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Gaming Technology to Encourage Healthy Weight and Activity in Youth (GameSquad)

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exergaming Condition
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring BMIz, Exergaming, Cardiovascular Disease

Eligibility Criteria

10 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Condition

Exergaming Condition

Arm 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.

Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 18, 2015
Last Updated
May 7, 2020
Sponsor
Pennington Biomedical Research Center
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT02560493
Brief Title
Gaming Technology to Encourage Healthy Weight and Activity in Youth
Acronym
GameSquad
Official Title
Gaming Technology to Encourage Healthy Weight and Activity in Youth
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
American Heart Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
BMIz, Exergaming, Cardiovascular Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Condition
Arm Type
No Intervention
Arm 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.
Arm Title
Exergaming Condition
Arm Type
Experimental
Arm Description
Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.
Intervention Type
Behavioral
Intervention Name(s)
Exergaming Condition
Intervention 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.
Primary Outcome Measure Information:
Title
Changes in Body Mass Index Z-score (BMIz) Compared to a Control Group
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 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)
Secondary Outcome Measure Information:
Title
Changes in Body Fat
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 trunk.
Time Frame
Change between Baseline (Week 0) and 6 months (Week 24)
Title
Changes in Systolic Blood Pressure
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.
Time Frame
Change between Baseline (Week 0) and 6 months (Week 24)
Title
Changes in Diastolic Blood Pressure
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.
Time Frame
Change between Baseline (Week 0) and 6 months (Week 24)
Title
Changes in Total Cholesterol
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.
Time Frame
Change between Baseline (Week 0) and 6 months (Week 24)
Title
Changes in Fasting Glucose
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.
Time Frame
Change between Baseline (Week 0) and 6 months (Week 24)
Title
Changes in Physical Activity
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 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)
Title
Changes in Diet
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.
Time Frame
Change between Baseline (Week 0) and 6 months (Week 24)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda E Staiano, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Gaming Technology to Encourage Healthy Weight and Activity in Youth

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