Childhood Obesity
Conditions
Keywords
BMIz, Exergaming, Cardiovascular Disease
Brief summary
The goal of the proposed randomized controlled trial is to test the efficacy of exergaming (i.e. video gaming that involves physical activity) to reduce adiposity in overweight and obese children.
Detailed description
The GAMESQUAD study is a 6-month, 2-arm randomized controlled trial among 46 overweight/obese children (aged 10 to 12 years) assigned to: 1) 3 hours/week of in-home exergaming or 2) a control group. An innovative aspect is the inclusion of a fitness trainer who will regularly video chat with the participant and virtually monitor gameplay. The study will advance the field by: 1) establishing the efficacy of exergaming to reduce BMIz among overweight and obese children and 2) demonstrating the potential of exergaming to reduce body fat and improve children's cardiovascular health.
Interventions
BEHAVIORALExergaming 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.
Sponsors
American Heart Association
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* BMI percentile \> or equal to 85 on the CDC growth chart * Participating household has a high-speed internet connection * At least 1 family member or friend who is willing to exergame in the home with the participant for 3 hours/week
Exclusion criteria
* Pregnant * Impairments that prevent normal ambulation * Previous history, or current symptoms of, cardiovascular disease, musculoskeletal injury, or epileptic seizures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Body Mass Index Z-score (BMIz) Compared to a Control Group | Change between Baseline (Week 0) and 6 months (Week 24) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Systolic Blood Pressure | Change between Baseline (Week 0) and 6 months (Week 24) | 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. |
| Changes in Diastolic Blood Pressure | Change between Baseline (Week 0) and 6 months (Week 24) | 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. |
| Changes in Total Cholesterol | Change between Baseline (Week 0) and 6 months (Week 24) | 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. |
| Changes in Body Fat | Change between Baseline (Week 0) and 6 months (Week 24) | 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. |
| Changes in Physical Activity | Change between Baseline (Week 0) and 6 months (Week 24) | 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. |
| Changes in Diet | Change between Baseline (Week 0) and 6 months (Week 24) | 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. |
| Changes in Fasting Glucose | Change between Baseline (Week 0) and 6 months (Week 24) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 23 |
| 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. | 23 |
| Total | 46 |
Baseline characteristics
| Characteristic | Exergaming Condition | Total | Control Condition |
|---|---|---|---|
| Age, Continuous | 11.3 years STANDARD_DEVIATION 0.8 | 11.2 years STANDARD_DEVIATION 0.8 | 10.8 years STANDARD_DEVIATION 0.8 |
| Body mass index, z-score | 2.06 z-score. STANDARD_DEVIATION 0.46 | 2.08 z-score. STANDARD_DEVIATION 0.44 | 2.10 z-score. STANDARD_DEVIATION 0.42 |
| Diastolic blood pressure percentile | 58.5 percentile STANDARD_DEVIATION 17.8 | 60.9 percentile STANDARD_DEVIATION 20.1 | 63.3 percentile STANDARD_DEVIATION 22.4 |
| Fat mass, kg | 30.4 kg STANDARD_DEVIATION 11.6 | 29.8 kg STANDARD_DEVIATION 9.6 | 29.3 kg STANDARD_DEVIATION 7.4 |
| Fat mass percentage | 42.0 percentage of fat mass STANDARD_DEVIATION 5.9 | 43.1 percentage of fat mass STANDARD_DEVIATION 4.9 | 44.1 percentage of fat mass STANDARD_DEVIATION 3.4 |
| HDL-cholesterol | 48.9 mg/dL STANDARD_DEVIATION 9.1 | 50.1 mg/dL STANDARD_DEVIATION 9.1 | 51.3 mg/dL STANDARD_DEVIATION 9.2 |
| LDL-cholesterol | 89.4 mg/dL STANDARD_DEVIATION 31.2 | 94.4 mg/dL STANDARD_DEVIATION 30.5 | 99.3 mg/dL STANDARD_DEVIATION 29.6 |
| Moderate-to-vigorous physical activity | 35.0 minutes/day STANDARD_DEVIATION 17.8 | 35.1 minutes/day STANDARD_DEVIATION 17.8 | 35.1 minutes/day STANDARD_DEVIATION 18.3 |
| 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 | 15 Participants | 26 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 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 | 7 Participants | 19 Participants | 12 Participants |
| Region of Enrollment United States | 23 participants | 46 participants | 23 participants |
| Reported dietary intake | 1700.0 kcal/day STANDARD_DEVIATION 905.4 | 1801.8 kcal/day STANDARD_DEVIATION 887.3 | 1894.4 kcal/day STANDARD_DEVIATION 881.2 |
| Sex: Female, Male Female | 23 Participants | 46 Participants | 23 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Systolic blood pressure percentile | 36.4 percentile STANDARD_DEVIATION 11.6 | 40.0 percentile STANDARD_DEVIATION 23.2 | 43.7 percentile STANDARD_DEVIATION 25.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 0 / 23 | 2 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
Primary
Changes in Body Mass Index Z-score (BMIz) Compared to a Control Group
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
Time frame: Change between Baseline (Week 0) and 6 months (Week 24)
Population: One participant was lost to follow-up.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control Condition | Changes in Body Mass Index Z-score (BMIz) Compared to a Control Group | 0.02 z-score | Standard Error 0.03 |
| Exergaming Condition | Changes in Body Mass Index Z-score (BMIz) Compared to a Control Group | -0.06 z-score | Standard Error 0.03 |
Secondary
Changes in Body Fat
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.
Time frame: Change between Baseline (Week 0) and 6 months (Week 24)
Population: One participant was lost to follow-up.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control Condition | Changes in Body Fat | 1.7 kg | Standard Error 0.5 |
| Exergaming Condition | Changes in Body Fat | 0.8 kg | Standard Error 0.5 |
Secondary
Changes in Diastolic Blood Pressure
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.
Time frame: Change between Baseline (Week 0) and 6 months (Week 24)
Population: One participant was lost to follow-up.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control Condition | Changes in Diastolic Blood Pressure | 8.3 percentile | Standard Error 4.2 |
| Exergaming Condition | Changes in Diastolic Blood Pressure | -7.4 percentile | Standard Error 4.3 |
Secondary
Changes in Diet
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.
Time frame: Change between Baseline (Week 0) and 6 months (Week 24)
Population: Some participants did not complete the dietary recalls.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control Condition | Changes in Diet | 269.5 kcal/day | Standard Error 200 |
| Exergaming Condition | Changes in Diet | -297.2 kcal/day | Standard Error 215 |
Secondary
Changes in Fasting Glucose
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.
Time frame: Change between Baseline (Week 0) and 6 months (Week 24)
Population: One participant was lost to follow-up.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control Condition | Changes in Fasting Glucose | 0.4 mg/dL | Standard Error 1.1 |
| Exergaming Condition | Changes in Fasting Glucose | 0.5 mg/dL | Standard Error 1.1 |
Secondary
Changes in Physical Activity
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control Condition | Changes in Physical Activity | -7.8 minutes/day | Standard Error 3.2 |
| Exergaming Condition | Changes in Physical Activity | 3.6 minutes/day | Standard Error 3.4 |
Secondary
Changes in Systolic Blood Pressure
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.
Time frame: Change between Baseline (Week 0) and 6 months (Week 24)
Population: One participant was lost to follow-up.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control Condition | Changes in Systolic Blood Pressure | 10.9 percentile | Standard Error 5 |
| Exergaming Condition | Changes in Systolic Blood Pressure | -5.0 percentile | Standard Error 5.1 |
Secondary
Changes in Total Cholesterol
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.
Time frame: Change between Baseline (Week 0) and 6 months (Week 24)
Population: One participant was lost to follow-up.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control Condition | Changes in Total Cholesterol | 6.7 mg/dL | Standard Error 3.5 |
| Exergaming Condition | Changes in Total Cholesterol | -7.1 mg/dL | Standard Error 3.5 |