Video Games for Obesity and Diabetes Prevention-Diab & Nano (G4H-DiabNano)
|ClinicalTrials.gov Identifier: NCT01846377|
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : February 20, 2018
|First Submitted Date ICMJE||May 1, 2013|
|First Posted Date ICMJE||May 3, 2013|
|Last Update Posted Date||February 20, 2018|
|Start Date ICMJE||April 2014|
|Primary Completion Date||September 2017 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||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) ]|
|Original Primary Outcome Measures ICMJE
||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 ]
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 History||Complete list of historical versions of study NCT01846377 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||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) ]|
|Original Secondary Outcome Measures ICMJE
||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 ]
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.
|Current Other Outcome Measures ICMJE
||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) ]|
|Original Other Outcome Measures ICMJE
||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 ]
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.
|Brief Title ICMJE||Video Games for Obesity and Diabetes Prevention-Diab & Nano|
|Official Title ICMJE||Video Games for Obesity and Diabetes Prevention: Efficacy Trial|
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).
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:
Parent Measures includes:
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
|Intervention ICMJE||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.
|Publications *||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.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||December 2017|
|Primary Completion Date||September 2017 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||10 Years to 12 Years (Child)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01846377|
|Other Study ID Numbers ICMJE||H-29172|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||
|Responsible Party||Thomas Baranowski, Baylor College of Medicine|
|Study Sponsor ICMJE||Baylor College of Medicine|
|Collaborators ICMJE||Not Provided|
|PRS Account||Baylor College of Medicine|
|Verification Date||February 2018|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP