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Body Mass IndexNCT03027570

The Impact of Incorporating an Exergame Activity Application in a Treatment Regimen for Overweight Children

A study testing Exergame activity_EXG and Application activity in people with Body Mass Index and Blood; Sugar, High, run by Bait Balev Hospital at 1 site in Israel.

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

80 children aged 5-13, BMI≥85%, will be recruited to a program for the treatment of overweight children.The intervention group will use the app "Just Dance Now" and The control group will be exposed to the usual program without the app. Read more about this study

Who is it for?
Ages 5 to 13 yearsHealthy volunteers can take part
What is being tested?
Exergame activity_EXG and Application activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteIsrael
Study dates
2 Mar 2017to 1 Jul 2018
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 5 to 13 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Children aged 5-13 from the center for the treatment of overweight children in the MACABI health organization
  • BMI≥85%.

Who cannot join

  • Children with physical disabilities, that don't allow participation in physical activity during the study.
  • Children who don't own a mobile phone or don't have an access to a computer to activate the app for one hour a day.
  • BMI<85%

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Centers for the treatment of overweight children - MACCABI health organization

    Beersheba

Other trials in Israel

About this study

80 children aged 5-13, BMI≥85%, will be recruited to a program for the treatment of overweight children.The intervention group will use the app "Just Dance Now" and The control group will be exposed to the usual program without the app. Measurements will be performed at the beginning of the program, the end and 3 months after completion of the intervention.

Read the detailed description

80 children aged 5-13, BMI≥85%, will be recruited to the five-month program, at two centers for the treatment of overweight children. The intervention group will use the app "Just Dance Now" and part of a weekly exercise session will be dedicated to a group app activity. The control group will be exposed to the usual program without the app.

Measurements of BMI, blood sugar and lipid profiles, as well as physical examination, and questionnaires regarding attitude and response to physical activity will be performed at the beginning of the program, the end and 3 months after completion of the intervention. Participation in the sessions will be documented and home activity recorded using a weekly log. ANOVA two-way repeated measures will be used to assess improvements in outcome measures.

Being tested
Control, Exergame activity_EXG, Application activity
Keywords
Exergame, Cellular apps, Smartphone, Overweight, Obesity, Children, Physical activity, Fitness, Motivation, BMI
Medical subject headings
Hyperglycemia, Lipid Metabolism Disorders, Overweight, Obesity, Motor Activity

What participants receive

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

  • ControlBehavioural

    Five-month interdisciplinary program, including: twice a week one-hour group exercise activity sessions, 3-5 group meetings with a dietician, 12-13 parent sessions with a social worker, and a healthy cooking workshop, each child will take part in individual sessions including: two appointments with a pediatrician, three sessions with a dietician and two sessions with a physical therapist serving as a consultant for physical activity.

  • Exergame activity_EXGBehavioural

    In addition to the treatment given to the control group (as described above), the EXG group will obtain home access to the app "Just Dance Now" and part of a weekly exercise session will include a group activity with the app.

  • Application activityOther

    The application - "Just Dance Now" will be downloaded to the cellular phone of the child or parent. Exercise using the app will be used by cell phone connection to the child's home computer and as part of exercise group activity.

Study groups in NCT03027570
Study groupRoleWhat they receive
ControlExperimentalFive-month program at two centers for the treatment of overweight children.
Receives: Behavioral: Control
Exergame activity_EXGExperimentalAdding an exergame activity application to the regimen at a center for the treatment of overweight children.
Receives: Behavioral: Exergame activity_EXG; Other: Application activity

What is being measured

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

  1. Changes in Body Mass index (BMI) score

    Measured: 5-8 months

Secondary outcomes (13)

  1. Changes in Behavioral Regulation in Exercise

    Determined using an Exercise regulation questionnaire (BREQ-2)

    Measured: 5-8 months

  2. Changes in Physical Self-Perception Profile

    Determined using a Physical Self-Perception Profile questionnaire (PSPP).

    Measured: 5-8 months

  3. Changes in Response toward home physical activity

    By filling a weekly activity log.

    Measured: 5-8 months

  4. Changes in Response toward physical activity sessions

    By filling physical activity session attendance.

    Measured: 5-8 months

  5. Changes in Level of physical activity

    By using a Physical Activity Questionnaire - for elementary School (PAQ-C).

    Measured: 5-8 months

  6. Blood sugar profile

    By measuring levels of HBAa1c and fasting glucose.

    Measured: 5-8 months

  7. Blood lipid profile

    By measuring levels of ADL, HDL, and Triglycerides.

    Measured: 5-8 months

  8. Aerobic capacity

    By using Modified YO-YO IR1 field test to estimate VO2Max levels.

    Measured: 5-8 months

  9. Speed and Agility

    By using 10*4 - Shuttle Run field test.

    Measured: 5-8 months

  10. Leg endurance ability

    By using Wall Sit up field test.

    Measured: 5-8 months

  11. Lower limb explosive power

    By using Standing Long Jump field test.

    Measured: 5-8 months

  12. Forearm muscle strength

    By using a hand grip failed test.

    Measured: 5-8 months

  13. Coordination levels

    By using Modified Alternate Hand Wall Toss filed Test

    Measured: 5-8 months

Timeline

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

  1. First posted23 Jan 2017 (estimated)
  2. Study start2 Mar 2017
  3. Primary completion6 Jun 2018
  4. Study completion1 Jul 2018

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 N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03027570
Sponsor's protocol ID
0067-16-BBL
Status last verified
Dec 2016
First submitted
4 Jan 2017
Last updated
2 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exergame activity_EXG and Application activity in people with Body Mass Index and Blood; Sugar, High, run by Bait Balev Hospital at 1 site in Israel.

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 3 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 2 Aug 2018. 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 Israel. 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?

Changes in Body Mass index (BMI) score (time frame: 5-8 months). 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 NCT03027570.

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 2 Aug 2018.

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