ObesityNCT04122950
Exergaming to Increase Physical Activity in Overweight/Obese Children and Adolescents
A study testing Exergaming in people with Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The primary purpose of this study is to examine the effects of regular exergaming for 8 weeks in 24 overweight/obese children and adolescents (10-17 years) on maximal aerobic fitness (VO2max) and physical activity levels measured before and after (8 weeks) intervention period, and in addition at follow-up (12 weeks). Read more about this study
- Who is it for?
- Ages 10 to 24 years
- Conditions the study is for
- Obesity
- What is being tested?
- Exergaming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNorway
- Study dates
- 24 Feb 2020to 28 Mar 2022
- 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 10 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Defined as overweight/obese for age and sex
- Able to ride a bike for up to 60 minutes
Who cannot join
- Known cardiovascular disease
- Taking beta-blockers or anti-arrhythmic drugs
- Other diseases that restrict them from doing High-Intensity Training
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose of this study is to examine the effects of regular exergaming for 8 weeks in 24 overweight/obese children and adolescents (10-17 years) on maximal aerobic fitness (VO2max) and physical activity levels measured before and after (8 weeks) intervention period, and in addition at follow-up (12 weeks). We also wish to investigate the effects on markers of cardio metabolic health and body composition, measured at baseline, 8 weeks and 12 weeks follow-up.
Also, the participants gaming frequency will be registered throughout the 8 week period, as well as during the follow-up between 8 and 12 weeks. Aim of this study is to investigate if access to this game can provide health benefits for overweight/obese children and adolescents.
- Conditions
- Obesity
- Being tested
- Exergaming
- Keywords
- Exercise therapy, Physical fitness, Gaming, Child, Healthy lifestyle, Fitness testing
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExergamingBehavioural
The participants in the Exergaming group will use the PlayPulse exergame for 45 minutes a minimum of three times per week for 8 weeks. Between 8 and 12 weeks the exergaming group will be provided with free access to the exergame but without the two mandatory exergaming sessions
| Study group | Role | What they receive |
|---|---|---|
| Exergaming | Experimental | The participants in the Exergaming group will use the PlayPulse exergame for 45 minutes a minimum of two times per week for 8 weeks. Between 8 and 12 weeks the exergaming group will be provided with free access to the exergame but without the two mandatory exergaming sessions Receives: Behavioral: Exergaming |
| Control | No intervention | Continue with normal daily routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily time physical activity (moderate, vigorous and very vigorous)
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period and at 12 weeks.
Measured: 12 weeks
Secondary outcomes (15)
Daily average energy expenditure
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.
Measured: 8 and 12 weeks
Daily average number of steps
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.
Measured: 8 and 12 weeks
Daily time in sedentary activity (< 3.0 metabolic equivalents = METs)
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.
Measured: 8 and 12 weeks
Daily time in moderate intensity activity (3.0-6.0 metabolic equivalents = METs)
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.
Measured: 8 and 12 weeks
Daily time in vigorous intensity activity
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.
Measured: 8 and 12 weeks
Daily time in very vigorous intensity activity (>9.0 metabolic equivalents = METs)
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.
Measured: 8 and 12 weeks
Daily average total physical activity duration
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.
Measured: 8 and 12 weeks
Bioelectrical impedance
Body composition assessed using bioelectrical impedance analysis (InBody 720)
Measured: 8 and 12 weeks
Blood Pressure
Measured: 8 and 12 weeks
Fasting circulating glucose, as blood marker of cardiometabolic health
Measured: 8 and 12 weeks
Fasting triglycerides, LDL-, HDL- and Total cholesterol, as blood marker of cardiometabolic health
Measured: 8 and 12 weeks
Circulating insulin concentration, as blood marker of cardiometabolic health
Measured: 8 and 12 weeks
glucose response to a 2 hour glucose tolerance test, as blood marker of cardiometabolic health
Measured: 8 and 12 weeks
VO2max
Maximal Aerobic Capacity
Measured: 8 and 12 weeks
Daily time physical activity (moderate, vigorous and very vigorous)
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period and at 8 weeks
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start24 Feb 2020
- Primary completion28 Mar 2022
- Study completion28 Mar 2022
Why it stopped: Few interested participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Øystein Risa, Study director, Norwegian University of Science and TechnologyTrine Moholdt, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122950
- Sponsor's protocol ID
- 2019/1082
- Status last verified
- Mar 2022
- First submitted
- 30 Sep 2019
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exergaming to Increase Physical Activity in Overweight/Obese Children and Adolescents
- ClinicalTrials.gov ID
- NCT04122950
- Acronym / sponsor ID
- 2019/1082
- Conditions
- Obesity
- Keywords
- Exercise therapy, Physical fitness, Gaming, Child, Healthy lifestyle, Fitness testing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Few interested participants
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 10 Oct 2019 (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.
The primary purpose of this study is to examine the effects of regular exergaming for 8 weeks in 24 overweight/obese children and adolescents (10-17 years) on maximal aerobic fitness (VO2max) and physical activity levels measured before and after (8 weeks) intervention period, and in addition at follow-up (12 weeks). We also wish to investigate the effects on markers of cardio metabolic health and body composition, measured at baseline, 8 weeks and 12 weeks follow-up.
Also, the participants gaming frequency will be registered throughout the 8 week period, as well as during the follow-up between 8 and 12 weeks. Aim of this study is to investigate if access to this game can provide health benefits for overweight/obese children and adolescents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergaming | Experimental | Behavioral: ExergamingThe participants in the Exergaming group will use the PlayPulse exergame for 45 minutes a minimum of two times per week for 8 weeks. Between 8 and 12 weeks the exergaming group will be provided with free access to the exergame but without the two mandatory exergaming sessions |
| Control | No intervention | –Continue with normal daily routine. |
Who may qualify
- Ages
- 10 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Defined as overweight/obese for age and sex
- Able to ride a bike for up to 60 minutes
Key exclusion criteria (3 listed)
- Known cardiovascular disease
- Taking beta-blockers or anti-arrhythmic drugs
- Other diseases that restrict them from doing High-Intensity Training
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 |
|---|---|---|
| ExergamingThe participants in the Exergaming group will use the PlayPulse exergame for 45 minutes a minimum of three times per week for 8 weeks. Between 8 and 12 weeks the exergaming group will be provided with free access to the exergame but without the two mandatory exergaming sessions | Behavioural | Exergaming |
Primary outcome
Daily time physical activity (moderate, vigorous and very vigorous)
Time frame: 12 weeks
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period and at 12 weeks.
15 secondary outcomes
Daily average energy expenditure
Time frame: 8 and 12 weeks
Daily average number of steps
Time frame: 8 and 12 weeks
Daily time in sedentary activity (< 3.0 metabolic equivalents = METs)
Time frame: 8 and 12 weeks
Daily time in moderate intensity activity (3.0-6.0 metabolic equivalents = METs)
Time frame: 8 and 12 weeks
Daily time in vigorous intensity activity
Time frame: 8 and 12 weeks
Daily time in very vigorous intensity activity (>9.0 metabolic equivalents = METs)
Time frame: 8 and 12 weeks
Daily average total physical activity duration
Time frame: 8 and 12 weeks
Bioelectrical impedance
Time frame: 8 and 12 weeks
Blood Pressure
Time frame: 8 and 12 weeks
Fasting circulating glucose, as blood marker of cardiometabolic health
Time frame: 8 and 12 weeks
Fasting triglycerides, LDL-, HDL- and Total cholesterol, as blood marker of cardiometabolic health
Time frame: 8 and 12 weeks
Circulating insulin concentration, as blood marker of cardiometabolic health
Time frame: 8 and 12 weeks
glucose response to a 2 hour glucose tolerance test, as blood marker of cardiometabolic health
Time frame: 8 and 12 weeks
VO2max
Time frame: 8 and 12 weeks
Daily time physical activity (moderate, vigorous and very vigorous)
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Few interested participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
Øystein Risa study director
Norwegian University of Science and Technology
Trine Moholdt, PhD principal investigator
Norwegian University of Science and Technology
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 in people with Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 7 Apr 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 Norway. 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 stopped early (reason given: Few interested participants). Results are not available in the source record.
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?
Daily time physical activity (moderate, vigorous and very vigorous) (time frame: 12 weeks). 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 7 Apr 2022.