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Barriers to Effective Weight Loss in Overweight Adolescents (TEENS)

2014年3月28日 更新者:Virginia Commonwealth University

Barriers to Effective Weight Loss in Overweight Adolescents Enrolled in an Intensive, Team-based, Family-centered Lifestyle Modification Program

The current study aims to investigate the impact of a comprehensive, team-based, family-centered, lifestyle modification program on body weight, metabolic abnormalities, fitness measures, and self-esteem in overweight adolescents beginning the study at ages 11-18 years. The intensive program will uniquely include a "team" structure and a component designed to address the role of parental modeling in effective lifestyle changes. By comparing the demographic, psychosocial, and metabolic characteristics of adolescents according to the degree of weight loss, the study will also more fully characterize the barriers that prevent successful participation in an intensive lifestyle modification program.

研究概览

地位

完全的

条件

详细说明

The study will annually enroll 100 - 200 adolescent male and female subjects between 11 and 18 years of age with a BMI > the 85th percentile and one parent. Adolescents enrolled in the study, will participate in a structured exercise program and meet regularly with a dietitian and behavior specialist for nutrition education and review and update of progress and goals. The study is designed for 2 years of participation with data collection points at baseline, 3 months, 6 months, 1 year and 2 years. Data collected from adolescents include demographic information anthropometric information (height, weight, blood pressure, temperature, pulse, percent body fat); assessments of nutritional knowledge, food choices and dietary intake; assessments of activity and fitness level of behavioral status (depression, self-esteem, self-confidence, satisfaction with life, happiness, perspectives on health, exercise and diet, family environment, quality of life, body awareness, teasing, social efficacy, self-perception, coping mechanisms), assessments of sleep time and quality and physiological and medical data (including blood and urine tests)

Parents will accompany their children to the nutrition and behavior support visits, and attend 12 group educational sessions to learn skills and strategies to help their children adopt healthier eating and exercise behaviors. Data collected from parents will include demographic, anthropometric measures (height, weight, blood pressure, temperature, pulse, percent body fat); and assessments of activity level, dietary intake and eating habits, behavioral status, child-feeding practices, and understanding of their child.

研究类型

介入性

注册 (实际的)

257

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Virginia
      • Richmond、Virginia、美国、23298
        • Virginia Commonwealth University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

11年 至 18年 (孩子、成人)

接受健康志愿者

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Age between 11 and 18
  • BMI at or above the 85th percentile for age and sex
  • At least one adult in the household who is committed to come to the program meetings

Exclusion Criteria:

  • Previous enrollment in VCU IRB 3354
  • Underlying genetic, neurologic, endocrine, or metabolic conditions that preclude weight loss with conventional diet and exercise programs
  • Weight greater than 400 pounds
  • Pregnancy in female adolescent subjects
  • Inability to understand program instructions due to language barrier or a mental disability
  • Primary residence outside a 30 mile radius program facility.
  • Primary participating parent, if female, cannot be pregnant during the period corresponding to the parents intervention.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Lifestyle Modification
Parents are randomized to attend 12 educational sessions covering strategies to manage children's health behaviors.
Dietary modification and regular physical activity
其他名称:
  • 减肥
  • Wellness
无干预:Control
Teen participates in lifestyle intervention, but parent does not attend parent education sessions

研究衡量的是什么?

主要结果指标

结果测量
大体时间
changes in BMI Z-score
大体时间:3 month, 6 month, 12 months and 24 months
3 month, 6 month, 12 months and 24 months

次要结果测量

结果测量
大体时间
Changes in body composition, metabolic and anthropometric measures, fitness measures, dietary intake, and quality of life scores.
大体时间:3 month, 6 month, 1 year and 2 years.
3 month, 6 month, 1 year and 2 years.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Gary L. Francis, M.D.、Virginia Commonwealth University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年10月1日

初级完成 (实际的)

2013年11月1日

研究完成 (实际的)

2013年11月1日

研究注册日期

首次提交

2007年11月20日

首先提交符合 QC 标准的

2007年11月21日

首次发布 (估计)

2007年11月22日

研究记录更新

最后更新发布 (估计)

2014年3月31日

上次提交的符合 QC 标准的更新

2014年3月28日

最后验证

2014年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • HM11113

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Lifestyle modification的临床试验

3
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