Trial Outcomes & Findings for Social Exergaming for Healthy Weight in Adolescent Girls (NCT NCT02003963)
NCT ID: NCT02003963
Last Updated: 2024-03-29
Results Overview
Assessed by dual energy x-ray absorptiometry
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Baseline clinic visit (week 0) and final clinic visit (week 13)
Results posted on
2024-03-29
Participant Flow
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.
Participant milestones
| Measure |
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.
|
Control (Self-Directed Care)
The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
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|---|---|---|
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Overall Study
STARTED
|
22
|
19
|
|
Overall Study
COMPLETED
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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.
|
Control (Self-Directed Care)
The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
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|---|---|---|
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Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Exergame Intervention
n=22 Participants
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.
|
Control (Self-Directed Care)
n=19 Participants
The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
|
Total
n=41 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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15.3 years
STANDARD_DEVIATION 1.2 • n=22 Participants
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16.1 years
STANDARD_DEVIATION 1.4 • n=19 Participants
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15.7 years
STANDARD_DEVIATION 1.3 • n=41 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=22 Participants
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19 Participants
n=19 Participants
|
41 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=22 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=22 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=22 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=22 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=22 Participants
|
12 Participants
n=19 Participants
|
26 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=22 Participants
|
7 Participants
n=19 Participants
|
15 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=22 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=22 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=41 Participants
|
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Region of Enrollment
United States
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22 participants
n=22 Participants
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19 participants
n=19 Participants
|
41 participants
n=41 Participants
|
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Weight
|
97.2 kilograms
STANDARD_DEVIATION 27.3 • n=22 Participants
|
101.1 kilograms
STANDARD_DEVIATION 26.1 • n=19 Participants
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99.15 kilograms
STANDARD_DEVIATION 26.7 • n=41 Participants
|
|
Height
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160.4 centimeters
STANDARD_DEVIATION 5.9 • n=22 Participants
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164.9 centimeters
STANDARD_DEVIATION 5.8 • n=19 Participants
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162.65 centimeters
STANDARD_DEVIATION 5.9 • n=41 Participants
|
|
BMI (z-score)
|
2.1 Z-score
STANDARD_DEVIATION 0.5 • n=22 Participants
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2.1 Z-score
STANDARD_DEVIATION 0.5 • n=19 Participants
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2.1 Z-score
STANDARD_DEVIATION 0.5 • n=41 Participants
|
|
BMI (percentile)
|
97.4 Percentile
STANDARD_DEVIATION 2.9 • n=22 Participants
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97.1 Percentile
STANDARD_DEVIATION 3.3 • n=19 Participants
|
97.3 Percentile
STANDARD_DEVIATION 3.1 • n=41 Participants
|
|
Waist Circumference
|
107.3 centimeters
STANDARD_DEVIATION 22.0 • n=22 Participants
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107.7 centimeters
STANDARD_DEVIATION 21.1 • n=19 Participants
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107.5 centimeters
STANDARD_DEVIATION 21.6 • n=41 Participants
|
|
DXA Total body fat
|
47.0 kilograms
STANDARD_DEVIATION 19.7 • n=22 Participants
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48.0 kilograms
STANDARD_DEVIATION 17.0 • n=19 Participants
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47.5 kilograms
STANDARD_DEVIATION 18.35 • n=41 Participants
|
|
DXA Total body fat percent
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48.3 percentile
STANDARD_DEVIATION 19.7 • n=22 Participants
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48.2 percentile
STANDARD_DEVIATION 6.3 • n=19 Participants
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48.25 percentile
STANDARD_DEVIATION 13 • n=41 Participants
|
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DXA leg fat
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16.2 kilograms
STANDARD_DEVIATION 5.6 • n=22 Participants
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16.2 kilograms
STANDARD_DEVIATION 4.7 • n=19 Participants
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16.2 kilograms
STANDARD_DEVIATION 5.2 • n=41 Participants
|
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DXA Leg fat percentage
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48.3 percentile
STANDARD_DEVIATION 5.6 • n=22 Participants
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48.0 percentile
STANDARD_DEVIATION 5.2 • n=19 Participants
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48.2 percentile
STANDARD_DEVIATION 5.4 • n=41 Participants
|
|
DXA Gynoid Fat
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7.6 kilograms
STANDARD_DEVIATION 2.5 • n=22 Participants
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8.1 kilograms
STANDARD_DEVIATION 2.2 • n=19 Participants
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7.9 kilograms
STANDARD_DEVIATION 4.7 • n=41 Participants
|
|
DXA Gynoid Fat Percentage
|
49.8 Percentile
STANDARD_DEVIATION 6.5 • n=22 Participants
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50.1 Percentile
STANDARD_DEVIATION 4.9 • n=19 Participants
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50 Percentile
STANDARD_DEVIATION 5.7 • n=41 Participants
|
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DXA Android Fat
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4.2 Kilograms
STANDARD_DEVIATION 2.2 • n=22 Participants
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4.4 Kilograms
STANDARD_DEVIATION 2.3 • n=19 Participants
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4.3 Kilograms
STANDARD_DEVIATION 2.3 • n=41 Participants
|
|
DXA Android Fat Percentile
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53.8 Percentile
STANDARD_DEVIATION 10.5 • n=22 Participants
|
54.3 Percentile
STANDARD_DEVIATION 9.2 • n=19 Participants
|
54.1 Percentile
STANDARD_DEVIATION 19.7 • n=41 Participants
|
|
DXA Trunk Fat
|
25.1 Kilograms
STANDARD_DEVIATION 13.6 • n=22 Participants
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26.1 Kilograms
STANDARD_DEVIATION 12.1 • n=19 Participants
|
25.6 Kilograms
STANDARD_DEVIATION 12.9 • n=41 Participants
|
|
DXA Trunk Fat Percentile
|
50.6 Percentile
STANDARD_DEVIATION 9.5 • n=22 Participants
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50.5 Percentile
STANDARD_DEVIATION 8.1 • n=19 Participants
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50.6 Percentile
STANDARD_DEVIATION 8.8 • n=41 Participants
|
|
DXA Bone Mineral Content (BMC)
|
2.6 Kilograms
STANDARD_DEVIATION 0.3 • n=22 Participants
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2.7 Kilograms
STANDARD_DEVIATION 0.3 • n=19 Participants
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2.65 Kilograms
STANDARD_DEVIATION 0.3 • n=41 Participants
|
|
DXA Bone Mineral Density (BMD)
|
1.2 Grams per centimeter squared
STANDARD_DEVIATION 0.1 • n=22 Participants
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1.2 Grams per centimeter squared
STANDARD_DEVIATION 0.1 • n=19 Participants
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1.2 Grams per centimeter squared
STANDARD_DEVIATION 0.1 • n=41 Participants
|
|
DXA BMD Trunk
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1.1 Grams per centimeter squared
STANDARD_DEVIATION 0.1 • n=22 Participants
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1.1 Grams per centimeter squared
STANDARD_DEVIATION 0.1 • n=19 Participants
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1.1 Grams per centimeter squared
STANDARD_DEVIATION 0.1 • n=41 Participants
|
|
DXA BMD Spine
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1.1 Grams per centimeter squared
STANDARD_DEVIATION 0.1 • n=22 Participants
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1.2 Grams per centimeter squared
STANDARD_DEVIATION 0.1 • n=19 Participants
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1.15 Grams per centimeter squared
STANDARD_DEVIATION 0.1 • n=41 Participants
|
|
DXA BMD Leg
|
1.3 Grams per centimeter squared
STANDARD_DEVIATION 0.1 • n=22 Participants
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1.3 Grams per centimeter squared
STANDARD_DEVIATION 0.1 • n=19 Participants
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1.3 Grams per centimeter squared
STANDARD_DEVIATION 0.1 • n=41 Participants
|
|
MRI Visceral Adipose Tissue
|
1.0 Kilograms
STANDARD_DEVIATION 0.7 • n=21 Participants • 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.
|
1.0 Kilograms
STANDARD_DEVIATION 0.7 • n=17 Participants • 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.
|
1.0 Kilograms
STANDARD_DEVIATION 0.7 • n=38 Participants • 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.
|
|
MRI Subcutaneous Adipose Tissue
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12.1 Kilograms
STANDARD_DEVIATION 5.6 • n=21 Participants • 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.
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12.3 Kilograms
STANDARD_DEVIATION 5.7 • n=17 Participants • 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.
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12.2 Kilograms
STANDARD_DEVIATION 5.65 • n=38 Participants • 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.
|
|
MRI Total Adipose Tissue
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13.1 Kilograms
STANDARD_DEVIATION 5.9 • n=21 Participants • 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.
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13.3 Kilograms
STANDARD_DEVIATION 6.3 • n=17 Participants • 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.
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13.2 Kilograms
STANDARD_DEVIATION 6.1 • n=38 Participants • 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.
|
|
Systolic Blood Pressure Percentile
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63.5 Percentile
STANDARD_DEVIATION 25.2 • n=22 Participants
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56.6 Percentile
STANDARD_DEVIATION 30.1 • n=19 Participants
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60.1 Percentile
STANDARD_DEVIATION 27.7 • n=41 Participants
|
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Diastolic Blood Pressure Percentile
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60.9 Percentile
STANDARD_DEVIATION 22.3 • n=22 Participants
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66.4 Percentile
STANDARD_DEVIATION 20.5 • n=19 Participants
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63.7 Percentile
STANDARD_DEVIATION 21.4 • n=41 Participants
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Cholesterol
|
149.6 Milligrams per deciliter
STANDARD_DEVIATION 21.6 • n=22 Participants
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163.1 Milligrams per deciliter
STANDARD_DEVIATION 27.3 • n=19 Participants
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156.6 Milligrams per deciliter
STANDARD_DEVIATION 24.5 • n=41 Participants
|
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High Density Lipoprotein
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47.4 Milligrams per deciliter
STANDARD_DEVIATION 7.3 • n=22 Participants
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52.7 Milligrams per deciliter
STANDARD_DEVIATION 10.5 • n=19 Participants
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50.1 Milligrams per deciliter
STANDARD_DEVIATION 8.9 • n=41 Participants
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Low-density Lipoprotein
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86.4 Milligrams per deciliter
STANDARD_DEVIATION 19.2 • n=22 Participants
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94.4 Milligrams per deciliter
STANDARD_DEVIATION 22.9 • n=19 Participants
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90.4 Milligrams per deciliter
STANDARD_DEVIATION 21.1 • n=41 Participants
|
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Triglycerides
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78.9 Milligrams per deciliter
STANDARD_DEVIATION 49.4 • n=22 Participants
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80.0 Milligrams per deciliter
STANDARD_DEVIATION 42.4 • n=19 Participants
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79.5 Milligrams per deciliter
STANDARD_DEVIATION 45.9 • n=41 Participants
|
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Glucose
|
87.6 Milligrams per deciliter
STANDARD_DEVIATION 6.4 • n=22 Participants
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91.8 Milligrams per deciliter
STANDARD_DEVIATION 21.8 • n=19 Participants
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89.7 Milligrams per deciliter
STANDARD_DEVIATION 28.2 • n=41 Participants
|
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Insulin
|
24.2 Micro unit per milliliter
STANDARD_DEVIATION 15.2 • n=22 Participants
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19.4 Micro unit per milliliter
STANDARD_DEVIATION 10.4 • n=19 Participants
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21.8 Micro unit per milliliter
STANDARD_DEVIATION 12.8 • n=41 Participants
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PRIMARY outcome
Timeframe: Baseline clinic visit (week 0) and final clinic visit (week 13)Population: Intent to treat
Assessed by dual energy x-ray absorptiometry
Outcome measures
| Measure |
Exergame Intervention
n=22 Participants
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 session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently.
|
Control (Self-Directed Care)
n=19 Participants
The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
|
|---|---|---|
|
Change in Body Fat
|
1.0 kg
Standard Deviation 0.5
|
1.6 kg
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: 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.
Assessed by magnetic resonance imaging
Outcome measures
| Measure |
Exergame Intervention
n=18 Participants
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 session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently.
|
Control (Self-Directed Care)
n=15 Participants
The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
|
|---|---|---|
|
Change in Visceral Adiposity
|
0.02 kg
Standard Deviation 0.03
|
0.04 kg
Standard Deviation 0.03
|
PRIMARY outcome
Timeframe: Baseline clinic visit (week 0) and final clinic visit (week 13)Resting systolic blood pressure percentile
Outcome measures
| Measure |
Exergame Intervention
n=20 Participants
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 session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently.
|
Control (Self-Directed Care)
n=18 Participants
The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
|
|---|---|---|
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Change in Resting Systolic Blood Pressure Percentile
|
-13.3 %ile
Standard Deviation 6.3
|
-1.8 %ile
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: 3 gaming sessions/week for 12 weeksPopulation: Attendance was only assessed for the "Exergame Intervention" participants
Attendance to exergaming intervention
Outcome measures
| Measure |
Exergame Intervention
n=22 Participants
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 session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently.
|
Control (Self-Directed Care)
n=19 Participants
The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
|
|---|---|---|
|
Feasibility (Adherence)
|
79 percentage exergaming sessions attended
Interval 28.0 to 100.0
|
NA percentage exergaming sessions attended
Attendance was only assessed for the "Exergame Intervention" participants
|
SECONDARY outcome
Timeframe: Baseline clinic visit (week 0) and final clinic visit (week 13)Population: Data reported on participants with complete accelerometry data
Actigraph accelerometer (7-day protocol using waking hours) and self-report instrument
Outcome measures
| Measure |
Exergame Intervention
n=19 Participants
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 session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently.
|
Control (Self-Directed Care)
n=18 Participants
The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
|
|---|---|---|
|
Change in Physical Activity
|
1.0 change in self-reported days/week of PA
Interval -7.0 to 7.0
|
-0.3 change in self-reported days/week of PA
Interval -7.0 to 7.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Exergame Intervention
n=22 Participants
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 session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently.
|
Control (Self-Directed Care)
n=19 Participants
The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
|
|---|---|---|
|
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
|
1.7 change in units on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Exergame Intervention
n=22 Participants
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 session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently.
|
Control (Self-Directed Care)
n=19 Participants
The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
|
|---|---|---|
|
Change From Baseline in Health-related Quality of Life
|
-0.1 change in units on a scale
Standard Error 1.5
|
-1.3 change in units on a scale
Standard Error 1.6
|
SECONDARY outcome
Timeframe: Baseline clinic visit (Week 0) and final clinic visit (Week 13)Population: Four participants refused to complete the final assessment.
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.
Outcome measures
| Measure |
Exergame Intervention
n=19 Participants
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 session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently.
|
Control (Self-Directed Care)
n=18 Participants
The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
|
|---|---|---|
|
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
|
0.44 change scores on a scale
Standard Deviation 1.7
|
Adverse Events
Exergame Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control (Self-Directed Care)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place