Home-Based Exergaming Intervention

NCT ID: NCT04540523

Last Updated: 2022-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-08

Study Completion Date

2025-08-31

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).

Detailed Description

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Conditions

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Physical Activity Health-related Fitness Cognition Screen Time

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Exergaming intervention group

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

Group Type EXPERIMENTAL

Exergaming intervention group

Intervention Type 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.

Traditional Physical Activity

Phone consultations and workshops for parents to offer 5 times, 30 minutes per session; traditional physical activity at home for 6 months.

Group Type ACTIVE_COMPARATOR

Traditional physical activity comparison

Intervention Type 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.

Attention control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Minnesota - Twin Cities

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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Intervention

Identifier Type: -

Identifier Source: org_study_id

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