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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04122950
• Other study ID #: 2019/1082
• Status: Terminated
• Phase: N/A
• Start date: February 24, 2020
• Est. completion date: March 28, 2022

Study information

• Verified date: March 2022
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 28, 2022
• Est. primary completion date: March 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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

Locations

Country	Name	City	State
Norway	Department of Circulation and Medical Imaging	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	8 and 12 weeks
Secondary	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.	8 and 12 weeks
Secondary	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.	8 and 12 weeks
Secondary	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.	8 and 12 weeks
Secondary	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.	8 and 12 weeks
Secondary	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.	8 and 12 weeks
Secondary	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.	8 and 12 weeks
Secondary	Bioelectrical impedance	Body composition assessed using bioelectrical impedance analysis (InBody 720)	8 and 12 weeks
Secondary	Blood Pressure		8 and 12 weeks
Secondary	Fasting circulating glucose, as blood marker of cardiometabolic health		8 and 12 weeks
Secondary	Fasting triglycerides, LDL-, HDL- and Total cholesterol, as blood marker of cardiometabolic health		8 and 12 weeks
Secondary	Circulating insulin concentration, as blood marker of cardiometabolic health		8 and 12 weeks
Secondary	glucose response to a 2 hour glucose tolerance test, as blood marker of cardiometabolic health		8 and 12 weeks
Secondary	VO2max	Maximal Aerobic Capacity	8 and 12 weeks
Secondary	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	8 weeks