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The Children in Action Feasibility Study

The Children in Action Feasibility Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01697124
Acronym
CIA
Enrollment
274
Registered
2012-10-02
Start date
2007-09-30
Completion date
2009-08-31
Last updated
2012-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Motor Activity, Obesity

Keywords

Physical activity, children, Head Start, SPARK-EC

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.

Interventions

BEHAVIORALSPARK-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

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Baylor College of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in physical activity at post-intervention.8 monthsMini-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

MeasureTime frameDescription
Change from baseline in gross motor skills at post intervention.8 monthsGross motor skills were measured using the Test of Gross Motor Development. Unit of measurement was the Total Gross Motor Development percentile rank.
Body Mass Index8 monthsBody Mass Index was calculated using height and weight measures collected on the preschool children. Unit of measurement was kilograms (wt.)/meters squared (ht.).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026