Home-Based Exergaming Intervention

NCT04540523 | Withdrawn

• 1 other identifier: Intervention
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

exergaming; Active video game; Home-based; preschool

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in health-related fitness

  0, 3, 12 months (follow-up)

• Change in percent body fat

  0, 3, 12 months (follow-up)

• Change in cognition

  0, 3, 12 months (follow-up)

• Change in screen time

  0, 3, 12 months (follow-up)

• Change in bodyweight

  0, 3, 12 months (follow-up)

Other Outcomes (3)

• Demographics and physical home environment moderators

  Through study completion, an average of 1 year.

• Motor skills competence covariate

  0, 3, 12 months (follow-up)

• Perceived competence covariate

  0, 3, 12 months (follow-up)

Study Arms (3)

Exergaming intervention group

EXPERIMENTAL

30 minutes of exergaming per session and 5 sessions of exergaming play per week for a 6-month period.

Behavioral: Exergaming intervention group

Traditional Physical Activity

ACTIVE COMPARATOR

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

Attention control group

NO INTERVENTION

Continue with usual activities at home with emailed physical activity tips.

Interventions

Exergaming intervention group BEHAVIORAL

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.

Exergaming intervention group

Traditional physical activity comparison BEHAVIORAL

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.

Traditional Physical Activity

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota - Twin Cities

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: September 7, 2020
• Study Start: September 8, 2020
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)