NCT03189862

Brief Summary

Physical inactivity in children is a major public health risk factor and a health objective for the nation. This study aims to investigate the short- and long-term effects of a movement and physical activity program - the Children Health and Motor Programs (CHAMP) on motor competence, perceived motor competence, and physical activity. A secondary aim of this project (i.e., Science of Behavior Change Administrative Supplement) is to examine the immediate (pre- to post-test) effects of the CHAMP intervention on self-regulation and associations between self-regulation and changes in motor competence, perceived motor competence, and physical activity. The long term goal is to provide evidence-based movement experiences during the early childhood years that promote and contribute to overall healthy growth and development.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
299

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

June 13, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 11, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 16, 2023

Completed
Last Updated

February 16, 2023

Status Verified

January 1, 2023

Enrollment Period

4.1 years

First QC Date

June 13, 2017

Results QC Date

October 31, 2022

Last Update Submit

January 20, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Motor Competence - Process Measures

    Motor competence process measures will be scored using the Test of Gross Motor Development-3rd Edition; scores for the two subscales - locomotor (score range: 0-46) \& object-control (score range: 0-54) will be reported as raw scores for each skill \& an overall score total MC score which is created by summing the subscales( score range: 0 (low motor competence) - 100 (high motor competence)). Locomotor, object control, and total raw scores will be used for data analyses when appropriate. All scores are interpreted as a higher score indicating better outcomes.

    Baseline (Month 0), post-intervention (month 9)

  • Physical Activity

    ActiGraph GTX3+ tri-axial accelerometer will be used to measure the frequency, intensity and duration of PA among children at school and in free-living settings. Participants will be asked to wear the same accelerometer for 7 full days (5 week and 2 weekend days). Data will be collected at 80 hz. Cut points from a study in preschoolers by Butte et al will be applied to activity counts. This study utilized information from all three axes (versus just the vertical axis) thus time spent in sedentary, light, moderate, and vigorous categories will be defined as vector magnitudes of up to 819 (sedentary), 3907 (light), 6111 (moderate) and above 6112 for vigorous activity. The outcome will be minutes of moderate-to-vigorous PA per day, greater than 6111 activity counts.

    Baseline (Month 0), post-intervention (month 9)

  • Motor Competence - Product Measure

    Motor competence product measures will consist of 1) kick \& throw velocity, catching %; hop \& jump distance \& running speed. Product scores will vary for each participant (i.e., kick and throw velocity - faster score is an indicator of MC, number of successful catches out of 5 attempts - more catches indicator of MC, hop and jump distance and running speed; greater distance \& speed is a better indicator of MC. Catching % will not be calculated into the motor competence score due to updates in the literature regarding this specific outcome. All scores are standardized (z-scores, m=0, SD=1) and summed to get a composite for ball skills (z-kick velocity + z-throw velocity), locomotor skills (z-run speed + z-hop speed, + z-jump distance), and total (all summed). A higher score reflects better competence.

    Baseline (Month 0), post-intervention (month 9)

Secondary Outcomes (12)

  • Duration of Changes in Motor Competence - Process Measures

    Follow-up measurements at year 2

  • Duration of Change in Physical Activity

    Follow-up measurements at year 2

  • Perceived Motor Competence (Global)

    Baseline (Month 0), post-intervention (month 9)

  • Perceived Motor Competence (Fundamental)

    Baseline (Month 0), post-intervention (month 9)

  • Duration of Change in Perceived Motor Competence (Global)

    Follow-up measurements at year 2

  • +7 more secondary outcomes

Other Outcomes (3)

  • Body Mass Index

    Baseline (Month 0), post-intervention (month 9), follow-up measurement at year 2

  • Waist Circumference

    Baseline (Month 0), post-intervention (month 9), Follow-up measurement at year 2

  • Body Fat Percentage

    Baseline (Month 0), post-intervention (month 9), Follow-up measurement at Year 2

Study Arms (2)

CHAMP

EXPERIMENTAL

CHAMP, is a mastery climate motor skills interventions, that provides children the opportunity to establish behaviors that reinforces decision-making while participating in a variety of challenging movement \& physical activity tasks. Duration of CHAMP is 30 min/day 4 days/week for 30 weeks. CHAMP consist of a) a 2-3 min of motor skill introductory activity that includes a group motor activity, the teaches the lesson, includes a demonstration, and understanding of developmentally appropriate learning clues b) 25 min of motor skill instruction \& practice where preschoolers engage in 3-4 motor activity stations that align with the TARGET structures c) \& 2-3 min motor skill closure activity that involves a review of the lesson \& critical elements.

Behavioral: Motor Skills Intervention

Control - Free Play

NO INTERVENTION

The control/free play condition will be the preschools typical activity programs (i.e., outdoor/indoor recess) and will be implemented according to the existing procedures within the preschool centers. The centers outdoor program consist of outdoor free-play activity on a large playground area with a variety of play structures (swings, slides, ladders) that promote gross movement and activity in preschoolers. For the control condition, there will be no planned instruction nor activities provided by the classroom teachers.

Interventions

The behavioral motor skills intervention (CHAMP) is an intervention strategy that uniquely addresses differences in children's developmental levels on an individualized basis. CHAMP does not equate to a "one size fits all" approach. Children will be in an environment that promotes opportunities for them to develop improvements in motor skills based on their specific individual needs and choices. The CHAMP intervention promotes a mastery climate that allows each individual child to be successful and learn while promoting intrinsic motivation and autonomy. CHAMP will be implemented 4x/week for 30 minutes across ≈30 weeks for ≈3000 minutes of intervention time.

CHAMP

Eligibility Criteria

Age42 Months - 60 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Recruitment is limited to two specific schools located in the Detroit Metro area.
  • Participants must be in the last year of preschool entering Kindergarten the next academic year is eligible to to participate in this study.

You may not qualify if:

  • \. Any preschooler with a severe developmental, cognitive, and/or physical disability as noted by school records is eligible to participate in this study but data will not be collected.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (16)

  • Robinson LE. Effect of a mastery climate motor program on object control skills and perceived physical competence in preschoolers. Res Q Exerc Sport. 2011 Jun;82(2):355-9. doi: 10.1080/02701367.2011.10599764. No abstract available.

    PMID: 21699116BACKGROUND
  • Robinson LE, Rudisill ME, Goodway JD. Instructional climates in preschool children who are at-risk. Part II: perceived physical competence. Res Q Exerc Sport. 2009 Sep;80(3):543-51. doi: 10.1080/02701367.2009.10599592.

    PMID: 19791640BACKGROUND
  • Robinson LE. The relationship between perceived physical competence and fundamental motor skills in preschool children. Child Care Health Dev. 2011 Jul;37(4):589-96. doi: 10.1111/j.1365-2214.2010.01187.x. Epub 2010 Dec 9.

    PMID: 21143273BACKGROUND
  • Robinson LE, Goodway JD. Instructional climates in preschool children who are at-risk. Part I: object-control skill development. Res Q Exerc Sport. 2009 Sep;80(3):533-42. doi: 10.1080/02701367.2009.10599591.

    PMID: 19791639BACKGROUND
  • Ulrich DA. Test of gross motor development-3. Austin, TX: Prod-Ed; 2015.

    BACKGROUND
  • Stodden DF, Langendorfer SJ, Fleisig GS, Andrews JR. Kinematic constraints associated with the acquisition of overarm throwing part I: step and trunk actions. Res Q Exerc Sport. 2006 Dec;77(4):417-27. doi: 10.1080/02701367.2006.10599377.

    PMID: 17243217BACKGROUND
  • Stodden DF, Langendorfer SJ, Fleisig GS, Andrews JR. Kinematic constraints associated with the acquisition of overarm throwing part II: upper extremity actions. Res Q Exerc Sport. 2006 Dec;77(4):428-36. doi: 10.1080/02701367.2006.10599378.

    PMID: 17243218BACKGROUND
  • Harter S, Pike R. The pictorial scale of perceived competence and social acceptance for young children. Child Dev. 1984 Dec;55(6):1969-82.

    PMID: 6525886BACKGROUND
  • Harter S. Manual for the Self-Perception Profile for Children. Denver, CO: University of Denver; 1985.

    BACKGROUND
  • Trost SG, McIver KL, Pate RR. Conducting accelerometer-based activity assessments in field-based research. Med Sci Sports Exerc. 2005 Nov;37(11 Suppl):S531-43. doi: 10.1249/01.mss.0000185657.86065.98.

    PMID: 16294116BACKGROUND
  • Choi L, Liu Z, Matthews CE, Buchowski MS. Validation of accelerometer wear and nonwear time classification algorithm. Med Sci Sports Exerc. 2011 Feb;43(2):357-64. doi: 10.1249/MSS.0b013e3181ed61a3.

    PMID: 20581716BACKGROUND
  • Willoughby M, Blair C. Test-retest reliability of a new executive function battery for use in early childhood. Child Neuropsychol. 2011;17(6):564-79. doi: 10.1080/09297049.2011.554390. Epub 2011 Jun 30.

    PMID: 21714751BACKGROUND
  • Raver CC, Jones SM, Li-Grining C, Zhai F, Bub K, Pressler E. CSRP's Impact on low-income preschoolers' preacademic skills: self-regulation as a mediating mechanism. Child Dev. 2011 Jan-Feb;82(1):362-78. doi: 10.1111/j.1467-8624.2010.01561.x.

    PMID: 21291447BACKGROUND
  • Wood AP, Palmer KK, Ouyang Z, Wang LU, Robinson LE. Developmental Changes in Motor Competence: The Influence of Physical Activity and BMI Percentile. Med Sci Sports Exerc. 2025 Dec 1;57(12):2690-2696. doi: 10.1249/MSS.0000000000003805. Epub 2025 Jul 3.

  • Robinson LE, Palmer KK, Wang L, Scott-Andrews KQ, Chinn KM, Sur I, Wengrovius C, Meng E, Veldman SLC, Miller AL. Protocol for a cluster randomized clinical trial of a mastery-climate motor skills intervention, Children's Health Activity and Motor Program (CHAMP), on self-regulation in preschoolers. PLoS One. 2023 Mar 9;18(3):e0282199. doi: 10.1371/journal.pone.0282199. eCollection 2023.

  • Robinson LE, Wang L, Colabianchi N, Stodden DF, Ulrich D. Protocol for a two-cohort randomized cluster clinical trial of a motor skills intervention: The Promoting Activity and Trajectories of Health (PATH) Study. BMJ Open. 2020 Jun 11;10(6):e037497. doi: 10.1136/bmjopen-2020-037497.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Leah E. Robinson
Organization
University of Michigan

Study Officials

  • Leah E Robinson, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 16, 2017

Study Start

September 11, 2017

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

February 16, 2023

Results First Posted

February 16, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations