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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Baylor College of Medicine
Sponsor:
Information provided by (Responsible Party):
Thomas Baranowski, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01846377
First received: May 1, 2013
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention
Obesity
Type 2 Diabetes
Behavioral: G4H-Diab-Nano

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Video Games for Obesity and Diabetes Prevention: Efficacy Trial

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 444
Study Start Date: April 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   10 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01846377

Locations
United States, Texas
Children's Nutrition Research Center, Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Jessica McLeod    713-798-0370    jamcleod@bcm.edu   
Contact: Janice Baranowski, MPH, RD    713-798-6763    jbaranow@bcm.edu   
Principal Investigator: Tom Baranowski, Ph.D.         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Tom Baranowski, PhD Baylor College of Medicine
  More Information

Publications:
Responsible Party: Thomas Baranowski, Professor of Pediatrics, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01846377     History of Changes
Other Study ID Numbers: H-29172
Study First Received: May 1, 2013
Last Updated: April 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
video game
diet
physical activity
sedentary behavior
obesity
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014