Clinical trial NCT01885325: Multi-component Intervention to Increase Physical Activity in Preschool Children
Official title: Multi-component Intervention to Increase Physical Activity in Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Physical Activity
Sedentary Behavior
Preschool Children
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-06-24
Enrollment: 708
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Minutes of Moderate-to- Vigorous Physical Activity (MVPA)
timeFrame: Measured at baseline and 10 months for each wave of data collection
Secondary outcomes:
measure: Change in Minutes of Sedentary Behavior
timeFrame: Measured at baseline and 10 months for each wave of data collection
measure: Change in Physical Activity Energy Expenditure (PAEE)
timeFrame: Measured at baseline and 10 months for each wave of data collection
measure: Change in Body Mass Index (BMI)
timeFrame: Measured at baseline and 10 months for each wave of data collection
Other outcomes:
Locations:
Study officials:
affiliation: University of South Carolina
name: Russell R Pate, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pate RR, Brown WH, Pfeiffer KA, Howie EK, Saunders RP, Addy CL, Dowda M. An Intervention to Increase Physical Activity in Children: A Randomized Controlled Trial With 4-Year-Olds in Preschools. Am J Prev Med. 2016 Jul;51(1):12-22. doi: 10.1016/j.amepre.2015.12.003. Epub 2016 Jan 20.
citation: Pfeiffer KA, Saunders RP, Brown WH, Dowda M, Addy CL, Pate RR. Study of Health and Activity in Preschool Environments (SHAPES): study protocol for a randomized trial evaluating a multi-component physical activity intervention in preschool children. BMC Public Health. 2013 Aug 7;13:728. doi: 10.1186/1471-2458-13-728.