Clinical trial NCT02003963: Social Exergaming for Healthy Weight in Adolescent Girls
Official title: Klub Kinect: Social Exergaming for Healthy Weight in Adolescent Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity and Physical Inactivity in Adolescents
Keywords: Physical Activity
Sedentary Behavior
Video Games
Exergames
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 41
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose is to evaluate the feasibility of a 12-week exergaming dance program for adolescent girls. This study combines dancing, video games, and a full body work-out to test if video games can increase physical activity and promote healthy weight in adolescent girls. We hypothesize that girls who play the dance exergames, versus those in the control group, will lose weight, decrease body fat and visceral fat, improve cardiovascular health, increase physical activity, and improve psychosocial health including self-confidence and quality of life.

Detailed description: Klub Kinect will last about 14 weeks for each participant. The program begins with a 3.5 hour clinic visit, the intervention lasts for 12 weeks, and the participant comes in for a final 3.5 hour clinic visit.

Eligibility criteria: Inclusion Criteria:

* Age 14-18 years old
* Female
* Postmenarchal
* BMI percentile equal to or greater than 85th on the U.S. Centers for Disease Control and Prevention growth chart
* Speak, understand, read, and write English
* Willing to accept randomization

Exclusion Criteria:

* Pregnant
* Hospitalization for mental illness within the past 5 years.
* Since the focus herein is on ambulatory activities, participants who use wheelchairs or other impairments that prevent normal ambulation will be excluded
* Indication of cardiac abnormality on an electrocardiogram that requires referral to a cardiologist
* Previous history of, or clinical symptoms or signs of, cardiovascular disease, stroke or transient ischemic attacks, chest pain, unusual dyspnea during physical activity/exercise, severe ankle edema, or intermittent claudication.
* Previous history of musculoskeletal injuries or problems causing severe pain during physical activity or exercise which interferes with daily activities.
* Participant has a pacemaker or other implanted medical device (including metal joint replacements).
* Participant is unable to complete all baseline testing (one session) within 1 month prior to the beginning of the intervention
* Medical problems, including epileptic seizures, that prevent video game play
* Family history of epileptic seizures
* Unable to make the commitment of coming to Pennington Biomedical Research Center for 3 weekly gaming sessions for 12 weeks

Primary outcomes:
measure: Change in Body Fat
timeFrame: Baseline clinic visit (week 0) and final clinic visit (week 13)
measure: Change in Visceral Adiposity
timeFrame: Baseline clinic visit (week 0) and final clinic visit (week 13)
measure: Change in Resting Systolic Blood Pressure Percentile
timeFrame: Baseline clinic visit (week 0) and final clinic visit (week 13)
Secondary outcomes:
measure: Feasibility (Adherence)
timeFrame: 3 gaming sessions/week for 12 weeks
measure: Change in Physical Activity
timeFrame: Baseline clinic visit (week 0) and final clinic visit (week 13)
measure: The Friendship Quality Questionnaire to Measure Change in Peer Support From Baseline to Week 13.
timeFrame: Baseline clinic visit (week 0) and final clinic visit (week 13)
measure: Change From Baseline in Health-related Quality of Life
timeFrame: Baseline clinic visit (week 0) and final clinic visit (week 13)
measure: Change From Baseline in Self-efficacy Towards Exercise on the Self-Efficacy for Healthy Eating and Physical Activity Measure (SE-HEPA) at Week 13
timeFrame: Baseline clinic visit (Week 0) and final clinic visit (Week 13)
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Amanda E Staiano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Staiano AE, Marker AM, Beyl RA, Hsia DS, Katzmarzyk PT, Newton RL. A randomized controlled trial of dance exergaming for exercise training in overweight and obese adolescent girls. Pediatr Obes. 2017 Apr;12(2):120-128. doi: 10.1111/ijpo.12117. Epub 2016 Feb 26.
citation: Staiano AE, Beyl RA, Hsia DS, Katzmarzyk PT, Newton RL Jr. Twelve weeks of dance exergaming in overweight and obese adolescent girls: Transfer effects on physical activity, screen time, and self-efficacy. J Sport Health Sci. 2017 Mar;6(1):4-10. doi: 10.1016/j.jshs.2016.11.005. Epub 2016 Nov 23.
citation: Staiano AE, Beyl RA, Hsia DS, Katzmarzyk PT, Newton RL Jr. A 12-week randomized controlled pilot study of dance exergaming in a group: Influence on psychosocial factors in adolescent girls. Cyberpsychology (Brno). 2018;12(2):3. doi: 10.5817/CP2018-2-3.