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Social Exergaming for Healthy Weight in Adolescent Girls (Klub Kinect)

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ClinicalTrials.gov Identifier: NCT02003963
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : April 21, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Amanda Staiano, Pennington Biomedical Research Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Obesity and Physical Inactivity in Adolescents Behavioral: Klub Kinect Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Change in Body Fat [ Time Frame: Baseline clinic visit (week 0) and final clinic visit (week 13) ]
    Assessed by dual energy x-ray absorptiometry

  2. Change in Visceral Adiposity [ Time Frame: Baseline clinic visit (week 0) and final clinic visit (week 13) ]
    Assessed by magnetic resonance imaging

  3. 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


Secondary Outcome Measures :
  1. Feasibility (Adherence) [ Time Frame: 3 gaming sessions/week for 12 weeks ]
    Attendance to exergaming intervention

  2. 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

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003963


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
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Principal Investigator: Amanda E Staiano, PhD Pennington Biomedical Research Center

Additional Information:
Publications of Results:
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Responsible Party: Amanda Staiano, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT02003963     History of Changes
Other Study ID Numbers: PBRC 2013-046
First Posted: December 6, 2013    Key Record Dates
Results First Posted: April 21, 2017
Last Update Posted: February 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amanda Staiano, Pennington Biomedical Research Center:
Physical Activity
Sedentary Behavior
Video Games
Exergames