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

Primary Purpose

Obesity

Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exergaming
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Exercise therapy, Physical fitness, Gaming, Child, Healthy lifestyle, Fitness testing

Eligibility Criteria

10 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Circulation and Medical Imaging

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exergaming

Control

Arm Description

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

Continue with normal daily routine.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 30, 2019
Last Updated
March 29, 2022
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04122950
Brief Title
Exergaming to Increase Physical Activity in Overweight/Obese Children and Adolescents
Official Title
Exergaming to Increase Physical Activity in Overweight/Obese Children and Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Few interested participants
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
March 28, 2022 (Actual)
Study Completion Date
March 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Exercise therapy, Physical fitness, Gaming, Child, Healthy lifestyle, Fitness testing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exergaming
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Continue with normal daily routine.
Intervention Type
Behavioral
Intervention Name(s)
Exergaming
Intervention Description
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
Primary Outcome Measure Information:
Title
Daily time physical activity (moderate, vigorous and very vigorous)
Description
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period and at 12 weeks.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Daily average energy expenditure
Description
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.
Time Frame
8 and 12 weeks
Title
Daily average number of steps
Description
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.
Time Frame
8 and 12 weeks
Title
Daily time in sedentary activity (< 3.0 metabolic equivalents = METs)
Description
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.
Time Frame
8 and 12 weeks
Title
Daily time in moderate intensity activity (3.0-6.0 metabolic equivalents = METs)
Description
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.
Time Frame
8 and 12 weeks
Title
Daily time in vigorous intensity activity
Description
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.
Time Frame
8 and 12 weeks
Title
Daily time in very vigorous intensity activity (>9.0 metabolic equivalents = METs)
Description
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.
Time Frame
8 and 12 weeks
Title
Daily average total physical activity duration
Description
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 8 weeks and 12 weeks.
Time Frame
8 and 12 weeks
Title
Bioelectrical impedance
Description
Body composition assessed using bioelectrical impedance analysis (InBody 720)
Time Frame
8 and 12 weeks
Title
Blood Pressure
Time Frame
8 and 12 weeks
Title
Fasting circulating glucose, as blood marker of cardiometabolic health
Time Frame
8 and 12 weeks
Title
Fasting triglycerides, LDL-, HDL- and Total cholesterol, as blood marker of cardiometabolic health
Time Frame
8 and 12 weeks
Title
Circulating insulin concentration, as blood marker of cardiometabolic health
Time Frame
8 and 12 weeks
Title
glucose response to a 2 hour glucose tolerance test, as blood marker of cardiometabolic health
Time Frame
8 and 12 weeks
Title
VO2max
Description
Maximal Aerobic Capacity
Time Frame
8 and 12 weeks
Title
Daily time physical activity (moderate, vigorous and very vigorous)
Description
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period and at 8 weeks
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Øystein Risa
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Trine Moholdt, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Circulation and Medical Imaging
City
Trondheim
ZIP/Postal Code
7491
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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