Computer Based Intervention for Type 2 Diabetes in Youth

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00570466
First received: December 6, 2007
Last updated: February 9, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Behavioral: Behavior Change Video Games
Behavioral: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Computer Based Intervention for Type 2 Diabetes in Youth: Phase 2

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Height, weight, waist circumference, propylthiouracil (PROP) sensitivity status and nutrition and physical activity psychosocial questionnaires. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Behavioral: Behavior Change Video Games
Two interactive, computer-based video games (9 sessions each) played in sequence to increase fruit,vegetable,water intake + physical activity + decrease TV viewing.
Placebo Comparator: 2
Parallel web and DVD based knowledge games on fruit, vegetable, water, physical activity and physical inactivity.
Behavioral: Control group
Web and DVD based knowledge games

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.

  Eligibility

Ages Eligible for Study:   10 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570466

Contacts
Contact: Janice C Baranowski, MPH 713-798-6763 jbaranow@bcm.tmc.edu
Contact: Dawn K Thomas 713-798-7143 dkthomas@bcm.tmc.edu

Locations
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: T Baranowski    713-798-6763      
Principal Investigator: Tom Baranowski, PhD         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Tom Baranowski, Ph.D. Baylor College of Medicine-Children's Nutrition Research Center
  More Information

No publications provided

Responsible Party: Tom Baranowski, Ph.D., Professor of Pediatrics, Baylor College of Medicine-Children's Nutrition Research Center
ClinicalTrials.gov Identifier: NCT00570466     History of Changes
Other Study ID Numbers: DK66724 (completed), U44-DK66724
Study First Received: December 6, 2007
Last Updated: February 9, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Type 2 Diabetes
Prevention
Children
Diet
Physical Activity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 31, 2014