Multi-component Intervention to Increase Physical Activity in Preschool Children

Physical Activity Clinical Trial

— SHAPES  

Official title:

Multi-component Intervention to Increase Physical Activity in Preschool Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885325
• Other study ID #: Pro00004884
• Secondary ID: 1R01HD055451
• Status: Completed
• Phase: N/A
• Start date: August 2008
• Est. completion date: June 2012

Study information

• Verified date: April 2019
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study addresses a critical public health problem, childhood obesity, by testing a physical activity intervention in the types of preschools that millions of children attend. Information gained in this study may lead to adoption of preschool policies and instructional practices that increase physical activity and reduce the risk of obesity in preschool children.

Description:

Obesity rates in 3-5 year-old American children have increased dramatically in recent decades. Concurrent with this alarming trend, time spent by young children in preschool settings has increased and their time spent in unstructured play has decreased. Recent studies have shown that children in preschools are engaged primarily in sedentary activities. Nonetheless, few interventions designed to increase PA or decrease sedentary behavior have been evaluated in preschool children. The proposed investigation tested a multicomponent intervention designed to increase physical activity energy expenditure (PAEE) in 3-5 year-old children. Sixteen preschools were randomly assigned to intervention or control groups. 500 children, in two annual waves of ~250 children, participated in the measurement protocol at baseline and after exposure to the intervention for 9 months. Child-level measures included moderate-to-vigorous PA, sedentary behavior, and PAEE measured by accelerometry; height, weight and waist circumference; and demographics. The intervention consisted of four components: Move IN (physical education and other indoor activity programming), Move OUT (recess and structured outdoor activity), Move to Learn (PA in classroom, academic lessons), and enhancing the social environment to promote PA. The study's intervention coordinator worked with the preschool directors, teachers, and assistant teachers to facilitate intervention implementation by providing training, materials, and ongoing support and feedback. An extensive process evaluation documented the extent to which the intervention was implemented. Effects of the intervention on PA, sedentary behavior, PAEE, and weight status were determined. In addition, the study examined factors that associate with change in physical activity, sedentary behavior, physical activity energy expenditure and body mass index during a school year in preschool children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 708
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

Inclusion Criteria:

• All children from participating K-4 classrooms at the participating schools were invited to participate.

Exclusion Criteria:

• Children were excluded only if they had a condition that would limit data collection using an accelerometer (e.g., non-ambulatory children)

Related Conditions & MeSH terms

• Physical Activity

Intervention

Other:
• Physical Activity Preschool Intervention
Preschools randomized to the multi-component physical activity preschool intervention received four major components:Move IN (physical education and other indoor activity programming), Move OUT (recess and structured outdoor activity), Move to Learn (Physical activity in classroom, academic lessons), and enhancing the social environment to promote PA.The focus in the physical education classes, recess, daily lessons, and reduction of sedentary time will be on providing activities that 3-to 5-year-old children enjoy.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of South Carolina	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Minutes of Moderate-to- Vigorous Physical Activity (MVPA)	MVPA was assessed using an accelerometer. Participants wore the accelerometer during all waking hours for 5 consecutive weekdays. MVPA was determined by applying count cutpoints to the accelerometer data and calculating minutes spent above the MVPA threshold (minutes per hour).	Measured at baseline and 10 months for each wave of data collection
Secondary	Change in Minutes of Sedentary Behavior	Sedentary behavior was assessed using an accelerometer. Participants wore the accelerometer during all waking hours for 5 consecutive weekdays. Time spent in sedentary behavior was determined by applying count cutpoints to the accelerometer data and calculating minutes spent below the light activity threshold (minutes per hour).	Measured at baseline and 10 months for each wave of data collection
Secondary	Change in Physical Activity Energy Expenditure (PAEE)	PAEE is an expression of the energy expended during physical activity. PAEE was assessed via objective measures of physical activity with accelerometry. Participants wore an accelerometer during all waking hours for 5 consecutive weekdays. PAEE was determined by applying criteria to the accelerometer output and weighting the minutes of activity by MET values appropriate for moderate (4 METs) and vigorous activity (7 METs) in this age group.	Measured at baseline and 10 months for each wave of data collection
Secondary	Change in Body Mass Index (BMI)	BMI was calculated from measured height and weight for each child and is reported as kg/m^2. Assessments were made using standard anthropometric procedures.	Measured at baseline and 10 months for each wave of data collection