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

• Sponsor: Norwegian University of Science and Technology (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04122950
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arms: 2
• Actual Duration (Months): 25.1
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Exergaming	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Exergaming to Increase Physical Activity in Overweight/Obese Children and Adolescents
• Actual Study Start Date: Feb 24, 2020
• Actual Primary Completion Date: Mar 28, 2022
• Actual Study Completion Date: Mar 28, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Daily time physical activity (moderate, vigorous and very vigorous) [12 weeks]

   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

1. Daily average energy expenditure [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.

2. Daily average number of steps [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.

3. Daily time in sedentary activity (< 3.0 metabolic equivalents = METs) [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.

4. Daily time in moderate intensity activity (3.0-6.0 metabolic equivalents = METs) [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.

5. Daily time in vigorous intensity activity [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.

6. Daily time in very vigorous intensity activity (>9.0 metabolic equivalents = METs) [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.

7. Daily average total physical activity duration [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. Bioelectrical impedance [8 and 12 weeks]

   Body composition assessed using bioelectrical impedance analysis (InBody 720)

9. Blood Pressure [8 and 12 weeks]

10. Fasting circulating glucose, as blood marker of cardiometabolic health [8 and 12 weeks]

11. Fasting triglycerides, LDL-, HDL- and Total cholesterol, as blood marker of cardiometabolic health [8 and 12 weeks]

12. Circulating insulin concentration, as blood marker of cardiometabolic health [8 and 12 weeks]

13. glucose response to a 2 hour glucose tolerance test, as blood marker of cardiometabolic health [8 and 12 weeks]

14. VO2max [8 and 12 weeks]

    Maximal Aerobic Capacity

15. Daily time physical activity (moderate, vigorous and very vigorous) [8 weeks]

    Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period and at 8 weeks

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 24 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Circulation and Medical Imaging	Trondheim		Norway	7491

Sponsors and Collaborators

• Norwegian University of Science and Technology

Investigators

• Study Director: Øystein Risa, Norwegian University of Science and Technology
• Principal Investigator: Trine Moholdt, PhD, Norwegian University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT04122950
• Other Study ID Numbers: 2019/1082
• First Posted: Oct 10, 2019
• Last Update Posted: Apr 7, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Norwegian University of Science and Technology: Exercise therapy; Physical fitness; Gaming; Child; Healthy lifestyle; Fitness testing
• Additional relevant MeSH terms: Overweight

Study Results

No Results Posted as of Apr 7, 2022