NCT01505244

Brief Summary

Children in the U.S. exhibit low levels of physical activity. In addition to the overall physical health and fitness benefits with increasing levels of physical activity, improvements in academic performance, mental cognition, and behavior may occur. Despite these benefits, opportunities for children to participate in physical activity are being reduced, particularly in schools. The proposed study is a pilot program with approximately 100 children ages 7-11 years expected to participate. All study participants will partake in a testing and measures session which will include body composition measures, nutrition and physical activity questionnaires, and curriculum-based measures. Following the first testing and measures session, 50 of the 100 children will participate in a 10-12 week, before-school, moderate to vigorous physical activity (MVPA) program. This program will consist of non-competitive, MVPA and occur 3 days/week at their school. Subsequent to the physical activity program, all 100 children will then participate in a follow-up testing and measures session. The objective of this proposed pilot study is to determine the feasibility of implementing a before-school, physical activity program as well as explore the effect the program may have on academic performance and health measures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 6, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

December 2, 2014

Status Verified

December 1, 2014

Enrollment Period

1.7 years

First QC Date

December 27, 2011

Last Update Submit

December 1, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in curriculum-based measures at 12 weeks

    The curriculum-based measures are unique methods of academic performance as these are sensitive to and are validated to monitor progress. Curriculum-based measures are easy to administer, can be given as often as wanted/needed, and provide immediate feedback. Progress monitoring focuses on individualized decision making in general and special education with respect to academic skill development at the elementary grades. Progress monitoring can be conducted frequently and is designed to estimate rates of improvement.

    12 weeks

Secondary Outcomes (1)

  • Change from baseline in health-related measures at 12 weeks

    12 weeks

Study Arms (1)

Physical Activity

EXPERIMENTAL

Before-school moderate to vigorous physical activity 3 days/week

Behavioral: Before-School Physical Activity

Interventions

3 days/week of before-school moderate to vigorous physical activity

Physical Activity

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • rd, 4th, or 5th grader currently attending Malletts Bay school
  • Group A participants only: Approval to participate in a moderate to vigorous physical activity program from the child's pediatrician

You may not qualify if:

  • Children will only be excluded from the study if both groups have reached their maximum capacity (n=50 in each group).
  • Group A participants only: Approval to participate in a moderate to vigorous physical activity program not received from the child's pediatrician
  • If a child has a known handicap and/or other medical condition and requires individualized education program (IEP) assistance, then the child may be excluded from the study if IEP accommodations are not available.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malletts Bay School

Colchester, Vermont, 05446, United States

Location

Related Publications (1)

  • Tompkins CL, Hopkins J, Goddard L, Brock DW. The effect of an unstructured, moderate to vigorous, before-school physical activity program in elementary school children on academics, behavior, and health. BMC Public Health. 2012 Jul 5;12:300. doi: 10.1186/1471-2458-12-300.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Connie L Tompkins, PhD

    University of Vermont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 27, 2011

First Posted

January 6, 2012

Study Start

September 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

December 2, 2014

Record last verified: 2014-12

Locations