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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pediatric Obesity

Intervention / Treatment
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* Behavioral: Exergaming
* Behavioral: Didactic health teaching


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exergaming and Didactic health teaching<br>Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching. | Behavioral: Exergaming<br>* 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.<br>Behavioral: Didactic health teaching<br>* 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.<br>|
| Active Comparator: Didactic health teaching<br>Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching. | Behavioral: Didactic health teaching<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Change from baseline at 6 months | 
| BMI Z-score Change | Measure was only taken on the subjects who participated in the Intervention group (exergaming combined with didactic teaching). | Change from baseline BMI z-score at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist Circumference Change |  | Change from baseline at 6 months | 
| Systolic Blood Pressure Change |  | Change from baseline Systolic BP at 6 months | 
| Heart Rate Change From Baseline to 6 Months |  | Change from baseline at 6 months | 
| 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. | Change in number from baseline shuttle run at 6 months | 
| 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. | Change from baseline at 6 months | 
| 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. | Change in hours from baseline at 6 months | 
| 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. | Change from week 1 to week 24 | 
| 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. | Change from baseline at 6 months | 
| 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. | Change from baseline to 6 months | 
| 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. | Change from baseline at 6 months | 
| 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. | Change from baseline at 6 months | 
| 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. | Change from baseline at 6 months | 
| 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. | Change from baseline at 6 months | 
| 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. | Change from baseline at 6 months | 
| 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. | Change from baseline at 6 months | 
| 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. | 6 months | 
| Waist Circumference Change |  | Change from 6 month waist circumference at 1 year | 
| Systolic Blood Pressure Change |  | Change from 6 month Systolic BP at 1 year | 
| Heart Rate Change |  | Change from 6 month Heart rate at 1 year | 
| 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. | Change in number from 6 month shuttle run at 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exergaming, Weight management