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

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.

Study Overview

• Status: Completed
• Conditions: Lipid Disorder; Body Image; Body Mass Index; Blood; Sugar, High
• Intervention / Treatment: Behavioral: Control; Behavioral: Exergame activity_EXG; Other: Application activity

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Beer sheva, Israel
    • Centers for the treatment of overweight children - MACCABI health organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 13 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Control; Five-month program at two centers for the treatment of overweight children.	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.
EXPERIMENTAL: Exergame activity_EXG; Adding an exergame activity application to the regimen at a center for the treatment of overweight children.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in Body Mass index (BMI) score	5-8 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bait Balev Hospital
• Collaborators: University of Haifa
• Investigators: Principal Investigator: Shai Kremer, MD, Maccabi health organization

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2017
• Primary Completion (ACTUAL): June 6, 2018
• Study Completion (ACTUAL): July 1, 2018

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (ESTIMATE): January 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 2, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Obesity; Children; Overweight; Motivation; Physical activity; Smartphone; Fitness; BMI; Exergame; Cellular apps
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Body Weight; Hyperglycemia; Overweight; Lipid Metabolism Disorders
• Other Study ID Numbers: 0067-16-BBL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No