Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02436330
Enrollment
84
Registered
2015-05-06
Start date
2011-03-31
Completion date
2013-09-30
Last updated
2015-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Obesity

Keywords

Exergaming, Weight management

Brief summary

Evaluation of the effectiveness of Exergaming for Health, a community-based multifaceted weight management program in a randomized controlled trial (RCT). Primary objective: to assess impact of the program on BMI z-scores. Secondary objectives: to measure impact on cardiovascular fitness, self-worth, sedentary screen time, and the influence of exergaming component on attendance and participation.

Detailed description

Eighty-four overweight pediatric subjects will be enrolled sequentially and randomized 2:1 in experimental and control groups for six months of weight management programming. The experimental group and their parents/guardians will participate in ten weekly 2-hour sessions, comprised of 1 hour of exergaming or exergaming combined with traditional exercise and 1 hour of didactic classes focusing on nutrition and psychosocial behaviors related to weight management. Following these 10 weeks, they will attend monthly 1-hour maintenance didactic classes. The control group and their parents/guardians will participate only in the didactic portion of the curricula for the same duration of time, 10 weeks, followed by monthly maintenance classes for the remainder of the 6 month period. The control group will then be offered participation in the Exergaming for Health program upon study completion. Comparisons between the two groups will be obtained through changes in the measurements of weight, height, BMI z-scores, shuttle run times, and responses to questionnaires about screen time, self-perception, and nutrition. Measurements of both groups will be obtained at baseline and 6 months and another set of measurements will be obtained on the experimental group at 12 months.

Interventions

BEHAVIORALExergaming

6 months of weight management programming consisting of 10 weekly sessions:1 hour of session was spent exergaming, which included active video game play and traditional group exercises. Some examples include: Dance, Dance, Revolution, Exerbike, Treadwall, Yoga, Spin class, etc.

BEHAVIORALDidactic 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.

Sponsors

University of Illinois at Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* Child with BMI greater than or equal to 85th percentile. * English speaking * Approval by Primary Care Doctor

Exclusion criteria

* Participants with medical, developmental or psychiatric diagnoses which preclude participation in both the physical activity and classroom portions of the curriculum. * Participants who are taking medications that positively or negatively affect weight.

Design outcomes

Primary

MeasureTime frameDescription
BMI Z-score ChangeChange from baseline at 6 monthsAll 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).

Secondary

MeasureTime frameDescription
Systolic Blood Pressure ChangeChange from baseline Systolic BP at 6 months
Heart Rate Change From Baseline to 6 MonthsChange from baseline at 6 months
Shuttle Run Change in Number of Shuttle RunsChange in number from baseline shuttle run at 6 monthsThe 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.
After School Screen Time as Reported on QuestionnaireChange from baseline at 6 monthsChange 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.
Saturday Screen Time as Assessed by QuestionnaireChange in hours from baseline at 6 monthsChange 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.
Activity Levels Measured by Pedometers (Weekly Steps)Change from week 1 to week 24Activity 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.
Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Physical Self-Worth Changes in Physical Self-worthChange from baseline at 6 monthsCY-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.
Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Global Self-Worth ScoreChange from baseline to 6 monthsCY-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.
Waist Circumference ChangeChange from baseline at 6 months
Change in Dietary Intake: % Fat (Block Alive FFQ)Change from baseline at 6 monthsThe 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.
Change in Dietary Intake: % Carbohydrates (Block Alive FFQ)Change from baseline at 6 monthsThe 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.
Change in Dietary Intake: Number of Vegetable Servings (Block Alive FFQ)Change from baseline at 6 monthsThe 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.
Change in Dietary Intake: Number of Fruit Servings (Block Alive FFQ)Change from baseline at 6 monthsThe 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.
Change in Dietary Intake: Number of Sugar Sweetened Beverages (Block Alive FFQ)Change from baseline at 6 monthsThe 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.
Exergaming Program Component Influence on Attendance6 monthsThe 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.
Heart Rate ChangeChange from 6 month Heart rate at 1 year
Dietary Change:Total Calorie Intake (kcal/Day) (Block Alive FFQ)Change from baseline at 6 monthsThe 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.

Participant flow

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.

Participants by arm

ArmCount
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.
60
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.
24
Total84

Withdrawals & dropouts

PeriodReasonFG000FG001
Cohort 1Lost to Follow-up52
Cohort 1Withdrawal by Subject01
Cohort 2Lost to Follow-up20
Cohort 2Withdrawal by Subject23
Cohort 3Lost to Follow-up10
Cohort 3Withdrawal by Subject40
Cohort 4Lost to Follow-up10
Cohort 4Withdrawal by Subject10
Cohort 5Lost to Follow-up32
Cohort 5Withdrawal by Subject32
Cohort 6Lost to Follow-up20
Cohort 6Withdrawal by Subject11

Baseline characteristics

CharacteristicExergaming and Didactic Health TeachingDidactic Health TeachingTotal
Age, Continuous10.0 years
STANDARD_DEVIATION 1.2
10.1 years
STANDARD_DEVIATION 1.1
10.1 years
STANDARD_DEVIATION 1.3
Baseline BMI z-score2.2 z-score2.2 z-score2.2 z-score
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
5 Participants4 Participants9 Participants
Race (NIH/OMB)
Black or African American
16 Participants6 Participants22 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
39 Participants14 Participants53 Participants
Sex: Female, Male
Female
37 Participants12 Participants49 Participants
Sex: Female, Male
Male
23 Participants12 Participants35 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 600 / 24
serious
Total, serious adverse events
0 / 600 / 24

Outcome results

Primary

BMI Z-score Change

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

ArmMeasureValue (MEAN)Dispersion
Exergaming and Didactic Health TeachingBMI Z-score Change-0.057 z-scoreStandard Deviation 0.118
Didactic Health TeachingBMI Z-score Change0.005 z-scoreStandard Deviation 0.0917
p-value: 0.096795% CI: [-0.1344, 0.0115]t-test, 2 sided
Primary

BMI Z-score Change

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

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.

ArmMeasureValue (MEAN)
Exergaming and Didactic Health TeachingBMI Z-score Change-0.0775 z-score
p-value: 0.033595% CI: [-0.1485, -0.00652]t-test, 2 sided
Secondary

Activity Levels Measured by Pedometers (Weekly Steps)

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

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.

ArmMeasureValue (MEAN)Dispersion
Exergaming and Didactic Health TeachingActivity Levels Measured by Pedometers (Weekly Steps)-6626 stepsStandard Deviation 21810
Didactic Health TeachingActivity Levels Measured by Pedometers (Weekly Steps)-9059.5 stepsStandard Deviation 26688.91
p-value: 0.81295% CI: [-18579.7, 23447.2]t-test, 2 sided
Secondary

After School Screen Time as Reported on Questionnaire

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

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.

ArmMeasureValue (MEAN)Dispersion
Exergaming and Didactic Health TeachingAfter School Screen Time as Reported on Questionnaire-0.7589 hoursStandard Deviation 3.068
Didactic Health TeachingAfter School Screen Time as Reported on Questionnaire0.188 hoursStandard Deviation 1.368
p-value: 0.220795% CI: [-2.4954, 0.6025]t-test, 2 sided
Secondary

Change in Dietary Intake: % Carbohydrates (Block Alive FFQ)

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

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.

ArmMeasureValue (MEAN)Dispersion
Exergaming and Didactic Health TeachingChange in Dietary Intake: % Carbohydrates (Block Alive FFQ)2.10 percentage of carbohydratesStandard Deviation 8.49
Didactic Health TeachingChange in Dietary Intake: % Carbohydrates (Block Alive FFQ)-5.12 percentage of carbohydratesStandard Deviation 7.95
p-value: 0.024795% CI: [0.973, 13.457]t-test, 2 sided
Secondary

Change in Dietary Intake: % Fat (Block Alive FFQ)

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

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.

ArmMeasureValue (MEAN)Dispersion
Exergaming and Didactic Health TeachingChange in Dietary Intake: % Fat (Block Alive FFQ)-1.25 percentage of fatStandard Deviation 8.49
Didactic Health TeachingChange in Dietary Intake: % Fat (Block Alive FFQ)3.00 percentage of fatStandard Deviation 7.09
p-value: 0.17695% CI: [-10.3835, 1.974]t-test, 2 sided
Secondary

Change in Dietary Intake: Number of Fruit Servings (Block Alive FFQ)

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

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.

ArmMeasureValue (MEAN)Dispersion
Exergaming and Didactic Health TeachingChange in Dietary Intake: Number of Fruit Servings (Block Alive FFQ)-0.13255 ServingsStandard Deviation 0.523
Didactic Health TeachingChange in Dietary Intake: Number of Fruit Servings (Block Alive FFQ)0.663 ServingsStandard Deviation 0.64
p-value: 0.000895% CI: [-1.235, -0.3566]t-test, 2 sided
Secondary

Change in Dietary Intake: Number of Sugar Sweetened Beverages (Block Alive FFQ)

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

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.

ArmMeasureValue (MEAN)Dispersion
Exergaming and Didactic Health TeachingChange in Dietary Intake: Number of Sugar Sweetened Beverages (Block Alive FFQ)-2.572 servingsStandard Deviation 8.402
Didactic Health TeachingChange in Dietary Intake: Number of Sugar Sweetened Beverages (Block Alive FFQ)-3.2374 servingsStandard Deviation 2.44
p-value: 0.697495% CI: [-2.9377, 4.3425]t-test, 2 sided
Secondary

Change in Dietary Intake: Number of Vegetable Servings (Block Alive FFQ)

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

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.

ArmMeasureValue (MEAN)Dispersion
Exergaming and Didactic Health TeachingChange in Dietary Intake: Number of Vegetable Servings (Block Alive FFQ)0.0078 servingsStandard Deviation 0.7755
Didactic Health TeachingChange in Dietary Intake: Number of Vegetable Servings (Block Alive FFQ)0.8248 servingsStandard Deviation 2.06
p-value: 0.276495% CI: [-2.4147, 0.7808]t-test, 2 sided
Secondary

Dietary Change:Total Calorie Intake (kcal/Day) (Block Alive FFQ)

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

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.

ArmMeasureValue (MEAN)Dispersion
Exergaming and Didactic Health TeachingDietary Change:Total Calorie Intake (kcal/Day) (Block Alive FFQ)-292.92 kcal/dayStandard Deviation 386.7
Didactic Health TeachingDietary Change:Total Calorie Intake (kcal/Day) (Block Alive FFQ)-45 kcal/dayStandard Deviation 358.5
p-value: 0.084995% CI: [-531.7, 35.8686]t-test, 2 sided
Secondary

Exergaming Program Component Influence on Attendance

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

ArmMeasureValue (NUMBER)
Exergaming and Didactic Health TeachingExergaming Program Component Influence on Attendance71 percentage of subjects
Secondary

Heart Rate Change

Time frame: 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.

ArmMeasureValue (MEAN)
Exergaming and Didactic Health TeachingHeart Rate Change2.7407 beats per minute
p-value: 0.3671t-test, 2 sided
Secondary

Heart Rate Change From Baseline to 6 Months

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Exergaming and Didactic Health TeachingHeart Rate Change From Baseline to 6 Months-9.9 beats per minuteStandard Deviation 13.77
Didactic Health TeachingHeart Rate Change From Baseline to 6 Months-7.0 beats per minuteStandard Deviation 9.69
p-value: 0.50195% CI: [-11.7, 5.8]t-test, 2 sided
Secondary

Saturday Screen Time as Assessed by Questionnaire

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

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.

ArmMeasureValue (MEAN)Dispersion
Exergaming and Didactic Health TeachingSaturday Screen Time as Assessed by Questionnaire-1.4 hoursStandard Deviation 3.36
Didactic Health TeachingSaturday Screen Time as Assessed by Questionnaire-0.3438 hoursStandard Deviation 2.36
p-value: 0.416495% CI: [-3.6407, 1.5425]t-test, 2 sided
Secondary

Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Global Self-Worth Score

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

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.

ArmMeasureValue (MEAN)Dispersion
Exergaming and Didactic Health TeachingSelf Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Global Self-Worth Score-0.238 scores on a scaleStandard Deviation 0.525
Didactic Health TeachingSelf Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Global Self-Worth Score-0.523 scores on a scaleStandard Deviation 0.53
p-value: 0.185695% CI: [-0.2051, 0.8041]t-test, 2 sided
Secondary

Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Physical Self-Worth Changes in Physical Self-worth

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

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.

ArmMeasureValue (MEAN)Dispersion
Exergaming and Didactic Health TeachingSelf 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 scaleStandard Deviation 0.746
Didactic Health TeachingSelf Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Physical Self-Worth Changes in Physical Self-worth-0.5 scores on a scaleStandard Deviation 0.385
p-value: 0.332695% CI: [-0.3037, 0.8711]t-test, 2 sided
Secondary

Shuttle Run Change in Number of Shuttle Runs

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

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.

ArmMeasureValue (MEAN)
Exergaming and Didactic Health TeachingShuttle Run Change in Number of Shuttle Runs0.10 number of runs
p-value: 0.4892t-test, 2 sided
Secondary

Shuttle Run Change in Number of Shuttle Runs

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

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.

ArmMeasureValue (MEAN)Dispersion
Exergaming and Didactic Health TeachingShuttle Run Change in Number of Shuttle Runs0.213 number of runsStandard Deviation 0.4014
Didactic Health TeachingShuttle Run Change in Number of Shuttle Runs-0.00085 number of runsStandard Deviation 0.376
p-value: 0.03595% CI: [0.0224, 0.5718]t-test, 2 sided
Secondary

Systolic Blood Pressure Change

Time frame: 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.

ArmMeasureValue (MEAN)
Exergaming and Didactic Health TeachingSystolic Blood Pressure Change3.5185 mmHg
p-value: 0.126595% CI: [-1.15, 8.33]t-test, 2 sided
Secondary

Systolic Blood Pressure Change

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Exergaming and Didactic Health TeachingSystolic Blood Pressure Change1 mmHgStandard Deviation 15
Didactic Health TeachingSystolic Blood Pressure Change0 mmHgStandard Deviation 15
p-value: 0.85195% CI: [-9, 11]t-test, 2 sided
Secondary

Waist Circumference Change

Time frame: 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.

ArmMeasureValue (MEAN)
Exergaming and Didactic Health TeachingWaist Circumference Change1.52 cm
p-value: 0.2122t-test, 2 sided
Secondary

Waist Circumference Change

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Exergaming and Didactic Health TeachingWaist Circumference Change-0.50 cmStandard Deviation 6.7
Didactic Health TeachingWaist Circumference Change-0.51 cmStandard Deviation 5.12
p-value: 0.99195% CI: [-5.2, 5.1]t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026