Home-Based Exergaming Intervention

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04540523
• Other study ID #: Intervention
• Status: Withdrawn
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: August 31, 2025

Study information

• Verified date: March 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognition
• Health-related Fitness
• Physical Activity
• Screen Time

Intervention

Behavioral:
• Exergaming intervention group
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.
• Traditional physical activity comparison
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.

Locations

Country	Name	City	State
United States	University of Minnesota - Twin Cities	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics and physical home environment moderators	A demographic survey, including sex, race/ethnicity, and exergaming experience, will be collected at baseline. Child's physical home environment information will be measured by a validated Home Environment Inventory. In detail, 33 items will be related to children's PA and sedentary behavior, with nearly half being assessed by direct observation (e.g., size of back yard and lawn area, number and positioning of TV and presence of other types of small screen entertainment) while the rest by parental report (e.g., family rule about TV use).	Through study completion, an average of 1 year.
Other	Motor skills competence covariate	The Test of Gross Motor Development-2 will be used to assess preschoolers' MSC. The instrument is a qualitative measure to assess the gross motor skills of children aged 3-10 years. The 5 skills tested are run, hop, jump, kick and throw. Children execute each skill twice. To evaluate skill performance, qualitative performance criteria are scored, with 1 indicating its presence and 0 its absence. If a skill is assessed using three performance criteria, the raw scores can therefore vary between 0-6. The highest raw total subtest score for the locomotor as well as the object control skills. Higher scores mean a better outcome.	0, 3, 12 months (follow-up)
Other	Perceived competence covariate	To examine children's perceived competence, the validated Pictorial Scale of Perceived Competence and Social Acceptance (PSPCSA)106 for preschool children will be used. In detail, the subscale of perceived physical competence will be assessed. A sample of the survey is provided in Appendix 1. Enjoyment. A modified Physical Activity Enjoyment Scale will be used to assess preschool children's enjoyment toward physical activity. This scale will use similar pictorial scale as the PSPCSA and has 4 levels for the children to choose for each item. It has shown acceptable validity for use with the preschool children. The scales will be individually administered at baseline in the PI's lab to protect the privacy of the child. Higher scores mean a better outcome.	0, 3, 12 months (follow-up)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)