A PATH (Promoting Activity and Trajectories of Health) for Children

NCT ID: NCT03189862

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 299 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-11
• Study Completion Date: 2021-11-01

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.

Conditions

Motor Performance; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

CHAMP

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.

Group Type: EXPERIMENTAL

Motor Skills Intervention

Intervention Type: BEHAVIORAL

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.

Control - Free Play

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Motor Skills Intervention

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 42 Months
• Maximum Eligible Age: 60 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Leah Robinson

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leah E Robinson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21699116 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19791640 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21143273 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19791639 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 17243217 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17243218 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 6525886 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 16294116 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20581716 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21714751 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21291447 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36893091 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32532781 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01HL132979-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00133319

Identifier Type: -

Identifier Source: org_study_id