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Computer Based Intervention for Type 2 Diabetes in Youth

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video Games
Web and DVD knowledge
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Prevention, Children, Diet, Physical Activity

Eligibility Criteria

10 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Video games

Web and DVD knowledge

Arm Description

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

Parallel web and DVD based knowledge games on fruit, vegetable, water, physical activity and physical inactivity.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 6, 2007
Last Updated
September 25, 2017
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00570466
Brief Title
Computer Based Intervention for Type 2 Diabetes in Youth
Official Title
Computer Based Intervention for Type 2 Diabetes in Youth: Phase 2
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
Baylor College of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 developed in Phase 1. The primary hypotheses for this SBIR-Phase 2 protocol are: The two video games will result in greater dietary and physical activity change than a knowledge based control group. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 Diabetes, Prevention, Children, Diet, Physical Activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Video games
Arm Type
Experimental
Arm Description
Two interactive, computer-based video games (9 sessions each) played in sequence to increase fruit, vegetable and water intake, physical activity and decrease TV viewing.
Arm Title
Web and DVD knowledge
Arm Type
Placebo Comparator
Arm Description
Parallel web and DVD based knowledge games on fruit, vegetable, water, physical activity and physical inactivity.
Intervention Type
Behavioral
Intervention Name(s)
Video Games
Intervention Description
Two interactive, computer-based video games (9 sessions each) played in sequence to increase fruit,vegetable,water intake + physical activity + decrease TV viewing.
Intervention Type
Behavioral
Intervention Name(s)
Web and DVD knowledge
Intervention Description
Web and DVD based knowledge games
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Height, weight, waist circumference, propylthiouracil (PROP) sensitivity status and nutrition and physical activity psychosocial questionnaires.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Baranowski, Ph.D.
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21146765
Citation
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.
Results Reference
result

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Computer Based Intervention for Type 2 Diabetes in Youth

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