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Completed

NCT Number: NCT02003963

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.

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Key information

Conditions

Obesity and Physical Inactivity in Adolescents Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sedentary Behavior Signs and Symptoms

Age range

14 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Klub Kinect

Behavioral

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

Klub Kinect: Social Exergaming for Healthy Weight in Adolescent Girls

Acronym: Klub Kinect

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2013
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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