Obesity and Physical Inactivity in AdolescentsKlub KinectNCT02003963
Social Exergaming for Healthy Weight in Adolescent Girls
A study testing Klub Kinect in people with Obesity and Physical Inactivity in Adolescents, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The purpose is to evaluate the feasibility of a 12-week exergaming dance program for adolescent girls. This study combines dancing, video games, and a full body work-out to test if video games can increase physical activity and promote healthy weight in adolescent girls. Read more about this study
- Who is it for?
- Ages 14 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity and Physical Inactivity in Adolescents
- What is being tested?
- Klub Kinect
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 14-18 years old
- Female
- Postmenarchal
- BMI percentile equal to or greater than 85th on the U.S. Centers for Disease Control and Prevention growth chart
- Speak, understand, read, and write English
- Willing to accept randomization
Who cannot join
- Pregnant
- Hospitalization for mental illness within the past 5 years.
- Since the focus herein is on ambulatory activities, participants who use wheelchairs or other impairments that prevent normal ambulation will be excluded
- Indication of cardiac abnormality on an electrocardiogram that requires referral to a cardiologist
- Previous history of, or clinical symptoms or signs of, cardiovascular disease, stroke or transient ischemic attacks, chest pain, unusual dyspnea during physical activity/exercise, severe ankle edema, or intermittent claudication.
- Previous history of musculoskeletal injuries or problems causing severe pain during physical activity or exercise which interferes with daily activities.
Show all 11Show fewer
- Participant has a pacemaker or other implanted medical device (including metal joint replacements).
- Participant is unable to complete all baseline testing (one session) within 1 month prior to the beginning of the intervention
- Medical problems, including epileptic seizures, that prevent video game play
- Family history of epileptic seizures
- Unable to make the commitment of coming to Pennington Biomedical Research Center for 3 weekly gaming sessions for 12 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Klub Kinect: Social Exergaming for Healthy Weight in Adolescent Girls
The purpose is to evaluate the feasibility of a 12-week exergaming dance program for adolescent girls. This study combines dancing, video games, and a full body work-out to test if video games can increase physical activity and promote healthy weight in adolescent girls. We hypothesize that girls who play the dance exergames, versus those in the control group, will lose weight, decrease body fat and visceral fat, improve cardiovascular health, increase physical activity, and improve psychosocial health including self-confidence and quality of life.
Read the detailed description
Klub Kinect will last about 14 weeks for each participant. The program begins with a 3.5 hour clinic visit, the intervention lasts for 12 weeks, and the participant comes in for a final 3.5 hour clinic visit.
- Being tested
- Klub Kinect
- Keywords
- Physical Activity, Sedentary Behavior, Video Games, Exergames
- Medical subject headings
- Obesity, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Klub KinectBehavioural
Dance Central and Just Dance are a series of rhythm games developed by Harmonix Music Systems exclusively for the Xbox 360 Kinect. The Dance Central suite of games (Dance Central 1, 2, and 3) and Just Dance will be played on the Xbox 360+ Kinect gaming console, which employs whole body movement using an infrared sensor that tracks body movements such that an external controller device is not required. The player performs dance moves demonstrated by on-screen characters and set to popular music, with a choice of over 650 dance moves, 90 dance routines, and over 300 songs.
The exergaming condition will wear a pedometer to record total steps during game play, and they will participate in private weigh-ins at each session to track body weight over the 12-week intervention.
| Study group | Role | What they receive |
|---|---|---|
| Exergame Intervention | Experimental | Participants randomly assigned to the exergame condition will participate in the intervention condition of "Klub Kinect." Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently. Receives: Behavioral: Klub Kinect |
| Control (Self-Directed Care) | No intervention | The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Fat
Assessed by dual energy x-ray absorptiometry
Measured: Baseline clinic visit (week 0) and final clinic visit (week 13)
Change in Visceral Adiposity
Assessed by magnetic resonance imaging
Measured: Baseline clinic visit (week 0) and final clinic visit (week 13)
Change in Resting Systolic Blood Pressure Percentile
Resting systolic blood pressure percentile
Measured: Baseline clinic visit (week 0) and final clinic visit (week 13)
Secondary outcomes (5)
Feasibility (Adherence)
Attendance to exergaming intervention
Measured: 3 gaming sessions/week for 12 weeks
Change in Physical Activity
Actigraph accelerometer (7-day protocol using waking hours) and self-report instrument
Measured: Baseline clinic visit (week 0) and final clinic visit (week 13)
The Friendship Quality Questionnaire to Measure Change in Peer Support From Baseline to Week 13.
The outcome is perceived peer conflict from the Friendship Quality Questionnaire, which is a 21-item self-report survey in which the participant answers questions about his or her best friend related to companionship, conflict, help/aid, security, and closeness, on a 5-point Likert scale. The survey is internally consistent, with α ranging from 0.71 to 0.86, and adequate criterion validity across sub-scales. The peer conflict sub-scale includes four questions and ranges from 4 to 20 points. A higher score indicates higher (worse) levels of peer conflict.
Measured: Baseline clinic visit (week 0) and final clinic visit (week 13)
Change From Baseline in Health-related Quality of Life
Self-report instrument to capture health-related quality of life (KIDSCREEN-10 Index). The scale ranges from 5 to 50, with a higher score indicating a better quality of life.
Measured: Baseline clinic visit (week 0) and final clinic visit (week 13)
Change From Baseline in Self-efficacy Towards Exercise on the Self-Efficacy for Healthy Eating and Physical Activity Measure (SE-HEPA) at Week 13
SE-HEPA is a 13-item self-report survey with items based on a 5-point Likert scale. Possible scores range from 1 (Disagree a Lot) to 5 (Agree a Lot). The items are summed to a total score, and a higher score indicates a higher level of self-efficacy (range: 13 to 65). Results are reported as change scores from baseline.
Measured: Baseline clinic visit (Week 0) and final clinic visit (Week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obesity and Physical Inactivity in AdolescentsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Staiano, Pennington Biomedical Research Center
- Investigators
- Amanda E Staiano, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003963
- Sponsor's protocol ID
- PBRC 2013-046
- Acronym
- Klub Kinect
- Status last verified
- Mar 2024
- First submitted
- 26 Nov 2013
- Last updated
- 29 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Staiano AE, Marker AM, Beyl RA, Hsia DS, Katzmarzyk PT, Newton RL. A randomized controlled trial of dance exergaming for exercise training in overweight and obese adolescent girls. Pediatr Obes. 2017 Apr;12(2):120-128. doi: 10.1111/ijpo.12117. Epub 2016 Feb 26.
PubMed 26918815Staiano AE, Beyl RA, Hsia DS, Katzmarzyk PT, Newton RL Jr. Twelve weeks of dance exergaming in overweight and obese adolescent girls: Transfer effects on physical activity, screen time, and self-efficacy. J Sport Health Sci. 2017 Mar;6(1):4-10. doi: 10.1016/j.jshs.2016.11.005. Epub 2016 Nov 23.
PubMed 28491483Staiano AE, Beyl RA, Hsia DS, Katzmarzyk PT, Newton RL Jr. A 12-week randomized controlled pilot study of dance exergaming in a group: Influence on psychosocial factors in adolescent girls. Cyberpsychology (Brno). 2018;12(2):3. doi: 10.5817/CP2018-2-3.
PubMed 31367239
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Klub Kinect: Social Exergaming for Healthy Weight in Adolescent Girls
- ClinicalTrials.gov ID
- NCT02003963
- Acronym / sponsor ID
- Klub Kinect / PBRC 2013-046
- Keywords
- Physical Activity, Sedentary Behavior, Video Games, Exergames
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Posted 21 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to evaluate the feasibility of a 12-week exergaming dance program for adolescent girls. This study combines dancing, video games, and a full body work-out to test if video games can increase physical activity and promote healthy weight in adolescent girls. We hypothesize that girls who play the dance exergames, versus those in the control group, will lose weight, decrease body fat and visceral fat, improve cardiovascular health, increase physical activity, and improve psychosocial health including self-confidence and quality of life.
Detailed description
Klub Kinect will last about 14 weeks for each participant. The program begins with a 3.5 hour clinic visit, the intervention lasts for 12 weeks, and the participant comes in for a final 3.5 hour clinic visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergame Intervention | Experimental | Behavioral: Klub KinectParticipants randomly assigned to the exergame condition will participate in the intervention condition of "Klub Kinect." Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently. |
| Control (Self-Directed Care) | No intervention | –The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 14-18 years old
- Female
- Postmenarchal
- BMI percentile equal to or greater than 85th on the U.S. Centers for Disease Control and Prevention growth chart
- Speak, understand, read, and write English
Key exclusion criteria (11 listed)
- Pregnant
- Hospitalization for mental illness within the past 5 years.
- Since the focus herein is on ambulatory activities, participants who use wheelchairs or other impairments that prevent normal ambulation will be excluded
- Indication of cardiac abnormality on an electrocardiogram that requires referral to a cardiologist
- Previous history of, or clinical symptoms or signs of, cardiovascular disease, stroke or transient ischemic attacks, chest pain, unusual dyspnea during physical activity/exercise, severe ankle edema, or intermittent claudication.
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 |
|---|---|---|
| Klub KinectDance Central and Just Dance are a series of rhythm games developed by Harmonix Music Systems exclusively for the Xbox 360 Kinect. The Dance Central suite of games (Dance Central 1, 2, and 3) and Just Dance will be played on the Xbox 360+ Kinect gaming console, which employs whole body movement using an infrared sensor that tracks body movements such that an external controller device is not required. The player performs dance moves demonstrated by on-screen characters and set to popular music, with a choice of over 650 dance moves, 90 dance routines, and over 300 songs. The exergaming condition will wear a pedometer to record total steps during game play, and they will participate in private weigh-ins at each session to track body weight over the 12-week intervention. | Behavioural | Exergame Intervention |
Primary outcome
Change in Body Fat
Time frame: Baseline clinic visit (week 0) and final clinic visit (week 13)
Assessed by dual energy x-ray absorptiometry
Change in Visceral Adiposity
Time frame: Baseline clinic visit (week 0) and final clinic visit (week 13)
Assessed by magnetic resonance imaging
Change in Resting Systolic Blood Pressure Percentile
Time frame: Baseline clinic visit (week 0) and final clinic visit (week 13)
Resting systolic blood pressure percentile
5 secondary outcomes
Feasibility (Adherence)
Time frame: 3 gaming sessions/week for 12 weeks
Change in Physical Activity
Time frame: Baseline clinic visit (week 0) and final clinic visit (week 13)
The Friendship Quality Questionnaire to Measure Change in Peer Support From Baseline to Week 13.
Time frame: Baseline clinic visit (week 0) and final clinic visit (week 13)
Change From Baseline in Health-related Quality of Life
Time frame: Baseline clinic visit (week 0) and final clinic visit (week 13)
Change From Baseline in Self-efficacy Towards Exercise on the Self-Efficacy for Healthy Eating and Physical Activity Measure (SE-HEPA) at Week 13
Time frame: Baseline clinic visit (Week 0) and final clinic visit (Week 13)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26918815Staiano AE, Marker AM, Beyl RA, Hsia DS, Katzmarzyk PT, Newton RL. A randomized controlled trial of dance exergaming for exercise training in overweight and obese adolescent girls. Pediatr Obes. 2017 Apr;12(2):120-128. doi: 10.1111/ijpo.12117. Epub 2016 Feb 26.
- Results publication: PubMed 28491483Staiano AE, Beyl RA, Hsia DS, Katzmarzyk PT, Newton RL Jr. Twelve weeks of dance exergaming in overweight and obese adolescent girls: Transfer effects on physical activity, screen time, and self-efficacy. J Sport Health Sci. 2017 Mar;6(1):4-10. doi: 10.1016/j.jshs.2016.11.005. Epub 2016 Nov 23.
- Results publication: PubMed 31367239Staiano AE, Beyl RA, Hsia DS, Katzmarzyk PT, Newton RL Jr. A 12-week randomized controlled pilot study of dance exergaming in a group: Influence on psychosocial factors in adolescent girls. Cyberpsychology (Brno). 2018;12(2):3. doi: 10.5817/CP2018-2-3.
- Participant registrationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Amanda E Staiano, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Klub Kinect in people with Obesity and Physical Inactivity in Adolescents, run by Pennington Biomedical Research Center 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 29 Mar 2024. 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?
Yes. Results are posted in the registry (first posted 21 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Body Fat (time frame: Baseline clinic visit (week 0) and final clinic visit (week 13)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02003963, which also lists 3 linked publications.
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 29 Mar 2024.