NCT05342701

Brief Summary

Currently, 10 million children participate in afterschool programs (ASPs) each day, and ASPs provide a great opportunity to enhance children's health outside of the regular school environment, particularly given the decline in physical education. This proposed, randomized cluster, controlled trial will examine the immediate (pre- to post-test) and sustained (1-year post-intervention follow-up) effects of CHAMP-ASP on physical activity (primary outcome), motor performance, perceived motor competence, health-related physical fitness, and weight status. CHAMP-ASP will be implemented by ASP staff and will be conducted in ASPs located in Ypsilanti/Ann Arbor, Michigan. Children (N = 264; CHAMP-ASP=132 and control=132) K-2 graders (typically ages 5-8 years) will participate 35 minutes/day X 3-4 days/week for 19 weeks (dose of 1995 - 2240 minutes). The aims are to: a) examine the immediate and sustained effects of CHAMP-ASP on physical activity, motor performance, and perceived motor competence relative to the control ASP, b) examine the immediate and sustained effects of CHAMP-ASP on secondary health outcomes - health-related physical fitness (cardiorespiratory fitness, muscular strength), and weight status compared to children in schools randomized to control ASP, and c) determine if perceived motor competence mediates the effect of CHAMP-ASP on moderate-to-vigorous physical activity.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress92%
Dec 2022Aug 2026

First Submitted

Initial submission to the registry

March 16, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3.8 years

First QC Date

March 16, 2022

Last Update Submit

February 25, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Changes in Motor Competence - process measures

    Process scores will be assessed with the Test of Gross Motor Development (TGMD, 3rd edition); scores from the two subscales (locomotor and ball skills) will be reported as raw scores for each skills and an overall score (total MC score). The project will assess changes overtime for this measure

    baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up

  • Changes in Motor Competence - product measures

    Product scores will use throwing speed, kicking speed, jump distance, running speed, and hopping speed. Product score will vary for each participant (i.e., kick, run, hopping, and throw velocity along with jumping distance - faster scores and greater distance are indicators of better MC).

    baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up

  • Changes in Physical Activity

    Actigraph GTX3+ tri-axial accelerometer will be used to measure the frequency, intensity, and duration of PA among children during the ASP 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 set to collect data in raw mode (30 Hz), and will be processed using ActiLife software or other, more advanced techniques, such as machine learning approaches.

    baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up

  • Changes in Health-related fitness - Cardiorespiratory endurance

    Cardiorespiratory endurance will be assessed with a 6-min walk test. For the 6-min walk test, the children walk as fast as possible around two cones for 6 minutes.

    baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up

  • Changes in Health-related fitness - Muscular Strength

    Muscular strength will be assessed with test of handgrip strength. Upper body strength will be assessed using a hand grip strength with a dynamometer, which has been deemed reliable and valid in 6-12-year-olds \[62\]. Grip will be appropriately adjusted for size, and two trials on the right and left sides (elbow extended) will be assessed (muscular strength). The sum of maximum score (kg) of two trials for each hand will be used in analyses.

    baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up

  • Changes in Health-related fitness - Body Composition

    Body composition (i.e., body fat) will be assessed with bioelectrical impedance. Body fat percentage will be the average of two measurements assessed (to the nearest 0.1%, respectively) with a bioelectric impedance analysis scale (Tanita). The assessment will be completed in a designated, private area

    baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up

Secondary Outcomes (7)

  • Demographics

    Baseline

  • Changes in Perceived Motor Competence (Global)

    baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up

  • Changes in Digital Scale of Perceived Motor Competence (DSPMC)

    baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up

  • CHAMP ASP Acceptability Questionnaire

    post-intervention (i.e., 24 weeks post baseline)

  • Family Questionnaire

    baseline

  • +2 more secondary outcomes

Study Arms (2)

CHAMP-ASP

EXPERIMENTAL

CHAMP, is a mastery climate motor skills intervention, that provides children the opportunity to establish behaviors that reinforce decision-making while participating in a motor activity tasks. Children will participate in CHAMP for 35 minutes/day 3-4 days per week for 19 weeks. Each 35-min session consists of three parts: 1. 3-5 min of motor skill introductory activity that includes a group motor activity, the teaching of the lesson that includes a demonstration and understanding of developmentally appropriate learning clues; 2. 25 min of motor skill instruction and practice (i.e., 'active motor engagement'), participants will be encouraged to move through 3-4 motor activity stations that align with the TARGET structure; and 3. 3 -5 min motor skill closure activity that involves a review of the lesson and critical elements.

Behavioral: Motor Skills Intervention

Control - Standard of Practice

NO INTERVENTION

The Control (standard of practice) condition will be the school typical ASP and will be implemented according to the existing procedures.

Interventions

The behavioral motor skill intervention (CHAMP) is an intervention strategy that uniquely address differences in children's development. CHAMP does not equate to a "one size fits all" approach. Children will be in an environment that promotes opportunities for them to development improvement 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 consists of 35 minutes/day X 3-4 days/week for 19 weeks (dose of 1995 - 2240 minutes). Each session will consist of three parts: (a) 3-5 min of motor skill introductory activity, (b) 25 min of motor skill instruction and practice, and (c) 3-5 min motor skill closure activity.

CHAMP-ASP

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Participants must be attending an ASP in the Ann-Arbor/Ypsilanti and Lansing/East Lansing area

You may not qualify if:

  • Participants diagnosed with syndromes or diseases that affect PA participation
  • Participants diagnosed with any major illness, developmental, and/or physical disability that limited their ability to participate in movement and physical activity programs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leah Elizabeth Robinson

Ann Arbor, Michigan, 48104, United States

Location

Related Publications (8)

  • Lohman TG, Ring K, Pfeiffer K, Camhi S, Arredondo E, Pratt C, Pate R, Webber LS. Relationships among fitness, body composition, and physical activity. Med Sci Sports Exerc. 2008 Jun;40(6):1163-70. doi: 10.1249/MSS.0b013e318165c86b.

    PMID: 18460987BACKGROUND
  • Lee IM, Shiroma EJ, Lobelo F, Puska P, Blair SN, Katzmarzyk PT; Lancet Physical Activity Series Working Group. Effect of physical inactivity on major non-communicable diseases worldwide: an analysis of burden of disease and life expectancy. Lancet. 2012 Jul 21;380(9838):219-29. doi: 10.1016/S0140-6736(12)61031-9.

    PMID: 22818936BACKGROUND
  • Robinson LE, Palmer KK, Bub KL. Effect of the Children's Health Activity Motor Program on Motor Skills and Self-Regulation in Head Start Preschoolers: An Efficacy Trial. Front Public Health. 2016 Sep 8;4:173. doi: 10.3389/fpubh.2016.00173. eCollection 2016.

    PMID: 27660751BACKGROUND
  • Robinson LE, Veldman SLC, Palmer KK, Okely AD. A Ball Skills Intervention in Preschoolers: The CHAMP Randomized Controlled Trial. Med Sci Sports Exerc. 2017 Nov;49(11):2234-2239. doi: 10.1249/MSS.0000000000001339.

    PMID: 29045324BACKGROUND
  • Robinson LE, Stodden DF, Barnett LM, Lopes VP, Logan SW, Rodrigues LP, D'Hondt E. Motor Competence and its Effect on Positive Developmental Trajectories of Health. Sports Med. 2015 Sep;45(9):1273-1284. doi: 10.1007/s40279-015-0351-6.

    PMID: 26201678BACKGROUND
  • Beets MW, Beighle A, Erwin HE, Huberty JL. After-school program impact on physical activity and fitness: a meta-analysis. Am J Prev Med. 2009 Jun;36(6):527-37. doi: 10.1016/j.amepre.2009.01.033. Epub 2009 Apr 11.

    PMID: 19362799BACKGROUND
  • Lima RA, Pfeiffer K, Larsen LR, Bugge A, Moller NC, Anderson LB, Stodden DF. Physical Activity and Motor Competence Present a Positive Reciprocal Longitudinal Relationship Across Childhood and Early Adolescence. J Phys Act Health. 2017 Jun;14(6):440-447. doi: 10.1123/jpah.2016-0473. Epub 2017 Feb 7.

    PMID: 28169569BACKGROUND
  • Robinson LE, Palmer KK, Santiago-Rodriguez ME, Myers ND, Wang L, Pfeiffer KA. Protocol for a multicenter-cluster randomized clinical trial of a motor skills intervention to promote physical activity and health in children: the CHAMP afterschool program study. BMC Public Health. 2022 Aug 13;22(1):1544. doi: 10.1186/s12889-022-13849-8.

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Leah E Robinson, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

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
Professor

Study Record Dates

First Submitted

March 16, 2022

First Posted

April 25, 2022

Study Start

December 1, 2022

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations