The Children in Action Feasibility Study

NCT01697124 | Completed DMC

• 2 other identifiers: H-20952R21HD054836-02
• Study Type: interventional
• Target: 274
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Motor Activity

Keywords

Physical activity; children; Head Start; SPARK-EC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from baseline in gross motor skills at post intervention.

  8 months

• Body Mass Index

  8 months

Study Arms (1)

SPARK-EC

EXPERIMENTAL

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

Interventions

SPARK-EC BEHAVIORAL

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

SPARK-EC

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years old
• attends Head Start
• African-American
• Hispanic-American

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Theresa A Nicklas, DrPH

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: October 2, 2012
• Study Start: September 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: October 2, 2012

Record last verified: 2012-09