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临床试验/NCT02436330
NCT02436330已完成不适用

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

University of Illinois at Chicago0 个研究点目标入组 84 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
主要终点
BMI Z-score Change

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child with BMI greater than or equal to 85th percentile.
  • English speaking
  • Approval by Primary Care Doctor

排除标准

  • 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.

结局指标

主要结局

BMI Z-score Change

时间窗: 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).

次要结局

  • Change in Dietary Intake: Number of Fruit Servings (Block Alive FFQ)(Change from baseline at 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 From Baseline to 6 Months(Change from baseline at 6 months)
  • Shuttle Run Change in Number of Shuttle Runs(Change in number from 6 month shuttle run at 1 year)
  • After School Screen Time as Reported on Questionnaire(Change from baseline at 6 months)
  • Saturday Screen Time as Assessed by Questionnaire(Change in hours from baseline at 6 months)
  • Activity Levels Measured by Pedometers (Weekly Steps)(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(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(Change from baseline to 6 months)
  • Dietary Change:Total Calorie Intake (kcal/Day) (Block Alive FFQ)(Change from baseline at 6 months)
  • Change in Dietary Intake: % Fat (Block Alive FFQ)(Change from baseline at 6 months)
  • Change in Dietary Intake: % Carbohydrates (Block Alive FFQ)(Change from baseline at 6 months)
  • Change in Dietary Intake: Number of Vegetable Servings (Block Alive FFQ)(Change from baseline at 6 months)
  • Change in Dietary Intake: Number of Sugar Sweetened Beverages (Block Alive FFQ)(Change from baseline at 6 months)
  • Exergaming Program Component Influence on Attendance(6 months)
  • Heart Rate Change(Change from 6 month Heart rate at 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy Christison, M.D.

Associate Professor of Pediatrics

University of Illinois at Chicago

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