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Trial record 1 of 2 for:    18019591 [PUBMED-IDS]
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Exergaming for Health: Impact of a Community-Based Active Video Gaming Curriculum in Pediatric Weight Management

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ClinicalTrials.gov Identifier: NCT02436330
Recruitment Status : Completed
First Posted : May 6, 2015
Results First Posted : December 14, 2015
Last Update Posted : December 14, 2015
Sponsor:
Information provided by (Responsible Party):
Amy Christison, M.D., University of Illinois at Chicago

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Pediatric Obesity
Interventions: Behavioral: Exergaming
Behavioral: Didactic health teaching

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Obese and overweight children (BMI ≥85th percentile) ages 8 through 12 years were referred to the program from their primary care practices or self-referred through advertisements distributed by the local park district and a community organization.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with medical, developmental or psychiatric diagnoses which precluded participation in the curriculum or those taking medication that could significantly affect weight were excluded. Eighty-four subjects, mean age 10.1 years (SD 1.3 years), participated in the study from April 2011 through September 2013.

Reporting Groups
  Description
Exergaming and Didactic Health Teaching

Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.

Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period.

n = 60 (71%) enrolled within 6 cohorts over the study period from April 2011 to September 2013.

Didactic Health Teaching

Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.

Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period.

n = 24 (29%) enrolled within 6 cohorts during the study period from April 2011 to September 2013


Participant Flow for 6 periods

Period 1:   Cohort 1
    Exergaming and Didactic Health Teaching   Didactic Health Teaching
STARTED   14   4 
COMPLETED   9   1 
NOT COMPLETED   5   3 
Lost to Follow-up                5                2 
Withdrawal by Subject                0                1 

Period 2:   Cohort 2
    Exergaming and Didactic Health Teaching   Didactic Health Teaching
STARTED   14   10 
COMPLETED   10   7 
NOT COMPLETED   4   3 
Lost to Follow-up                2                0 
Withdrawal by Subject                2                3 

Period 3:   Cohort 3
    Exergaming and Didactic Health Teaching   Didactic Health Teaching
STARTED   12   0 [1] 
COMPLETED   7   0 
NOT COMPLETED   5   0 
Lost to Follow-up                1                0 
Withdrawal by Subject                4                0 
[1] Enrollment too low to have control group. All subjects in this cohort received intervention.

Period 4:   Cohort 4
    Exergaming and Didactic Health Teaching   Didactic Health Teaching
STARTED   6   0 [1] 
COMPLETED   4   0 
NOT COMPLETED   2   0 
Lost to Follow-up                1                0 
Withdrawal by Subject                1                0 
[1] Enrollment too low to have control group. All subjects in this cohort received intervention.

Period 5:   Cohort 5
    Exergaming and Didactic Health Teaching   Didactic Health Teaching
STARTED   10   5 
COMPLETED   4   1 
NOT COMPLETED   6   4 
Lost to Follow-up                3                2 
Withdrawal by Subject                3                2 

Period 6:   Cohort 6
    Exergaming and Didactic Health Teaching   Didactic Health Teaching
STARTED   4   5 
COMPLETED   1   4 
NOT COMPLETED   3   1 
Lost to Follow-up                2                0 
Withdrawal by Subject                1                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subjects were enrolled sequentially and randomized 2:1 into two arms: the intervention group receiving both didactic and exergaming physical activity curriculum and the control group, who received didactic curriculum only. The control group were offered participation in the exergaming activities 6 months after randomization.

Reporting Groups
  Description
Exergaming and Didactic Health Teaching

Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.

Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period.

Didactic Health Teaching

Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.

Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period.

Total Total of all reporting groups

Baseline Measures
   Exergaming and Didactic Health Teaching   Didactic Health Teaching   Total 
Overall Participants Analyzed 
[Units: Participants]
 60   24   84 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 10.0  (1.2)   10.1  (1.1)   10.1  (1.3) 
[1] Obese and overweight children (BMI greater than or equal to 85th percentile) ages 8 years through 12 years were enrolled.
Gender 
[Units: Participants]
     
Female   37   12   49 
Male   23   12   35 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   5   4   9 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   16   6   22 
White   39   14   53 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Baseline BMI z-score 
[Units: Z-score]
Mean (Full Range)
 2.2 
 (1.43 to 2.86) 
 2.2 
 (1.27 to 2.96) 
 2.2 
 (1.27 to 2.96) 


  Outcome Measures

1.  Primary:   BMI Z-score Change   [ Time Frame: Change from baseline at 6 months ]

2.  Primary:   BMI Z-score Change   [ Time Frame: Change from baseline BMI z-score at 1 year ]

3.  Secondary:   Waist Circumference Change   [ Time Frame: Change from baseline at 6 months ]

4.  Secondary:   Systolic Blood Pressure Change   [ Time Frame: Change from baseline Systolic BP at 6 months ]

5.  Secondary:   Heart Rate Change From Baseline to 6 Months   [ Time Frame: Change from baseline at 6 months ]

6.  Secondary:   Shuttle Run Change in Number of Shuttle Runs   [ Time Frame: Change in number from baseline shuttle run at 6 months ]

7.  Secondary:   After School Screen Time as Reported on Questionnaire   [ Time Frame: Change from baseline at 6 months ]

8.  Secondary:   Saturday Screen Time as Assessed by Questionnaire   [ Time Frame: Change in hours from baseline at 6 months ]

9.  Secondary:   Activity Levels Measured by Pedometers (Weekly Steps)   [ Time Frame: Change from week 1 to week 24 ]

10.  Secondary:   Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Physical Self-Worth Changes in Physical Self-worth   [ Time Frame: Change from baseline at 6 months ]

11.  Secondary:   Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Global Self-Worth Score   [ Time Frame: Change from baseline to 6 months ]

12.  Secondary:   Dietary Change:Total Calorie Intake (kcal/Day) (Block Alive FFQ)   [ Time Frame: Change from baseline at 6 months ]

13.  Secondary:   Change in Dietary Intake: % Fat (Block Alive FFQ)   [ Time Frame: Change from baseline at 6 months ]

14.  Secondary:   Change in Dietary Intake: % Carbohydrates (Block Alive FFQ)   [ Time Frame: Change from baseline at 6 months ]

15.  Secondary:   Change in Dietary Intake: Number of Vegetable Servings (Block Alive FFQ)   [ Time Frame: Change from baseline at 6 months ]

16.  Secondary:   Change in Dietary Intake: Number of Fruit Servings (Block Alive FFQ)   [ Time Frame: Change from baseline at 6 months ]

17.  Secondary:   Change in Dietary Intake: Number of Sugar Sweetened Beverages (Block Alive FFQ)   [ Time Frame: Change from baseline at 6 months ]

18.  Secondary:   Exergaming Program Component Influence on Attendance   [ Time Frame: 6 months ]

19.  Secondary:   Waist Circumference Change   [ Time Frame: Change from 6 month waist circumference at 1 year ]

20.  Secondary:   Systolic Blood Pressure Change   [ Time Frame: Change from 6 month Systolic BP at 1 year ]

21.  Secondary:   Heart Rate Change   [ Time Frame: Change from 6 month Heart rate at 1 year ]

22.  Secondary:   Shuttle Run Change in Number of Shuttle Runs   [ Time Frame: Change in number from 6 month shuttle run at 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations: incomplete data collection (baseline & follow-up), those lost to follow-up may have been unwilling to continue because of weight gain, low enrollment numbers, and control subjects were offered intervention activities after 6 months.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Amy L. Christison
Organization: University of Illinois College of Medicine at Peoria
phone: 309-624-9188
e-mail: alc@uic.edu


Publications:
Ridley K, Olds T. Video center games: Energy cost and children's behaviors. Pediatric Exercise Science. 2001;13:413-421.
McDougall J DM. <br />Children, video games and physical activity. an exploratory study. Int J on Disability and Human Development. 2008;7(1):89-94.
Whitehead JR. A study of children's physical self-perception using an adapted physical self-perception questionnaire. Pediatr Exercise Science. 1995(7):132-151.


Responsible Party: Amy Christison, M.D., University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02436330     History of Changes
Other Study ID Numbers: 209418
First Submitted: April 20, 2015
First Posted: May 6, 2015
Results First Submitted: May 28, 2015
Results First Posted: December 14, 2015
Last Update Posted: December 14, 2015