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Technology Based Obesity Prevention Project (TeBOPP)

Primary Purpose

Obesity in Children

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video game based obesity education
Sponsored by
Valleywise Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity in Children

Eligibility Criteria

8 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients of Latino ethnicity, 8 to 15 years of age who register in the pediatric ED and patients who visit the three FLCs and are accompanied by a parent/guardian who is 18 years or older and able to communicate in English or Spanish
  • A patient must receive an Emergency Severity Index (ESI) Version 3 score of 4/5 indicating non-urgent status for recruitment in the pediatric ED.

Exclusion Criteria:

  • Medically unstable patients (in the pediatric ED), patients with ESI score of 1-3 (life threatening medical/surgical condition).
  • Incarcerated patients or patients from juvenile detention facilities.

Sites / Locations

  • Maricopa Integrated Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Video game based obesity education

No intervention

Arm Description

This is the intervention group. They will be given the opportunity to play an interactive educational video game for teaching health and nutrition.

This is the control group that will receive only printed information about health and nutrition and will not be given the opportunity to play the educational video game.

Outcomes

Primary Outcome Measures

Improvement in knowledge regarding a healthy diet and nutrition among parents/children using a video game based educational intervention
Nutrition knowledge measured by change in each subject's scores on pre and post tests developed by the investigator especially for this study.

Secondary Outcome Measures

Improvement in parent/child communication and intent to adopt a healthier lifestyle using a video game based educational intervention
Improvement in communication levels were obtained with pre and post satisfaction surveys

Full Information

First Posted
November 5, 2013
Last Updated
March 27, 2019
Sponsor
Valleywise Health
Collaborators
Arizona State University, Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT01981434
Brief Title
Technology Based Obesity Prevention Project (TeBOPP)
Official Title
Technology Based Obesity Prevention Project (TeBOPP)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 27, 2013 (Actual)
Primary Completion Date
July 26, 2016 (Actual)
Study Completion Date
July 26, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valleywise Health
Collaborators
Arizona State University, Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Technology-Based Obesity Prevention Project (TeBOPP) is a bilingual (English/Spanish) family-based educational intervention that will use a novel videogame format to educate underserved inner city Latino children and adolescent patients and their parents about healthy diet and exercise. To the best of our knowledge this is the first family focused obesity prevention educational intervention using a gaming scenario where both parents and children/teens (8-15 years) participate simultaneously. The goals are to improve parent-child (teen) knowledge regarding healthy food habits and create a change in attitude towards healthy eating and exercise. Hypothesis: We hypothesize that game-based avatars (i.e., a graphical representation of an individual within a virtual space) can create change in knowledge and attitude towards healthy eating and exercise.
Detailed Description
Childhood obesity has reached epidemic proportions in recent years and has become the number one challenge among child healthcare providers in the United States. Unhealthy dietary habits and lack of physical activity are among the key factors attributed to increase in overweight and obesity rates among children and adolescents. Obesity is associated with a much higher risk for chronic medical conditions and increasingly diseases among the old like diabetes is becoming commonplace among the young. This growing epidemic may prove to have a tremendous societal impact and may prove to be a colossal economic and health burden in the future if it is not confronted aggressively at this stage. Unfortunately the obesity epidemic has affected the minority and socio economically deprived population in a disproportionate manner. Inner city Latino children and adolescents are being increasingly affected and targeted intervention for this population group is of paramount importance. In this project, we intend to study the role of an immersive video game technology using simulated game-based avatars to educate parents and children simultaneously about the importance of healthy diet and exercise, assess knowledge gained and retention and their change in attitudes towards adoption of a healthier lifestyle. Such an innovative educational model deployed using a bilingual (English/Spanish) videogame format which is a natural draw for this age group will likely capture their attention and be successful in conveying the intended message encouraging adoption of healthy diet and exercise. By encouraging parental participation, knowledge gained is expected to be shared and encourage parent-child discussion thereby fostering a team effort to combat obesity and promote a healthy lifestyle in the family as a whole. The intervention will be specifically tailored to its target population for better acceptance. Our patient population primarily comprises of Mexican-American children and families and issues relating over weight and obesity are most problematic in this population group. A Needs Assessment Survey will be conducted at the start of the project and socio-cultural attributes impacting diet and exercise habits will be assessed. This information will be used to address these specific issues in the game design. If this culturally and linguistically responsive obesity prevention educational intervention for Latino children and families proves a success, future research will focus on making the application easily downloadable on to a mobile internet device for dissemination to a much larger audience. Since the proposed intervention is based on the concepts of cognitive behavior therapy, opportunities for repeat play is likely to reinforce knowledge gain and encourage a positive health behavior change.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity in Children

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Video game based obesity education
Arm Type
Active Comparator
Arm Description
This is the intervention group. They will be given the opportunity to play an interactive educational video game for teaching health and nutrition.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
This is the control group that will receive only printed information about health and nutrition and will not be given the opportunity to play the educational video game.
Intervention Type
Other
Intervention Name(s)
Video game based obesity education
Intervention Description
The intervention will be in the form of a videogame in which both parent and their children will participate. The game incorporates lessons from research on avatars (e.g., the Proteus Effect), and game dynamics to explore ways to increase healthy eating and exercise.
Primary Outcome Measure Information:
Title
Improvement in knowledge regarding a healthy diet and nutrition among parents/children using a video game based educational intervention
Description
Nutrition knowledge measured by change in each subject's scores on pre and post tests developed by the investigator especially for this study.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Improvement in parent/child communication and intent to adopt a healthier lifestyle using a video game based educational intervention
Description
Improvement in communication levels were obtained with pre and post satisfaction surveys
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
Game usage time up to completion.
Description
Game usage was tracked throughout the study.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients of Latino ethnicity, 8 to 15 years of age who register in the pediatric ED and patients who visit the three FLCs and are accompanied by a parent/guardian who is 18 years or older and able to communicate in English or Spanish A patient must receive an Emergency Severity Index (ESI) Version 3 score of 4/5 indicating non-urgent status for recruitment in the pediatric ED. Exclusion Criteria: Medically unstable patients (in the pediatric ED), patients with ESI score of 1-3 (life threatening medical/surgical condition). Incarcerated patients or patients from juvenile detention facilities.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dean Coonrod, MD
Organizational Affiliation
District Medical Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maricopa Integrated Health System
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Technology Based Obesity Prevention Project (TeBOPP)

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