Exergaming to Increase Physical Activity in Overweight/Obese Children and Adolescents

March 29, 2022 updated by: Norwegian University of Science and Technology

The primary purpose of this study is to examine the effects of regular exergaming for 8 weeks in 24 overweight/obese children and adolescents (10-17 years) on maximal aerobic fitness (VO2max) and physical activity levels measured before and after (8 weeks) intervention period, and in addition at follow-up (12 weeks). We also wish to investigate the effects on markers of cardio metabolic health and body composition, measured at baseline, 8 weeks and 12 weeks follow-up.

Also, the participants gaming frequency will be registered throughout the 8 week period, as well as during the follow-up between 8 and 12 weeks. Aim of this study is to investigate if access to this game can provide health benefits for overweight/obese children and adolescents.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7491
        • Department of Circulation and Medical Imaging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Defined as overweight/obese for age and sex
  • Able to ride a bike for up to 60 minutes

Exclusion Criteria:

  • Known cardiovascular disease
  • Taking beta-blockers or anti-arrhythmic drugs
  • Other diseases that restrict them from doing High-Intensity Training

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exergaming
The participants in the Exergaming group will use the PlayPulse exergame for 45 minutes a minimum of two times per week for 8 weeks. Between 8 and 12 weeks the exergaming group will be provided with free access to the exergame but without the two mandatory exergaming sessions
Behavioral: Exergaming
The participants in the Exergaming group will use the PlayPulse exergame for 45 minutes a minimum of three times per week for 8 weeks. Between 8 and 12 weeks the exergaming group will be provided with free access to the exergame but without the two mandatory exergaming sessions
No Intervention: Control
Continue with normal daily routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily time physical activity (moderate, vigorous and very vigorous)
Time Frame: 12 weeks
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period and at 12 weeks.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily average energy expenditure
Time Frame: 8 and 12 weeks
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.
8 and 12 weeks
Daily average number of steps
Time Frame: 8 and 12 weeks
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.
8 and 12 weeks
Daily time in sedentary activity (< 3.0 metabolic equivalents = METs)
Time Frame: 8 and 12 weeks
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.
8 and 12 weeks
Daily time in moderate intensity activity (3.0-6.0 metabolic equivalents = METs)
Time Frame: 8 and 12 weeks
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.
8 and 12 weeks
Daily time in vigorous intensity activity
Time Frame: 8 and 12 weeks
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.
8 and 12 weeks
Daily time in very vigorous intensity activity (>9.0 metabolic equivalents = METs)
Time Frame: 8 and 12 weeks
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.
8 and 12 weeks
Daily average total physical activity duration
Time Frame: 8 and 12 weeks
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.
8 and 12 weeks
Bioelectrical impedance
Time Frame: 8 and 12 weeks
Body composition assessed using bioelectrical impedance analysis (InBody 720)
8 and 12 weeks
Blood Pressure
Time Frame: 8 and 12 weeks
8 and 12 weeks
Fasting circulating glucose, as blood marker of cardiometabolic health
Time Frame: 8 and 12 weeks
8 and 12 weeks
Fasting triglycerides, LDL-, HDL- and Total cholesterol, as blood marker of cardiometabolic health
Time Frame: 8 and 12 weeks
8 and 12 weeks
Circulating insulin concentration, as blood marker of cardiometabolic health
Time Frame: 8 and 12 weeks
8 and 12 weeks
glucose response to a 2 hour glucose tolerance test, as blood marker of cardiometabolic health
Time Frame: 8 and 12 weeks
8 and 12 weeks
VO2max
Time Frame: 8 and 12 weeks
Maximal Aerobic Capacity
8 and 12 weeks
Daily time physical activity (moderate, vigorous and very vigorous)
Time Frame: 8 weeks
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period and at 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2020

Primary Completion (Actual)

March 28, 2022

Study Completion (Actual)

March 28, 2022

Study Registration Dates

First Submitted

September 30, 2019

First Submitted That Met QC Criteria

October 9, 2019

First Posted (Actual)

October 10, 2019

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/1082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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