- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02003963
Social Exergaming for Healthy Weight in Adolescent Girls (Klub Kinect)
Klub Kinect: Social Exergaming for Healthy Weight in Adolescent Girls
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Louisiana
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Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Exergame Intervention
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.
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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. |
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No Intervention: Control (Self-Directed Care)
The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Fat
Time Frame: Baseline clinic visit (week 0) and final clinic visit (week 13)
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Assessed by dual energy x-ray absorptiometry
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Baseline clinic visit (week 0) and final clinic visit (week 13)
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Change in Visceral Adiposity
Time Frame: Baseline clinic visit (week 0) and final clinic visit (week 13)
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Assessed by magnetic resonance imaging
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Baseline clinic visit (week 0) and final clinic visit (week 13)
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Change in Resting Systolic Blood Pressure Percentile
Time Frame: Baseline clinic visit (week 0) and final clinic visit (week 13)
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Resting systolic blood pressure percentile
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Baseline clinic visit (week 0) and final clinic visit (week 13)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Feasibility (Adherence)
Time Frame: 3 gaming sessions/week for 12 weeks
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Attendance to exergaming intervention
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3 gaming sessions/week for 12 weeks
|
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Change in Physical Activity
Time Frame: Baseline clinic visit (week 0) and final clinic visit (week 13)
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Actigraph accelerometer (7-day protocol using waking hours) and self-report instrument
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Baseline clinic visit (week 0) and final clinic visit (week 13)
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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)
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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.
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Baseline clinic visit (week 0) and final clinic visit (week 13)
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Change From Baseline in Health-related Quality of Life
Time Frame: Baseline clinic visit (week 0) and final clinic visit (week 13)
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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.
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Baseline clinic visit (week 0) and final clinic visit (week 13)
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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)
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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.
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Baseline clinic visit (Week 0) and final clinic visit (Week 13)
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Collaborators and Investigators
Investigators
- Principal Investigator: Amanda E Staiano, PhD, Pennington Biomedical Research Center
Publications and helpful links
General 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.
- Staiano 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.
- Staiano 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PBRC 2013-046
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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