Expired Study
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Baton Rouge, Louisiana 70808


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

PBRC 2015-037


NCT ID:

NCT02560493


Secondary ID:


Study Acronym:

GameSquad


Brief Title:

Gaming Technology to Encourage Healthy Weight and Activity in Youth


Official Title:

Gaming Technology to Encourage Healthy Weight and Activity in Youth


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

10 Years


Maximum Age:

12 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pennington Biomedical Research Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

46


Enrollment Type:

Actual


Overall Contact Information

Official Name:Amanda E Staiano, PhD
Principal Investigator
Pennington Biomedical Research Center

Study Dates

Start Date:October 2015
Completion Date:September 2016
Completion Type:Actual
Primary Completion Date:September 2016
Primary Completion Type:Actual
Verification Date:July 2019
Last Changed Date:July 15, 2019
First Received Date:September 18, 2015
First Results Date:January 29, 2019

Study Outcomes

Outcome Type:Primary Outcome
Measure:Changes in Body Mass Index Z-score (BMIz) Compared to a Control Group
Time Frame:Change between Baseline (Week 0) and 6 months (Week 24)
Safety Issues:False
Description: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 t
Outcome Type:Secondary Outcome
Measure:Changes in Body Fat
Time Frame:Change between Baseline (Week 0) and 6 months (Week 24)
Safety Issues:False
Description: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 tr
Outcome Type:Secondary Outcome
Measure:Changes in Systolic Blood Pressure
Time Frame:Change between Baseline (Week 0) and 6 months (Week 24)
Safety Issues:False
Description: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 Type:Secondary Outcome
Measure:Changes in Diastolic Blood Pressure
Time Frame:Change between Baseline (Week 0) and 6 months (Week 24)
Safety Issues:False
Description: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 Type:Secondary Outcome
Measure:Changes in Total Cholesterol
Time Frame:Change between Baseline (Week 0) and 6 months (Week 24)
Safety Issues:False
Description: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 Type:Secondary Outcome
Measure:Changes in Fasting Glucose
Time Frame:Change between Baseline (Week 0) and 6 months (Week 24)
Safety Issues:False
Description: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 Type:Secondary Outcome
Measure:Changes in Physical Activity
Time Frame:Change between Baseline (Week 0) and 6 months (Week 24)
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Changes in Diet
Time Frame:Change between Baseline (Week 0) and 6 months (Week 24)
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Behavioral
Name:Exergaming Condition
Description: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.
Arm Name:Exergaming Condition

Study Arms

Study Arm Type:Experimental
Arm Name:Exergaming Condition
Description:Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.
Study Arm Type:No Intervention
Arm Name:Control Condition
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Pennington Biomedical Research Center
Agency Class:Other
Agency Type:Collaborator
Agency Name:American Heart Association

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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