Obesity in ChildrenNCT01981434
Technology Based Obesity Prevention Project (TeBOPP)
A study testing Video game based obesity education in people with Obesity in Children, run by Valleywise Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity in Children
- What is being tested?
- Video game based obesity education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2013to 26 Jul 2016
- 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 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Maricopa Integrated Health System
Phoenix, Arizona, 85008
About this study
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.
Read the 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.
- Conditions
- Obesity in Children
- Being tested
- Video game based obesity education
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video game based obesity educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Video game based obesity education | Active comparator | This is the intervention group. They will be given the opportunity to play an interactive educational video game for teaching health and nutrition. Receives: Other: Video game based obesity education |
| No intervention | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (1)
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study start27 Aug 2013
- Primary completion26 Jul 2016
- Study completion26 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity in ChildrenStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valleywise Health
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Dean Coonrod, MD, Principal investigator, District Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981434
- Sponsor's protocol ID
- 2013-132
- Status last verified
- Mar 2019
- First submitted
- 5 Nov 2013
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Based Obesity Prevention Project (TeBOPP)
- ClinicalTrials.gov ID
- NCT01981434
- Acronym / sponsor ID
- 2013-132
- Conditions
- Obesity in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Valleywise HealthUniversity, hospital or other
- Collaborators
- Arizona State University, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 27 Aug 2013 (actual)
- Primary completion
- 26 Jul 2016 (actual)
- Study completion
- 26 Jul 2016 (actual)
- First posted
- 11 Nov 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video game based obesity education | Active comparator | Other: Video game based obesity educationThis is the intervention group. They will be given the opportunity to play an interactive educational video game for teaching health and nutrition. |
| No intervention | No intervention | –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. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Video game based obesity educationThe 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. | Other | Video game based obesity education |
Primary outcome
Improvement in knowledge regarding a healthy diet and nutrition among parents/children using a video game based educational intervention
Time frame: 18 months
Nutrition knowledge measured by change in each subject's scores on pre and post tests developed by the investigator especially for this study.
1 secondary outcome
Improvement in parent/child communication and intent to adopt a healthier lifestyle using a video game based educational intervention
Time frame: 18 months
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 29 Mar 2019.
- Individual participant dataSharing planned: No
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Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
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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.
Dean Coonrod, MD principal investigator
District Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video game based obesity education in people with Obesity in Children, run by Valleywise Health 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 2 inclusion and 2 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 29 Mar 2019. 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?
Improvement in knowledge regarding a healthy diet and nutrition among parents/children using a video game based educational intervention (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2019.