Social Exergaming for Healthy Weight in Adolescent Girls

Study Overview
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Brief Summary
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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
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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.

Official Title
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Klub Kinect: Social Exergaming for Healthy Weight in Adolescent Girls

Conditions
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Obesity and Physical Inactivity in Adolescents

Intervention / Treatment
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* Behavioral: Klub Kinect


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exergame Intervention<br>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. | Behavioral: Klub Kinect<br>* 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.<br>|
| No Intervention: Control (Self-Directed Care)<br>The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Fat | Assessed by dual energy x-ray absorptiometry | Baseline clinic visit (week 0) and final clinic visit (week 13) | 
| Change in Visceral Adiposity | Assessed by magnetic resonance imaging | Baseline clinic visit (week 0) and final clinic visit (week 13) | 
| Change in Resting Systolic Blood Pressure Percentile | Resting systolic blood pressure percentile | Baseline clinic visit (week 0) and final clinic visit (week 13) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility (Adherence) | Attendance to exergaming intervention | 3 gaming sessions/week for 12 weeks | 
| Change in Physical Activity | Actigraph accelerometer (7-day protocol using waking hours) and self-report instrument | 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. | 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. | 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. | Baseline clinic visit (Week 0) and final clinic visit (Week 13) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, Sedentary Behavior, Video Games, Exergames