Obesity and Physical Inactivity in Adolescents
Conditions
Keywords
Physical Activity, Sedentary Behavior, Video Games, Exergames
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.
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.
Interventions
BEHAVIORALKlub 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.
Sponsors
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Resting Systolic Blood Pressure Percentile | Baseline clinic visit (week 0) and final clinic visit (week 13) | Resting systolic blood pressure percentile |
| Change in Body Fat | Baseline clinic visit (week 0) and final clinic visit (week 13) | Assessed by dual energy x-ray absorptiometry |
| Change in Visceral Adiposity | Baseline clinic visit (week 0) and final clinic visit (week 13) | Assessed by magnetic resonance imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Health-related Quality of Life | 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. |
| Feasibility (Adherence) | 3 gaming sessions/week for 12 weeks | Attendance to exergaming intervention |
| Change From Baseline in Self-efficacy Towards Exercise on the Self-Efficacy for Healthy Eating and Physical Activity Measure (SE-HEPA) at Week 13 | 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. |
| Change in Physical Activity | 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. | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| Control (Self-Directed Care) The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit. | 19 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Total | Control (Self-Directed Care) | Exergame Intervention |
|---|---|---|---|
| Age, Continuous | 15.7 years STANDARD_DEVIATION 1.3 | 16.1 years STANDARD_DEVIATION 1.4 | 15.3 years STANDARD_DEVIATION 1.2 |
| BMI (percentile) | 97.3 Percentile STANDARD_DEVIATION 3.1 | 97.1 Percentile STANDARD_DEVIATION 3.3 | 97.4 Percentile STANDARD_DEVIATION 2.9 |
| BMI (z-score) | 2.1 Z-score STANDARD_DEVIATION 0.5 | 2.1 Z-score STANDARD_DEVIATION 0.5 | 2.1 Z-score STANDARD_DEVIATION 0.5 |
| Cholesterol | 156.6 Milligrams per deciliter STANDARD_DEVIATION 24.5 | 163.1 Milligrams per deciliter STANDARD_DEVIATION 27.3 | 149.6 Milligrams per deciliter STANDARD_DEVIATION 21.6 |
| Diastolic Blood Pressure Percentile | 63.7 Percentile STANDARD_DEVIATION 21.4 | 66.4 Percentile STANDARD_DEVIATION 20.5 | 60.9 Percentile STANDARD_DEVIATION 22.3 |
| DXA Android Fat | 4.3 Kilograms STANDARD_DEVIATION 2.3 | 4.4 Kilograms STANDARD_DEVIATION 2.3 | 4.2 Kilograms STANDARD_DEVIATION 2.2 |
| DXA Android Fat Percentile | 54.1 Percentile STANDARD_DEVIATION 19.7 | 54.3 Percentile STANDARD_DEVIATION 9.2 | 53.8 Percentile STANDARD_DEVIATION 10.5 |
| DXA BMD Leg | 1.3 Grams per centimeter squared STANDARD_DEVIATION 0.1 | 1.3 Grams per centimeter squared STANDARD_DEVIATION 0.1 | 1.3 Grams per centimeter squared STANDARD_DEVIATION 0.1 |
| DXA BMD Spine | 1.15 Grams per centimeter squared STANDARD_DEVIATION 0.1 | 1.2 Grams per centimeter squared STANDARD_DEVIATION 0.1 | 1.1 Grams per centimeter squared STANDARD_DEVIATION 0.1 |
| DXA BMD Trunk | 1.1 Grams per centimeter squared STANDARD_DEVIATION 0.1 | 1.1 Grams per centimeter squared STANDARD_DEVIATION 0.1 | 1.1 Grams per centimeter squared STANDARD_DEVIATION 0.1 |
| DXA Bone Mineral Content (BMC) | 2.65 Kilograms STANDARD_DEVIATION 0.3 | 2.7 Kilograms STANDARD_DEVIATION 0.3 | 2.6 Kilograms STANDARD_DEVIATION 0.3 |
| DXA Bone Mineral Density (BMD) | 1.2 Grams per centimeter squared STANDARD_DEVIATION 0.1 | 1.2 Grams per centimeter squared STANDARD_DEVIATION 0.1 | 1.2 Grams per centimeter squared STANDARD_DEVIATION 0.1 |
| DXA Gynoid Fat | 7.9 kilograms STANDARD_DEVIATION 4.7 | 8.1 kilograms STANDARD_DEVIATION 2.2 | 7.6 kilograms STANDARD_DEVIATION 2.5 |
| DXA Gynoid Fat Percentage | 50 Percentile STANDARD_DEVIATION 5.7 | 50.1 Percentile STANDARD_DEVIATION 4.9 | 49.8 Percentile STANDARD_DEVIATION 6.5 |
| DXA leg fat | 16.2 kilograms STANDARD_DEVIATION 5.2 | 16.2 kilograms STANDARD_DEVIATION 4.7 | 16.2 kilograms STANDARD_DEVIATION 5.6 |
| DXA Leg fat percentage | 48.2 percentile STANDARD_DEVIATION 5.4 | 48.0 percentile STANDARD_DEVIATION 5.2 | 48.3 percentile STANDARD_DEVIATION 5.6 |
| DXA Total body fat | 47.5 kilograms STANDARD_DEVIATION 18.35 | 48.0 kilograms STANDARD_DEVIATION 17 | 47.0 kilograms STANDARD_DEVIATION 19.7 |
| DXA Total body fat percent | 48.25 percentile STANDARD_DEVIATION 13 | 48.2 percentile STANDARD_DEVIATION 6.3 | 48.3 percentile STANDARD_DEVIATION 19.7 |
| DXA Trunk Fat | 25.6 Kilograms STANDARD_DEVIATION 12.9 | 26.1 Kilograms STANDARD_DEVIATION 12.1 | 25.1 Kilograms STANDARD_DEVIATION 13.6 |
| DXA Trunk Fat Percentile | 50.6 Percentile STANDARD_DEVIATION 8.8 | 50.5 Percentile STANDARD_DEVIATION 8.1 | 50.6 Percentile STANDARD_DEVIATION 9.5 |
| Glucose | 89.7 Milligrams per deciliter STANDARD_DEVIATION 28.2 | 91.8 Milligrams per deciliter STANDARD_DEVIATION 21.8 | 87.6 Milligrams per deciliter STANDARD_DEVIATION 6.4 |
| Height | 162.65 centimeters STANDARD_DEVIATION 5.9 | 164.9 centimeters STANDARD_DEVIATION 5.8 | 160.4 centimeters STANDARD_DEVIATION 5.9 |
| High Density Lipoprotein | 50.1 Milligrams per deciliter STANDARD_DEVIATION 8.9 | 52.7 Milligrams per deciliter STANDARD_DEVIATION 10.5 | 47.4 Milligrams per deciliter STANDARD_DEVIATION 7.3 |
| Insulin | 21.8 Micro unit per milliliter STANDARD_DEVIATION 12.8 | 19.4 Micro unit per milliliter STANDARD_DEVIATION 10.4 | 24.2 Micro unit per milliliter STANDARD_DEVIATION 15.2 |
| Low-density Lipoprotein | 90.4 Milligrams per deciliter STANDARD_DEVIATION 21.1 | 94.4 Milligrams per deciliter STANDARD_DEVIATION 22.9 | 86.4 Milligrams per deciliter STANDARD_DEVIATION 19.2 |
| MRI Subcutaneous Adipose Tissue | 12.2 Kilograms STANDARD_DEVIATION 5.65 | 12.3 Kilograms STANDARD_DEVIATION 5.7 | 12.1 Kilograms STANDARD_DEVIATION 5.6 |
| MRI Total Adipose Tissue | 13.2 Kilograms STANDARD_DEVIATION 6.1 | 13.3 Kilograms STANDARD_DEVIATION 6.3 | 13.1 Kilograms STANDARD_DEVIATION 5.9 |
| MRI Visceral Adipose Tissue | 1.0 Kilograms STANDARD_DEVIATION 0.7 | 1.0 Kilograms STANDARD_DEVIATION 0.7 | 1.0 Kilograms STANDARD_DEVIATION 0.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 12 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 7 Participants | 8 Participants |
| Region of Enrollment United States | 41 participants | 19 participants | 22 participants |
| Sex: Female, Male Female | 41 Participants | 19 Participants | 22 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Systolic Blood Pressure Percentile | 60.1 Percentile STANDARD_DEVIATION 27.7 | 56.6 Percentile STANDARD_DEVIATION 30.1 | 63.5 Percentile STANDARD_DEVIATION 25.2 |
| Triglycerides | 79.5 Milligrams per deciliter STANDARD_DEVIATION 45.9 | 80.0 Milligrams per deciliter STANDARD_DEVIATION 42.4 | 78.9 Milligrams per deciliter STANDARD_DEVIATION 49.4 |
| Waist Circumference | 107.5 centimeters STANDARD_DEVIATION 21.6 | 107.7 centimeters STANDARD_DEVIATION 21.1 | 107.3 centimeters STANDARD_DEVIATION 22 |
| Weight | 99.15 kilograms STANDARD_DEVIATION 26.7 | 101.1 kilograms STANDARD_DEVIATION 26.1 | 97.2 kilograms STANDARD_DEVIATION 27.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 19 |
| other Total, other adverse events | 0 / 22 | 0 / 19 |
| serious Total, serious adverse events | 0 / 22 | 0 / 19 |
Outcome results
Primary
Change in Body Fat
Assessed by dual energy x-ray absorptiometry
Time frame: Baseline clinic visit (week 0) and final clinic visit (week 13)
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exergame Intervention | Change in Body Fat | 1.0 kg | Standard Deviation 0.5 |
| Control (Self-Directed Care) | Change in Body Fat | 1.6 kg | Standard Deviation 0.5 |
Primary
Change in Resting Systolic Blood Pressure Percentile
Resting systolic blood pressure percentile
Time frame: Baseline clinic visit (week 0) and final clinic visit (week 13)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exergame Intervention | Change in Resting Systolic Blood Pressure Percentile | -13.3 %ile | Standard Deviation 6.3 |
| Control (Self-Directed Care) | Change in Resting Systolic Blood Pressure Percentile | -1.8 %ile | Standard Deviation 6.4 |
Primary
Change in Visceral Adiposity
Assessed by magnetic resonance imaging
Time frame: Baseline clinic visit (week 0) and final clinic visit (week 13)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exergame Intervention | Change in Visceral Adiposity | 0.02 kg | Standard Deviation 0.03 |
| Control (Self-Directed Care) | Change in Visceral Adiposity | 0.04 kg | Standard Deviation 0.03 |
p-value: 0.05ANCOVA
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.
Time frame: Baseline clinic visit (week 0) and final clinic visit (week 13)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exergame Intervention | Change From Baseline in Health-related Quality of Life | -0.1 change in units on a scale | Standard Error 1.5 |
| Control (Self-Directed Care) | Change From Baseline in Health-related Quality of Life | -1.3 change in units on a scale | Standard Error 1.6 |
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.
Time frame: Baseline clinic visit (Week 0) and final clinic visit (Week 13)
Population: Four participants refused to complete the final assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exergame Intervention | Change From Baseline in Self-efficacy Towards Exercise on the Self-Efficacy for Healthy Eating and Physical Activity Measure (SE-HEPA) at Week 13 | 0.37 change scores on a scale | Standard Deviation 1.7 |
| Control (Self-Directed Care) | Change From Baseline in Self-efficacy Towards Exercise on the Self-Efficacy for Healthy Eating and Physical Activity Measure (SE-HEPA) at Week 13 | 0.44 change scores on a scale | Standard Deviation 1.7 |
Secondary
Change in Physical Activity
Actigraph accelerometer (7-day protocol using waking hours) and self-report instrument
Time frame: Baseline clinic visit (week 0) and final clinic visit (week 13)
Population: Data reported on participants with complete accelerometry data
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Exergame Intervention | Change in Physical Activity | 1.0 change in self-reported days/week of PA |
| Control (Self-Directed Care) | Change in Physical Activity | -0.3 change in self-reported days/week of PA |
Secondary
Feasibility (Adherence)
Attendance to exergaming intervention
Time frame: 3 gaming sessions/week for 12 weeks
Population: Attendance was only assessed for the Exergame Intervention participants
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Exergame Intervention | Feasibility (Adherence) | 79 percentage exergaming sessions attended |
| Control (Self-Directed Care) | Feasibility (Adherence) | NA percentage exergaming sessions attended |
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.
Time frame: Baseline clinic visit (week 0) and final clinic visit (week 13)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exergame Intervention | The Friendship Quality Questionnaire to Measure Change in Peer Support From Baseline to Week 13. | -0.4 change in units on a scale | Standard Error 0.7 |
| Control (Self-Directed Care) | The Friendship Quality Questionnaire to Measure Change in Peer Support From Baseline to Week 13. | 1.7 change in units on a scale | Standard Error 0.7 |