search
Back to results

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

Primary Purpose

Body Mass Index, Blood; Sugar, High, Lipid Disorder

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Control
Exergame activity_EXG
Application activity
Sponsored by
Bait Balev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Body Mass Index focused on measuring Exergame, Cellular apps, Smartphone, Overweight, Obesity, Children, Physical activity, Fitness, Motivation, BMI

Eligibility Criteria

5 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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%

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control

Exergame activity_EXG

Arm Description

Five-month program at two centers for the treatment of overweight children.

Adding an exergame activity application to the regimen at a center for the treatment of overweight children.

Outcomes

Primary Outcome Measures

Changes in Body Mass index (BMI) score

Secondary Outcome Measures

Changes in Behavioral Regulation in Exercise
Determined using an Exercise regulation questionnaire (BREQ-2)
Changes in Physical Self-Perception Profile
Determined using a Physical Self-Perception Profile questionnaire (PSPP).
Changes in Response toward home physical activity
By filling a weekly activity log.
Changes in Response toward physical activity sessions
By filling physical activity session attendance.
Changes in Level of physical activity
By using a Physical Activity Questionnaire - for elementary School (PAQ-C).
Blood sugar profile
By measuring levels of HBAa1c and fasting glucose.
Blood lipid profile
By measuring levels of ADL, HDL, and Triglycerides.
Aerobic capacity
By using Modified YO-YO IR1 field test to estimate VO2Max levels.
Speed and Agility
By using 10*4 - Shuttle Run field test.
Leg endurance ability
By using Wall Sit up field test.
Lower limb explosive power
By using Standing Long Jump field test.
Forearm muscle strength
By using a hand grip failed test.
Coordination levels
By using Modified Alternate Hand Wall Toss filed Test

Full Information

First Posted
January 4, 2017
Last Updated
August 1, 2018
Sponsor
Bait Balev Hospital
Collaborators
University of Haifa
search

1. Study Identification

Unique Protocol Identification Number
NCT03027570
Brief Title
The Impact of Incorporating an Exergame Activity Application in a Treatment Regimen for Overweight Children
Official Title
The Impact of Incorporating an Exergame Activity Application in a Treatment Regimen for Overweight Children
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2, 2017 (Actual)
Primary Completion Date
June 6, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bait Balev Hospital
Collaborators
University of Haifa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. Measurements will be performed at the beginning of the program, the end and 3 months after completion of the intervention.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Mass Index, Blood; Sugar, High, Lipid Disorder, Body Image
Keywords
Exergame, Cellular apps, Smartphone, Overweight, Obesity, Children, Physical activity, Fitness, Motivation, BMI

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Description
Five-month program at two centers for the treatment of overweight children.
Arm Title
Exergame activity_EXG
Arm Type
Experimental
Arm Description
Adding an exergame activity application to the regimen at a center for the treatment of overweight children.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exergame activity_EXG
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Application activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Body Mass index (BMI) score
Time Frame
5-8 months
Secondary Outcome Measure Information:
Title
Changes in Behavioral Regulation in Exercise
Description
Determined using an Exercise regulation questionnaire (BREQ-2)
Time Frame
5-8 months
Title
Changes in Physical Self-Perception Profile
Description
Determined using a Physical Self-Perception Profile questionnaire (PSPP).
Time Frame
5-8 months
Title
Changes in Response toward home physical activity
Description
By filling a weekly activity log.
Time Frame
5-8 months
Title
Changes in Response toward physical activity sessions
Description
By filling physical activity session attendance.
Time Frame
5-8 months
Title
Changes in Level of physical activity
Description
By using a Physical Activity Questionnaire - for elementary School (PAQ-C).
Time Frame
5-8 months
Title
Blood sugar profile
Description
By measuring levels of HBAa1c and fasting glucose.
Time Frame
5-8 months
Title
Blood lipid profile
Description
By measuring levels of ADL, HDL, and Triglycerides.
Time Frame
5-8 months
Title
Aerobic capacity
Description
By using Modified YO-YO IR1 field test to estimate VO2Max levels.
Time Frame
5-8 months
Title
Speed and Agility
Description
By using 10*4 - Shuttle Run field test.
Time Frame
5-8 months
Title
Leg endurance ability
Description
By using Wall Sit up field test.
Time Frame
5-8 months
Title
Lower limb explosive power
Description
By using Standing Long Jump field test.
Time Frame
5-8 months
Title
Forearm muscle strength
Description
By using a hand grip failed test.
Time Frame
5-8 months
Title
Coordination levels
Description
By using Modified Alternate Hand Wall Toss filed Test
Time Frame
5-8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children aged 5-13 from the center for the treatment of overweight children in the MACABI health organization BMI≥85%. Exclusion Criteria: 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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shai Kremer, MD
Organizational Affiliation
Maccabi health organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centers for the treatment of overweight children - MACCABI health organization
City
Beer sheva
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs