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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exergame Intervention | Experimental | 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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| Control (Self-Directed Care) | No Intervention | The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda E Staiano, PhD | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26918815 | Result | 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. | |
| 28491483 | Result | 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. |
| Label | URL |
|---|---|
| Participant registration | View source |
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Overweight and obese adolescent girls were recruited for study participation. Participants were screened and enrolled at Pennington Biomedical Research Center. 200 adolescents expressed interest in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | Control (Self-Directed Care) | The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Body Fat | Assessed by dual energy x-ray absorptiometry | Intent to treat | Posted | Mean | Standard Deviation | kg | Baseline clinic visit (week 0) and final clinic visit (week 13) |
|
8 months (entire duration of the study)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amanda Staiano | Pennington Biomedical Research Center | 2257632729 | amanda.staiano@pbrc.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009043 | Motor Activity |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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) |
| 31367239 | Result | 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. |
| BG001 | Control (Self-Directed Care) | The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Weight | Mean | Standard Deviation | kilograms |
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| Height | Mean | Standard Deviation | centimeters |
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| BMI (z-score) | Mean | Standard Deviation | Z-score |
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| BMI (percentile) | Mean | Standard Deviation | Percentile |
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| Waist Circumference | Mean | Standard Deviation | centimeters |
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| DXA Total body fat | Mean | Standard Deviation | kilograms |
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| DXA Total body fat percent | Mean | Standard Deviation | percentile |
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| DXA leg fat | Mean | Standard Deviation | kilograms |
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| DXA Leg fat percentage | Mean | Standard Deviation | percentile |
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| DXA Gynoid Fat | Mean | Standard Deviation | kilograms |
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| DXA Gynoid Fat Percentage | Mean | Standard Deviation | Percentile |
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| DXA Android Fat | Mean | Standard Deviation | Kilograms |
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| DXA Android Fat Percentile | Mean | Standard Deviation | Percentile |
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| DXA Trunk Fat | Mean | Standard Deviation | Kilograms |
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| DXA Trunk Fat Percentile | Mean | Standard Deviation | Percentile |
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| DXA Bone Mineral Content (BMC) | Mean | Standard Deviation | Kilograms |
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| DXA Bone Mineral Density (BMD) | Mean | Standard Deviation | Grams per centimeter squared |
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| DXA BMD Trunk | Mean | Standard Deviation | Grams per centimeter squared |
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| DXA BMD Spine | Mean | Standard Deviation | Grams per centimeter squared |
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| DXA BMD Leg | Mean | Standard Deviation | Grams per centimeter squared |
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| MRI Visceral Adipose Tissue | The sample did not include 3 participants who did not undergo the MRI scan due to exceeding weight limits for the MRI machine or having a metal object in the body. | Mean | Standard Deviation | Kilograms |
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| MRI Subcutaneous Adipose Tissue | The sample did not include 3 participants who did not undergo the MRI scan due to exceeding weight limits for the MRI machine or having a metal object in the body. | Mean | Standard Deviation | Kilograms |
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| MRI Total Adipose Tissue | The sample did not include 3 participants who did not undergo the MRI scan due to exceeding weight limits for the MRI machine or having a metal object in the body. | Mean | Standard Deviation | Kilograms |
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| Systolic Blood Pressure Percentile | Mean | Standard Deviation | Percentile |
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| Diastolic Blood Pressure Percentile | Mean | Standard Deviation | Percentile |
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| Cholesterol | Mean | Standard Deviation | Milligrams per deciliter |
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| High Density Lipoprotein | Mean | Standard Deviation | Milligrams per deciliter |
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| Low-density Lipoprotein | Mean | Standard Deviation | Milligrams per deciliter |
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| Triglycerides | Mean | Standard Deviation | Milligrams per deciliter |
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| Glucose | Mean | Standard Deviation | Milligrams per deciliter |
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| Insulin | Mean | Standard Deviation | Micro unit per milliliter |
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| Primary | Change in Visceral Adiposity | Assessed by magnetic resonance imaging | Intent to treat. Three participants did not complete baseline or final MRI scan due to exceeding weight limit or metal-containing object in the body, and five participants refused to complete final MRI scan. | Posted | Mean | Standard Deviation | kg | Baseline clinic visit (week 0) and final clinic visit (week 13) |
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| Primary | Change in Resting Systolic Blood Pressure Percentile | Resting systolic blood pressure percentile | Posted | Mean | Standard Deviation | %ile | Baseline clinic visit (week 0) and final clinic visit (week 13) |
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| Secondary | Feasibility (Adherence) | Attendance to exergaming intervention | Attendance was only assessed for the "Exergame Intervention" participants | Posted | Mean | Full Range | percentage exergaming sessions attended | 3 gaming sessions/week for 12 weeks |
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| Secondary | Change in Physical Activity | Actigraph accelerometer (7-day protocol using waking hours) and self-report instrument | Data reported on participants with complete accelerometry data | Posted | Mean | Full Range | change in self-reported days/week of PA | Baseline clinic visit (week 0) and final clinic visit (week 13) |
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| Secondary | 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. | Posted | Mean | Standard Error | change in units on a scale | Baseline clinic visit (week 0) and final clinic visit (week 13) |
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| Secondary | 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. | Posted | Mean | Standard Error | change in units on a scale | Baseline clinic visit (week 0) and final clinic visit (week 13) |
|
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| Secondary | 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. | Four participants refused to complete the final assessment. | Posted | Mean | Standard Deviation | change scores on a scale | Baseline clinic visit (Week 0) and final clinic visit (Week 13) |
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| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Control (Self-Directed Care) | The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit. | 0 | 19 | 0 | 19 | 0 | 19 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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