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

Body Image Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03027570
• Other study ID #: 0067-16-BBL
• Status: Completed
• Phase: N/A
• Start date: March 2, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: December 2016
• Source: Bait Balev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 1, 2018
• Est. primary completion date: June 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 13 Years

Eligibility

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%

Related Conditions & MeSH terms

• Blood; Sugar, High
• Body Image
• Body Mass Index
• Hyperglycemia
• Lipid Disorder
• Lipid Metabolism Disorders
• Overweight

Intervention

Behavioral:
• Control
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_EXG
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.

Other:
• Application activity
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.

Locations

Country	Name	City	State
Israel	Centers for the treatment of overweight children - MACCABI health organization	Beer sheva

Sponsors (2)

Lead Sponsor	Collaborator
Bait Balev Hospital	University of Haifa

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Body Mass index (BMI) score		5-8 months
Secondary	Changes in Behavioral Regulation in Exercise	Determined using an Exercise regulation questionnaire (BREQ-2)	5-8 months
Secondary	Changes in Physical Self-Perception Profile	Determined using a Physical Self-Perception Profile questionnaire (PSPP).	5-8 months
Secondary	Changes in Response toward home physical activity	By filling a weekly activity log.	5-8 months
Secondary	Changes in Response toward physical activity sessions	By filling physical activity session attendance.	5-8 months
Secondary	Changes in Level of physical activity	By using a Physical Activity Questionnaire - for elementary School (PAQ-C).	5-8 months
Secondary	Blood sugar profile	By measuring levels of HBAa1c and fasting glucose.	5-8 months
Secondary	Blood lipid profile	By measuring levels of ADL, HDL, and Triglycerides.	5-8 months
Secondary	Aerobic capacity	By using Modified YO-YO IR1 field test to estimate VO2Max levels.	5-8 months
Secondary	Speed and Agility	By using 10*4 - Shuttle Run field test.	5-8 months
Secondary	Leg endurance ability	By using Wall Sit up field test.	5-8 months
Secondary	Lower limb explosive power	By using Standing Long Jump field test.	5-8 months
Secondary	Forearm muscle strength	By using a hand grip failed test.	5-8 months
Secondary	Coordination levels	By using Modified Alternate Hand Wall Toss filed Test	5-8 months