NCT03027570

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

March 2, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2018

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 2, 2018

Status Verified

December 1, 2016

Enrollment Period

1.3 years

First QC Date

January 4, 2017

Last Update Submit

August 1, 2018

Conditions

Keywords

ExergameCellular appsSmartphoneOverweightObesityChildrenPhysical activityFitnessMotivationBMI

Outcome Measures

Primary Outcomes (1)

  • Changes in Body Mass index (BMI) score

    5-8 months

Secondary Outcomes (13)

  • Changes in Behavioral Regulation in Exercise

    5-8 months

  • Changes in Physical Self-Perception Profile

    5-8 months

  • Changes in Response toward home physical activity

    5-8 months

  • Changes in Response toward physical activity sessions

    5-8 months

  • Changes in Level of physical activity

    5-8 months

  • +8 more secondary outcomes

Study Arms (2)

Control

EXPERIMENTAL

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

Behavioral: Control

Exergame activity_EXG

EXPERIMENTAL

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

Behavioral: Exergame activity_EXGOther: Application activity

Interventions

ControlBEHAVIORAL

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.

Control

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.

Exergame activity_EXG

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.

Exergame activity_EXG

Eligibility Criteria

Age5 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centers for the treatment of overweight children - MACCABI health organization

Beersheba, Israel

Location

MeSH Terms

Conditions

HyperglycemiaLipid Metabolism DisordersOverweightObesityMotor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Shai Kremer, MD

    Maccabi health organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2017

First Posted

January 23, 2017

Study Start

March 2, 2017

Primary Completion

June 6, 2018

Study Completion

July 1, 2018

Last Updated

August 2, 2018

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations