Home-Based Exergaming Intervention

Study Overview
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Brief Summary
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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).

Official Title
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Effects of Home-based Exergaming on Preschoolers' Physical Activity and Cognition

Conditions
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Physical Activity, Health-related Fitness, Cognition, Screen Time

Intervention / Treatment
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* Behavioral: Exergaming intervention group
* Behavioral: Traditional physical activity comparison


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exergaming intervention group<br>30 minutes of exergaming per session and 5 sessions of exergaming play per week for a 6-month period. | Behavioral: Exergaming intervention group<br>* In addition to usual daily activity, the parent and child from each family will receive 3 game consoles (Wii, Kinect, and LeapTV) and various exergames (e.g., Nickelodeon Fit, Dance and Sports, Just Dance) with all necessary peripherals to play the games. Specifically, they will receive one game console and related exergames every 2 months to experience the variety of exergames and maintain interest in the games over time. Each parent will receive a booklet (established in our pilots studies) provides a standardized gameplay curriculum to play during each session, and attend training workshops at baseline and 3rd month in the PI's lab. The parent will be instructed to have the child perform exergaming at home for 30 minutes/session, 5 times per week, for 6 months. The games will be age appropriate for children 4-5-years-old. The games have been easy for children to learn and use in our pilot studies.<br>|
| Active Comparator: Traditional Physical Activity<br>Phone consultations and workshops for parents to offer 5 times, 30 minutes per session; traditional physical activity at home for 6 months. | Behavioral: Traditional physical activity comparison<br>* Home-based behavioral (e.g., nutrition/PA) interventions for young children usually only target parent for multiple reasons. In this study, group workshop sessions will offered to parents at baseline, 3rd month and 6th month, including information concerning how to promote PA and reduce sedentary behaviors. Identical curricular contents (e.g., dance/sports) for home PA will be offered to parents at baseline and 3rd month in the PI's lab. Parents will also learn about PA and sedentary behavior and their impact on health and cognition. Meanwhile, the intervention staff will encourage parents to increase their lifestyle activity such as taking stairs instead of the elevator and housecleaning. Parents will also learn to shape their child and their PA and sedentary behaviors to attain the following goals: 2 hour or less screen time and at least 180 min. PA per day for children; and at least 150 min. moderate PA for parents per week.<br>|
| No Intervention: Attention control group<br>Continue with usual activities at home with emailed physical activity tips. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity levels | 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. | 0, 3, 12 months (follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health-related fitness | 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. | 0, 3, 12 months (follow-up) | 
| Change in percent body fat | Children's body fat percentage (bioelectrical impedance analysis) will be assessed by a TanitaBC-558 Ironman Body Composition Monitor digit weight scale. | 0, 3, 12 months (follow-up) | 
| Change in cognition | 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. | 0, 3, 12 months (follow-up) | 
| Change in screen time | 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. | 0, 3, 12 months (follow-up) | 
| Change in bodyweight | Children's bodyweight (in kilograms) will be assessed by aTanitaBC-558 Ironman Body Composition Monitor digit weight scale. | 0, 3, 12 months (follow-up) | 
| Change in body mass index (BMI) | 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. | 0, 3, 12 months (follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Active video game, Home-based, preschool, exergaming