Barriers to Effective Weight Loss in Overweight Adolescents (TEENS)
Barriers to Effective Weight Loss in Overweight Adolescents Enrolled in an Intensive, Team-based, Family-centered Lifestyle Modification Program
研究概览
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Virginia
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Richmond、Virginia、美国、23298
- Virginia Commonwealth University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
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实验性的:Lifestyle Modification
Parents are randomized to attend 12 educational sessions covering strategies to manage children's health behaviors.
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Dietary modification and regular physical activity
其他名称:
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无干预:Control
Teen participates in lifestyle intervention, but parent does not attend parent education sessions
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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changes in BMI Z-score
大体时间:3 month, 6 month, 12 months and 24 months
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3 month, 6 month, 12 months and 24 months
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次要结果测量
结果测量 |
大体时间 |
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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.
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3 month, 6 month, 1 year and 2 years.
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合作者和调查者
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
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Lifestyle modification的临床试验
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Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)完全的肥胖 | 心血管危险因素 | 糖尿病风险