Healthy Weight for Teens
2021年2月1日 更新者：Children's Hospital Medical Center, Cincinnati
Enhancing Effectiveness Of Existing Weight Management Programs For Teens With Severe Obesity: A 6-Month Feasibility Pilot
POWER is uniquely positioned to evaluate characteristics of multi-component PWM programs that are associated with "favorable" health outcomes for treatment-seeking youth with obesity.
The POWER Data Coordinating Center developed ranking reports of the 33 participating sites based on weight status change at 6 months.
An in-depth review of program design of 4 "top-performing" sites was conducted.
A unique feature identified was offering an individual program orientation session to patient-families prior to the start of the multi-component PWM program.
This orientation helped patient-families better understand the program's expectations, and offered an opportunity to evaluate readiness to change, barriers for making lifestyle changes, and mental health problems.
This information was used to tailor the intervention to better meet the needs of participating patient-families.
When a survey of program characteristics was conducted of the 33 participating sites, this "top-performing site" was the only one to offer such a program orientation session prior to patient-families starting the PWM program.
Therefore this program feature was included as part of the "bundle of program enhancements" (BPE) for this proposed pragmatic pilot study.
研究概览
研究类型
介入性
注册 (实际的)
60
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
-
-
Indiana
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Cincinnati、Indiana、美国、45229
- Cincinnati Children's Hospital Medical Center
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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
12年 至 18年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- ≥ 12 years of age and < 18
- Scheduled for a new patient clinic visit at the multi-component PWM program at CCHMC or HDVCH
- Severe obesity (≥ 120% of the 95th percentile for BMI based on age and gender at time of screening visit)
- Able to understand and complete the consent process
- Have access to a smart phone, device, or computer with a web camera
- Have access to the internet
Exclusion Criteria:
- Lacking capacity to provide informed consent
- Non-English speaking
- Participating in any other weight management program or research study related to weight management
- Have a sibling participating in any other weight management program or research study related to weight management
- Taking anti-obesity medication (Phentermine, Orlistat, Qsymia, Naltrxone-Bupropion, Lorcaserin, others at the discretion of the PI)
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：Telehealth Intervention
This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.
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Contact will be made with participants via Face Time or Skype.
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无干预：Standard of Care Control
This arm will participate in their normal clinic/program routine.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Test whether existing multi-component PWM programs can successfully implement the BPE for adolescents with severe obesity using existing clinical staff.
大体时间：2 years
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Successful implementation of a "bundle of program enhancements" by existing clinical staff within existing pediatric weight management programs.
This success will be defined by ≥80% of randomized intervention group participants and their parent/guardian attending the individual program orientation prior to their initial medical assessment as part of the pediatric weight management program and completing the interactive remote follow-up encounters to achieve the 26 provider contact hours in combination with time spent at clinic visits over the 6 month treatment period.
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2 years
|
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Evaluate rates of retention and attrition among intervention group as compared to the control group. participants in the Intervention group
大体时间：2 years
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Completion of the 6 month treatment period will be tracked.
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2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Test whether the Intervention group has greater rates of participation and retention in standard-of-care clinic visits and group sessions (if offered) compared to the Control group.
大体时间：2 years
|
Attendance at scheduled clinic visits will be tracked during the 6 month treatment period.
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2 years
|
|
Test whether participants in the Intervention group have better health outcomes when compared to participants in the Control group after the 6-month treatment period.
大体时间：2 years
|
The health outcome to be evaluated is change in percent of the 95th percentile for body mass index.
|
2 years
|
|
Test whether participants in the Intervention group have better health outcomes when compared to participants in the Control group after the 6-month treatment period.
大体时间：2 years
|
The health outcome to be evaluated is change in percent body fat (%).
|
2 years
|
|
Test whether participants in the Intervention group have better health outcomes when compared to participants in the Control group after the 6-month treatment period.
大体时间：2 years
|
The health outcome to be evaluated is change in skeletal muscle mass (kg).
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2 years
|
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Test whether participants in the Intervention group have better health outcomes when compared to participants in the Control group after the 6-month treatment period.
大体时间：2 years
|
The health outcome to be evaluated is change in both systolic and diastolic blood pressure (mmHg).
|
2 years
|
|
Test whether participants in the Intervention group have better health outcomes when compared to participants in the Control group after the 6-month treatment period.
大体时间：2 years
|
The health outcome to be evaluated is change in lab values including HbA1C, ALT, non-HDL cholesterol, triglycerides and fasting glucose.
|
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。
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 (实际的)
2018年7月18日
初级完成 (实际的)
2020年6月1日
研究完成 (实际的)
2020年12月1日
研究注册日期
首次提交
2019年4月11日
首先提交符合 QC 标准的
2019年5月3日
首次发布 (实际的)
2019年5月6日
研究记录更新
最后更新发布 (实际的)
2021年2月2日
上次提交的符合 QC 标准的更新
2021年2月1日
最后验证
2021年1月1日
更多信息
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.