NCT04122950

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

February 24, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2022

Completed
Last Updated

April 7, 2022

Status Verified

March 1, 2022

Enrollment Period

2.1 years

First QC Date

September 30, 2019

Last Update Submit

March 29, 2022

Conditions

Obesity

Keywords

Exercise therapyPhysical fitnessGamingChildHealthy lifestyleFitness testing

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (15)

  • Daily average energy expenditure

    8 and 12 weeks

  • Daily average number of steps

    8 and 12 weeks

  • Daily time in sedentary activity (< 3.0 metabolic equivalents = METs)

    8 and 12 weeks

  • Daily time in moderate intensity activity (3.0-6.0 metabolic equivalents = METs)

    8 and 12 weeks

  • Daily time in vigorous intensity activity

    8 and 12 weeks

  • +10 more secondary outcomes

Study Arms (2)

Exergaming

EXPERIMENTAL

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

Control

NO INTERVENTION

Continue with normal daily routine.

Interventions

ExergamingBEHAVIORAL

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

Exergaming

Eligibility Criteria

Age10 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Circulation and Medical Imaging

Trondheim, 7491, Norway

Location

MeSH Terms

Conditions

Obesity

Interventions

Exergaming

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Øystein Risa

    Norwegian University of Science and Technology

    STUDY DIRECTOR

  • Trine Moholdt, PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2019

First Posted

October 10, 2019

Study Start

February 24, 2020

Primary Completion

March 28, 2022

Study Completion

March 28, 2022

Last Updated

April 7, 2022

Record last verified: 2022-03

Locations

NO(1)