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Childhood ObesityPhase 4NCT01757925

Evaluation of a Commercial Gaming Impact in a Childhood Obesity Intervention

A Phase 4 study testing weight managment program and Active Gaming in people with Childhood Obesity, run by UnitedHealth Group at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Recently, researchers have been interested in the use of game play, mechanics and psychology for health-related engagement and behavior change. While initial studies have shown some increases in health knowledge and/or behavior through gaming, there remains concern that the vehicle for change is associated with a… Read more about this study

Who is it for?
Ages 6 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Childhood Obesity
What is being tested?
weight managment program and Active Gaming
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
11 sitesUnited States
Study dates
Aug 2011to Sep 2012
Phase
Phase 4
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 6 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Children ages 6 - 12 with Parent or Gaurdian.
  • Child must be enroll in JOIN Program,
  • Child must have a BMI in the 85th percentile

Who cannot join

  • English Speaking Participants only

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites
  • YMCA Andvore

    Andover, Massachusetts, 01810

  • Barrinton YMCA

    Barrington, Rhode Island, 02806

  • YMCA Lawrence

    Lawrence, Massachusetts, 01840

  • YMCA Merrimack Valley of MAss

    Methuen, Massachusetts, 01844

  • Jones Elementary

    Missouri City, Texas, 77498

  • Barabara Jordan Elementary

    Richmond, Texas, 77407

  • Newman YMCA

    Seakonk, Rhode Island, 02771

  • Oyster Creek Elementary

    Sugarland, Texas, 77498

  • Townwest Elementary

    Sugraland, Texas, 77498

  • YMCA Kent

    Warwick, Rhode Island, 02886

  • YMCA Boroughs

    Westborough, Massachusetts, 01580

Other trials in United States

About this study

Recently, researchers have been interested in the use of game play, mechanics and psychology for health-related engagement and behavior change. While initial studies have shown some increases in health knowledge and/or behavior through gaming, there remains concern that the vehicle for change is associated with a perceived sedentary behavior (6).

More recently, commercially available gaming devices are able to directly promote physical activity through a new set of "kinetic controllers" added to the gaming experience. UHG plans to evaluate the most recent of these kinetic controller technologies in the context of a second iteration of JOIN (described above) to be implemented among a pilot group of overweight and/or obese children whose BMI percentile is above the 85th.

This study will evaluate the effect of a commercial controller-free Exercise Gaming and Entertainment Experience (EGEE) on physical activity levels in the context of a weight management program in approximately 70 children ages 6 to12. The study will compare the differences in physical activity levels over 16 weeks in two groups of children.

Read the detailed description

The Center for Health Reform and Modernization at UHG will compare levels of physical activity, assessed by accelerometry, among children randomly assigned to WMA or WM+E groups. Specific aims of this evaluation are:

  • Compare the two groups on changes in the daily minutes of physical activity (mild, moderate and vigorous) after sessions 1, 8 and 15, respectively (Sessions are typically one week a part. Due to holiday schedules, there may be a lapse of two weeks between sessions).
  • Compare the two groups on changes in the daily minutes of sedentary behavior after sessions 1, 8 and 15, respectively
  • Compare the two groups on changes in relative weight (weight, BMI percentile, BMI z-score) at sessions 1, 8, and 16 weeks, respectively
  • Compare the two groups on measures of program satisfaction at 1, 8, and 16 weeks, respectively

Participation in the post session one session is required in order to be eligible for the study requirements include:

  • A signed consent/ assent from the parent and child.
  • The child must be able to participate in physical activity similar to exercise gaming
  • The family must have a TV/monitor that supports Microsoft Kinect
  • The family must have internet connection in the home

The family's decision to participate in the study does not affect the child's'/ parent's overall ability to fully participate in the JOIN Program. All JOIN program materials will be the same whether or not JOIN participants agree to be in the study. All aspects of the study will be conducted outside of the standard class time. Interested and eligible participants will be scheduled to attend a study visit immediately after their first JOIN class. During that study visit, written informed consent/assent from the parent/child will be obtained.

Once a participant has agreed to enroll and have been consented/assented he/she will be informed of study group to which he/she has been randomly assigned. There are two options: 1) weight management alone or 2) weight management plus exercise gaming and entertainment experience. Randomization will occur at the group level (i.e., all consented/assented children in the Wed at 5 p group). Classes will be randomized in pairs of 2 and based on enrollment.

Treatment JOIN consists of 16 weekly Core in-person group sessions followed by 8 monthly mastery group sessions. While the JOIN Program continues for one year, the study will only occur over the first 16 weeks. YMCA sessions last 75 minutes and include a weight assessment of the child prior to each session. The groups are led by a YMCA facilitator. The topics for the first 16 sessions are listed below.

Child Activity Monitor. At sessions 1, 8, and 15 an actigraph will be distributed to each participating child in group 1 and 2. Each child will wear it for 1 week (7 days) during waking hours, and return it at the next session. An activity monitor provides no feedback to participants and provides an objective measure of physical activity (mild, moderate, vigorous) as well as sedentary behavior through downloaded data. The GT3XE Triaxial Activity Monitor w/Extended Memory® (produced by Actigraph) is a small, omni-directional accelerometer (Actigraph), which has already been approved by the FDA for measuring subject's physical activity, and energy expenditure level. The activity monitor (Actigraph) is a small, 1 inch by 1 inch, device that is worn at the hip level attached to an adjustable belt (also provided by the study). The belt can be worn below or above clothing.

Being tested
weight managment program, Active Gaming
Keywords
activity, gaming, obesity, Active Gaming, Control
Medical subject headings
Pediatric Obesity, Motor Activity, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • weight managment programBehavioural

    a comprehensive peditric weight management program consisting of 16 weekly group sessions

  • Active GamingOther

    Also called Hands free Kinect gaming device plus 2 games

    partcipants will be given a gaming device and 2 games (1 at baseline and 1 at week 8)

Study groups in NCT01757925
Study groupRoleWhat they receive
Active GamingExperimentalParticipants will receivce a weight management program plus active gaming device
Receives: Behavioral: weight managment program; Other: Active Gaming
Control GroupActive comparatorParticipants will receive a weight management program without active gaming
Receives: Behavioral: weight managment program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MVPA

    difference between groups in MVPA at week 16 as assess by accelerometry

    Measured: 16 weeks

Secondary outcomes (2)
  1. relative weight

    difference in % overweight, bmi z-score between groups at week 16

    Measured: 16 weeks

  2. quality of life

    Differences between groups in pediatric qulaitry of life as assessed by parents and children

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2012 (estimated)
  2. Study startAug 2011
  3. Primary completionSep 2012
  4. Study completionSep 2012

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01757925
Sponsor's protocol ID
JXBX 2012 11-214
Status last verified
Dec 2012
First submitted
21 Dec 2012
Last updated
31 Dec 2012
Results posted
No
Data monitoring committee
No

Publications

  • Trost SG, Sundal D, Foster GD, Lent MR, Vojta D. Effects of a pediatric weight management program with and without active video games a randomized trial. JAMA Pediatr. 2014 May;168(5):407-13. doi: 10.1001/jamapediatrics.2013.3436.

    PubMed 24589566

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing weight managment program and Active Gaming in people with Childhood Obesity, run by UnitedHealth Group at 11 sites 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 3 inclusion and 1 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 31 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

MVPA (time frame: 16 weeks). 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 NCT01757925, which also lists 1 linked publication.

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 31 Dec 2012.

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