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Type 2 DiabetesNCT00570466

Computer Based Intervention for Type 2 Diabetes in Youth

A study testing Video Games and Web and DVD knowledge in people with Type 2 Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Interactive multimedia programs have been demonstrated to produce substantial change in children's dietary behaviors. This SBIR-Phase 2 protocol will evaluate the two video game interventions designed to change diabetes related behaviors, including diet and physical activity: Escape from Diab! and Nanoswarm that were… Read more about this study

Who is it for?
Ages 10 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes
What is being tested?
Video Games and Web and DVD knowledge
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
153 participants
Where
1 siteUnited States
Study dates
Jan 2008to Dec 2011
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

  • Healthy 10-12 year old African-American, Hispanic-American, Anglo or Asian children.
  • Able to fluently speak, read and write English.
  • Able to play computer video games.
  • DSL or high-speed internet connection at home.
  • No dietary restrictions that limit their intake of fruit \& vegetables or water.
  • No medical, physical handicaps or other reasons that would limit their physical activity.
  • Greater than 50% BMI, but less than 95% BMI.

Who cannot join

  • Children who are not in the target age range of 10-12 years old.
  • Not able to fluently speak, read and write English.
  • Not able to play computer video games.
  • No DSL or high-speed internet connection at home.
  • Dietary restrictions that limit their intake of fruit \& vegetables or water.
  • Medical, physical handicaps or other reasons that would limit their physical activity.
  • Less than 50% BMI or greater than 95% BMI.
  • History of epileptic seizures.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Baylor College of Medicine

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Computer Based Intervention for Type 2 Diabetes in Youth: Phase 2

Interactive multimedia programs have been demonstrated to produce substantial change in children's dietary behaviors. This SBIR-Phase 2 protocol will evaluate the two video game interventions designed to change diabetes related behaviors, including diet and physical activity: Escape from Diab! and Nanoswarm that were developed in Phase 1. The primary hypotheses for this SBIR-Phase 2 protocol are:

  1. The two video games will result in greater dietary and physical activity change than a knowledge based control group.
  2. The effects of the video games will be mediated by changes in child preferences for FV and PA, self-efficacy to change FV intake and PA, and intrinsic motivation to eat FV and PA.

We will test these hypotheses by evaluating the two video games in a randomized experiment. To minimize costs, we will evaluate the impact of the games on behavior (diet and PA), BMI and related psychosocial variables, but not blood values. Our long-term goal is reducing the incidence of Type 2 diabetes and related health problems in youth.

Read the detailed description

Increasing numbers of minority youth are at risk for developing Type 2 Diabetes (T2D) because of family history and overweight. While precise incidence and prevalence rates for T2D among children are not available, the prevalence has increased substantially in the last ten years, likely due to parallel increases in obesity among children. These cases are expected to progress to end organ damage at an early age, with the resultant increased personal and societal costs. Probable risk factors for T2DM include ethnicity (African American, Hispanic, Native American), family history of diabetes, and obesity. Prevention is key to reducing risks for T2D. The only modifiable risk factor is weight, which reflects dietary and physical activity practices. A diet high in fruit and vegetables, and appropriate in total calories and low in dietary fat are likely protective against both obesity and T2D. Although national data suggest the percentage of kilocalories (kcal) from fat consumed by children aged 2-17 decreased between 1989 and 1995 (now at 33% of total kcal), actual fat intakes did not decrease. Kcal intake, however, increased. Children's current intake of fruit and vegetables is less than one-half of the 5-A-Day goal. Changing the diet and physical activity practices to impact adiposity among children 10 to 12 years old before the onset of obesity or early in obesity holds great promise of preventing T2D. Furthermore, it is approximately this age that children assume more responsibility for their diet and physical activity, and thereby the intervention can be expected to have a greater impact on behavior. Children at the 50%tile or higher BMI are those most likely to progress to obesity, and thereby provide an important target group for obesity prevention.

Video games focused on promoting T2D-related changes in diet and physical activity, based on the most current theories of health behavior, hold the promise of preventing T2D among children, and thereby reducing lifelong disease burden. Unlike traditional media-based interventions (print, graphic, audio/visual, television broadcast), computer technology provides opportunities to influence behavior change through direct, personalized interactive experiences.

As part of a SBIR-Phase I, we created two video games: Escape from Diab! and Nanoswarm - Invasion from Inner Space. These intervention video games propose to increase fruit and vegetable intake to reduce total calories by displacing high fat, high calorie foods; increase water intake to decrease sweetened beverage consumption and total calories; increase physical activity; and decrease inactivity (e.g., TV watching, playing commercial video games). The behavioral and educational objectives address national behavior change objectives, including:

  • Three to five servings of fruit (F) or 100% fruit juice (J) per day and Four to seven servings of vegetables (V) per day (based on child recommended calorie intake for age and weight),
  • Five to eight glasses of water (W) per day,
  • Moderate to vigorous Physical Activity (PA) of at least 60 min/day, and
  • Physical Inactivity (PI) (TV, e-games, telephone) of no more than 2 hours per day.

Both games use an adventure storyline to capture the children's interest and attention, and thereby enhance their desire to keep coming back to the game across multiple sessions (between which behavior change goals are attempted). The storylines provide messages that reinforce the diet and physical activity change objectives. Seamlessly woven into each adventure session are programmed procedures for promoting behavior change (goal setting, goal review), which were tailored to characteristics of the child obtained through self report. Behavior change knowledge games, seamlessly woven into the storyline, are used to provide the basis for effective goal setting; and energy balance games, also seamlessly woven into the storyline, are used to provide the knowledge necessary to effectively self control caloric intake and output.

Conditions
Type 2 Diabetes
Being tested
Video Games, Web and DVD knowledge
Keywords
Type 2 Diabetes, Prevention, Children, Diet, Physical Activity
Medical subject headings
Diabetes Mellitus, Type 2, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video GamesBehavioural

    Two interactive, computer-based video games (9 sessions each) played in sequence to increase fruit,vegetable,water intake + physical activity + decrease TV viewing.

  • Web and DVD knowledgeBehavioural

    Web and DVD based knowledge games

Study groups in NCT00570466
Study groupRoleWhat they receive
Video gamesExperimentalTwo interactive, computer-based video games (9 sessions each) played in sequence to increase fruit, vegetable and water intake, physical activity and decrease TV viewing.
Receives: Behavioral: Video Games
Web and DVD knowledgePlacebo comparatorParallel web and DVD based knowledge games on fruit, vegetable, water, physical activity and physical inactivity.
Receives: Behavioral: Web and DVD knowledge

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dietary intake of servings of fruit and vegetables as measured by three 24-hour dietary recalls; and minutes of moderate to vigorous physical activity as measured by 5 days of accelerometry.

    Measured: 6 months

Secondary outcomes (1)
  1. Height, weight, waist circumference, propylthiouracil (PROP) sensitivity status and nutrition and physical activity psychosocial questionnaires.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2007 (estimated)
  2. Study startJan 2008
  3. Primary completionMay 2009
  4. Study completionDec 2011

Resources

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
None (open label)
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00570466
Sponsor's protocol ID
DK66724 (completed)
Other IDs
U44DK066724, U01DK061231
Status last verified
Sep 2014
First submitted
6 Dec 2007
Last updated
27 Sep 2017
Results posted
No
Data monitoring committee
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

Questions about this trial

What is this clinical trial studying?

A study testing Video Games and Web and DVD knowledge in people with Type 2 Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 7 inclusion and 8 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 27 Sep 2017. 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. Some participants in this study may receive a placebo. 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?

Dietary intake of servings of fruit and vegetables as measured by three 24-hour dietary recalls; and minutes of moderate to vigorous physical activity as measured by 5 days of accelerometry. (time frame: 6 months). 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 NCT00570466, 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 27 Sep 2017.

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Clinical Trial NCT00570466 | AzTrials