Clinical trial NCT04122950: 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
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Keywords: Exercise therapy
Physical fitness
Gaming
Child
Healthy lifestyle
Fitness testing
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 6
Sex: ALL
Minimum age (years): 10
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Daily time physical activity (moderate, vigorous and very vigorous)
timeFrame: 12 weeks
Secondary outcomes:
measure: Daily average energy expenditure
timeFrame: 8 and 12 weeks
measure: Daily average number of steps
timeFrame: 8 and 12 weeks
measure: Daily time in sedentary activity (< 3.0 metabolic equivalents = METs)
timeFrame: 8 and 12 weeks
measure: Daily time in moderate intensity activity (3.0-6.0 metabolic equivalents = METs)
timeFrame: 8 and 12 weeks
measure: Daily time in vigorous intensity activity
timeFrame: 8 and 12 weeks
measure: Daily time in very vigorous intensity activity (>9.0 metabolic equivalents = METs)
timeFrame: 8 and 12 weeks
measure: Daily average total physical activity duration
timeFrame: 8 and 12 weeks
measure: Bioelectrical impedance
timeFrame: 8 and 12 weeks
measure: Blood Pressure
timeFrame: 8 and 12 weeks
measure: Fasting circulating glucose, as blood marker of cardiometabolic health
timeFrame: 8 and 12 weeks
measure: Fasting triglycerides, LDL-, HDL- and Total cholesterol, as blood marker of cardiometabolic health
timeFrame: 8 and 12 weeks
measure: Circulating insulin concentration, as blood marker of cardiometabolic health
timeFrame: 8 and 12 weeks
measure: glucose response to a 2 hour glucose tolerance test, as blood marker of cardiometabolic health
timeFrame: 8 and 12 weeks
measure: VO2max
timeFrame: 8 and 12 weeks
measure: Daily time physical activity (moderate, vigorous and very vigorous)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Circulation and Medical Imaging
Study officials:
affiliation: Norwegian University of Science and Technology
name: Øystein Risa
role: STUDY_DIRECTOR
affiliation: Norwegian University of Science and Technology
name: Trine Moholdt, PhD
role: PRINCIPAL_INVESTIGATOR
References: