Video Games for Obesity and Diabetes Prevention-Diab & Nano (G4H-DiabNano)

February 19, 2018 updated by: Thomas Baranowski, Baylor College of Medicine

Video Games for Obesity and Diabetes Prevention: Efficacy Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

200

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
    • Texas
      • Houston, Texas, United States, 77030
        • Children's Nutrition Research Center, Baylor College of Medicine

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

Yes

Genders Eligible for Study

All

Description

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.

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
Experimental: G4H-Diab-Nano
Intervention - play two videogames Diab and Nanoswarm (9 sessions each, 18 total sessions) over a 12-week time period.
Behavioral: G4H-Diab-Nano
The Diab and Nanoswarm games present fun, challenging: knowledge mini-games enabling children to learn desired behavior changes; goal-setting tailored to child's current behaviors and preferences to make lifestyle changes; problem solving to enable children to find strategies to overcome behavior change barriers; motivational statements tailored to child's values to enhance their desire to make the goal related lifestyle changes; and energy balance games to enable them to balance food portions with physical activities. Each game has 9 sessions each with approximately 45-60 min of game-play. At the end of each session, goals are set. The child is allowed to re-play non-behavior change mini-games, and view video segments, but not redo their goal setting or behavior change mini-games.
No Intervention: Wait List Control
5-months after baseline assessment they will receive the two video games: 1) Diab and 2) Nanoswarm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: Three time points: baseline, post intervention (approximately three months post baseline), two month post intervention (approximately 5 months post baseline)
Three time points: baseline, post intervention (approximately three months post baseline), two month post intervention (approximately 5 months post baseline)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Fruit and Vegetable Intake
Time Frame: Three time points: baseline, post intervention (approximately three months post baseline), two month post intervention (approximately 5 months post baseline)
Three time points: baseline, post intervention (approximately three months post baseline), two month post intervention (approximately 5 months post baseline)

Other Outcome Measures

Outcome Measure
Time Frame
Change in Moderate to Vigorous Physical Activity
Time Frame: Three time points: baseline, post intervention (approximately three months post baseline), two month post intervention (approximately 5 months post baseline)
Three time points: baseline, post intervention (approximately three months post baseline), two month post intervention (approximately 5 months post baseline)

Collaborators and Investigators

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

Sponsor

Baylor College of Medicine

Investigators

  • Principal Investigator: Tom Baranowski, PhD, Baylor College of Medicine

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

April 1, 2014

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

May 1, 2013

First Submitted That Met QC Criteria

May 2, 2013

First Posted (Estimate)

May 3, 2013

Study Record Updates

Last Update Posted (Actual)

February 20, 2018

Last Update Submitted That Met QC Criteria

February 19, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-29172

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.

Clinical Trials on Obesity

Clinical Trials on G4H-Diab-Nano

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe