Video Games for Obesity and Diabetes Prevention
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.
|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|
- 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).
- 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.
- 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.
|Study Start Date:||September 2013|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
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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|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 firstname.lastname@example.org|
|Contact: Janice Baranowski, MPH, RD 713-798-6763 email@example.com|
|Principal Investigator: Tom Baranowski, Ph.D.|
|Principal Investigator:||Tom Baranowski, PhD||Baylor College of Medicine|