Trial Outcomes & Findings for Gaming Technology to Encourage Healthy Weight and Activity in Youth (NCT NCT02560493)
NCT ID: NCT02560493
Last Updated: 2024-03-29
Results Overview
Height and weight will be collected at Screening, Week 0, and Week 24. Standing height will be measured in cm with a Harpenden stadiometer (Holtain Limited, Crymych, UK) with shoes removed while the participant holds breath and an assessor applies light traction to align the participant's head along the Frankfort Horizontal Plane. Weight will be measured in kg with a Michelli GSE 460 scale (G.T. Michelli Co., Baton Rouge, LA) while wearing a hospital gown and undergarments. Measures will be taken twice and recorded to the nearest 0.1 units, with a third if the initial 2 measures are greater than 0.5 units apart. BMIz will be calculated based on the child's age, sex, height, and weight using the 2000 Centers for Disease Control and Prevention (CDC) Growth Charts. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean
COMPLETED
NA
46 participants
Change between Baseline (Week 0) and 6 months (Week 24)
2024-03-29
Participant Flow
Participant milestones
| Measure |
Control Condition
Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.
|
Exergaming Condition
Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.
Exergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.
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|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
22
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One participant's accelerometry data did not meet standards for completeness (10 hours/day with at least 4 days/week including 1 weekend day).
Baseline characteristics by cohort
| Measure |
Control Condition
n=23 Participants
Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.
|
Exergaming Condition
n=23 Participants
Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.
Exergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.
|
Total
n=46 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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10.8 years
STANDARD_DEVIATION 0.8 • n=23 Participants
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11.3 years
STANDARD_DEVIATION 0.8 • n=23 Participants
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11.2 years
STANDARD_DEVIATION 0.8 • n=46 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=23 Participants
|
23 Participants
n=23 Participants
|
46 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=23 Participants
|
15 Participants
n=23 Participants
|
26 Participants
n=46 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=23 Participants
|
7 Participants
n=23 Participants
|
19 Participants
n=46 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=23 Participants
|
1 Participants
n=23 Participants
|
1 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=46 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=23 Participants
|
23 participants
n=23 Participants
|
46 participants
n=46 Participants
|
|
Body mass index, z-score
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2.10 z-score.
STANDARD_DEVIATION 0.42 • n=23 Participants
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2.06 z-score.
STANDARD_DEVIATION 0.46 • n=23 Participants
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2.08 z-score.
STANDARD_DEVIATION 0.44 • n=46 Participants
|
|
Fat mass, kg
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29.3 kg
STANDARD_DEVIATION 7.4 • n=23 Participants
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30.4 kg
STANDARD_DEVIATION 11.6 • n=23 Participants
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29.8 kg
STANDARD_DEVIATION 9.6 • n=46 Participants
|
|
Fat mass percentage
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44.1 percentage of fat mass
STANDARD_DEVIATION 3.4 • n=23 Participants
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42.0 percentage of fat mass
STANDARD_DEVIATION 5.9 • n=23 Participants
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43.1 percentage of fat mass
STANDARD_DEVIATION 4.9 • n=46 Participants
|
|
Systolic blood pressure percentile
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43.7 percentile
STANDARD_DEVIATION 25.9 • n=23 Participants
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36.4 percentile
STANDARD_DEVIATION 11.6 • n=23 Participants
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40.0 percentile
STANDARD_DEVIATION 23.2 • n=46 Participants
|
|
Diastolic blood pressure percentile
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63.3 percentile
STANDARD_DEVIATION 22.4 • n=23 Participants
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58.5 percentile
STANDARD_DEVIATION 17.8 • n=23 Participants
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60.9 percentile
STANDARD_DEVIATION 20.1 • n=46 Participants
|
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HDL-cholesterol
|
51.3 mg/dL
STANDARD_DEVIATION 9.2 • n=23 Participants
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48.9 mg/dL
STANDARD_DEVIATION 9.1 • n=23 Participants
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50.1 mg/dL
STANDARD_DEVIATION 9.1 • n=46 Participants
|
|
LDL-cholesterol
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99.3 mg/dL
STANDARD_DEVIATION 29.6 • n=23 Participants
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89.4 mg/dL
STANDARD_DEVIATION 31.2 • n=23 Participants
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94.4 mg/dL
STANDARD_DEVIATION 30.5 • n=46 Participants
|
|
Moderate-to-vigorous physical activity
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35.1 minutes/day
STANDARD_DEVIATION 18.3 • n=22 Participants • One participant's accelerometry data did not meet standards for completeness (10 hours/day with at least 4 days/week including 1 weekend day).
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35.0 minutes/day
STANDARD_DEVIATION 17.8 • n=23 Participants • One participant's accelerometry data did not meet standards for completeness (10 hours/day with at least 4 days/week including 1 weekend day).
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35.1 minutes/day
STANDARD_DEVIATION 17.8 • n=45 Participants • One participant's accelerometry data did not meet standards for completeness (10 hours/day with at least 4 days/week including 1 weekend day).
|
|
Reported dietary intake
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1894.4 kcal/day
STANDARD_DEVIATION 881.2 • n=22 Participants • Some participants did not provide complete data on the dietary recall and were not included in these analyses.
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1700.0 kcal/day
STANDARD_DEVIATION 905.4 • n=20 Participants • Some participants did not provide complete data on the dietary recall and were not included in these analyses.
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1801.8 kcal/day
STANDARD_DEVIATION 887.3 • n=42 Participants • Some participants did not provide complete data on the dietary recall and were not included in these analyses.
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PRIMARY outcome
Timeframe: Change between Baseline (Week 0) and 6 months (Week 24)Population: One participant was lost to follow-up.
Height and weight will be collected at Screening, Week 0, and Week 24. Standing height will be measured in cm with a Harpenden stadiometer (Holtain Limited, Crymych, UK) with shoes removed while the participant holds breath and an assessor applies light traction to align the participant's head along the Frankfort Horizontal Plane. Weight will be measured in kg with a Michelli GSE 460 scale (G.T. Michelli Co., Baton Rouge, LA) while wearing a hospital gown and undergarments. Measures will be taken twice and recorded to the nearest 0.1 units, with a third if the initial 2 measures are greater than 0.5 units apart. BMIz will be calculated based on the child's age, sex, height, and weight using the 2000 Centers for Disease Control and Prevention (CDC) Growth Charts. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean
Outcome measures
| Measure |
Control Condition
n=23 Participants
Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.
|
Exergaming Condition
n=22 Participants
Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.
Exergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.
|
|---|---|---|
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Changes in Body Mass Index Z-score (BMIz) Compared to a Control Group
|
0.02 z-score
Standard Error 0.03
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-0.06 z-score
Standard Error 0.03
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SECONDARY outcome
Timeframe: Change between Baseline (Week 0) and 6 months (Week 24)Population: One participant was lost to follow-up.
A dual energy x-ray absorptiometry (DXA) scan will be completed at Week 0 and Week 24 with a GE iDXA whole-body scanner (GE Medical Systems, Milwaukee, WI) to measure adiposity, including total body fat mass and regional fat mass in the extremities and trunk.
Outcome measures
| Measure |
Control Condition
n=23 Participants
Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.
|
Exergaming Condition
n=22 Participants
Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.
Exergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.
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|---|---|---|
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Changes in Body Fat
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1.7 kg
Standard Error 0.5
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0.8 kg
Standard Error 0.5
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SECONDARY outcome
Timeframe: Change between Baseline (Week 0) and 6 months (Week 24)Population: One participant was lost to follow-up.
Resting blood pressure will be assessed at Screening, Week 0, and Week 24 using standard clinical procedures on a standard mercury manometer. The participant's age-, sex-, and height-specific percentile will be calculated.
Outcome measures
| Measure |
Control Condition
n=23 Participants
Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.
|
Exergaming Condition
n=22 Participants
Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.
Exergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.
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|---|---|---|
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Changes in Systolic Blood Pressure
|
10.9 percentile
Standard Error 5.0
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-5.0 percentile
Standard Error 5.1
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SECONDARY outcome
Timeframe: Change between Baseline (Week 0) and 6 months (Week 24)Population: One participant was lost to follow-up.
Resting blood pressure will be assessed at Screening, Week 0, and Week 24 using standard clinical procedures on a standard mercury manometer. The participant's age-, sex-, and height-specific percentile will be calculated.
Outcome measures
| Measure |
Control Condition
n=23 Participants
Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.
|
Exergaming Condition
n=22 Participants
Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.
Exergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.
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|---|---|---|
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Changes in Diastolic Blood Pressure
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8.3 percentile
Standard Error 4.2
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-7.4 percentile
Standard Error 4.3
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SECONDARY outcome
Timeframe: Change between Baseline (Week 0) and 6 months (Week 24)Population: One participant was lost to follow-up.
A blood sample will be taken at Week 0 and Week 24 by a trained phlebotomist following standard clinic procedures after an 8-hour fast. Serum concentrations of total cholesterol will be assayed on a DXC600 from Trinity.
Outcome measures
| Measure |
Control Condition
n=23 Participants
Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.
|
Exergaming Condition
n=22 Participants
Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.
Exergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.
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|---|---|---|
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Changes in Total Cholesterol
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6.7 mg/dL
Standard Error 3.5
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-7.1 mg/dL
Standard Error 3.5
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SECONDARY outcome
Timeframe: Change between Baseline (Week 0) and 6 months (Week 24)Population: One participant was lost to follow-up.
A blood sample will be taken at Week 0 and Week 24 by a trained phlebotomist following standard clinic procedures after an 8-hour fast. Serum concentrations of glucose will be obtained from a DXC600 by Beckman Coulter.
Outcome measures
| Measure |
Control Condition
n=23 Participants
Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.
|
Exergaming Condition
n=22 Participants
Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.
Exergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.
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|---|---|---|
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Changes in Fasting Glucose
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0.4 mg/dL
Standard Error 1.1
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0.5 mg/dL
Standard Error 1.1
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SECONDARY outcome
Timeframe: Change between Baseline (Week 0) and 6 months (Week 24)Population: Several participants did not meet criteria for complete accelerometry data (at least 4 days of 10 hours/day including 1 weekend day) at both time points.
Physical activity will be assessed with an Actigraph GT3X+ accelerometer (ActiGraph, of Ft. Walton Beach, FL) to determine changes in habitual physical activity outside of the gaming intervention. Participants will wear the accelerometer for two bouts of 7-days following Week 0 baseline clinic visit and Week 24 clinic visit, but not during the gaming intervention.
Outcome measures
| Measure |
Control Condition
n=19 Participants
Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.
|
Exergaming Condition
n=16 Participants
Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.
Exergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.
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|---|---|---|
|
Changes in Physical Activity
|
-7.8 minutes/day
Standard Error 3.2
|
3.6 minutes/day
Standard Error 3.4
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SECONDARY outcome
Timeframe: Change between Baseline (Week 0) and 6 months (Week 24)Population: Some participants did not complete the dietary recalls.
Dietary information will be collected from the participant at Week 0 and Week 24. Healthy diet score will be determined by the NCI Self-administered 24-hour Dietary Recall (ASA24-Kids). This survey is administered on a computer through a web-based program.
Outcome measures
| Measure |
Control Condition
n=22 Participants
Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.
|
Exergaming Condition
n=19 Participants
Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.
Exergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.
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|---|---|---|
|
Changes in Diet
|
269.5 kcal/day
Standard Error 200.0
|
-297.2 kcal/day
Standard Error 215.0
|
Adverse Events
Control Condition
Exergaming Condition
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Condition
n=23 participants at risk
Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.
|
Exergaming Condition
n=23 participants at risk
Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.
Exergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.
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|---|---|---|
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Musculoskeletal and connective tissue disorders
Injury during game play
|
0.00%
0/23
|
8.7%
2/23 • Number of events 2
|
Additional Information
Dr. Amanda Staiano
LSU's Pennington Biomedical Research Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place