Motor PerformancePATHNCT03189862
A PATH (Promoting Activity and Trajectories of Health) for Children
A study testing Motor Skills Intervention in people with Motor Performance and Physical Activity, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 42 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Motor Performance, Physical Activity
- What is being tested?
- Motor Skills Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2017to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 1. 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Ethnic-minorities and low income children engage in less physical activity (PA)1 and, as a result, have an increased risk of cardiovascular disease. Promoting health-enhancing and sustainable PA levels across childhood and adolescence in low income and minority populations provides important health benefits. However, most PA interventions in children have not led to long-term, sustainable PA behavior. We propose a potential limitation in PA interventions has been the lack of focus on critical developmental processes (i.e., motor development and psychological constructs including perceived competence) that are established correlates of PA and may strongly impact the long-term sustainability of children's PA behaviors.
Co-investigator, Stodden et al. proposed a developmental model hypothesizing mechanisms that promote positive longitudinal change in PA from early (≈3 yrs) to late childhood (≈12 yrs). In this model, a causal pathway that impacts PA is the development of motor competence (MC, i.e., coordination and control of human movement) and perceived motor competence (PMC; i.e., perceptions of movement capabilities). PMC is directly linked to MC and influences PA as it mediates the relationship between MC and PA across childhood. Empirical evidence supports the model's hypotheses showing that MC, PMC, and PA are positively related across childhood. Principal Investigator, Robinson found that children as early as 3 yrs old demonstrate positive associations among MC, PMC, and PA, which suggests early childhood is an optimal time to promote positive MC and PMC in order to decrease the risk of developing unhealthy PA habits.
Robinson has conceptualized and tested a theoretically grounded intervention (the Children's Health Activity Motor Program; CHAMP), which aligns with tenets of the Stodden et al. model by focusing on improving MC and PMC. Studies by the PI show highly impactful results on MC and PMC. CHAMP produced strong increases in MC (improvement to the 70th%tile, up from the 15th%tile) and PMC (30% improvement) over a 9-week intervention and results were sustained following a 12-week retention. During the 30-min intervention, CHAMP participants engaged in more PA (i.e., 50% more time) compared to children in the control.13 While these intervention results are very encouraging, there is a need to examine the long-term effects of the intervention on MC and PMC and whether improvements lead to sustained PA. To date, there have been no large-scale treatment studies that have examined the long-term effects of a MC and PA-based intervention on MC, PMC, and PA in young children.
This proposed study will address these gaps utilizing a cluster randomized control trial. The CHAMP intervention will be implemented in a high minority and low-income population, namely Head Start preschoolers (N = 300; 3.5-5 yrs old), with a 3-year follow-up to examine the immediate (pre- to post-test) and sustained (across middle childhood) impact on MC, PMC, and daily PA. 30 classes of preschool children will be randomly assigned to either the treatment (CHAMP, n = 15) or control (normal preschool free-play/recess, n = 15) conditions. The CHAMP intervention will be implemented for 30 minutes/day, 4 days/week, for 30 weeks (dose of 3000 minutes). Measurements of MC (product and process), PMC (via self-perceptions of MC), and PA (via accelerometry), will occur at baseline (month 0), post-intervention (month 9), and follow-up at May of Year 2, 3, and 4. The specific aims of this study are to:
Aim 1: Examine the immediate post-intervention effect of CHAMP (compared to control participants) on MC, PMC, and PA in preschool-age children.
Aim 2: Assess the sustainable effect of CHAMP (compared to control participants) on MC, PMC, and PA across middle childhood.
Aim 3: Examine and compare the immediate and long-term mediating effect of PMC on the relationship between MC and PA in preschool-age children in the CHAMP and control.
IMPACT: Positive findings will support the development of early childhood education MC and PA programs that promote positive and sustainable PA behaviors that contribute to healthy growth and development.
- Conditions
- Motor Performance, Physical Activity
- Being tested
- Motor Skills Intervention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Skills InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (Month 0), post-intervention (month 9)
Secondary outcomes (12)
Duration of Changes in 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.
Due to the covid-19 pandemic, data was only collected at the follow-up period in Year 2 (year 3 and 4 was not collected)
Measured: Follow-up measurements at year 2
Duration of Change in 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. More minutes of MVPA is better. Due to the covid-19 pandemic, data was only collected at the follow-up period in Year 2 (year 3 and 4 was not collected)
Measured: Follow-up measurements at year 2
Perceived Motor Competence (Global)
Will be assessed with the Harter \& Pike Pictorial Scale of PMC and Social Acceptance (PSPCSA). The PSPCSA will measure the child's global perceived physical competence. The PSPCSA physical competence subscale consists of six items that are presented in pictures and each child will select a picture that is more like them. The six items included are swinging, climbing, tying shoe laces, skipping, running, \& hopping.Children will (1) select the picture that is most like them. One picture depicts a child who is skilled competent and the other shows a child who is not skilled; (2) focus on the designated picture and indicate whether they are just a "little bit" or "a lot" like that picture. Separate pictures for girls and boys will be used in accordance with the manual procedures. The range of scores for each item on the test is 1 (low competence) to 4 (high competence), and children's final score is an average scaled score across all 6 items (1= low- 4=high).
Measured: Baseline (Month 0), post-intervention (month 9)
Perceived Motor Competence (Fundamental)
Global perceived motor competence will be assessed with the Digital Scale of Perceived Motor Competence (DSPMC). THis video-based assessment allows children to see motor skills in action rather than a static picture. The scale is the identical layout and item structure to the PSPCSA but aligns with the 12 fundamental motor skills of the TGMD. For the assessment, the child will watch 12 sets of video pairs and select the video from each pair where the person moves most like them. One video depicts a child who is skilled and the other shows a child who is not skilled. Once children select the video where the person moved like them, they indicate whether the person in the video moved a "little bit" or "a lot" like themselves. The DSPMC yields three scores- locomotor (6 video pairs), ball skills (6 video pairs), and total (all 12 video pairs). The final score from each is an average scale score that ranges in value from 1 (low perceived competence) to 4 (high perceived competence).
Measured: Baseline (Month 0), post-intervention (month 9)
Duration of Change in Perceived Motor Competence (Global)
Will be assessed with the Harter \& Pike Pictorial Scale of PMC and Social Acceptance (PSPCSA). The PSPCSA will measure the child's global perceived physical competence. The PSPCSA physical competence subscale consists of six items that are presented in pictures and each child will select a picture that is more like them. The six items included are swinging, climbing, tying shoe laces, skipping, running, \& hopping.Children will (1) select the picture that is most like them. One picture depicts a child who is skilled competent and the other shows a child who is not skilled; (2) focus on the designated picture and indicate whether they are just a "little bit" or "a lot" like that picture. Separate pictures for girls and boys will be used in accordance with the manual procedures. The range of scores for each item on the test is 1 (low competence) to 4 (high competence), and children's final score is an average scaled score across all 6 items (1= low- 4=high).
Measured: Follow-up measurements at year 2
Duration of Change in Perceived Motor Competence (Fundamental)
Global perceived motor competence will be assessed with the Digital Scale of Perceived Motor Competence (DSPMC). THis video-based assessment allows children to see motor skills in action rather than a static picture. The scale is the identical layout and item structure to the PSPCSA but aligns with the 12 fundamental motor skills of the TGMD. For the assessment, the child will watch 12 sets of video pairs and select the video from each pair where the person moves most like them. One video depicts a child who is skilled and the other shows a child who is not skilled. Once children select the video where the person moved like them, they indicate whether the person in the video moved a "little bit" or "a lot" like themselves. The DSPMC yields three scores- locomotor (6 video pairs), ball skills (6 video pairs), and total (all 12 video pairs). The final score from each is an average scale score that ranges in value from 1 (low perceived competence) to 4 (high perceived competence).
Measured: Follow-up measurements at year 2
Cognitive Flexibility
The Dimensional Change Cart Sort (DCCS) Task is a measure of cognitive flexibility. The task requires children to learn and remember a rule and apply it one way, and then apply a new rule as instructions change. Children match pictures that vary by two dimensions, shape (rabbit vs. boat) and color (brown vs. white). Children complete trials with one set of instructions, then another, and are encouraged to go as fast as they can without making mistakes. The final score was between 0-12, one point for each stimulus sorted correctly after the sort.
Measured: Baseline (Month 0), post-intervention (month 9)
Working Memory
Working Memory will be assessed using a visual-spatial working memory task which requires children to accurately recall information they have seen before. Children are shown visual information (stickers on the body of a cartoon character) and next shown the character without the stickers, and asked to identify these locations after a brief retention interval. Test trials increase in difficulty (i.e., WM demand) as the task progresses. Test continues until a max. of 8 levels or failure on all 3 trials at the same level of difficulty. For working memory, more accurate responses reflect better self-regulation.WM capacity was indexed by a point score calculated as follows: beginning from Level 1, one point for each consecutive level in which at least two of the three trials were performed accurately, plus 1/3 of a point for all correct trials thereafter. Therefore, final scores are between 0-8 with higher scores reflecting better working memory.
Measured: Baseline (Month 0), post-intervention (month 9)
Behavioral Inhibition
The Head-Toes-Knees-Shoulders Task (HTKS; 10 min.) will be used to measure behavioral inhibition. It reflects a child's ability to remember commands and to behaviorally inhibit a pre-potent response in favor of a less-dominant response. A child is trained to perform actions in response to an examiner's commands (e.g., "touch your toes") then asked to do the opposite (e.g., touch toes when instruction is "touch your head"). Scores across trials are summed to reflect self-regulation. The task has begins with 6 practice items and between the first and second set of items there are 5 more practice trials. The score range is 0-60; higher score equal better behavioral inhibition.
Measured: Baseline (Month 0), post-intervention (month 9)
Observed Self-Regulation
Observed self-regulation will also evaluate the child ability to stay on-task during Head-Toes-Knees-Shoulders (HTKS) as an aspect of self-regulation. Child compliance and engagement will also be rated using the Child Assessor Report which has been used in prior SR trials. This 10-item questionnaire is scored on a 0-3 scale. The average scale score is taken across the 10-items, and higher score indicates better observed self-regulation behaviors.
Measured: Baseline (Month 0), post-intervention (month 9)
Teacher Reported Self-Regulation
Teacher-Reported. Teachers will report on child emotion regulation, another key aspect of SR at this age, using the 24-item Emotion Regulation Checklist (ERC), which generates Emotion Regulation and Negative Lability subscales. It is a 24 item, four-point Likert scale 1 = Never to 4 = Almost Always). The avg scale score is taken for both Emotional Regulation and Negative Labiltiy and a higher score indicates better emotional regulation (i.e., self-regulation behaviors).
Measured: Baseline (Month 0), post-intervention (month 9)
Duration of Change 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.
Measured: Follow-up measurements at year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start11 Sep 2017
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Motor PerformanceStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Leah Robinson, University of Michigan
- Investigators
- Leah E Robinson, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189862
- Sponsor's protocol ID
- HUM00133319
- Other IDs
- 1R01HL132979-01
- Acronym
- PATH
- Status last verified
- Jan 2023
- First submitted
- 13 Jun 2017
- Last updated
- 16 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21699116Robinson 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.
PubMed 19791640Robinson 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.
PubMed 21143273Robinson 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.
PubMed 19791639Ulrich DA. Test of gross motor development-3. Austin, TX: Prod-Ed; 2015.
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.
PubMed 17243217Stodden 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.
PubMed 17243218Harter S, Pike R. The pictorial scale of perceived competence and social acceptance for young children. Child Dev. 1984 Dec;55(6):1969-82.
PubMed 6525886Harter S. Manual for the Self-Perception Profile for Children. Denver, CO: University of Denver; 1985.
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.
PubMed 16294116Choi 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.
PubMed 20581716Willoughby 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.
PubMed 21714751Raver 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.
PubMed 21291447Wood 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.
PubMed 40605193Robinson 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.
PubMed 36893091
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PATH (Promoting Activity and Trajectories of Health) for Children
- ClinicalTrials.gov ID
- NCT03189862
- Acronym / sponsor ID
- PATH / HUM00133319
- Conditions
- Motor Performance, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 16 Jun 2017 (actual)
- Results
- Posted 16 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Ethnic-minorities and low income children engage in less physical activity (PA)1 and, as a result, have an increased risk of cardiovascular disease. Promoting health-enhancing and sustainable PA levels across childhood and adolescence in low income and minority populations provides important health benefits. However, most PA interventions in children have not led to long-term, sustainable PA behavior. We propose a potential limitation in PA interventions has been the lack of focus on critical developmental processes (i.e., motor development and psychological constructs including perceived competence) that are established correlates of PA and may strongly impact the long-term sustainability of children's PA behaviors.
Co-investigator, Stodden et al. proposed a developmental model hypothesizing mechanisms that promote positive longitudinal change in PA from early (≈3 yrs) to late childhood (≈12 yrs). In this model, a causal pathway that impacts PA is the development of motor competence (MC, i.e., coordination and control of human movement) and perceived motor competence (PMC; i.e., perceptions of movement capabilities). PMC is directly linked to MC and influences PA as it mediates the relationship between MC and PA across childhood. Empirical evidence supports the model's hypotheses showing that MC, PMC, and PA are positively related across childhood. Principal Investigator, Robinson found that children as early as 3 yrs old demonstrate positive associations among MC, PMC, and PA, which suggests early childhood is an optimal time to promote positive MC and PMC in order to decrease the risk of developing unhealthy PA habits.
Robinson has conceptualized and tested a theoretically grounded intervention (the Children's Health Activity Motor Program; CHAMP), which aligns with tenets of the Stodden et al. model by focusing on improving MC and PMC. Studies by the PI show highly impactful results on MC and PMC. CHAMP produced strong increases in MC (improvement to the 70th%tile, up from the 15th%tile) and PMC (30% improvement) over a 9-week intervention and results were sustained following a 12-week retention. During the 30-min intervention, CHAMP participants engaged in more PA (i.e., 50% more time) compared to children in the control.13 While these intervention results are very encouraging, there is a need to examine the long-term effects of the intervention on MC and PMC and whether improvements lead to sustained PA. To date, there have been no large-scale treatment studies that have examined the long-term effects of a MC and PA-based intervention on MC, PMC, and PA in young children.
This proposed study will address these gaps utilizing a cluster randomized control trial. The CHAMP intervention will be implemented in a high minority and low-income population, namely Head Start preschoolers (N = 300; 3.5-5 yrs old), with a 3-year follow-up to examine the immediate (pre- to post-test) and sustained (across middle childhood) impact on MC, PMC, and daily PA. 30 classes of preschool children will be randomly assigned to either the treatment (CHAMP, n = 15) or control (normal preschool free-play/recess, n = 15) conditions. The CHAMP intervention will be implemented for 30 minutes/day, 4 days/week, for 30 weeks (dose of 3000 minutes). Measurements of MC (product and process), PMC (via self-perceptions of MC), and PA (via accelerometry), will occur at baseline (month 0), post-intervention (month 9), and follow-up at May of Year 2, 3, and 4. The specific aims of this study are to:
Aim 1: Examine the immediate post-intervention effect of CHAMP (compared to control participants) on MC, PMC, and PA in preschool-age children.
Aim 2: Assess the sustainable effect of CHAMP (compared to control participants) on MC, PMC, and PA across middle childhood.
Aim 3: Examine and compare the immediate and long-term mediating effect of PMC on the relationship between MC and PA in preschool-age children in the CHAMP and control.
IMPACT: Positive findings will support the development of early childhood education MC and PA programs that promote positive and sustainable PA behaviors that contribute to healthy growth and development.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHAMP | Experimental | Behavioral: Motor Skills InterventionCHAMP, 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. |
| 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. |
Who may qualify
- Ages
- 42 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor Skills InterventionThe 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. | Behavioural | CHAMP |
Primary outcome
Motor Competence - Process Measures
Time frame: Baseline (Month 0), post-intervention (month 9)
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.
Physical Activity
Time frame: Baseline (Month 0), post-intervention (month 9)
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.
Motor Competence - Product Measure
Time frame: Baseline (Month 0), post-intervention (month 9)
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.
12 secondary outcomes
Duration of Changes in Motor Competence - Process Measures
Time frame: Follow-up measurements at year 2
Duration of Change in Physical Activity
Time frame: Follow-up measurements at year 2
Perceived Motor Competence (Global)
Time frame: Baseline (Month 0), post-intervention (month 9)
Perceived Motor Competence (Fundamental)
Time frame: Baseline (Month 0), post-intervention (month 9)
Duration of Change in Perceived Motor Competence (Global)
Time frame: Follow-up measurements at year 2
Duration of Change in Perceived Motor Competence (Fundamental)
Time frame: Follow-up measurements at year 2
Cognitive Flexibility
Time frame: Baseline (Month 0), post-intervention (month 9)
Working Memory
Time frame: Baseline (Month 0), post-intervention (month 9)
Behavioral Inhibition
Time frame: Baseline (Month 0), post-intervention (month 9)
Observed Self-Regulation
Time frame: Baseline (Month 0), post-intervention (month 9)
Teacher Reported Self-Regulation
Time frame: Baseline (Month 0), post-intervention (month 9)
Duration of Change Motor Competence - Product Measure
Time frame: Follow-up measurements at year 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21699116Robinson 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.
- Background: PubMed 19791640Robinson 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.
- Background: PubMed 21143273Robinson 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.
- Background: PubMed 19791639Robinson 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.
- BackgroundUlrich DA. Test of gross motor development-3. Austin, TX: Prod-Ed; 2015.
- Background: PubMed 17243217Stodden 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.
- Background: PubMed 17243218Stodden 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.
- Background: PubMed 6525886Harter S, Pike R. The pictorial scale of perceived competence and social acceptance for young children. Child Dev. 1984 Dec;55(6):1969-82.
- BackgroundHarter S. Manual for the Self-Perception Profile for Children. Denver, CO: University of Denver; 1985.
- Background: PubMed 16294116Trost 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.
- Background: PubMed 20581716Choi 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.
- Background: PubMed 21714751Willoughby 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.
- Individual participant dataSharing planned: No
Related trials for Motor Performance
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Motor Imagery and Turning Practice to Improve Mobility: Pilot Trial
Mobility Impairment, Community Dwelling Older Adults
Not yet recruiting
The Effects of Ischemic Conditioning in Individuals With Parkinson's Disease
Parkinson Disease
RecruitingObservational study
Predicting Future Errors During Skill Performance
Healthy
Active, not recruiting
Effects of Individualized Preferred and Higher Treadmill Walking Speeds Followed by Cognitive Training on Heart Rate Variability, Gait Performance, and Motor-Cognitive Function in Older Adults With Type 2 Diabetes: A Randomized Controlled Trial With 4-Week Retention Follow-up
Diabetes Mellitus, Type 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leah E Robinson, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Skills Intervention in people with Motor Performance and Physical Activity, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Competence - Process Measures (time frame: Baseline (Month 0), post-intervention (month 9)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03189862, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.