Video Games for Obesity and Diabetes Prevention

This study is not yet open for participant recruitment.
Verified May 2013 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: May 2, 2013
Last verified: May 2013
  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. "Escape from Diab" and "Nanoswarm: Invasion from Inner Space" are two video games guided in their design by four behavior change theories that were targeted at increasing fruit, vegetable and water intakes, and lowering sedentary behaviors, and have been shown to change these children's diet and physical activity practices in a pilot study with a relatively low risk sample. In light of this preliminary success, it is important to test the efficacy of these interventions on diabetes risks (i.e. fasting insulin) with higher risk children (which should increase the effect) and with a larger sample to learn how the games change behaviors using mediating variable analyses. A study with 444 high risk (85%tile<BMI<99%tile) 10 to 12 year old children is proposed. Children will be randomly assigned to treatment or control groups. The control group will be a wait-list control and receive the intervention at the end of the second post assessment. Video games are a promising low cost approach to intervention since the games have already been developed, and can be broadly disseminated by simply reproducing and distributing their DVDs. No study has appeared that tested the effects of theory based video games on diet and physical activity that was adequately powered to investigate mediating variables. Conducting the mediating variable analyses will inform the design of future video games and enhance their ability to promote health behavior change. While using video games for health promotion is controversial, this study will establish whether video games efficaciously change diabetes risks (especially insulin, diet and physical activity) among children.


Condition Intervention
Obesity
Type 2 Diabetes
Behavioral: 1)Diab and 2)Nanoswarm

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 up to 3 months post baseline (immediate post intervention) [ Time Frame: Three time points: baseline, up to three months post baseline (immediate post), two month post immediate post ] [ Designated as safety issue: No ]
    Fasting blood will be drawn to assess fasting insulin. The evening before data collection, study staff will call the child scheduled for the next day's blood draws to remind them not to eat any food or drink except water after midnight and not to eat breakfast. At check-in, students will be questioned about the last time they had anything to eat or drink and will be rescheduled if they are not fasting. Standard procedures will be followed by nurses and licensed phlebotomists. A study physician will be available by phone in case of adverse events. A numbing cream will be applied with appropriate consent. Blood will be drawn in the CNRC metabolic unit. Samples will be inserted in EDTA tubes, placed on ice, centrifuged at 4oC and transferred to labeled storage tubes and frozen at -80oC until analyzed. Plasma insulin will be measured using commercially available double sandwich assay on an Elecsys 1010 instrument (Roche Diagnostics Corporation, Indianapolis, IN).


Secondary Outcome Measures:
  • Change in Fruit and Vegetable Intake [ Time Frame: Three time points: baseline, up to three months post baseline (immediate post), two month post immediate post ] [ Designated as safety issue: No ]
    The investigators will use the ASA24-Kids to assess usual dietary intake, and obtain three 24-hour dietary recalls (24hdr) using ASA24-Kids on nonconsecutive days at each observation. Three days has been demonstrated to obtain acceptably reliable estimates of usual intake. The 24hdr will be obtained for two weekdays, and one weekend day. ASA24-Kids will ask the child where each meal/snack was eaten, who else was there, whether a TV was on and whether they attended to the TV during the meal. Children 10 years and older can give a reasonably accurate self-report of intake. 24hdr completed by telephone have been found to provide accurate data from 8-10 year old African-American girls and adolescents. The dietary recalls will be analyzed for servings of fruit and vegetables. The investigators will assess fruit and vegetable servings by day of the week, meal/snack, and environment. The investigators helped create the ASA24-Kids and conducted the first validation study.


Other Outcome Measures:
  • Change in Moderate to Vigorous Physical Activity [ Time Frame: Three time points: baseline, up to three months post baseline (immediate post), two month post immediate post ] [ Designated as safety issue: No ]
    Physical activity will be assessed using the latest Actigraph GT3X accelerometer. This accelerometer is a small device which measures acceleration in 3 dimensions plus step counts. Accelerometers have been shown to provide accurate and reliable assessments of activity among youth. Participants will wear accelerometers for seven days (with a minimum of 600 min of recording from 6am to midnight to count as a valid day) and mean minutes of MVPA will be established for weekdays and weekend days using published cut-points. Accelerometer counts per minute, an indication of the volume of activity in which the children engaged, will be calculated.


Estimated Enrollment: 444
Study Start Date: September 2013
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Two serious videogames for health
This efficacy trial will be conducted using a two group design (treatment (trt), control (ctl)) with randomization to group occurring after baseline assessment (to obviate observer bias), and three assessment periods (baseline, immediate post and 2 month post). The treatment group will play the 1)Diab and 2)Nanoswarm videogames.
Behavioral: 1)Diab and 2)Nanoswarm
The Escape from Diab and Nanoswarm games present fun, challenging: 1) knowledge mini-games that enable children to learn what constitutes desired behavior; 2) goal-setting activities tailored to a child's current behaviors and preferences to make specific lifestyle changes; 3) problem solving routines to enable children to determine strategies to overcome likely barriers to behavior changes; 4) motivational statements tailored to a child's values to enhance the child's desire to make the goal related lifestyle changes; and 5) energy balance games to enable children to select appropriate portions and aerobic/strength enhancing physical activities. Each game has 9 sessions with approximately 45-60 min of game-play per session. At the end of each session, the child was allowed to return to the game to re-play certain mini-games, and related video segments, but could not redo the goal setting or review portions.
No Intervention: Wait List Control

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  Eligibility

Ages Eligible for Study:   10 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusionary criteria are being 10-12 years of age with a 85th%tileBMI <participant <99th%tileBMI and willing to complete all measures including providing a blood sample and having a computer with internet access. The minimum computer requirements (commonly found in a wide range of home computers) include: Microsoft Windows XP or newer; Microsoft Direct X graphics, Pixel Shader 1.0 or newer; monitor capable of 1280 x 768 screen resolution; 1.5 GHz CPU or greater; 256 Mbytes of RAM or greater; internet connection (broadband suggested for downloaded install file); and approximately 3 GB of free hard drive space; keyboard and mouse (gamepad optional); and audio with speakers or headphones.

Exclusion Criteria:

  • Exclusionary criteria include the child not speaking English (since both games are in English), have a medical condition that influences diet, physical activity, obesity, the ability to complete questionnaires, or having type 2 diabetes mellitus.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01846377

Locations
United States, Texas
Children's Nutrition Research Center, Baylor College of Medicine Not yet recruiting
Houston, Texas, United States, 77030
Contact: Alicia Beltran, MS    713-798-0503    abeltran@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: May 2, 2013
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 April 17, 2014