NCT01846377

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 20, 2018

Status Verified

February 1, 2018

Enrollment Period

3.4 years

First QC Date

May 1, 2013

Last Update Submit

February 19, 2018

Conditions

Keywords

video gamedietphysical activitysedentary behaviorobesitydiabetes

Outcome Measures

Primary Outcomes (1)

  • 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)

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

Secondary Outcomes (1)

  • Change in Fruit and Vegetable Intake

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

Other Outcomes (1)

  • Change in Moderate to Vigorous Physical Activity

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

Study Arms (2)

G4H-Diab-Nano

EXPERIMENTAL

Intervention - play two videogames Diab and Nanoswarm (9 sessions each, 18 total sessions) over a 12-week time period.

Behavioral: G4H-Diab-Nano

Wait List Control

NO INTERVENTION

5-months after baseline assessment they will receive the two video games: 1) Diab and 2) Nanoswarm.

Interventions

G4H-Diab-NanoBEHAVIORAL

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.

G4H-Diab-Nano

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Nutrition Research Center, Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 21146765BACKGROUND

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Motor ActivitySedentary BehaviorDiabetes Mellitus

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Tom Baranowski, PhD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

May 1, 2013

First Posted

May 3, 2013

Study Start

April 1, 2014

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

February 20, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations