PH iWell Study to Compare an Online Interactive Technology to Self-directed Care in Overweight or Obese Individuals
2011年4月17日 更新者：SK Telecom Americas, Inc.
SKTA iWell21 Clinical Trial Protocol. This is a Randomized Control Trial of 500 Adult Participants Randomized to Two Arms: Control Arm: Self Directed Program (SDP), Intervention Arm: Dynamic On-line Interactive Technology (DOIT)
This is a six month lifestyle management study to compare the effects of iWell; a dynamic online interactive technology to a self-directed program in overweight or obese individuals.
The primary aim is to test the hypothesis that dynamic online interactive technology intervention is more effective than self-directed program in obtaining and maintaining weight loss and other biometric improvements.
研究概览
详细说明
Optimal health behavior is difficult to sustain over extended periods.
This study seeks to demonstrate that technology can be a low cost scaleable solution that will provide the user with sufficient customization and personalization through social networking approaches such that sustainability of optimal health behavior is realized.
研究类型
介入性
注册 (预期的)
500
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
-
-
Oregon
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Springfield、Oregon、美国、97477
- PeaceHealth Laboratories
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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
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- age 18-70 years old
- overweight or obese men and women with BMI between 24 and 38, inclusive
- concerned about weight/health (and motivated in losing weight)
- stable medications for past 3 months
- willing/able to use Web-based services
- willingness not to use weight loss medications for the duration of the trial
- able and willing to give informed consent and participate in the interventions
- willing to come to three sessions and visits
- willingness to be randomized to intervention or control group
Exclusion Criteria:
- contraindication to weight loss (e.g., malignancy or other serious illness)
- Type 1 DM and Type 2 DM with other end organ compromise (renal, retinal or other)
- Recent (within 6 months) cardiovascular event (MI or stroke)
- current symptoms of angina
- heart, renal, or liver disease (excluding kidney stone)
- cancer or active neoplasm (excluding skin cancers)
- hyperthyroidism
- mental conditions that would preclude full participation
- prior weight-loss (bariatric) surgery or plan for these procedures
- liposuction surgery in past 12 months or plan for these procedures
- recent weight loss in the past 3 months (>20 lbs)
- use of prescription weight loss medication in 3 months prior to screening
- current use of medications for treatment of psychosis or manic-depressive illness
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：支持治疗
- 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 |
|---|---|
|
无干预：Self directed
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Receives support and encouragement with minimal contact.
Receives printed lifestyle guidelines with diet and physical activity recommendations.
其他名称：
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有源比较器：Technology assisted health behavior
The intervention arm will have access to a dynamic online environment with social networking and device data uploads that include activity data, weight data and laboratory data at frequent intervals to nudge optimal health behavior.
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Web-based interactive program using an hpod sensor that tracks physical activity as well as biometric parameters into the iWell server and is transmitted to the internet site via the users PC.
Also serves as a social networking site.
其他名称：
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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 |
|---|---|
|
Weight loss from baseline
大体时间：at 6 months
|
at 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood pressure change from baseline
大体时间：at 3 months
|
Systolic blood pressure and diastolic blood pressure
|
at 3 months
|
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Triglyceride level change from baseline
大体时间：at 3 months
|
Participants will have a venous draw to determine Triglyceride levels
|
at 3 months
|
|
High density lipoprotein level change from baseline
大体时间：at 3 months
|
Venous draw to determine high density lipoprotein levels
|
at 3 months
|
|
Physical activity adjustment from baseline
大体时间：at 3 months
|
Standardized activity questionaire and activity monitoring device will be used to determine adjustments in activity for each arm
|
at 3 months
|
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Blood pressure change from baseline
大体时间：at 6 months
|
at 6 months
|
|
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Triglyceride level change from baseline
大体时间：at 6 months
|
at 6 months
|
|
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High density lipoprotein level change from baseline
大体时间：at 6 months
|
at 6 months
|
|
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Physical activity adjustment from baseline
大体时间：at 6months
|
Standardized activity questionaire and activity monitoring device will be used to determine adjustments in activity for each arm
|
at 6months
|
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：Brigitte Piniewski, MD、PeaceHealth Laboratories
- 首席研究员：David Kil、SKTelecom Americas
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
2010年10月1日
初级完成 (预期的)
2011年10月1日
研究完成 (预期的)
2012年10月1日
研究注册日期
首次提交
2010年10月22日
首先提交符合 QC 标准的
2011年3月28日
首次发布 (估计)
2011年3月29日
研究记录更新
最后更新发布 (估计)
2011年4月19日
上次提交的符合 QC 标准的更新
2011年4月17日
最后验证
2011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.