Clinical trial NCT05342701: The CHAMP ASP: Promoting Physical Activity & Health in Children
Official title: The CHAMP Afterschool Program: Promoting Physical Activity & Health in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Inactivity
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2022-04-25
Enrollment: 264
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Promoting health-enhancing and sustainable physical activity levels across childhood and adolescence contributes to adult health. The Children's Health Activity Motor Program (CHAMP) is an evidence-based intervention that demonstrates impactful results on motor performance, perceived motor competence, and physical activity in physical education and movement-based settings. 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. The long-term goal is to provide a sustainable, ecologically-relevant, and evidence-based program during the early elementary years that is health-enhancing and increases physical activity in school-age children. Findings could significantly influence future physical activity interventions and support a sustainable, ecologically-relevant (delivered by ASP staff) evidence-based program (i.e., CHAMP) that contributes to long-term health-enhancing physical activity and health in children.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in Motor Competence - process measures
timeFrame: baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up
measure: Changes in Motor Competence - product measures
timeFrame: baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up
measure: Changes in Physical Activity
timeFrame: baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up
measure: Changes in Health-related fitness - Cardiorespiratory endurance
timeFrame: baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up
measure: Changes in Health-related fitness - Muscular Strength
timeFrame: baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up
measure: Changes in Health-related fitness - Body Composition
timeFrame: baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up
Secondary outcomes:
measure: Demographics
timeFrame: Baseline
measure: Changes in Perceived Motor Competence (Global)
timeFrame: baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up
measure: Changes in Digital Scale of Perceived Motor Competence (DSPMC)
timeFrame: baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up
measure: CHAMP ASP Acceptability Questionnaire
timeFrame: post-intervention (i.e., 24 weeks post baseline)
measure: Family Questionnaire
timeFrame: baseline
measure: Changes Social-emotional measure
timeFrame: baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up
measure: Changes in Body Mass Index
timeFrame: baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Leah Elizabeth Robinson
state: Michigan
Study officials:
affiliation: University of Michigan
name: Leah E Robinson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.