Clinical trial NCT02436330: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: Exergaming, Weight management
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 84
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: BMI Z-score Change
timeFrame: Change from baseline at 6 months
measure: BMI Z-score Change
timeFrame: Change from baseline BMI z-score at 1 year
Secondary outcomes:
measure: Waist Circumference Change
timeFrame: Change from baseline at 6 months
measure: Systolic Blood Pressure Change
timeFrame: Change from baseline Systolic BP at 6 months
measure: Heart Rate Change From Baseline to 6 Months
timeFrame: Change from baseline at 6 months
measure: Shuttle Run Change in Number of Shuttle Runs
timeFrame: Change in number from baseline shuttle run at 6 months
measure: After School Screen Time as Reported on Questionnaire
timeFrame: Change from baseline at 6 months
measure: Saturday Screen Time as Assessed by Questionnaire
timeFrame: Change in hours from baseline at 6 months
measure: Activity Levels Measured by Pedometers (Weekly Steps)
timeFrame: Change from week 1 to week 24
measure: Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Physical Self-Worth Changes in Physical Self-worth
timeFrame: Change from baseline at 6 months
measure: Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Global Self-Worth Score
timeFrame: Change from baseline to 6 months
measure: Dietary Change:Total Calorie Intake (kcal/Day) (Block Alive FFQ)
timeFrame: Change from baseline at 6 months
measure: Change in Dietary Intake: % Fat (Block Alive FFQ)
timeFrame: Change from baseline at 6 months
measure: Change in Dietary Intake: % Carbohydrates (Block Alive FFQ)
timeFrame: Change from baseline at 6 months
measure: Change in Dietary Intake: Number of Vegetable Servings (Block Alive FFQ)
timeFrame: Change from baseline at 6 months
measure: Change in Dietary Intake: Number of Fruit Servings (Block Alive FFQ)
timeFrame: Change from baseline at 6 months
measure: Change in Dietary Intake: Number of Sugar Sweetened Beverages (Block Alive FFQ)
timeFrame: Change from baseline at 6 months
measure: Exergaming Program Component Influence on Attendance
timeFrame: 6 months
measure: Waist Circumference Change
timeFrame: Change from 6 month waist circumference at 1 year
measure: Systolic Blood Pressure Change
timeFrame: Change from 6 month Systolic BP at 1 year
measure: Heart Rate Change
timeFrame: Change from 6 month Heart rate at 1 year
measure: Shuttle Run Change in Number of Shuttle Runs
timeFrame: Change in number from 6 month shuttle run at 1 year
Other outcomes:
Locations:
Study officials:
affiliation: University of Illinois College of Medicine at Peoria
name: Amy L. Christison, MD
role: PRINCIPAL_INVESTIGATOR
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