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临床试验/NCT04362280
NCT04362280Unknown不适用

Teens Committed to Health Through Activity, Relationships, and Good Eating (Take CHARGE!)

University of Houston2 个研究点 分布在 1 个国家目标入组 392 人开始时间: 2018年8月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
392
试验地点
2
主要终点
Standardized BMI

研究概览

简要总结

This study will evaluate the preliminary efficacy of a school-based weight management program for underserved adolescents. The program was designed with a phased treatment structure to provide more intensive treatment to participants who do not respond to treatment initially. Specifically, this study aims to examine differences in zBMI over time between students who do not respond to the first semester and receive more intensive treatment in the second semester, responders to first semester who receive more intensive treatment in the second semester, non-responders to the first semester who receive usual treatment in the second semester, and responders who receive usual treatment in the second semester at the end of the second semester, 1 year follow-up, and 2 year follow-up.

详细描述

Childhood obesity has reached epidemic proportions. Schools have been identified as a focal point for intervention because children spend almost half their day in school. On average, school-based interventions have shown modest short-term improvements in weight outcomes. However, considerable individual variation is found within treatments. Current clinical guidelines for childhood obesity recommend a staged treatment approach in which every few months treatment plans are reevaluated based on an individual's progress toward weight outcomes. When an individual doesn't sufficiently progress toward outcome goals, his/her treatment is escalated to be more individualized, include more structure, and greater social support. This method parallels a treatment paradigm used in other areas of medical treatment in which medication type and dose are altered when an individual does not respond to initial care. Obesity treatment provided in the school setting does not follow a similar structure of care. Despite the recognized variation between individuals, school-based obesity interventions are typically evaluated by mean changes in weight outcomes over time. Although this is sufficient to evaluate the efficacy of a program, it does not identify individuals who are not responsive to treatment. Following clinical best practices, it is likely that treatment needs to be escalated for those who do not respond to initial treatment. Currently no escalated treatment options, like that provided in clinical settings, are available in schools. This is a critical gap given the immense individual variability to treatment response and pediatric tracking of BMI. This study will develop and evaluate an escalated school-based treatment for individuals resistant to initial treatment, called Take CHARGE! (Teens Committed to Health through Activity, Relationships, and Good Eating). Specifically, a pilot randomized control trial will A.) examine differences in zBMI between Take CHARGE and a treatment as usual condition over an academic school semester among low SES, racial/ethnic minority youth resistant to initial treatment, and will B.) determine the proportion of students resistant to school-based behavioral obesity treatment. Understanding the proportion of children who are resistant to school-based intervention is a critical first step in treating this high-risk group of children.

研究设计

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

入排标准

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

入选标准

  • Aged 10-17 years old
  • Student enrolled in a Physical Education (PE) class at the YES Prep Brays Oak Campus during either the 2018-2019 or 2019-2020 school year
  • provides written parental consent and student assent

排除标准

  • Is pregnant or becomes pregnant during the study.
  • Is unable to participate in PE class for more than 5 consecutive school days.
  • Does not meet all of the inclusion criteria listed above

研究组 & 干预措施

Treatment as Usual (TAU)

Active Comparator

PE class as usual which consisted of choice time.

干预措施: TAU (Behavioral)

结局指标

主要结局

Standardized BMI

时间窗: up to 2 years

Examine zBMI over the course of the intervention between study arms

次要结局

  • Social Network(up to 6 months)

研究者

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

Craig A Johnston

Associate Professor

University of Houston

研究点 (2)

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