NCT00570466

Brief Summary

Interactive multimedia programs have been demonstrated to produce substantial change in children's dietary behaviors. This SBIR-Phase 2 protocol will evaluate the two video game interventions designed to change diabetes related behaviors, including diet and physical activity: Escape from Diab! and Nanoswarm that were developed in Phase 1. The primary hypotheses for this SBIR-Phase 2 protocol are:

  1. 1.The two video games will result in greater dietary and physical activity change than a knowledge based control group.
  2. 2.The effects of the video games will be mediated by changes in child preferences for FV and PA, self-efficacy to change FV intake and PA, and intrinsic motivation to eat FV and PA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable type-2-diabetes

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

December 6, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 11, 2007

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 27, 2017

Status Verified

September 1, 2014

Enrollment Period

1.3 years

First QC Date

December 6, 2007

Last Update Submit

September 25, 2017

Conditions

Type 2 Diabetes

Keywords

Type 2 DiabetesPreventionChildrenDietPhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Dietary intake of servings of fruit and vegetables as measured by three 24-hour dietary recalls; and minutes of moderate to vigorous physical activity as measured by 5 days of accelerometry.

    6 months

Secondary Outcomes (1)

  • Height, weight, waist circumference, propylthiouracil (PROP) sensitivity status and nutrition and physical activity psychosocial questionnaires.

    6 months

Study Arms (2)

Video games

EXPERIMENTAL

Two interactive, computer-based video games (9 sessions each) played in sequence to increase fruit, vegetable and water intake, physical activity and decrease TV viewing.

Behavioral: Video Games

Web and DVD knowledge

PLACEBO COMPARATOR

Parallel web and DVD based knowledge games on fruit, vegetable, water, physical activity and physical inactivity.

Behavioral: Web and DVD knowledge

Interventions

Video GamesBEHAVIORAL

Two interactive, computer-based video games (9 sessions each) played in sequence to increase fruit,vegetable,water intake + physical activity + decrease TV viewing.

Video games
Web and DVD knowledgeBEHAVIORAL

Web and DVD based knowledge games

Web and DVD knowledge

Eligibility Criteria

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

You may qualify if:

  • Healthy 10-12 year old African-American, Hispanic-American, Anglo or Asian children.
  • Able to fluently speak, read and write English.
  • Able to play computer video games.
  • DSL or high-speed internet connection at home.
  • No dietary restrictions that limit their intake of fruit \& vegetables or water.
  • No medical, physical handicaps or other reasons that would limit their physical activity.
  • Greater than 50% BMI, but less than 95% BMI.

You may not qualify if:

  • Children who are not in the target age range of 10-12 years old.
  • Not able to fluently speak, read and write English.
  • Not able to play computer video games.
  • No DSL or high-speed internet connection at home.
  • Dietary restrictions that limit their intake of fruit \& vegetables or water.
  • Medical, physical handicaps or other reasons that would limit their physical activity.
  • Less than 50% BMI or greater than 95% BMI.
  • History of epileptic seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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: 21146765RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Tom Baranowski, Ph.D.

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2007

First Posted

December 11, 2007

Study Start

January 1, 2008

Primary Completion

May 1, 2009

Study Completion

December 1, 2011

Last Updated

September 27, 2017

Record last verified: 2014-09

Locations

US(1)