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临床试验/NCT01374646
NCT01374646已完成不适用

Effects of a Community-based Program to Treat Childhood and Adolescent Obesity

UnitedHealth Group2 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
155
试验地点
2
主要终点
Change in weight and body mass index (BMI) in children and teens at 6 months

研究概览

简要总结

This study will evaluate the effectiveness of a comprehensive community based program on reducing excess weight in children and teens. This study will recruit 150 participants between the ages of 6-12 and 13-17.

详细描述

This study will evaluate the effectiveness of a comprehensive community based program on reducing excess weight. Overweight and obese study participants will be grouped with peers of similar ages and their parent/guardians. The participants will be divided into 2 groups, child (6-12 yrs. old) and teens (13-17 yrs. old) and will be accompanied by their parent/guardian. 150 participants will be recruited for this study.

This 6-month program (12 in-person group workshop sessions and 12 at-home sessions) takes the best components of current evidence for individual treatment and places them in a comprehensive community based program. These include:

  • Parental involvement
  • Reduction in consumption of sugar sweetened beverages
  • Reduction of screen time
  • Self-monitoring
  • Physical activity
  • Stimulus control

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Enrollment in another weight loss program or study
  • Diagnosis of type 1 or type 2 diabetes
  • Pre-existing medical conditions (e.g., Prader Willi) that affect weight and appetite
  • Medications (e.g., steroids) that affect weight or appetite
  • Serious or unstable medical or psychological conditions that, in the opinion of the Principal Investigator, would compromise the participant's safety or successful participation in the study

结局指标

主要结局

Change in weight and body mass index (BMI) in children and teens at 6 months

时间窗: 6 Months

Assess the effects of a community based program on weight change in children ages 6-12 and teens ages 13-17. Assessments will occur at baseline, 3 and 6 months.

次要结局

  • Change in weight and BMI in parent/guardian/care giver at 6 months(6 months)
  • Changes in intake and sedentary behavior at 6 months(6 months)
  • Process Outcomes(6 Months)
  • Change in physical activity level in children and teens at 6 months(6 months)

研究者

申办方类型
Industry

研究点 (2)

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