Clinical trial NCT03189862: A PATH (Promoting Activity and Trajectories of Health) for Children
Official title: A PATH (Promoting Activity and Trajectories of Health) for Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Performance
Physical Activity
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-06-16
Enrollment: 299
Sex: ALL
Minimum age (years): 42
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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.

Primary outcomes:
measure: Motor Competence - Process Measures
timeFrame: Baseline (Month 0), post-intervention (month 9)
measure: Physical Activity
timeFrame: Baseline (Month 0), post-intervention (month 9)
measure: Motor Competence - Product Measure
timeFrame: Baseline (Month 0), post-intervention (month 9)
Secondary outcomes:
measure: Duration of Changes in Motor Competence - Process Measures
timeFrame: Follow-up measurements at year 2
measure: Duration of Change in Physical Activity
timeFrame: Follow-up measurements at year 2
measure: Perceived Motor Competence (Global)
timeFrame: Baseline (Month 0), post-intervention (month 9)
measure: Perceived Motor Competence (Fundamental)
timeFrame: Baseline (Month 0), post-intervention (month 9)
measure: Duration of Change in Perceived Motor Competence (Global)
timeFrame: Follow-up measurements at year 2
measure: Duration of Change in Perceived Motor Competence (Fundamental)
timeFrame: Follow-up measurements at year 2
measure: Cognitive Flexibility
timeFrame: Baseline (Month 0), post-intervention (month 9)
measure: Working Memory
timeFrame: Baseline (Month 0), post-intervention (month 9)
measure: Behavioral Inhibition
timeFrame: Baseline (Month 0), post-intervention (month 9)
measure: Observed Self-Regulation
timeFrame: Baseline (Month 0), post-intervention (month 9)
measure: Teacher Reported Self-Regulation
timeFrame: Baseline (Month 0), post-intervention (month 9)
measure: Duration of Change Motor Competence - Product Measure
timeFrame: Follow-up measurements at year 2
Other outcomes:
measure: Body Mass Index
timeFrame: Baseline (Month 0), post-intervention (month 9), follow-up measurement at year 2
measure: Waist Circumference
timeFrame: Baseline (Month 0), post-intervention (month 9), Follow-up measurement at year 2
measure: Body Fat Percentage
timeFrame: Baseline (Month 0), post-intervention (month 9), Follow-up measurement at Year 2
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Leah E Robinson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.