school days. Participants' physical activity will be monitored during the baseline conditioning and intervention days. The experimental intervention will last for one week.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Hispanic children between 3 - 5 years of age on the date of randomization. A child is defined as Hispanic if their parent/guardian identifies the child's ethnicity as "Hispanic" or "Latino", regardless of race.
Key exclusion criteria (1 listed)
- Children will not be eligible if they have a condition limiting their participation in the intervention (unable to participate in routine outdoor play time at school, requiring oxygen supplementation for exertion, developmental or physical disability preventing participations in the interventions, participants who can not increase their physical activity for any reason); if they have a condition limiting participation in the assessment (parent/guardian is not able to read surveys in English or Spanish, if child is unable to wear the activity monitor); or if parent/guardian is unable to read, understand or complete informed consent in English or Spanish.
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 |
|---|---|---|
| Physical Activity | Behavioural | – |
Primary outcome
Children's physical activity levels will be monitored Monday thru Friday of the experimental intervention week using the ActiGraph Accelerometer
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 5 Oct 2006.
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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.
Sofiya Alhassan, Ph.D. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Physical Activity in people with Obesity, run by Stanford University 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 1 inclusion and 1 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 5 Oct 2006. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Children's physical activity levels will be monitored Monday thru Friday of the experimental intervention week using the ActiGraph Accelerometer. 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 5 Oct 2006.