Trial Outcomes & Findings for Exergaming for Health: Impact of a Community-Based Active Video Gaming Curriculum in Pediatric Weight Management (NCT NCT02436330)

NCT ID: NCT02436330

Last Updated: 2015-12-14

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 84 participants
• Primary outcome timeframe: Change from baseline at 6 months
• Results posted on: 2015-12-14

Participant Flow

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.

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.

Participant milestones

Measure	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
Cohort 1 STARTED	14	4
Cohort 1 COMPLETED	9	1
Cohort 1 NOT COMPLETED	5	3
Cohort 2 STARTED	14	10
Cohort 2 COMPLETED	10	7
Cohort 2 NOT COMPLETED	4	3
Cohort 3 STARTED	12	0
Cohort 3 COMPLETED	7	0
Cohort 3 NOT COMPLETED	5	0
Cohort 4 STARTED	6	0
Cohort 4 COMPLETED	4	0
Cohort 4 NOT COMPLETED	2	0
Cohort 5 STARTED	10	5
Cohort 5 COMPLETED	4	1
Cohort 5 NOT COMPLETED	6	4
Cohort 6 STARTED	4	5
Cohort 6 COMPLETED	1	4
Cohort 6 NOT COMPLETED	3	1

Reasons for withdrawal

Measure	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
Cohort 1 Lost to Follow-up	5	2
Cohort 1 Withdrawal by Subject	0	1
Cohort 2 Lost to Follow-up	2	0
Cohort 2 Withdrawal by Subject	2	3
Cohort 3 Lost to Follow-up	1	0
Cohort 3 Withdrawal by Subject	4	0
Cohort 4 Lost to Follow-up	1	0
Cohort 4 Withdrawal by Subject	1	0
Cohort 5 Lost to Follow-up	3	2
Cohort 5 Withdrawal by Subject	3	2
Cohort 6 Lost to Follow-up	2	0
Cohort 6 Withdrawal by Subject	1	1

Baseline Characteristics

Exergaming for Health: Impact of a Community-Based Active Video Gaming Curriculum in Pediatric Weight Management

Baseline characteristics by cohort

Measure	Exergaming and Didactic Health Teaching n=60 Participants 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 n=24 Participants 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 n=84 Participants Total of all reporting groups
Age, Continuous	10.0 years STANDARD_DEVIATION 1.2 • n=5 Participants	10.1 years STANDARD_DEVIATION 1.1 • n=7 Participants	10.1 years STANDARD_DEVIATION 1.3 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	12 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	12 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	6 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants	14 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline BMI z-score	2.2 z-score n=5 Participants	2.2 z-score n=7 Participants	2.2 z-score n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline at 6 months

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).

Outcome measures

Measure	Exergaming and Didactic Health Teaching n=35 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.	Didactic Health Teaching n=13 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
BMI Z-score Change	-0.057 z-score Standard Deviation 0.118	0.005 z-score Standard Deviation 0.0917

PRIMARY outcome

Timeframe: Change from baseline BMI z-score at 1 year

Population: 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.

Measure was only taken on the subjects who participated in the Intervention group (exergaming combined with didactic teaching).

Outcome measures

Measure	Exergaming and Didactic Health Teaching n=28 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.	Didactic Health Teaching Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
BMI Z-score Change	-0.0775 z-score Interval -0.1485 to -0.00652	—

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: 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.

Outcome measures

Measure	Exergaming and Didactic Health Teaching n=34 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.	Didactic Health Teaching n=8 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Waist Circumference Change	-0.50 cm Standard Deviation 6.70	-0.51 cm Standard Deviation 5.12

SECONDARY outcome

Timeframe: Change from baseline Systolic BP at 6 months

Population: 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.

Outcome measures

Measure	Exergaming and Didactic Health Teaching n=33 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.	Didactic Health Teaching n=12 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Systolic Blood Pressure Change	1 mmHg Standard Deviation 15	0 mmHg Standard Deviation 15

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: 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.

Outcome measures

Measure	Exergaming and Didactic Health Teaching n=33 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.	Didactic Health Teaching n=12 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Heart Rate Change From Baseline to 6 Months	-9.9 beats per minute Standard Deviation 13.77	-7.0 beats per minute Standard Deviation 9.69

SECONDARY outcome

Timeframe: Change in number from baseline shuttle run at 6 months

Population: 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.

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.

Outcome measures

Measure	Exergaming and Didactic Health Teaching n=24 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.	Didactic Health Teaching n=13 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Shuttle Run Change in Number of Shuttle Runs	0.213 number of runs Standard Deviation 0.4014	-0.00085 number of runs Standard Deviation 0.376

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: 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.

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.

Outcome measures

Measure	Exergaming and Didactic Health Teaching n=28 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.	Didactic Health Teaching n=8 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
After School Screen Time as Reported on Questionnaire	-0.7589 hours Standard Deviation 3.068	0.188 hours Standard Deviation 1.368

SECONDARY outcome

Timeframe: Change in hours from baseline at 6 months

Population: 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.

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.

Outcome measures

Measure	Exergaming and Didactic Health Teaching n=28 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.	Didactic Health Teaching n=8 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Saturday Screen Time as Assessed by Questionnaire	-1.4 hours Standard Deviation 3.36	-0.3438 hours Standard Deviation 2.36

SECONDARY outcome

Timeframe: Change from week 1 to week 24

Population: 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.

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.

Outcome measures

Measure	Exergaming and Didactic Health Teaching n=13 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.	Didactic Health Teaching n=10 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Activity Levels Measured by Pedometers (Weekly Steps)	-6626 steps Standard Deviation 21810	-9059.5 steps Standard Deviation 26688.91

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: 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.

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.

Outcome measures

Measure	Exergaming and Didactic Health Teaching n=26 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.	Didactic Health Teaching n=7 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Physical Self-Worth Changes in Physical Self-worth	-0.218 scores on a scale Standard Deviation 0.746	-0.5 scores on a scale Standard Deviation 0.385

SECONDARY outcome

Timeframe: Change from baseline to 6 months

Population: 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.

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.

Outcome measures

Measure	Exergaming and Didactic Health Teaching n=26 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.	Didactic Health Teaching n=7 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Global Self-Worth Score	-0.238 scores on a scale Standard Deviation 0.525	-0.523 scores on a scale Standard Deviation 0.53

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: 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.

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.

Outcome measures

Measure	Exergaming and Didactic Health Teaching n=28 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.	Didactic Health Teaching n=10 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Dietary Change:Total Calorie Intake (kcal/Day) (Block Alive FFQ)	-292.92 kcal/day Standard Deviation 386.7	-45 kcal/day Standard Deviation 358.5

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: 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.

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.

Outcome measures

Measure	Exergaming and Didactic Health Teaching n=28 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.	Didactic Health Teaching n=10 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Change in Dietary Intake: % Fat (Block Alive FFQ)	-1.25 percentage of fat Standard Deviation 8.49	3.00 percentage of fat Standard Deviation 7.09

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: 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.

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.

Outcome measures

Measure	Exergaming and Didactic Health Teaching n=28 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.	Didactic Health Teaching n=10 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Change in Dietary Intake: % Carbohydrates (Block Alive FFQ)	2.10 percentage of carbohydrates Standard Deviation 8.49	-5.12 percentage of carbohydrates Standard Deviation 7.95

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: 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.

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.

Outcome measures

Measure	Exergaming and Didactic Health Teaching n=25 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.	Didactic Health Teaching n=9 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Change in Dietary Intake: Number of Vegetable Servings (Block Alive FFQ)	0.0078 servings Standard Deviation 0.7755	0.8248 servings Standard Deviation 2.06

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: 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.

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.

Outcome measures

Measure	Exergaming and Didactic Health Teaching n=25 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.	Didactic Health Teaching n=9 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Change in Dietary Intake: Number of Fruit Servings (Block Alive FFQ)	-0.13255 Servings Standard Deviation 0.523	0.663 Servings Standard Deviation 0.64

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: 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.

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.

Outcome measures

Measure	Exergaming and Didactic Health Teaching n=27 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.	Didactic Health Teaching n=10 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Change in Dietary Intake: Number of Sugar Sweetened Beverages (Block Alive FFQ)	-2.572 servings Standard Deviation 8.402	-3.2374 servings Standard Deviation 2.44

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Measure	Exergaming and Didactic Health Teaching n=35 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.	Didactic Health Teaching Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Exergaming Program Component Influence on Attendance	71 percentage of subjects	—

SECONDARY outcome

Timeframe: Change from 6 month waist circumference at 1 year

Population: 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.

Outcome measures

Measure	Exergaming and Didactic Health Teaching n=25 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.	Didactic Health Teaching Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Waist Circumference Change	1.52 cm Interval -0.9278 to 3.9678	—

SECONDARY outcome

Timeframe: Change from 6 month Systolic BP at 1 year

Population: 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.

Outcome measures

Measure	Exergaming and Didactic Health Teaching n=27 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.	Didactic Health Teaching Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Systolic Blood Pressure Change	3.5185 mmHg Interval -1.0625 to 8.0996	—

SECONDARY outcome

Timeframe: Change from 6 month Heart rate at 1 year

Population: 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.

Outcome measures

Measure	Exergaming and Didactic Health Teaching n=27 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.	Didactic Health Teaching Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Heart Rate Change	2.7407 beats per minute Interval -3.3961 to 8.8776	—

SECONDARY outcome

Timeframe: Change in number from 6 month shuttle run at 1 year

Population: 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.

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.

Outcome measures

Measure	Exergaming and Didactic Health Teaching n=20 Participants Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.	Didactic Health Teaching Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Shuttle Run Change in Number of Shuttle Runs	0.10 number of runs Interval -0.1968 to 0.3968	—

Adverse Events

Exergaming and Didactic Health Teaching

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Didactic Health Teaching

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Amy L. Christison

University of Illinois College of Medicine at Peoria

Phone: 309-624-9188

Email: alc@uic.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place