Clinical trial NCT02560493: Gaming Technology to Encourage Healthy Weight and Activity in Youth
Official title: Gaming Technology to Encourage Healthy Weight and Activity in Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: BMIz
Exergaming
Cardiovascular Disease
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2015-09-25
Enrollment: 46
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes in Body Mass Index Z-score (BMIz) Compared to a Control Group
timeFrame: Change between Baseline (Week 0) and 6 months (Week 24)
Secondary outcomes:
measure: Changes in Body Fat
timeFrame: Change between Baseline (Week 0) and 6 months (Week 24)
measure: Changes in Systolic Blood Pressure
timeFrame: Change between Baseline (Week 0) and 6 months (Week 24)
measure: Changes in Diastolic Blood Pressure
timeFrame: Change between Baseline (Week 0) and 6 months (Week 24)
measure: Changes in Total Cholesterol
timeFrame: Change between Baseline (Week 0) and 6 months (Week 24)
measure: Changes in Fasting Glucose
timeFrame: Change between Baseline (Week 0) and 6 months (Week 24)
measure: Changes in Physical Activity
timeFrame: Change between Baseline (Week 0) and 6 months (Week 24)
measure: Changes in Diet
timeFrame: Change between Baseline (Week 0) and 6 months (Week 24)
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Amanda E Staiano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Staiano AE, Beyl RA, Guan W, Hendrick CA, Hsia DS, Newton RL Jr. Home-based exergaming among children with overweight and obesity: a randomized clinical trial. Pediatr Obes. 2018 Nov;13(11):724-733. doi: 10.1111/ijpo.12438. Epub 2018 Jul 20.