Clinical trial NCT04540523: Home-Based Exergaming Intervention
Official title: Effects of Home-based Exergaming on Preschoolers' Physical Activity and Cognition
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Physical Activity
Health-related Fitness
Cognition
Screen Time
Keywords: exergaming
Active video game
Home-based
preschool
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will employ a 3-arm randomized clinical trial to determine the effects of a 6-month home-based exergaming intervention on preschoolers' physical activity, health-related fitness, cognition, and screen time, across time, at 3, 6 and 12 months, and as an exploratory outcome, will explore the moderating effects of parent involvement and physical home environment on the intervention role of exergaming across time. Briefly, a total of 330 child-parent dyads from the Twin Cities area in Minnesota will be individually randomly assigned to: 1) an exergaming intervention group (30 min. per session, 5 sessions exergaming play per week for a 6-month period); 2) a traditional PA group (phone consultations and workshops for parents to offer 5 times 30 min. PA at home for 6 months); and 3) an attention control group (continue with usual activities at home with emailed PA tips).


Eligibility criteria: Inclusion Criteria:

* response to an advertisement for the study;
* has only one child aged 4-5 years old in the family;
* speaks English;
* family with income within 185% of the Federal Poverty Guideline Levels determined by parents' self-report;
* has a TV with HDMI port or VGA port or video port at home
* the child has no medical conditions or physical disabilities that prohibit engagement in PA;
* physically inactive child who does not meet 120 min. PA per day;
* parental agreement to participating in the home visits and evaluations;
* lives within 20 miles of the UMN;
* family willingness to commit to 6 months of intervention and 6 months of follow-up;
* not moving out of area for the next 12 months.

Exclusion Criteria:

* children/parents from families that already own exergame(s) as these children tend to possess high experience levels with exergaming play;
* child who are physically active for more than recommended 180 min. PA per day as reported by parents.

Primary outcomes:
measure: Change in physical activity levels
timeFrame: 0, 3, 12 months (follow-up)
Secondary outcomes:
measure: Change in health-related fitness
timeFrame: 0, 3, 12 months (follow-up)
measure: Change in percent body fat
timeFrame: 0, 3, 12 months (follow-up)
measure: Change in cognition
timeFrame: 0, 3, 12 months (follow-up)
measure: Change in screen time
timeFrame: 0, 3, 12 months (follow-up)
measure: Change in bodyweight
timeFrame: 0, 3, 12 months (follow-up)
measure: Change in body mass index (BMI)
timeFrame: 0, 3, 12 months (follow-up)
Other outcomes:
measure: Demographics and physical home environment moderators
timeFrame: Through study completion, an average of 1 year.
measure: Motor skills competence covariate
timeFrame: 0, 3, 12 months (follow-up)
measure: Perceived competence covariate
timeFrame: 0, 3, 12 months (follow-up)
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota - Twin Cities
state: Minnesota
Study officials:
References: