The Children in Action Feasibility Study

Study Overview
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Brief Summary
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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.

Official Title
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The Children in Action Feasibility Study

Conditions
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Obesity, Motor Activity

Intervention / Treatment
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* Behavioral: SPARK-EC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPARK-EC<br>SPARK-EC curriculum for preschoolers offered instruction and practice in a comprehensive program designed to promote motor development through increased physical activity. | Behavioral: SPARK-EC<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in physical activity at post-intervention. | 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. | 8 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, children, Head Start, SPARK-EC