Physical ActivityNCT04540523
Home-Based Exergaming Intervention
A study testing Exergaming intervention group and Traditional physical activity comparison in people with Physical Activity and Health-related Fitness, run by University of Minnesota at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Health-related Fitness, Cognition
- What is being tested?
- Exergaming intervention group and Traditional physical activity comparison
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2020to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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;
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota - Twin Cities
Minneapolis, Minnesota, 55455
About this study
Official title: Effects of Home-based Exergaming on Preschoolers' Physical Activity and Cognition
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
- Being tested
- Exergaming intervention group, Traditional physical activity comparison
- Keywords
- exergaming, Active video game, Home-based, preschool
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergaming intervention groupBehavioural
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 comparisonBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exergaming intervention group | Experimental | 30 minutes of exergaming per session and 5 sessions of exergaming play per week for a 6-month period. Receives: 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. Receives: Behavioral: Traditional physical activity comparison |
| Attention control group | No intervention | Continue with usual activities at home with emailed physical activity tips. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 3, 12 months (follow-up)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0, 3, 12 months (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start8 Sep 2020 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Why it stopped: Project not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540523
- Sponsor's protocol ID
- Intervention
- Status last verified
- Mar 2022
- First submitted
- 24 Aug 2020
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Home-based Exergaming on Preschoolers' Physical Activity and Cognition
- ClinicalTrials.gov ID
- NCT04540523
- Acronym / sponsor ID
- Intervention
- Conditions
- Physical Activity, Health-related Fitness, Cognition, Screen Time
- Keywords
- exergaming, Active video game, Home-based, preschool
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 8 Sep 2020 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exergaming intervention group | Experimental | Behavioral: Exergaming intervention group30 minutes of exergaming per session and 5 sessions of exergaming play per week for a 6-month period. |
| Traditional Physical Activity | Active comparator | Behavioral: Traditional physical activity comparisonPhone consultations and workshops for parents to offer 5 times, 30 minutes per session; traditional physical activity at home for 6 months. |
| Attention control group | No intervention | –Continue with usual activities at home with emailed physical activity tips. |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exergaming intervention groupIn 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. | Behavioural | Exergaming intervention group |
| Traditional physical activity comparisonHome-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. | Behavioural | Traditional Physical Activity |
Primary outcome
Change in physical activity levels
Time frame: 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.
6 secondary outcomes
Change in health-related fitness
Time frame: 0, 3, 12 months (follow-up)
Change in percent body fat
Time frame: 0, 3, 12 months (follow-up)
Change in cognition
Time frame: 0, 3, 12 months (follow-up)
Change in screen time
Time frame: 0, 3, 12 months (follow-up)
Change in bodyweight
Time frame: 0, 3, 12 months (follow-up)
Change in body mass index (BMI)
Time frame: 0, 3, 12 months (follow-up)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Physical Activity
RecruitingPhase 1
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
B-cell Mediated Autoimmune Disorders
Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
Not yet recruiting
Blood Parameter Changes Following Aerobic Exercise in Professional Soccer Players
Exercise Physiology, Blood Parameters
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergaming intervention group and Traditional physical activity comparison in people with Physical Activity and Health-related Fitness, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical activity levels (time frame: 0, 3, 12 months (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.