Social Exergaming for Healthy Weight in Adolescent Girls (Klub Kinect)
|ClinicalTrials.gov Identifier: NCT02003963|
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : April 21, 2017
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity and Physical Inactivity in Adolescents||Behavioral: Klub Kinect||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Klub Kinect: Social Exergaming for Healthy Weight in Adolescent Girls|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
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.
Behavioral: Klub Kinect
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.
No Intervention: Control (Self-Directed Care)
The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
- 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
- Feasibility (Adherence) [ Time Frame: 3 gaming sessions/week for 12 weeks ]Attendance to exergaming intervention
- Change in Physical Activity [ Time Frame: Baseline clinic visit (week 0) and final clinic visit (week 13) ]Actigraph accelerometer (7-day protocol using waking hours) and self-report instrument
- 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) ]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.
- Change From Baseline in Health-related Quality of Life [ Time Frame: Baseline clinic visit (week 0) and final clinic visit (week 13) ]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.
- 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) ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003963
|United States, Louisiana|
|Pennington Biomedical Research Center|
|Baton Rouge, Louisiana, United States, 70808|
|Principal Investigator:||Amanda E Staiano, PhD||Pennington Biomedical Research Center|