CHAMP-ASP for Sedentary Lifestyle

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sedentary LifestyleMotor Skills Intervention - Behavioral
Eligibility
5 - 8
All Sexes
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Study 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.

Treatment Effectiveness

Study Objectives

6 Primary · 7 Secondary · Reporting Duration: baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up

Baseline
Demographics
baseline
Family Questionnaire
Year 1
Changes Social-emotional measure
Changes in Body Mass Index
Changes in Digital Scale of Perceived Motor Competence (DSPMC)
Changes in Health-related fitness - Body Composition
Changes in Health-related fitness - Cardiorespiratory endurance
Changes in Health-related fitness - Muscular Strength
Changes in Motor Competence - process measures
Changes in Motor Competence - product measures
Changes in Perceived Motor Competence (Global)
Changes in Physical Activity
Week 24
CHAMP ASP Acceptability Questionnaire

Trial Safety

Trial Design

2 Treatment Groups

Control - Standard of Practice
1 of 2
CHAMP-ASP
1 of 2

Active Control

Experimental Treatment

264 Total Participants · 2 Treatment Groups

Primary Treatment: CHAMP-ASP · No Placebo Group · N/A

CHAMP-ASP
Behavioral
Experimental Group · 1 Intervention: Motor Skills Intervention · Intervention Types: Behavioral
Control - Standard of PracticeNoIntervention Group · 1 Intervention: Control - Standard of Practice · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Motor Skills Intervention
2017
N/A
~300

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up

Who is running the clinical trial?

University of MichiganLead Sponsor
1,632 Previous Clinical Trials
6,417,114 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
529 Previous Clinical Trials
10,287,305 Total Patients Enrolled
2 Trials studying Sedentary Lifestyle
312 Patients Enrolled for Sedentary Lifestyle
Leah E Robinson, PhDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
300 Total Patients Enrolled

Eligibility Criteria

Age 5 - 8 · All Participants · 1 Total Inclusion Criteria

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References