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The Children in Action Feasibility Study (CIA)

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Theresa A Nicklas, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01697124
First received: September 17, 2012
Last updated: September 28, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Obesity
Motor Activity
 Behavioral: SPARK-EC

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Children in Action Feasibility Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Change from baseline in physical activity at post-intervention. [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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:
  • Change from baseline in gross motor skills at post intervention. [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Body Mass Index was calculated using height and weight measures collected on the preschool children. Unit of measurement was kilograms (wt.)/meters squared (ht.).


Enrollment: 274
Study Start Date: September 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPARK-EC
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
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

  Eligibility

Ages Eligible for Study:   3 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01697124

Sponsors and Collaborators
Baylor College of Medicine
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Theresa A Nicklas, DrPH Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Theresa A Nicklas, Professor of Pediatrics, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01697124     History of Changes
Other Study ID Numbers: H-20952, R21HD054836-02
Study First Received: September 17, 2012
Last Updated: September 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Physical activity
children
Head Start
SPARK-EC

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013