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

Primary Purpose

Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exergaming
Didactic health teaching
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pediatric Obesity focused on measuring Exergaming, Weight management

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Exergaming and Didactic health teaching

    Didactic health teaching

    Arm Description

    Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.

    Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Waist Circumference Change
    Systolic Blood Pressure Change
    Heart Rate Change From Baseline to 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.
    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.
    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.
    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.
    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.
    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.
    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 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 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 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 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 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.
    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.
    Waist Circumference Change
    Systolic Blood Pressure Change
    Heart Rate Change
    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.

    Full Information

    First Posted
    April 20, 2015
    Last Updated
    November 5, 2015
    Sponsor
    University of Illinois at Chicago
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02436330
    Brief Title
    Exergaming for Health: Impact of a Community-Based Active Video Gaming Curriculum in Pediatric Weight Management
    Official Title
    Exergaming for Health: Impact of a Community-Based Active Video Gaming Curriculum in Pediatric Weight Management
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2011 (undefined)
    Primary Completion Date
    September 2013 (Actual)
    Study Completion Date
    September 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Illinois at Chicago

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pediatric Obesity
    Keywords
    Exergaming, Weight management

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    84 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Exergaming and Didactic health teaching
    Arm Type
    Experimental
    Arm Description
    Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
    Arm Title
    Didactic health teaching
    Arm Type
    Active Comparator
    Arm Description
    Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exergaming
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Didactic health teaching
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    BMI Z-score Change
    Description
    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
    Title
    BMI Z-score Change
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Waist Circumference Change
    Time Frame
    Change from baseline at 6 months
    Title
    Systolic Blood Pressure Change
    Time Frame
    Change from baseline Systolic BP at 6 months
    Title
    Heart Rate Change From Baseline to 6 Months
    Time Frame
    Change from baseline at 6 months
    Title
    Shuttle Run Change in Number of Shuttle Runs
    Description
    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
    Title
    After School Screen Time as Reported on Questionnaire
    Description
    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
    Title
    Saturday Screen Time as Assessed by Questionnaire
    Description
    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
    Title
    Activity Levels Measured by Pedometers (Weekly Steps)
    Description
    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
    Title
    Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Physical Self-Worth Changes in Physical Self-worth
    Description
    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
    Title
    Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Global Self-Worth Score
    Description
    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
    Title
    Dietary Change:Total Calorie Intake (kcal/Day) (Block Alive FFQ)
    Description
    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
    Title
    Change in Dietary Intake: % Fat (Block Alive FFQ)
    Description
    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
    Title
    Change in Dietary Intake: % Carbohydrates (Block Alive FFQ)
    Description
    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
    Title
    Change in Dietary Intake: Number of Vegetable Servings (Block Alive FFQ)
    Description
    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
    Title
    Change in Dietary Intake: Number of Fruit Servings (Block Alive FFQ)
    Description
    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
    Title
    Change in Dietary Intake: Number of Sugar Sweetened Beverages (Block Alive FFQ)
    Description
    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
    Title
    Exergaming Program Component Influence on Attendance
    Description
    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
    Title
    Waist Circumference Change
    Time Frame
    Change from 6 month waist circumference at 1 year
    Title
    Systolic Blood Pressure Change
    Time Frame
    Change from 6 month Systolic BP at 1 year
    Title
    Heart Rate Change
    Time Frame
    Change from 6 month Heart rate at 1 year
    Title
    Shuttle Run Change in Number of Shuttle Runs
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amy L. Christison, MD
    Organizational Affiliation
    University of Illinois College of Medicine at Peoria
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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