Comparison of Weight Loss Programs for Individuals With Severe Obesity
2012年4月18日 更新者：Jessica Unick、The Miriam Hospital
Comparison of a Traditional Behavioral Weight Loss Program Versus a Technology - Based Weight Loss Program in Severely Obese Individuals
The purpose of this study is to evaluate the effectiveness of a technology-based system (the Body Media FIT system) for enhancing weight loss in severely obese individuals (BMI: ≥ 40 kg/m2).
The investigators will compare two 6-month interventions: 1) a standard behavioral weight loss program (SBT) and 2) a standard behavioral weight loss program plus the use of the Body Media FIT system (SBT+FIT).
The Body Media® FIT system is a novel weight loss tool consisting of an armband that measures energy expenditure, a digital display watch that provides "real time" physical activity and energy expenditure feedback, and access to a system website which allows individuals to track their food intake and set exercise and dietary goals.
We will examine differences in physical activity, weight loss, and program adherence between groups.
研究概览
研究类型
介入性
注册 (实际的)
29
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
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Rhode Island
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Providence、Rhode Island、美国、02903
- Weight Control and Diabetes Research 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
21年 至 55年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age 21-55
- Body mass index (BMI) ≥40kg/m2 (or no more than 440 lbs)
Exclusion Criteria:
- Recent weight loss (≥ 10 pounds within the past 6 months)
- Currently pregnant, pregnant within the last 6 months, or planning on becoming pregnant in the next 6 months.
- Presence of any condition that would limit exercise participation (assessed by the Physical Activity Readiness Questionnaire (PAR-Q)).
- A history of myocardial infarction or other heart-related surgeries.
- Currently enrolled in a commercial weight loss program.
- A recent (< 1 year) diagnosis or hospitalization for a psychological condition or history of psychosis (e.g. - Schizophrenia, Bipolar, Eating Disorder)
- Diagnosed with cancer within the past year or currently undergoing cancer treatment.
- Currently taking weight loss medications.
- Currently do not have daily access to a computer or Internet.
- Individuals with diabetes
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 |
|---|---|
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实验性的：SBT + technology system (SBT+FIT)
Participants will receive a standard behavioral weight loss program and will also be asked to use the Body Media FIT system as part of their weight loss intervention.
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Participants will receive a standard behavioral weight loss program and will also be asked to use the Body Media FIT system as part of their weight loss intervention.
Individuals will come to weekly group meetings for 6-months and will be instructed to reduce caloric intake, increase physical activity, and self-monitor their weight, eating, and exercise behaviors.
Participants in this group will also wear an armband that measures energy expenditure and they will log their food intake on the internet.
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实验性的：Standard behavioral treatment (SBT)
Participants receive a standard behavioral weight loss program similar to that used in other large trials such as Look AHEAD and the Diabetes Prevention Program.
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Participants receive a standard behavioral weight loss program similar to that used in other large trials such as Look AHEAD and the Diabetes Prevention Program.
Individuals will come to weekly group meetings for 6-months and will be instructed to reduce caloric intake, increase physical activity, and self-monitor their weight, eating, and exercise behaviors.
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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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Change in body weight
大体时间：6-months
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6-months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Change in physical activity
大体时间：6-months
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6-months
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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：Rena Wing, PhD、The Miriam Hospital
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
2011年3月1日
初级完成 (实际的)
2011年10月1日
研究完成 (实际的)
2011年10月1日
研究注册日期
首次提交
2011年4月5日
首先提交符合 QC 标准的
2011年4月5日
首次发布 (估计)
2011年4月6日
研究记录更新
最后更新发布 (估计)
2012年4月20日
上次提交的符合 QC 标准的更新
2012年4月18日
最后验证
2012年4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.
SBT + technology system (SBT+FIT)的临床试验
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Lora BurkeNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)完全的
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Centre Hospitalier Régional d'Orléans完全的
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Intermountain Health Care, Inc.National Heart, Lung, and Blood Institute (NHLBI); University of Utah招聘中
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Harvard Pilgrim Health CareUniversity of Pennsylvania; Washington University School of Medicine; Duke University; Rush University... 和其他合作者完全的