The Children in Action Feasibility Study

NCT ID: NCT01697124

Last Updated: 2012-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-08-31

Brief Summary

The Children in Action (CIA) program was a five month physical activity intervention. This intervention was a feasibility study with 3- to 5-year-olds enrolled in four Head Start centers. After baseline assessment, centers were matched by ethnicity and for number of participants and randomly assigned to either the intervention or the control condition. A total of 224 preschool children were randomly selected across the four centers. To evaluate the efficacy of the CIA intervention, the change in physical activity, gross motor skills and weight during the awake time and used mixed effect time-series regression models was compared. Observations did not show a statistical difference between intervention and control groups in physical activity level during the awake time, gross motor development or weight status. It was demonstrated that it is feasible to conduct the SPARK-EC curriculum among preschool children attending Head Start Centers but that an increased dose and/or longer intervention duration will be required to impact gross motor skills, weight status and physical activity levels during this critical early childhood development stage.

Conditions

Obesity; Motor Activity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

SPARK-EC

SPARK-EC curriculum for preschoolers offered instruction and practice in a comprehensive program designed to promote motor development through increased physical activity.

Group Type: EXPERIMENTAL

SPARK-EC

Intervention Type: BEHAVIORAL

The CIA study was a 5 month physical activity change intervention that utilized the SPARK-EC curriculum as the intervention. The SPARK-EC curriculum was designed to be a quality, comprehensive physical activity program for the preschool setting. Pre-and Post-intervention assessments were conducted

Interventions

SPARK-EC

The CIA study was a 5 month physical activity change intervention that utilized the SPARK-EC curriculum as the intervention. The SPARK-EC curriculum was designed to be a quality, comprehensive physical activity program for the preschool setting. Pre-and Post-intervention assessments were conducted

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 3-5 years old
• attends Head Start
• African-American
• Hispanic-American

Exclusion Criteria

• older than 5 years old
• does not attend Head Start
• race/ethnicity other than African-American or Hispanic-American
• has a disability or handicap that would prevent them from participating in physical activities

• 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

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Theresa A Nicklas

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Theresa A Nicklas, DrPH

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Other Identifiers

R21HD054836-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-20952

Identifier Type: -

Identifier Source: org_study_id