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

November 5, 2015 updated by: Amy Christison, M.D., University of Illinois at Chicago
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Behavioral: 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.
Active Comparator: Didactic health teaching
Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI Z-score Change
Time Frame: 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).
Change from baseline at 6 months
BMI Z-score Change
Time Frame: Change from baseline BMI z-score at 1 year
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
Time Frame: Change from baseline at 6 months
Change from baseline at 6 months
Systolic Blood Pressure Change
Time Frame: Change from baseline Systolic BP at 6 months
Change from baseline Systolic BP at 6 months
Heart Rate Change From Baseline to 6 Months
Time Frame: Change from baseline at 6 months
Change from baseline at 6 months
Shuttle Run Change in Number of Shuttle Runs
Time Frame: Change in number from baseline shuttle run at 6 months
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
Time Frame: Change from baseline at 6 months
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
Time Frame: Change in hours from baseline at 6 months
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)
Time Frame: Change from week 1 to week 24
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
Time Frame: Change from baseline at 6 months
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
Time Frame: Change from baseline to 6 months
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)
Time Frame: Change from baseline at 6 months
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)
Time Frame: Change from baseline at 6 months
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)
Time Frame: Change from baseline at 6 months
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)
Time Frame: Change from baseline at 6 months
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)
Time Frame: Change from baseline at 6 months
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)
Time Frame: Change from baseline at 6 months
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
Time Frame: 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.
6 months
Waist Circumference Change
Time Frame: Change from 6 month waist circumference at 1 year
Change from 6 month waist circumference at 1 year
Systolic Blood Pressure Change
Time Frame: Change from 6 month Systolic BP at 1 year
Change from 6 month Systolic BP at 1 year
Heart Rate Change
Time Frame: Change from 6 month Heart rate at 1 year
Change from 6 month Heart rate at 1 year
Shuttle Run Change in Number of Shuttle Runs
Time Frame: Change in number from 6 month shuttle run at 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Investigators

  • Principal Investigator: Amy L. Christison, MD, University of Illinois College of Medicine at Peoria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

April 20, 2015

First Submitted That Met QC Criteria

May 3, 2015

First Posted (Estimate)

May 6, 2015

Study Record Updates

Last Update Posted (Estimate)

December 14, 2015

Last Update Submitted That Met QC Criteria

November 5, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 209418

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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