Home-Based Exergaming Intervention

Not Applicable

Withdrawn

• Conditions: Cognition; Screen Time; Physical Activity; Health-related Fitness
• Interventions: Behavioral: Traditional physical activity comparison; Behavioral: Exergaming intervention group

• Registration Number: NCT04540523
• Lead Sponsor: University of Minnesota

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-08-24
• Study First Submitted QC: 2020-08-31
• Study First Posted: 2020-09-07
• Study Start: 2020-09-08
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-17
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Physical Activity	Traditional physical activity comparison	Phone consultations and workshops for parents to offer 5 times, 30 minutes per session; traditional physical activity at home for 6 months.
Exergaming intervention group	Exergaming intervention group	30 minutes of exergaming per session and 5 sessions of exergaming play per week for a 6-month period.

Primary Outcome Measures

Name	Time	Method
Change in physical activity levels	0, 3, 12 months (follow-up)	Preschoolers' 5-day daily PA levels will be assessed using ActiGraph Link GT9X accelerometers (Pensacola, FL) at each testing cycle. The Link is lightweight and resembles a watch, and is a valid and reliable measure of PA among young children in free-living settings. Children will be instructed to wear the accelerometers on the non-dominant wrist at all times with the exception of time spent swimming for 3 weekday and 2 weekend days. In this project, activity counts will be set at 1-second epochs. Counts will be interpreted using empirically based cut points that define different PA intensities for preschoolers. Children's daily average minutes engaged in PA (MVPA and light PA) and sedentary behavior will be used as the outcome variables. Acceptable inclusion criteria for PA data will be recording of an average of 10 hours of accelerometer data per day. Compliance with wearing monitors will be facilitated according to Trost recommendations.

Secondary Outcome Measures

Name	Time	Method
Change in percent body fat	0, 3, 12 months (follow-up)	Children's body fat percentage (bioelectrical impedance analysis) will be assessed by a TanitaBC-558 Ironman Body Composition Monitor digit weight scale.
Change in cognition	0, 3, 12 months (follow-up)	The computer-administered NIH Toolbox will be used to measure children's attention, inhibitory control, and cognitive flexibility. These are individually-administered tasks that require an environment that is reasonably quiet and distraction-free.
Change in bodyweight	0, 3, 12 months (follow-up)	Children's bodyweight (in kilograms) will be assessed by aTanitaBC-558 Ironman Body Composition Monitor digit weight scale.
Change in body mass index (BMI)	0, 3, 12 months (follow-up)	Multiple measurements (height \[cm\] and weight \[kg\]) will be aggregated to arrive at one reported value of BMI (i.e., weight and height will be combined to report BMI in kg/m\^2). To allow for growth, the BMI calculated from height and weight will be standardized using the CDC LMS method which yields BMI Z-scores for age and sex.
Change in health-related fitness	0, 3, 12 months (follow-up)	Cardiovascular Fitness. Preschool children's cardiovascular fitness will be assessed by a modified YMCA 3-minute step test. Children will step up and down for three minutes on a 6-inch riser to a metronome beep set at 96 beats per minute (each beep corresponding to one movement of the leg with 4 beeps representing one up-down cycle). Children's heart rate will be assessed immediately before and after the conclusion of the test by the researchers via palpation of the carotid/radial artery with the child's one-minute heart rate. Children will be encouraged to do their best while performing the tests in the PAEL lab.
Change in screen time	0, 3, 12 months (follow-up)	TV allowance devices will be attached to every TV and computer in each home to track children's sedentary screen time. Exergame consoles have functions to record intervention children's playing time and thus track their active screen time. In addition, a validated screen time survey will be administered to the parents. It includes parent report of child hours spent watching TV, videos/DVD, playing video/computer games/ exergaming, surfing internet, etc. for below periods (wake-up until noon, noon until 6 pm, 6 pm until bedtime). Children's total and passive screen time will be used as the outcome variables.

Trial Locations

Locations (1)

University of Minnesota - Twin Cities; 🇺🇸 Minneapolis, Minnesota, United States