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Stanford Preschool Physical Activity Project

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ClinicalTrials.gov Identifier: NCT00285792
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : October 5, 2006
Sponsor:
Information provided by:
Stanford University

Tracking Information
First Submitted Date  ICMJE January 31, 2006
First Posted Date  ICMJE February 2, 2006
Last Update Posted Date October 5, 2006
Study Start Date  ICMJE December 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2006)
Children's physical activity levels will be monitored Monday thru Friday of the experimental intervention week using the ActiGraph Accelerometer
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stanford Preschool Physical Activity Project
Official Title  ICMJE Stanford Preschool Physical Activity Project
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Obesity
Intervention  ICMJE Behavioral: Physical Activity
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: January 31, 2006)
60
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

- 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.

Exclusion Criteria:

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00285792
Other Study ID Numbers  ICMJE 96534
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sofiya Alhassan, Ph.D. Stanford University
PRS Account Stanford University
Verification Date July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP