LIVE SMART: Smartphone Intervention for Weight Control
2017年5月26日 更新者：John Graham Thomas、The Miriam Hospital
The purpose of this study is to compare three methods of delivering behavioral weight loss treatment.Participants are randomly assigned to one of three 18-month weight loss treatments (group, individual, or smartphone treatment).
Participants who are assigned to group treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6 months, and then monthly for the final 6 months.
Participants who are assigned to individual treatment will attend one-on-one sessions with a weight loss counselor every month for 18 months.
Participants who are assigned to smartphone treatment will use a smartphone to learn and practice weight loss skills.
They will also attend one-on-one sessions with a weight loss counselor every month for 18 months.
Assessment visits are conducted at baseline, 6, 12, and 18 months.
研究概览
研究类型
介入性
注册 (实际的)
276
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 Resarch 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
18年 至 70年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Body Mass Index (kg/m2) of 25-45.
- English language fluency
- Ability to read at a 6th grade level
- Availability to attend weekly treatment sessions in Providence, RI
Exclusion Criteria:
- Any heart condition that limits ability to participate in physical activity
- Chest Pain
- Any cognitive of physical limitation that would preclude use of a smartphone
- Serious mental illness
- Historical or current eating disorder
- Previous or planned bariatric surgery
- Use of weight loss medication
- Recent pregnancy or a plan to become pregnant in the next 6 months
- Participation in a study at the Weight Control and Diabetes Research Center within the last two years
- A weight loss of greater than 5% body weight in the last 6 months
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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有源比较器：Group Treatment
Participants who are assigned to group treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6 months, and then monthly for the final 6 months.
Participants will be weighed individually at the start of each group meeting.
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Participants receive instructions for making healthy changes to their diet and physical activity habits.
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有源比较器：Individual Treatment
Participants who are assigned to individual treatment will attend one-on-one sessions with a weight loss counselor every month for 18 months.
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Participants receive instructions for making healthy changes to their diet and physical activity habits.
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实验性的：Smartphone Treatment
Participants who are assigned to smartphone treatment will use a smartphone to learn and practice weight loss skills.
They will also attend one-on-one sessions with a weight loss counselor every month for 18 months.
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Participants receive instructions for making healthy changes to their diet and physical activity habits.
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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
大体时间：Change from baseline to 18-months.
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Change from baseline to 18-months.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Weight-related Behaviors
大体时间：Change from baseline to 18-months.
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Questionnaire measures of diet, physical activity, and other weight related behaviors such as self-monitoring.
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Change from baseline to 18-months.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Engagement with Smartphone Treatment system
大体时间：Mueasured continuously for the 18-month treatment.
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Frequency and duration of use of intervention resources made available to the smartphone treatment arm.
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Mueasured continuously for the 18-month treatment.
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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。
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。
一般刊物
- Bond DS, Thomas JG, O'Leary KC, Lipton RB, Peterlin BL, Roth J, Rathier L, Wing RR. Objectively measured physical activity in obese women with and without migraine. Cephalalgia. 2015 Sep;35(10):886-93. doi: 10.1177/0333102414562970. Epub 2014 Dec 4.
- Goldstein SP, Goldstein CM, Bond DS, Raynor HA, Wing RR, Thomas JG. Associations between self-monitoring and weight change in behavioral weight loss interventions. Health Psychol. 2019 Dec;38(12):1128-1136. doi: 10.1037/hea0000800. Epub 2019 Sep 26.
- Thomas JG, Bond DS, Raynor HA, Papandonatos GD, Wing RR. Comparison of Smartphone-Based Behavioral Obesity Treatment With Gold Standard Group Treatment and Control: A Randomized Trial. Obesity (Silver Spring). 2019 Apr;27(4):572-580. doi: 10.1002/oby.22410. Epub 2019 Feb 19.
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
2012年11月1日
初级完成 (实际的)
2016年8月1日
研究完成 (实际的)
2016年8月1日
研究注册日期
首次提交
2012年11月6日
首先提交符合 QC 标准的
2012年11月7日
首次发布 (估计)
2012年11月12日
研究记录更新
最后更新发布 (实际的)
2017年5月30日
上次提交的符合 QC 标准的更新
2017年5月26日
最后验证
2017年5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.