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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
Enrollment 84

Recruitment Details 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 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.
Arm/Group Title Exergaming and Didactic Health Teaching Didactic Health Teaching
Hide Arm/Group Description

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.

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

Period Title: Cohort 1
Started 14 4
Completed 9 1
Not Completed 5 3
Reason Not Completed
Lost to Follow-up             5             2
Withdrawal by Subject             0             1
Period Title: Cohort 2
Started 14 10
Completed 10 7
Not Completed 4 3
Reason Not Completed
Lost to Follow-up             2             0
Withdrawal by Subject             2             3
Period Title: Cohort 3
Started 12 0 [1]
Completed 7 0
Not Completed 5 0
Reason Not Completed
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 Title: Cohort 4
Started 6 0 [1]
Completed 4 0
Not Completed 2 0
Reason Not Completed
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 Title: Cohort 5
Started 10 5
Completed 4 1
Not Completed 6 4
Reason Not Completed
Lost to Follow-up             3             2
Withdrawal by Subject             3             2
Period Title: Cohort 6
Started 4 5
Completed 1 4
Not Completed 3 1
Reason Not Completed
Lost to Follow-up             2             0
Withdrawal by Subject             1             1
Arm/Group Title Exergaming and Didactic Health Teaching Didactic Health Teaching Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 60 24 84
Hide Baseline Analysis Population Description
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.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 24 participants 84 participants
10.0  (1.2) 10.1  (1.1) 10.1  (1.3)
[1]
Measure Description: Obese and overweight children (BMI greater than or equal to 85th percentile) ages 8 years through 12 years were enrolled.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 24 participants 84 participants
Female
37
  61.7%
12
  50.0%
49
  58.3%
Male
23
  38.3%
12
  50.0%
35
  41.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 24 participants 84 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
   8.3%
4
  16.7%
9
  10.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
16
  26.7%
6
  25.0%
22
  26.2%
White
39
  65.0%
14
  58.3%
53
  63.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Baseline BMI z-score  
Mean (Full Range)
Unit of measure:  Z-score
Number Analyzed 60 participants 24 participants 84 participants
2.2
(1.43 to 2.86)
2.2
(1.27 to 2.96)
2.2
(1.27 to 2.96)
1.Primary Outcome
Title BMI Z-score Change
Hide Description All subjects were asked to dress in light athletic clothing and have their weight and height measured at baseline (the first group session) and at 6 months. Research assistants were trained using guidelines from the National Health and Nutrition Examination Survey (NHANES) Anthropometry Procedures Manual and demonstrated accurate measures on 3 separate children. The Seca 217 portable stadiometer was used for all height measurements and the HealthOMeter 844 KL scale was used for all weight measurements. BMI z-scores were calculated using software available from the Children's Hospital of Philadelphia Research Institute (http://stokes.chop.edu/web/zcore).
Time Frame Change from baseline at 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exergaming and Didactic Health Teaching Didactic Health Teaching
Hide Arm/Group Description:
Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Overall Number of Participants Analyzed 35 13
Mean (Standard Deviation)
Unit of Measure: z-score
-0.057  (0.118) 0.005  (0.0917)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exergaming and Didactic Health Teaching, Didactic Health Teaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0967
Comments We checked the distribution of bmiz changes between baseline and 6 months, and there is one subject from control group had bigger changes than others. After excluding this subject, the results are still similar with previous.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.0615
Confidence Interval (2-Sided) 95%
-0.1344 to 0.0115
Estimation Comments [Not Specified]
2.Primary Outcome
Title BMI Z-score Change
Hide Description Measure was only taken on the subjects who participated in the Intervention group (exergaming combined with didactic teaching).
Time Frame Change from baseline BMI z-score at 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Complete data was not available for all 35 subjects for this outcome measure. BMI z-score change from baseline to 1 year was only collected on 28 of the 35 participants.
Arm/Group Title Exergaming and Didactic Health Teaching
Hide Arm/Group Description:
Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
Overall Number of Participants Analyzed 28
Mean (95% Confidence Interval)
Unit of Measure: z-score
-0.0775
(-0.1485 to -0.00652)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exergaming and Didactic Health Teaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0335
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.0775
Confidence Interval (2-Sided) 95%
-0.1485 to -0.00652
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Waist Circumference Change
Hide Description [Not Specified]
Time Frame Change from baseline at 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Incomplete data available for analysis. Change in waist circumference from baseline to 6 month measurements was only collected on 34/35 of the Experimental group and 8/13 of the Active comparator group. The other participants did not show up for the 6 month measurements.
Arm/Group Title Exergaming and Didactic Health Teaching Didactic Health Teaching
Hide Arm/Group Description:
Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Overall Number of Participants Analyzed 34 8
Mean (Standard Deviation)
Unit of Measure: cm
-0.50  (6.70) -0.51  (5.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exergaming and Didactic Health Teaching, Didactic Health Teaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.991
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-5.2 to 5.1
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Systolic Blood Pressure Change
Hide Description [Not Specified]
Time Frame Change from baseline Systolic BP at 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Incomplete data available for analysis. Blood pressure was taken and documented at baseline and at 6 months, however, not all participants were in attendance. Complete data was only available for 33/35 Experimental group participants and 12/13 from the Active comparator group. Available data was analyzed.
Arm/Group Title Exergaming and Didactic Health Teaching Didactic Health Teaching
Hide Arm/Group Description:
Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Overall Number of Participants Analyzed 33 12
Mean (Standard Deviation)
Unit of Measure: mmHg
1  (15) 0  (15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exergaming and Didactic Health Teaching, Didactic Health Teaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.851
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1
Confidence Interval (2-Sided) 95%
-9 to 11
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Heart Rate Change From Baseline to 6 Months
Hide Description [Not Specified]
Time Frame Change from baseline at 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Missing Data: Heart rate measurements at baseline and at 6 months was only available for 33/35 Experimental group participants and 12/13 Active comparator group participants. Not all participants attended the 6 month measurement/data collection visit.
Arm/Group Title Exergaming and Didactic Health Teaching Didactic Health Teaching
Hide Arm/Group Description:
Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Overall Number of Participants Analyzed 33 12
Mean (Standard Deviation)
Unit of Measure: beats per minute
-9.9  (13.77) -7.0  (9.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exergaming and Didactic Health Teaching, Didactic Health Teaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.501
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.9
Confidence Interval (2-Sided) 95%
-11.7 to 5.8
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Shuttle Run Change in Number of Shuttle Runs
Hide Description The shuttle run was completed by participants at baseline (session 1) and at 6 months. The shuttle run is a standardized field assessment that requires participants to run 20 meters within sequentially shortened time frames of recorded beeps.
Time Frame Change in number from baseline shuttle run at 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Missing Data: Shuttle run was completed by participants at baseline and at 6 months to document the change in number of runs. Not all participants attended the 6 month measurement visit, therefore, complete data was only available on 24/35 of the Experimental group and 13/13 of the Active comparator group. Available data was analyzed.
Arm/Group Title Exergaming and Didactic Health Teaching Didactic Health Teaching
Hide Arm/Group Description:
Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Overall Number of Participants Analyzed 24 13
Mean (Standard Deviation)
Unit of Measure: number of runs
0.213  (0.4014) -0.00085  (0.376)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exergaming and Didactic Health Teaching, Didactic Health Teaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.2971
Confidence Interval (2-Sided) 95%
0.0224 to 0.5718
Estimation Comments [Not Specified]
7.Secondary Outcome
Title After School Screen Time as Reported on Questionnaire
Hide Description Change in after school screen time (reported out as fraction of 1 hour) will be measured by subject response on questionnaire taken at baseline and at 6 months for both groups. After school screen time was defined as the amount of time spent on any screen, on the average weekday afternoon/evening, including: watching television, computer use (laptop, desk top, tablet) or playing video games on the television or other hand held device.
Time Frame Change from baseline at 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Missing Data: Survey data regarding "after school screen time" was collected from participants at baseline and again at 6 months. Not all participants completed both surveys, therefore, analysis for this outcome measure only included 28/35 participants from the Experimental group and 8/13 participants from the Active comparator group.
Arm/Group Title Exergaming and Didactic Health Teaching Didactic Health Teaching
Hide Arm/Group Description:
Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Overall Number of Participants Analyzed 28 8
Mean (Standard Deviation)
Unit of Measure: hours
-0.7589  (3.068) 0.188  (1.368)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exergaming and Didactic Health Teaching, Didactic Health Teaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2207
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.9464
Confidence Interval (2-Sided) 95%
-2.4954 to 0.6025
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Saturday Screen Time as Assessed by Questionnaire
Hide Description Change in Saturday screen time (reported out as fraction of an hour) will be measured by subject response on questionnaire taken at baseline and at 6 months for both groups. Saturday screen time was defined as the amount of time spent on any screen, on an average Saturday, including: watching television, computer use (laptop, desk top, tablet) or playing video games on the television or other hand held device.
Time Frame Change in hours from baseline at 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Missing Data: Survey data regarding "Saturday screen time" was collected from participants at baseline and again at 6 months. Not all participants completed both surveys, therefore, analysis for this outcome measure only included 28/35 participants from the Experimental group and 8/13 participants from the Active comparator group.
Arm/Group Title Exergaming and Didactic Health Teaching Didactic Health Teaching
Hide Arm/Group Description:
Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Overall Number of Participants Analyzed 28 8
Mean (Standard Deviation)
Unit of Measure: hours
-1.4  (3.36) -0.3438  (2.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exergaming and Didactic Health Teaching, Didactic Health Teaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4164
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.0491
Confidence Interval (2-Sided) 95%
-3.6407 to 1.5425
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Activity Levels Measured by Pedometers (Weekly Steps)
Hide Description Activity will be measured by pedometers (number of steps) during week 1 and week 24 for both groups. Subjects used the Yamax 200 pedometer to count the steps they took over 1 weeks time.
Time Frame Change from week 1 to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Missing data: Data was not available from all participants from pedometer use at both the 1 week and 24 week mark, therefore, this analysis only includes 13/35 participant data from the Experimental group and 10/13 participant data collected from the Active comparator group.
Arm/Group Title Exergaming and Didactic Health Teaching Didactic Health Teaching
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 13 10
Mean (Standard Deviation)
Unit of Measure: steps
-6626  (21810) -9059.5  (26688.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exergaming and Didactic Health Teaching, Didactic Health Teaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.812
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2433.7
Confidence Interval (2-Sided) 95%
-18579.7 to 23447.2
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Physical Self-Worth Changes in Physical Self-worth
Hide Description CY-PSPP questionnaire was completed by participants in both groups at baseline and at 6 months. Change in the Physical Self-worth scores, which was 1 of 6 sub-domains, is analyzed. This sub-domain contains 6 questions with responses ranging from 1-4 for each question with 1 being the minimum and 4 being the maximum (best) score. The sub-domain score is then calculated as the mean of the 6 responses (minimum to maximum of 1 to 4).The change in score from baseline to 6 months was compared.
Time Frame Change from baseline at 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Missing Data: The CY-PSPP questionnaire was not completed by all participants at both the baseline visit and the 6 month mark. Therefore this analysis only includes data for participants who completed the questionnaire at both times: 26/35 from the Experimental group and 7/13 from the Active Comparator group.
Arm/Group Title Exergaming and Didactic Health Teaching Didactic Health Teaching
Hide Arm/Group Description:
Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Overall Number of Participants Analyzed 26 7
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.218  (0.746) -0.5  (0.385)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exergaming and Didactic Health Teaching, Didactic Health Teaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3326
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.2837
Confidence Interval (2-Sided) 95%
-0.3037 to 0.8711
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Global Self-Worth Score
Hide Description CY-PSPP questionnaire was completed by participants in both groups at baseline and at 6 months. Change in the Global Self-worth scores, which was 1 of 6 sub-domains, is analyzed. This sub-domain contains 6 questions with responses ranging from 1-4 for each question with 1 being the minimum and 4 being the maximum (best) score. The sub-domain score is then calculated as the mean of the 6 responses (minimum to maximum of 1 to 4).The change in score from baseline to 6 months was compared.
Time Frame Change from baseline to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Missing Data: The CY-PSPP questionnaire was not completed by all participants at both the baseline visit and the 6 month mark. Therefore this analysis only includes data for participants who completed the questionnaire at both times: 26/35 from the Experimental group and 7/13 from the Active Comparator group.
Arm/Group Title Exergaming and Didactic Health Teaching Didactic Health Teaching
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 26 7
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.238  (0.525) -0.523  (0.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exergaming and Didactic Health Teaching, Didactic Health Teaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1856
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.2995
Confidence Interval (2-Sided) 95%
-0.2051 to 0.8041
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Dietary Change:Total Calorie Intake (kcal/Day) (Block Alive FFQ)
Hide Description The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total kcal/kg/day is then estimated based upon participant responses.
Time Frame Change from baseline at 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Missing data: Not all participants completed this survey at both time points. 28/35 from the Experimental group had complete response and 10/13 from the Active comparator group had complete response. Analysis was completed on the available data.
Arm/Group Title Exergaming and Didactic Health Teaching Didactic Health Teaching
Hide Arm/Group Description:
Subjects attending exergaming/physical activity along with classroom structured nutrition/health education.
Subjects only receiving classroom structured nutrition/health education.
Overall Number of Participants Analyzed 28 10
Mean (Standard Deviation)
Unit of Measure: kcal/day
-292.92  (386.7) -45  (358.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exergaming and Didactic Health Teaching, Didactic Health Teaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0849
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -247.9
Confidence Interval (2-Sided) 95%
-531.7 to 35.8686
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change in Dietary Intake: % Fat (Block Alive FFQ)
Hide Description The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total %dietary fat intake per day is then estimated based upon participant responses.
Time Frame Change from baseline at 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Missing data: Not all participants completed this survey at both time points. 28/35 from the Experimental group had complete response and 10/13 from the Active comparator group had complete response regarding the %fat in their daily diet. Analysis was completed on the available data.
Arm/Group Title Exergaming and Didactic Health Teaching Didactic Health Teaching
Hide Arm/Group Description:
Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Overall Number of Participants Analyzed 28 10
Mean (Standard Deviation)
Unit of Measure: percentage of fat
-1.25  (8.49) 3.00  (7.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exergaming and Didactic Health Teaching, Didactic Health Teaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.176
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.2048
Confidence Interval (2-Sided) 95%
-10.3835 to 1.9740
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change in Dietary Intake: % Carbohydrates (Block Alive FFQ)
Hide Description The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total % dietary carbohydrates is then estimated based upon participant responses.
Time Frame Change from baseline at 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Missing data: Not all participants completed this survey at both time points. 28/35 from the Experimental group had complete response and 10/13 from the Active comparator group had complete response regarding %carbohydrates in their daily diet. Analysis was completed on the available data.
Arm/Group Title Exergaming and Didactic Health Teaching Didactic Health Teaching
Hide Arm/Group Description:
Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Overall Number of Participants Analyzed 28 10
Mean (Standard Deviation)
Unit of Measure: percentage of carbohydrates
2.10  (8.49) -5.12  (7.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exergaming and Didactic Health Teaching, Didactic Health Teaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0247
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 7.2151
Confidence Interval (2-Sided) 95%
0.973 to 13.457
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change in Dietary Intake: Number of Vegetable Servings (Block Alive FFQ)
Hide Description The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total number of vegetable servings per day is then estimated based upon participant responses.
Time Frame Change from baseline at 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Missing data: Not all participants completed this survey at both time points. 25/35 from the Experimental group had complete response and 9/13 from the Active comparator group had complete response regarding daily vegetable intake. Analysis was completed on the available data.
Arm/Group Title Exergaming and Didactic Health Teaching Didactic Health Teaching
Hide Arm/Group Description:
Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Overall Number of Participants Analyzed 25 9
Mean (Standard Deviation)
Unit of Measure: servings
0.0078  (0.7755) 0.8248  (2.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exergaming and Didactic Health Teaching, Didactic Health Teaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2764
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.8169
Confidence Interval (2-Sided) 95%
-2.4147 to 0.7808
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change in Dietary Intake: Number of Fruit Servings (Block Alive FFQ)
Hide Description The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total number of fruit servings per day is then estimated based upon participant responses.
Time Frame Change from baseline at 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Missing data: Not all participants completed this survey at both time points. 25/35 from the Experimental group had complete response and 9/13 from the Active comparator group had complete response regarding daily fruit intake. Analysis was completed on the available data.
Arm/Group Title Exergaming and Didactic Health Teaching Didactic Health Teaching
Hide Arm/Group Description:
Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Overall Number of Participants Analyzed 25 9
Mean (Standard Deviation)
Unit of Measure: Servings
-0.13255  (0.523) 0.663  (0.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exergaming and Didactic Health Teaching, Didactic Health Teaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.7958
Confidence Interval (2-Sided) 95%
-1.2350 to -0.3566
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change in Dietary Intake: Number of Sugar Sweetened Beverages (Block Alive FFQ)
Hide Description The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total number of sugar sweetened beverages per day is then estimated based upon participant responses.
Time Frame Change from baseline at 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Missing data: Not all participants completed this survey at both time points. 27/35 from the Experimental group had complete response and 10/13 from the Active comparator group had complete response regarding sugar sweetened beverage daily intake. Analysis was completed on the available data.
Arm/Group Title Exergaming and Didactic Health Teaching Didactic Health Teaching
Hide Arm/Group Description:
Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Overall Number of Participants Analyzed 27 10
Mean (Standard Deviation)
Unit of Measure: servings
-2.572  (8.402) -3.2374  (2.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exergaming and Didactic Health Teaching, Didactic Health Teaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6974
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.7024
Confidence Interval (2-Sided) 95%
-2.9377 to 4.3425
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Exergaming Program Component Influence on Attendance
Hide Description The experimental group will answer a questionnaire at the end of the 6 month study period, measuring the importance of specific components of the curriculum and motivators which influenced enrollment and compliance with participation. Of interest is measuring the influence of the exergaming curriculum as compared to these other factors. This is a 16-item, 3-point Likert-scale (1 = least important and 3 = most important) questionnaire created specifically for this study. Results were reported based on % of participants rating "3" ,most important, for each curriculum component.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exergaming and Didactic Health Teaching
Hide Arm/Group Description:
Intervention group subjects (exergaming combined with didactic nutrition teaching) with continued participation at 6 months completed this questionnaire regarding attitudes/perceptions towards participation.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: percentage of subjects
71
19.Secondary Outcome
Title Waist Circumference Change
Hide Description [Not Specified]
Time Frame Change from 6 month waist circumference at 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One year data was only collected for the participants assigned to the "Exergaming and Didactic Health Teaching" group. Only 25/35 participants had waist measurements collected at both 6 months and 1 year. Available data was analyzed.
Arm/Group Title Exergaming and Didactic Health Teaching
Hide Arm/Group Description:
Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
Overall Number of Participants Analyzed 25
Mean (95% Confidence Interval)
Unit of Measure: cm
1.52
(-0.9278 to 3.9678)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exergaming and Didactic Health Teaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2122
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
20.Secondary Outcome
Title Systolic Blood Pressure Change
Hide Description [Not Specified]
Time Frame Change from 6 month Systolic BP at 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One year data was only collected for the participants assigned to the "Exergaming and Didactic Health Teaching" group. Systolic blood pressure was only documented at 6 months and 1 year for 27/35 of the participants. Available data is what was analyzed.
Arm/Group Title Exergaming and Didactic Health Teaching
Hide Arm/Group Description:
Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
Overall Number of Participants Analyzed 27
Mean (95% Confidence Interval)
Unit of Measure: mmHg
3.5185
(-1.0625 to 8.0996)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exergaming and Didactic Health Teaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1265
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.61
Confidence Interval (2-Sided) 95%
-1.15 to 8.33
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Heart Rate Change
Hide Description [Not Specified]
Time Frame Change from 6 month Heart rate at 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One year data was only collected for the participants assigned to the "Exergaming and Didactic Health Teaching" group. Heart rate data was collected at 6 month and 1 year for 27/35 of the participants. Available data was analyzed.
Arm/Group Title Exergaming and Didactic Health Teaching
Hide Arm/Group Description:
Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
Overall Number of Participants Analyzed 27
Mean (95% Confidence Interval)
Unit of Measure: beats per minute
2.7407
(-3.3961 to 8.8776)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exergaming and Didactic Health Teaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3671
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
22.Secondary Outcome
Title Shuttle Run Change in Number of Shuttle Runs
Hide Description The shuttle run was completed again by participants in the Experimental group at 1 year. The shuttle run is a standardized field assessment that requires participants to run 20 meters within sequentially shortened time frames of recorded beeps.
Time Frame Change in number from 6 month shuttle run at 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One year data was only collected for the participants assigned to the "Exergaming and Didactic Health Teaching" group. Shuttle run was completed by 20/35 participants in the Experimental group at both 6 months and 1 year. Available data was analyzed.
Arm/Group Title Exergaming and Didactic Health Teaching
Hide Arm/Group Description:
Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
Overall Number of Participants Analyzed 20
Mean (95% Confidence Interval)
Unit of Measure: number of runs
0.10
(-0.1968 to 0.3968)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exergaming and Didactic Health Teaching
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4892
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Adverse Event data collected throughout the length of the study for all participants (12 month participation period).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Exergaming and Didactic Health Teaching Didactic Health Teaching
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Exergaming and Didactic Health Teaching Didactic Health Teaching
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Exergaming and Didactic Health Teaching Didactic Health Teaching
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Exergaming and Didactic Health Teaching Didactic Health Teaching
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/24 (0.00%) 
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.
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
EMail: 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