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A Scalable Weight Control Intervention for Adolescents (TEEN JOIN)

2017年4月20日 更新者:Elissa Jelalian、The Miriam Hospital

TEEN JOIN: A Scalable Weight Control Intervention for Adolescents

Community-based programs are needed to improve dissemination of efficacious treatment for adolescent obesity. The current study aims to modify a community-based program, delivered through the YMCA, to increase its effectiveness with adolescents. Adolescents will be randomized to either a 16-week standard program (JOIN) or a targeted intervention tailored for adolescents (TEEN JOIN). Primary outcomes include changes in BMI, objectively measured physical activity, and self-efficacy, assessed at 4 months and 10 months following randomization.

研究概览

详细说明

In 2010, the U.S. Preventive Services Task Force (USPSTF) provided a Grade recommendation B (i.e. the service is recommended with moderate/high certainty of benefit) for clinicians to screen children ages 6-17 years for obesity and refer identified youth to comprehensive behavioral programs. The challenge in meeting this objective is the lack of community-based obesity treatments to which to refer, particularly for adolescents. The JOIN program, developed as a collaboration between United HealthGroup and Y-USA is a pediatric weight control intervention targeted toward a broad age range of youth from 6-17 years that is: 1) based on well established and evidence based principles; 2) delivered by YMCA facilitators within a community setting: and 3) potentially scalable nationally. Findings from a 6-month pilot study examining the effectiveness of JOIN demonstrated impressive changes in weight status for school age children, but more modest results for adolescents. The primary aim of this study is to modify the JOIN program to increase its effectiveness with adolescents while retaining its potential for scalability.

A total of 120 adolescents (ages 13-17) with BMI > 85th% and < 50 will be randomly assigned to a 16-week targeted program (TEEN JOIN), or the traditional JOIN intervention, followed by biweekly and monthly maintenance sessions. Evaluation of adolescent height, weight, objective physical activity and psychosocial outcomes will be obtained at baseline, 4 months, and 10 months. Additional outcomes will include treatment feasibility, including attendance, completion of diet and physical activity monitoring logs, and exit interviews with adolescents and parents regarding the intervention. The investigators will also obtain preliminary indicators of cost effectiveness. It is hypothesized that adolescents who are randomized to TEEN JOIN will demonstrate greater decrease in BMI at 4 and 10 months than those randomized to JOIN. It is further hypothesized that adolescents randomized to TEEN JOIN will demonstrate greater increases in participation in moderate-vigorous physical activity and greater improvements in self-concept, self-efficacy related to physical activity, and group cohesion than adolescents who receive the standard JOIN condition.

研究类型

介入性

注册 (预期的)

120

阶段

  • 阶段2

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

    • Rhode Island
      • Providence、Rhode Island、美国、02903
        • 招聘中
        • Weight Management and Diabetes Research Center, The Miriam Hospital/Alpert Medical School of Brown University
        • 接触:

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

13年 至 17年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 13 to 17 years
  • BMI > 85th percentile and absolute BMI < 50
  • have at least one parent available to provide consent and participate in sessions
  • speak English
  • agree to study participation and random assignment

Exclusion Criteria:

  • currently involved in another weight loss program
  • have a medical condition that would interfere with the prescribed dietary plan or participation in physical activity
  • developmentally delayed such that the intervention materials will not be appropriate
  • in treatment for a major psychiatric disorder, including an eating disorder, or are diagnosed with a major psychiatric disorder at the time of screening.

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
有源比较器:JOIN FOR ME
The JOIN for ME curriculum includes 16 weekly in person sessions followed by 4 biweekly and 4 monthly maintenance sessions for a 10-month program. Weekly meetings are scheduled for 60 minutes and are facilitated by a YMCA coach. Interventions include behavioral weight control and parent-based incentives. Parents attend group at weeks 1, 2 and 16 with their teen.
Prescription of diet & physical activity and behavioral strategies for weight control
Adolescents earn reinforcements from their parents (outside of group)
实验性的:TEEN JOIN
Similar to the JOIN FOR ME condition, adolescents in the TEEN JOIN condition attend 16 weekly in person sessions followed by 4 biweekly and 4 monthly maintenance sessions for a 10-month program. Interventions include behavioral weight control, group-based physical activity, and group-based incentives. Parents attend separate meetings at weeks 1, 2, and 16.
Prescription of diet & physical activity and behavioral strategies for weight control
Teens exercise for 60 minutes with their group
Adolescents earn reinforcements within group

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Change in Body Mass Index (BMI, kg/m2)
大体时间:Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)

次要结果测量

结果测量
措施说明
大体时间
Objective time spent in moderate and vigorous physical activity measured by the Senswear Mini (MINI) armband
大体时间:Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
Objectively-measured moderate and vigorous physical activity
Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
Self-Efficacy Questionnaire
大体时间:Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
Adolescents' confidence in their ability to lose weight and engage in physical activity
Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)

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。

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

2014年9月1日

初级完成 (预期的)

2017年7月1日

研究完成 (预期的)

2017年12月1日

研究注册日期

首次提交

2015年4月21日

首先提交符合 QC 标准的

2015年4月21日

首次发布 (估计)

2015年4月24日

研究记录更新

最后更新发布 (实际的)

2017年4月21日

上次提交的符合 QC 标准的更新

2017年4月20日

最后验证

2017年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • 1R34DK10098101A1

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.

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