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

Pediatric Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02436330
• Other study ID #: 209418
• Status: Completed
• Phase: N/A
• First received: April 20, 2015
• Last updated: November 5, 2015
• Start date: March 2011
• Est. completion date: September 2013

Study information

• Verified date: November 2015
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pediatric Obesity

Intervention

Behavioral:
• Exergaming
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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

References & Publications (50)

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* Note: There are 50 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Change from baseline at 6 months	No
Primary	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	No
Secondary	Waist Circumference Change		Change from baseline at 6 months	No
Secondary	Systolic Blood Pressure Change		Change from baseline Systolic BP at 6 months	No
Secondary	Heart Rate Change From Baseline to 6 Months		Change from baseline at 6 months	No
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.	Change in number from baseline shuttle run at 6 months	No
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.	Change from baseline at 6 months	No
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.	Change in hours from baseline at 6 months	No
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.	Change from week 1 to week 24	No
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.	Change from baseline at 6 months	No
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.	Change from baseline to 6 months	No
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.	Change from baseline at 6 months	No
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.	Change from baseline at 6 months	No
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.	Change from baseline at 6 months	No
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.	Change from baseline at 6 months	No
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.	Change from baseline at 6 months	No
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.	Change from baseline at 6 months	No
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.	6 months	No
Secondary	Waist Circumference Change		Change from 6 month waist circumference at 1 year	No
Secondary	Systolic Blood Pressure Change		Change from 6 month Systolic BP at 1 year	No
Secondary	Heart Rate Change		Change from 6 month Heart rate at 1 year	No
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.	Change in number from 6 month shuttle run at 1 year	No