The Children in Action Feasibility Study

Not Applicable

Completed

• Conditions: Obesity; Motor Activity
• Interventions: Behavioral: SPARK-EC

• Registration Number: NCT01697124
• Lead Sponsor: Baylor College of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2012-09
• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-09-28
• Last Update Submitted: 2012-09-28
• Study First Posted: 2012-10-02
• Last Update Posted: 2012-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 274

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change from baseline in physical activity at post-intervention.	8 months	Mini-Mitter Actical, an accelerometer-based activity monitor, was used to assess physical activity of the preschool children. Unit of measurement was mean percentage of time spent in sedentary, light and moderate-vigorous physical activity each day.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in gross motor skills at post intervention.	8 months	Gross motor skills were measured using the Test of Gross Motor Development. Unit of measurement was the Total Gross Motor Development percentile rank.
Body Mass Index	8 months	Body Mass Index was calculated using height and weight measures collected on the preschool children. Unit of measurement was kilograms (wt.)/meters squared (ht.).