Multi-component Intervention to Increase Physical Activity in Preschool Children

NCT ID: NCT01885325

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 708 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2012-06-30

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.

Conditions

Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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 Physical Activity.

Group Type: EXPERIMENTAL

Physical Activity Preschool Intervention

Intervention Type: OTHER

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.

Control

The preschools in the control group did not receive the intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Russell Pate

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Russell R Pate, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

References

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.

Reference Type: DERIVED

PMID: 26803357 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23919808 (View on PubMed)

Other Identifiers

1R01HD055451

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00004884

Identifier Type: -

Identifier Source: org_study_id