Clinical trial NCT01846377: Video Games for Obesity and Diabetes Prevention-Diab & Nano
Official title: Video Games for Obesity and Diabetes Prevention: Efficacy Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Type 2 Diabetes
Keywords: video game
diet
physical activity
sedentary behavior
obesity
diabetes
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 200
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: With the increasing rates of child obesity and diabetes, innovative programs are needed that capture children's attention and permit behavior change messages to get through. Serious video games with their immersive stories offer one such promising alternative due to their low cost approach to intervention since the games have already been developed, and can be broadly disseminated by simply reproducing and distributing their DVDs. While using video games for health promotion is controversial, this study will establish whether video games can effectively change diabetes and obesity risks (especially fasting insulin, diet and physical activity) among children.

"Escape from Diab" and "Nanoswarm: Invasion from Inner Space" are two video games that targeted children to increase fruit, vegetable and water intakes, reduce sedentary behaviors (SB), and increase physical activity in a pilot study with a relatively low risk children. In light of this, it is important to test whether these games can help decrease diabetes (i.e. fasting insulin) and obesity risks with high risk (85%tile \< BMI \< 99%tile) 10 to 12 year old children.

Children will be randomly assigned to treatment or control groups. The treatment group will play "Diab" and "Nano" over a 3-month time period. A wait-list control group will receive the "Diab" and "Nano" games at the end of their second post assessment (5-months post baseline assessment).

Detailed description: This project is to conduct an efficacy trial of Diab and Nanoswarm to assess their potential for minimizing T2D and obesity risks. The proposed research will be conducted in two phases, covering a 3-year period: implementation and evaluation phase of 2.5 years and an analysis phase of 0.5 years.

Specific Aim 1: Conduct an efficacy outcome evaluation of Diab and Nano using a randomized clinical trial.

Hypothesis 1: Children will decrease fasting insulin by, at least, 2μU/dl, increase FV intake by at least 1.0 servings/day, and increase MVPA by at least 10 min/day from baseline to up to 3 months post baseline.

Hypothesis 2: Diet, MVPA and fasting insulin changes will not be moderated by demographic characteristics (e.g. gender, age, ethnic group).

Hypothesis 3: Fasting insulin change will be mediated by changes in diet, PA and SB.

Hypothesis 4: Diet and PA change outcomes will be mediated by changes in child's preferences and intrinsic motivation for FV and PA.

Control Intervention will be a wait list group and receive the intervention at the end of the 5-month post assessment.

Intervention: Children will play the games at home. Each game session should take about 45 to 60 minutes to complete with an ability to go back and replay the non-behavior mini-games.

Child Measures include:

* Fasting insulin and glucose
* Height, weight and waist circumference
* Body mass index (BMI; kg/m2) BMI %
* Fruit, vegetable and beverage intake by food frequency, and preferences, self efficacy, and intrinsic motivation
* Physical activity (PA) by Actigraph GT3X accelerometer and PA preferences/enjoyment, self efficacy, intrinsic motivation and home equipment availability
* Transportation/immersion/liking of video games played
* Social desirability to reflect giving answers that are socially acceptable or expected

Parent Measures includes:

* Family demographics
* Food and physical activity equipment availability at home
* Report of if their child liked and played the video games

Eligibility criteria: Inclusion criteria:

* Children who are 10-12 years of age
* with a 85th%tile to 99th%tile BMI
* willing to complete all measures including providing a blood sample and
* having internet access and a computer with these minimum requirements:
* Operating System: Microsoft Windows XP (SP3), Windows Vista (SP2), Windows 7 (SP1), Windows 8 or 8.1 Processor: 2.13 GHz Intel Core 2 Duo E6400 or 2.8 GHz AMD Athlon 64 x2 5600+ minimum System Memory: 2Gbytes RAM Screen Resolution: 1280 x 800 minimum Hard Drive: 10Gbytes minimum free space Sound: Sound card with speakers or headphone jack DVD Optical Drive (needed for installation only) DirectX Runtimes: (October 2006 version or newer) Internet: Broadband Connection Computer Manufactured after 2009.

Exclusion Criteria:

* Child does not speak English (since both games are in English),
* has a medical condition that influences diet, physical activity, obesity, or the ability to complete questionnaires,
* has type 2 diabetes mellitus;
* does not have a qualified computer and internet access at home.

Primary outcomes:
measure: Change in fasting insulin from baseline to immediate post intervention (approximately 3 months post baseline assessment) and 2-months post intervention (approximately 5 months post baseline assessment)
timeFrame: Three time points: baseline, post intervention (approximately three months post baseline), two month post intervention (approximately 5 months post baseline)
Secondary outcomes:
measure: Change in Fruit and Vegetable Intake
timeFrame: Three time points: baseline, post intervention (approximately three months post baseline), two month post intervention (approximately 5 months post baseline)
Other outcomes:
measure: Change in Moderate to Vigorous Physical Activity
timeFrame: Three time points: baseline, post intervention (approximately three months post baseline), two month post intervention (approximately 5 months post baseline)
Locations:
city: Houston
country: United States
facility: Children's Nutrition Research Center, Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Tom Baranowski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baranowski T, Baranowski J, Thompson D, Buday R, Jago R, Griffith MJ, Islam N, Nguyen N, Watson KB. Video game play, child diet, and physical activity behavior change a randomized clinical trial. Am J Prev Med. 2011 Jan;40(1):33-8. doi: 10.1016/j.amepre.2010.09.029.