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

University of Michigan logo

University of Michigan

Status

Completed

Conditions

Motor Performance
Physical Activity

Treatments

Behavioral: Motor Skills Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03189862
HUM00133319
1R01HL132979-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

299 patients

Sex

All

Ages

42 to 60 months old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

299 participants in 2 patient groups

CHAMP
Experimental group
Description:
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.
Treatment:
Behavioral: Motor Skills Intervention
Control - Free Play
No Intervention group
Description:
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.

Trial documents
3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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