Childhood ObesityNCT01374386
Impact of Exergaming on Adolescent Youth
A study testing Exergaming in people with Childhood Obesity, run by Charles Drew University of Medicine and Science at 1 site in United States.
Trial summary
The purpose of this study is to gather information on how much exercising with video games (ExerGaming) can increase the physical activity among overweight and youth. This study will try to see if participating in physical activity and exercising with video games at the same time can make overweight children move… Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Exergaming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Oct 2012
- 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 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- male and female
- aged 12-14 years
- baseline BMI > 25
- gender- and age-specific 85th percentile cutoff points from the CDC growth chart
- parental consent and subject assent
Who cannot join
- subjects not meeting the inclusion criteria or with physician-determined musculoskeletal, cardiopulmonary, metabolic, psychological, neuro-developmental or behavioral conditions that make mild-to-moderate physical activity potentially hazardous.
- Participants under the age of 12 are excluded from the study because Weingart YMCA has an age policy. Children under the age of 12 are not allowed to be at the facility alone. Therefore, the minimum age for the study is 12 years old so supervision is not a problem.
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles Drew University of Medicine and Science
Los Angeles, California, 90059
About this study
Official title: RCMI Clinical Research Infrastructure Initiative: Exergaming
The purpose of this study is to gather information on how much exercising with video games (ExerGaming) can increase the physical activity among overweight and youth. This study will try to see if participating in physical activity and exercising with video games at the same time can make overweight children move around more to better their own health. The hypothesis is that those in Exergaming arm will physiological changes and increase physical activity.
- Conditions
- Childhood Obesity
- Being tested
- Exergaming
- Keywords
- adolescent obesity
- 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
Participants will have access to Exergaming equipment (video games that require physical activity)
| Study group | Role | What they receive |
|---|---|---|
| Usual Physical Activity | No intervention | Participants in this arm are do not have access to Exergames, only usual physical activity at the gym |
| Exergaming | Experimental | Participants in this arm will have access to usual physical activity at the gym as well as access to Exergaming equipment (video games that require physical activity) Receives: Behavioral: Exergaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean daily physical activity
Change in mean daily physical activity from baseline (7-day activity log expressed as Kcal/day from relative MET intensity
Measured: 2 years
Secondary outcomes (1)
Change in caloric expenditure, body composition, and BMI
(a) Total daily caloric expenditure, (b) change in body composition (total body estimates of fat mass, fat-free mass, and lean body mass), and (c) change in BMI z score from baseline.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2011 (estimated)
- Study startOct 2010
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Why it stopped: The study did not receive funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Martins, Charles Drew University of Medicine and Science
- Investigators
- David Martins, MD, Msc, Principal investigator, Charles Drew University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374386
- Sponsor's protocol ID
- 09-10-2240-02
- Status last verified
- Nov 2017
- First submitted
- 14 Jun 2011
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCMI Clinical Research Infrastructure Initiative: Exergaming
- ClinicalTrials.gov ID
- NCT01374386
- Acronym / sponsor ID
- 09-10-2240-02
- Conditions
- Childhood Obesity
- Keywords
- adolescent obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study did not receive funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 16 Jun 2011 (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.
The purpose of this study is to gather information on how much exercising with video games (ExerGaming) can increase the physical activity among overweight and youth. This study will try to see if participating in physical activity and exercising with video games at the same time can make overweight children move around more to better their own health. The hypothesis is that those in Exergaming arm will physiological changes and increase physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Physical Activity | No intervention | –Participants in this arm are do not have access to Exergames, only usual physical activity at the gym |
| Exergaming | Experimental | Behavioral: ExergamingParticipants in this arm will have access to usual physical activity at the gym as well as access to Exergaming equipment (video games that require physical activity) |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- male and female
- aged 12-14 years
- baseline BMI > 25
- gender- and age-specific 85th percentile cutoff points from the CDC growth chart
- parental consent and subject assent
Key exclusion criteria (2 listed)
- subjects not meeting the inclusion criteria or with physician-determined musculoskeletal, cardiopulmonary, metabolic, psychological, neuro-developmental or behavioral conditions that make mild-to-moderate physical activity potentially hazardous.
- Participants under the age of 12 are excluded from the study because Weingart YMCA has an age policy. Children under the age of 12 are not allowed to be at the facility alone. Therefore, the minimum age for the study is 12 years old so supervision is not a problem.
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 |
|---|---|---|
| ExergamingParticipants will have access to Exergaming equipment (video games that require physical activity) | Behavioural | Exergaming |
Primary outcome
Change in mean daily physical activity
Time frame: 2 years
Change in mean daily physical activity from baseline (7-day activity log expressed as Kcal/day from relative MET intensity
1 secondary outcome
Change in caloric expenditure, body composition, and BMI
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
Related trials for Childhood Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
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.
David Martins, MD, Msc principal investigator
Charles Drew University of Medicine and Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergaming in people with Childhood Obesity, run by Charles Drew University of Medicine and Science 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 5 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: withdrawn, as of the sponsor's last update on 13 Nov 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in mean daily physical activity (time frame: 2 years). 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 13 Nov 2017.