ObesityG4H-DiabNanoNCT01846377
Video Games for Obesity and Diabetes Prevention-Diab & Nano
A study testing G4H-Diab-Nano in people with Obesity and Type 2 Diabetes, run by Baylor College of Medicine at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- G4H-Diab-Nano
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Nutrition Research Center, Baylor College of Medicine
Houston, Texas, 77030
About this study
Official title: 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).
Read the 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
- Conditions
- Obesity, Type 2 Diabetes
- Being tested
- G4H-Diab-Nano
- Keywords
- video game, diet, physical activity, sedentary behavior, obesity, diabetes
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Motor Activity, Sedentary Behavior, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G4H-Diab-NanoBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| G4H-Diab-Nano | Experimental | Intervention - play two videogames Diab and Nanoswarm (9 sessions each, 18 total sessions) over a 12-week time period. Receives: Behavioral: G4H-Diab-Nano |
| Wait List Control | No intervention | 5-months after baseline assessment they will receive the two video games: 1) Diab and 2) Nanoswarm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Three time points: baseline, post intervention (approximately three months post baseline), two month post intervention (approximately 5 months post baseline)
Secondary outcomes (1)
Change in Fruit and Vegetable Intake
Measured: Three time points: baseline, post intervention (approximately three months post baseline), two month post intervention (approximately 5 months post baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startApr 2014
- Primary completionSep 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Baranowski, Baylor College of Medicine
- Investigators
- Tom Baranowski, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846377
- Sponsor's protocol ID
- H-29172
- Acronym
- G4H-DiabNano
- Status last verified
- Feb 2018
- First submitted
- 1 May 2013
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 21146765
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Games for Obesity and Diabetes Prevention: Efficacy Trial
- ClinicalTrials.gov ID
- NCT01846377
- Acronym / sponsor ID
- G4H-DiabNano / H-29172
- Conditions
- Obesity, Type 2 Diabetes
- Keywords
- video game, diet, physical activity, sedentary behavior, obesity, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G4H-Diab-Nano | Experimental | Behavioral: G4H-Diab-NanoIntervention - play two videogames Diab and Nanoswarm (9 sessions each, 18 total sessions) over a 12-week time period. |
| Wait List Control | No intervention | –5-months after baseline assessment they will receive the two video games: 1) Diab and 2) Nanoswarm. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G4H-Diab-NanoThe 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. | Behavioural | G4H-Diab-Nano |
Primary outcome
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)
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
- Background: PubMed 21146765Baranowski 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.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Baranowski, PhD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G4H-Diab-Nano in people with Obesity and Type 2 Diabetes, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01846377, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2018.