Pediatric ObesityNCT02436330
Exergaming for Health: Impact of a Community-Based Active Video Gaming Curriculum in Pediatric Weight Management
A study testing Exergaming and Didactic health teaching in people with Pediatric Obesity, run by University of Illinois Chicago.
Trial summary
Evaluation of the effectiveness of Exergaming for Health, a community-based multifaceted weight management program in a randomized controlled trial (RCT). Primary objective: to assess impact of the program on BMI z-scores. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Exergaming and Didactic health teaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child with BMI greater than or equal to 85th percentile.
- English speaking
- Approval by Primary Care Doctor
Who cannot join
- Participants with medical, developmental or psychiatric diagnoses which preclude participation in both the physical activity and classroom portions of the curriculum.
- Participants who are taking medications that positively or negatively affect weight.
About this study
Evaluation of the effectiveness of Exergaming for Health, a community-based multifaceted weight management program in a randomized controlled trial (RCT). Primary objective: to assess impact of the program on BMI z-scores. Secondary objectives: to measure impact on cardiovascular fitness, self-worth, sedentary screen time, and the influence of exergaming component on attendance and participation.
Read the detailed description
Eighty-four overweight pediatric subjects will be enrolled sequentially and randomized 2:1 in experimental and control groups for six months of weight management programming. The experimental group and their parents/guardians will participate in ten weekly 2-hour sessions, comprised of 1 hour of exergaming or exergaming combined with traditional exercise and 1 hour of didactic classes focusing on nutrition and psychosocial behaviors related to weight management. Following these 10 weeks, they will attend monthly 1-hour maintenance didactic classes. The control group and their parents/guardians will participate only in the didactic portion of the curricula for the same duration of time, 10 weeks, followed by monthly maintenance classes for the remainder of the 6 month period. The control group will then be offered participation in the Exergaming for Health program upon study completion.
Comparisons between the two groups will be obtained through changes in the measurements of weight, height, BMI z-scores, shuttle run times, and responses to questionnaires about screen time, self-perception, and nutrition. Measurements of both groups will be obtained at baseline and 6 months and another set of measurements will be obtained on the experimental group at 12 months.
- Conditions
- Pediatric Obesity
- Being tested
- Exergaming, Didactic health teaching
- Keywords
- Exergaming, Weight management
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExergamingBehavioural
6 months of weight management programming consisting of 10 weekly sessions:1 hour of session was spent "exergaming", which included active video game play and traditional group exercises. Some examples include: Dance, Dance, Revolution, Exerbike, Treadwall, Yoga, Spin class, etc.
Didactic health teachingBehavioural
6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1 hour didactic health teaching sessions for the remainder of the 6 month period.
| Study group | Role | What they receive |
|---|---|---|
| Exergaming and Didactic health teaching | Experimental | Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching. Receives: Behavioral: Exergaming; Behavioral: Didactic health teaching |
| Didactic health teaching | Active comparator | Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching. Receives: Behavioral: Didactic health teaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI Z-score Change
All subjects were asked to dress in light athletic clothing and have their weight and height measured at baseline (the first group session) and at 6 months. Research assistants were trained using guidelines from the National Health and Nutrition Examination Survey (NHANES) Anthropometry Procedures Manual and demonstrated accurate measures on 3 separate children. The Seca 217 portable stadiometer was used for all height measurements and the HealthOMeter 844 KL scale was used for all weight measurements. BMI z-scores were calculated using software available from the Children's Hospital of Philadelphia Research Institute (http://stokes.chop.edu/web/zcore).
Measured: Change from baseline at 6 months
BMI Z-score Change
Measure was only taken on the subjects who participated in the Intervention group (exergaming combined with didactic teaching).
Measured: Change from baseline BMI z-score at 1 year
Secondary outcomes (20)
Waist Circumference Change
Measured: Change from baseline at 6 months
Systolic Blood Pressure Change
Measured: Change from baseline Systolic BP at 6 months
Heart Rate Change From Baseline to 6 Months
Measured: Change from baseline at 6 months
Shuttle Run Change in Number of Shuttle Runs
The shuttle run was completed by participants at baseline (session 1) and at 6 months. The shuttle run is a standardized field assessment that requires participants to run 20 meters within sequentially shortened time frames of recorded beeps.
Measured: Change in number from baseline shuttle run at 6 months
After School Screen Time as Reported on Questionnaire
Change in after school screen time (reported out as fraction of 1 hour) will be measured by subject response on questionnaire taken at baseline and at 6 months for both groups. After school screen time was defined as the amount of time spent on any screen, on the average weekday afternoon/evening, including: watching television, computer use (laptop, desk top, tablet) or playing video games on the television or other hand held device.
Measured: Change from baseline at 6 months
Saturday Screen Time as Assessed by Questionnaire
Change in Saturday screen time (reported out as fraction of an hour) will be measured by subject response on questionnaire taken at baseline and at 6 months for both groups. Saturday screen time was defined as the amount of time spent on any screen, on an average Saturday, including: watching television, computer use (laptop, desk top, tablet) or playing video games on the television or other hand held device.
Measured: Change in hours from baseline at 6 months
Activity Levels Measured by Pedometers (Weekly Steps)
Activity will be measured by pedometers (number of steps) during week 1 and week 24 for both groups. Subjects used the Yamax 200 pedometer to count the steps they took over 1 weeks time.
Measured: Change from week 1 to week 24
Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Physical Self-Worth Changes in Physical Self-worth
CY-PSPP questionnaire was completed by participants in both groups at baseline and at 6 months. Change in the Physical Self-worth scores, which was 1 of 6 sub-domains, is analyzed. This sub-domain contains 6 questions with responses ranging from 1-4 for each question with 1 being the minimum and 4 being the maximum (best) score. The sub-domain score is then calculated as the mean of the 6 responses (minimum to maximum of 1 to 4).The change in score from baseline to 6 months was compared.
Measured: Change from baseline at 6 months
Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Global Self-Worth Score
CY-PSPP questionnaire was completed by participants in both groups at baseline and at 6 months. Change in the Global Self-worth scores, which was 1 of 6 sub-domains, is analyzed. This sub-domain contains 6 questions with responses ranging from 1-4 for each question with 1 being the minimum and 4 being the maximum (best) score. The sub-domain score is then calculated as the mean of the 6 responses (minimum to maximum of 1 to 4).The change in score from baseline to 6 months was compared.
Measured: Change from baseline to 6 months
Dietary Change:Total Calorie Intake (kcal/Day) (Block Alive FFQ)
The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total kcal/kg/day is then estimated based upon participant responses.
Measured: Change from baseline at 6 months
Change in Dietary Intake: % Fat (Block Alive FFQ)
The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total %dietary fat intake per day is then estimated based upon participant responses.
Measured: Change from baseline at 6 months
Change in Dietary Intake: % Carbohydrates (Block Alive FFQ)
The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total % dietary carbohydrates is then estimated based upon participant responses.
Measured: Change from baseline at 6 months
Change in Dietary Intake: Number of Vegetable Servings (Block Alive FFQ)
The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total number of vegetable servings per day is then estimated based upon participant responses.
Measured: Change from baseline at 6 months
Change in Dietary Intake: Number of Fruit Servings (Block Alive FFQ)
The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total number of fruit servings per day is then estimated based upon participant responses.
Measured: Change from baseline at 6 months
Change in Dietary Intake: Number of Sugar Sweetened Beverages (Block Alive FFQ)
The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total number of sugar sweetened beverages per day is then estimated based upon participant responses.
Measured: Change from baseline at 6 months
Exergaming Program Component Influence on Attendance
The experimental group will answer a questionnaire at the end of the 6 month study period, measuring the importance of specific components of the curriculum and motivators which influenced enrollment and compliance with participation. Of interest is measuring the influence of the exergaming curriculum as compared to these other factors. This is a 16-item, 3-point Likert-scale (1 = least important and 3 = most important) questionnaire created specifically for this study. Results were reported based on % of participants rating "3" ,most important, for each curriculum component.
Measured: 6 months
Waist Circumference Change
Measured: Change from 6 month waist circumference at 1 year
Systolic Blood Pressure Change
Measured: Change from 6 month Systolic BP at 1 year
Heart Rate Change
Measured: Change from 6 month Heart rate at 1 year
Shuttle Run Change in Number of Shuttle Runs
The shuttle run was completed again by participants in the Experimental group at 1 year. The shuttle run is a standardized field assessment that requires participants to run 20 meters within sequentially shortened time frames of recorded beeps.
Measured: Change in number from 6 month shuttle run at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startMar 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Christison, M.D., University of Illinois Chicago
- Investigators
- Amy L. Christison, MD, Principal investigator, University of Illinois College of Medicine at Peoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436330
- Sponsor's protocol ID
- 209418
- Status last verified
- Nov 2015
- First submitted
- 20 Apr 2015
- Last updated
- 14 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sacher PM, Kolotourou M, Chadwick PM, Cole TJ, Lawson MS, Lucas A, Singhal A. Randomized controlled trial of the MEND program: a family-based community intervention for childhood obesity. Obesity (Silver Spring). 2010 Feb;18 Suppl 1:S62-8. doi: 10.1038/oby.2009.433.
PubMed 20107463Vandewater EA, Shim MS, Caplovitz AG. Linking obesity and activity level with children's television and video game use. J Adolesc. 2004 Feb;27(1):71-85. doi: 10.1016/j.adolescence.2003.10.003.
PubMed 15013261Gortmaker SL, Cheung LW, Peterson KE, Chomitz G, Cradle JH, Dart H, Fox MK, Bullock RB, Sobol AM, Colditz G, Field AE, Laird N. Impact of a school-based interdisciplinary intervention on diet and physical activity among urban primary school children: eat well and keep moving. Arch Pediatr Adolesc Med. 1999 Sep;153(9):975-83. doi: 10.1001/archpedi.153.9.975.
PubMed 10482216Robinson TN. Reducing children's television viewing to prevent obesity: a randomized controlled trial. JAMA. 1999 Oct 27;282(16):1561-7. doi: 10.1001/jama.282.16.1561.
PubMed 10546696Daley AJ. Can exergaming contribute to improving physical activity levels and health outcomes in children? Pediatrics. 2009 Aug;124(2):763-71. doi: 10.1542/peds.2008-2357. Epub 2009 Jul 13.
PubMed 19596728Lanningham-Foster L, Jensen TB, Foster RC, Redmond AB, Walker BA, Heinz D, Levine JA. Energy expenditure of sedentary screen time compared with active screen time for children. Pediatrics. 2006 Dec;118(6):e1831-5. doi: 10.1542/peds.2006-1087.
PubMed 17142504Ridley K, Olds T. Video center games: Energy cost and children's behaviors. Pediatric Exercise Science. 2001;13:413-421.
Unnithan VB, Houser W, Fernhall B. Evaluation of the energy cost of playing a dance simulation video game in overweight and non-overweight children and adolescents. Int J Sports Med. 2006 Oct;27(10):804-9. doi: 10.1055/s-2005-872964.
PubMed 17006803Mellecker RR, McManus AM. Energy expenditure and cardiovascular responses to seated and active gaming in children. Arch Pediatr Adolesc Med. 2008 Sep;162(9):886-91. doi: 10.1001/archpedi.162.9.886.
PubMed 18762609Wang X, Perry AC. Metabolic and physiologic responses to video game play in 7- to 10-year-old boys. Arch Pediatr Adolesc Med. 2006 Apr;160(4):411-5. doi: 10.1001/archpedi.160.4.411.
PubMed 16585487Segal KR, Dietz WH. Physiologic responses to playing a video game. Am J Dis Child. 1991 Sep;145(9):1034-6. doi: 10.1001/archpedi.1991.02160090086030.
PubMed 1877563Ni Mhurchu C, Maddison R, Jiang Y, Jull A, Prapavessis H, Rodgers A. Couch potatoes to jumping beans: a pilot study of the effect of active video games on physical activity in children. Int J Behav Nutr Phys Act. 2008 Feb 7;5:8. doi: 10.1186/1479-5868-5-8.
PubMed 18257911Maddison R, Mhurchu CN, Jull A, Jiang Y, Prapavessis H, Rodgers A. Energy expended playing video console games: an opportunity to increase children's physical activity? Pediatr Exerc Sci. 2007 Aug;19(3):334-43. doi: 10.1123/pes.19.3.334.
PubMed 18019591Chin A Paw MJ, Jacobs WM, Vaessen EP, Titze S, van Mechelen W. The motivation of children to play an active video game. J Sci Med Sport. 2008 Apr;11(2):163-6. doi: 10.1016/j.jsams.2007.06.001. Epub 2007 Aug 13.
PubMed 17706461McDougall J DM. <br />Children, video games and physical activity. an exploratory study. Int J on Disability and Human Development. 2008;7(1):89-94.
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exergaming for Health: Impact of a Community-Based Active Video Gaming Curriculum in Pediatric Weight Management
- ClinicalTrials.gov ID
- NCT02436330
- Acronym / sponsor ID
- 209418
- Conditions
- Pediatric Obesity
- Keywords
- Exergaming, Weight management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Posted 14 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the effectiveness of Exergaming for Health, a community-based multifaceted weight management program in a randomized controlled trial (RCT). Primary objective: to assess impact of the program on BMI z-scores. Secondary objectives: to measure impact on cardiovascular fitness, self-worth, sedentary screen time, and the influence of exergaming component on attendance and participation.
Detailed description
Eighty-four overweight pediatric subjects will be enrolled sequentially and randomized 2:1 in experimental and control groups for six months of weight management programming. The experimental group and their parents/guardians will participate in ten weekly 2-hour sessions, comprised of 1 hour of exergaming or exergaming combined with traditional exercise and 1 hour of didactic classes focusing on nutrition and psychosocial behaviors related to weight management. Following these 10 weeks, they will attend monthly 1-hour maintenance didactic classes. The control group and their parents/guardians will participate only in the didactic portion of the curricula for the same duration of time, 10 weeks, followed by monthly maintenance classes for the remainder of the 6 month period. The control group will then be offered participation in the Exergaming for Health program upon study completion.
Comparisons between the two groups will be obtained through changes in the measurements of weight, height, BMI z-scores, shuttle run times, and responses to questionnaires about screen time, self-perception, and nutrition. Measurements of both groups will be obtained at baseline and 6 months and another set of measurements will be obtained on the experimental group at 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergaming and Didactic health teaching | Experimental | Behavioral: Exergaming, Behavioral: Didactic health teachingParticipation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching. |
| Didactic health teaching | Active comparator | Behavioral: Didactic health teachingParticipation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child with BMI greater than or equal to 85th percentile.
- English speaking
- Approval by Primary Care Doctor
Key exclusion criteria (2 listed)
- Participants with medical, developmental or psychiatric diagnoses which preclude participation in both the physical activity and classroom portions of the curriculum.
- Participants who are taking medications that positively or negatively affect weight.
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 |
|---|---|---|
| Exergaming6 months of weight management programming consisting of 10 weekly sessions:1 hour of session was spent "exergaming", which included active video game play and traditional group exercises. Some examples include: Dance, Dance, Revolution, Exerbike, Treadwall, Yoga, Spin class, etc. | Behavioural | Exergaming and Didactic health teaching |
| Didactic health teaching6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1 hour didactic health teaching sessions for the remainder of the 6 month period. | Behavioural | Didactic health teaching, Exergaming and Didactic health teaching |
Primary outcome
BMI Z-score Change
Time frame: Change from baseline at 6 months
All subjects were asked to dress in light athletic clothing and have their weight and height measured at baseline (the first group session) and at 6 months. Research assistants were trained using guidelines from the National Health and Nutrition Examination Survey (NHANES) Anthropometry Procedures Manual and demonstrated accurate measures on 3 separate children. The Seca 217 portable stadiometer was used for all height measurements and the HealthOMeter 844 KL scale was used for all weight measurements. BMI z-scores were calculated using software available from the Children's Hospital of Philadelphia Research Institute (http://stokes.chop.edu/web/zcore).
BMI Z-score Change
Time frame: Change from baseline BMI z-score at 1 year
Measure was only taken on the subjects who participated in the Intervention group (exergaming combined with didactic teaching).
20 secondary outcomes
Waist Circumference Change
Time frame: Change from baseline at 6 months
Systolic Blood Pressure Change
Time frame: Change from baseline Systolic BP at 6 months
Heart Rate Change From Baseline to 6 Months
Time frame: Change from baseline at 6 months
Shuttle Run Change in Number of Shuttle Runs
Time frame: Change in number from baseline shuttle run at 6 months
After School Screen Time as Reported on Questionnaire
Time frame: Change from baseline at 6 months
Saturday Screen Time as Assessed by Questionnaire
Time frame: Change in hours from baseline at 6 months
Activity Levels Measured by Pedometers (Weekly Steps)
Time frame: Change from week 1 to week 24
Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Physical Self-Worth Changes in Physical Self-worth
Time frame: Change from baseline at 6 months
Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Global Self-Worth Score
Time frame: Change from baseline to 6 months
Dietary Change:Total Calorie Intake (kcal/Day) (Block Alive FFQ)
Time frame: Change from baseline at 6 months
Change in Dietary Intake: % Fat (Block Alive FFQ)
Time frame: Change from baseline at 6 months
Change in Dietary Intake: % Carbohydrates (Block Alive FFQ)
Time frame: Change from baseline at 6 months
Change in Dietary Intake: Number of Vegetable Servings (Block Alive FFQ)
Time frame: Change from baseline at 6 months
Change in Dietary Intake: Number of Fruit Servings (Block Alive FFQ)
Time frame: Change from baseline at 6 months
Change in Dietary Intake: Number of Sugar Sweetened Beverages (Block Alive FFQ)
Time frame: Change from baseline at 6 months
Exergaming Program Component Influence on Attendance
Time frame: 6 months
Waist Circumference Change
Time frame: Change from 6 month waist circumference at 1 year
Systolic Blood Pressure Change
Time frame: Change from 6 month Systolic BP at 1 year
Heart Rate Change
Time frame: Change from 6 month Heart rate at 1 year
Shuttle Run Change in Number of Shuttle Runs
Time frame: Change in number from 6 month shuttle run at 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20107463Sacher PM, Kolotourou M, Chadwick PM, Cole TJ, Lawson MS, Lucas A, Singhal A. Randomized controlled trial of the MEND program: a family-based community intervention for childhood obesity. Obesity (Silver Spring). 2010 Feb;18 Suppl 1:S62-8. doi: 10.1038/oby.2009.433.
- Background: PubMed 15013261Vandewater EA, Shim MS, Caplovitz AG. Linking obesity and activity level with children's television and video game use. J Adolesc. 2004 Feb;27(1):71-85. doi: 10.1016/j.adolescence.2003.10.003.
- Background: PubMed 10482216Gortmaker SL, Cheung LW, Peterson KE, Chomitz G, Cradle JH, Dart H, Fox MK, Bullock RB, Sobol AM, Colditz G, Field AE, Laird N. Impact of a school-based interdisciplinary intervention on diet and physical activity among urban primary school children: eat well and keep moving. Arch Pediatr Adolesc Med. 1999 Sep;153(9):975-83. doi: 10.1001/archpedi.153.9.975.
- Background: PubMed 10546696Robinson TN. Reducing children's television viewing to prevent obesity: a randomized controlled trial. JAMA. 1999 Oct 27;282(16):1561-7. doi: 10.1001/jama.282.16.1561.
- Background: PubMed 19596728Daley AJ. Can exergaming contribute to improving physical activity levels and health outcomes in children? Pediatrics. 2009 Aug;124(2):763-71. doi: 10.1542/peds.2008-2357. Epub 2009 Jul 13.
- Background: PubMed 17142504Lanningham-Foster L, Jensen TB, Foster RC, Redmond AB, Walker BA, Heinz D, Levine JA. Energy expenditure of sedentary screen time compared with active screen time for children. Pediatrics. 2006 Dec;118(6):e1831-5. doi: 10.1542/peds.2006-1087.
- BackgroundRidley K, Olds T. Video center games: Energy cost and children's behaviors. Pediatric Exercise Science. 2001;13:413-421.
- Background: PubMed 17006803Unnithan VB, Houser W, Fernhall B. Evaluation of the energy cost of playing a dance simulation video game in overweight and non-overweight children and adolescents. Int J Sports Med. 2006 Oct;27(10):804-9. doi: 10.1055/s-2005-872964.
- Background: PubMed 18762609Mellecker RR, McManus AM. Energy expenditure and cardiovascular responses to seated and active gaming in children. Arch Pediatr Adolesc Med. 2008 Sep;162(9):886-91. doi: 10.1001/archpedi.162.9.886.
- Background: PubMed 16585487Wang X, Perry AC. Metabolic and physiologic responses to video game play in 7- to 10-year-old boys. Arch Pediatr Adolesc Med. 2006 Apr;160(4):411-5. doi: 10.1001/archpedi.160.4.411.
- Background: PubMed 1877563Segal KR, Dietz WH. Physiologic responses to playing a video game. Am J Dis Child. 1991 Sep;145(9):1034-6. doi: 10.1001/archpedi.1991.02160090086030.
- Background: PubMed 18257911Ni Mhurchu C, Maddison R, Jiang Y, Jull A, Prapavessis H, Rodgers A. Couch potatoes to jumping beans: a pilot study of the effect of active video games on physical activity in children. Int J Behav Nutr Phys Act. 2008 Feb 7;5:8. doi: 10.1186/1479-5868-5-8.
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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.
Amy L. Christison, MD principal investigator
University of Illinois College of Medicine at Peoria
Questions about this trial
What is this clinical trial studying?
A study testing Exergaming and Didactic health teaching in people with Pediatric Obesity, run by University of Illinois Chicago.
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 3 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 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 14 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
BMI Z-score Change (time frame: Change from baseline at 6 months). The study lists 2 primary outcomes in all. 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 NCT02436330, which also lists 50 linked publications.
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 14 Dec 2015.