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

March 27, 2024 updated by: Amanda Staiano, Pennington Biomedical Research Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: Exergaming Condition
Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
Change between Baseline (Week 0) and 6 months (Week 24)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Body Fat
Time Frame: 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.
Change between Baseline (Week 0) and 6 months (Week 24)
Changes in Systolic Blood Pressure
Time Frame: 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.
Change between Baseline (Week 0) and 6 months (Week 24)
Changes in Diastolic Blood Pressure
Time Frame: 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.
Change between Baseline (Week 0) and 6 months (Week 24)
Changes in Total Cholesterol
Time Frame: 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.
Change between Baseline (Week 0) and 6 months (Week 24)
Changes in Fasting Glucose
Time Frame: 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.
Change between Baseline (Week 0) and 6 months (Week 24)
Changes in Physical Activity
Time Frame: 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.
Change between Baseline (Week 0) and 6 months (Week 24)
Changes in Diet
Time Frame: 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.
Change between Baseline (Week 0) and 6 months (Week 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Collaborators

American Heart Association

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 18, 2015

First Submitted That Met QC Criteria

September 23, 2015

First Posted (Estimated)

September 25, 2015

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBRC 2015-037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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