The Children in Action Feasibility Study

Obesity Clinical Trial

— CIA  

Official title:

The Children in Action Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697124
• Other study ID #: H-20952
• Secondary ID: R21HD054836-02
• Status: Completed
• Phase: N/A
• First received: September 17, 2012
• Last updated: September 28, 2012
• Start date: September 2007
• Est. completion date: August 2009

Study information

• Verified date: September 2012
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 5 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Motor Activity
• Obesity

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No