Impact of Self-Monitoring Technology and Interventionist Contact on Weight Loss
2015年9月21日 更新者:The Miriam Hospital
Despite continued research on effective interventions, obesity remains a major public health issue in the United States.
Current treatments, including behavioral weight management programs, weight loss surgery, and pharmacotherapy, tend to be high in cost and have limited reach, reducing the ability of these treatments to address the population-wide scope of the obesity epidemic.
Recent advances in technology that improve the ease of self-monitoring and provide targeted feedback offer promise to help larger groups of individuals to lose weight.
Despite the commercial popularity of these products, however, little research has been conducted to evaluate their impact on excess body weight or to determine how they should ideally be implemented.
Two key questions need to be addressed.
First, is use of self-monitoring technology sufficient to produce weight loss, or must this technology be combined with interventionist contact?
Second, how cost-effective is a technology-based intervention, with and without interventionist contact?
The current study is small prospective, randomized pilot study comparing a self-guided self-monitoring condition (SC) to a technology only condition (TECH) and a technology plus interventionist support condition (TECH+INT).
All participants will all be given basic weight management information knowledge and randomized to one of three conditions.
Participants in the self-guided self-monitoring condition (SC) will receive traditional paper self-monitoring logs, a standard body weight scale, and a pedometer and calorie book; participants in the technology-based condition (TECH) will receive an electronic activity monitor and WiFi-enabled body weight scale, and will track caloric intake via an associated website; and participants in the interventionist contact condition (TECH+INT) will receive the same technology as in the TECH condition, combined with weekly interventionist contact delivered via telephone.
We will compare the impact of each condition on weight loss and investigate preliminary cost-effectiveness.
研究概览
研究类型
介入性
注册 (实际的)
80
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 & 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
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 between 18 and 70
- BMI between 27 and 40 kg/m2
- Access to a computer and WIFI in the home
Exclusion Criteria:
- Weight over 340 lbs
- Physical limitations that prevent walking 1/4 mile without stopping
- Currently participating in another weight loss program or taking weight loss medication
- Currently pregnant, lactating, less than 6-months post-partum, or plans to become pregnant during the 6-month study period
- Uncontrolled hypertension or diabetes
- History of coronary heart disease
- Terminal Illness
- Plans to relocate during the 6-month study period
- Substance Abuse
- Severe psychiatric disorders
- Dementia
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:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:SC
Self-guided self-monitoring condition.
Participants will receive standard self-monitoring tools and information on weight regulation.
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实验性的:TECH
Technology condition.
Participants will receive self-monitoring technology and information regarding weight regulation.
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实验性的:TECH+INT
Technology plus interventionist contact arm.
Participants will receive self-monitoring technology, information regarding weight regulation, and interventionist contact via telephone.
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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
大体时间:6 months post randomization
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6 months post randomization
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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:Kathryn M Ross, PhD MPH、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。
一般刊物
- Chhabria K, Ross KM, Sacco SJ, Leahey TM. The Assessment of Supportive Accountability in Adults Seeking Obesity Treatment: Psychometric Validation Study. J Med Internet Res. 2020 Jul 28;22(7):e17967. doi: 10.2196/17967.
- Ross KM, Wing RR. Impact of newer self-monitoring technology and brief phone-based intervention on weight loss: A randomized pilot study. Obesity (Silver Spring). 2016 Aug;24(8):1653-9. doi: 10.1002/oby.21536. Epub 2016 Jul 1.
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
2013年12月1日
初级完成 (实际的)
2015年6月1日
研究完成 (实际的)
2015年6月1日
研究注册日期
首次提交
2013年11月25日
首先提交符合 QC 标准的
2013年11月25日
首次发布 (估计)
2013年12月3日
研究记录更新
最后更新发布 (估计)
2015年9月23日
上次提交的符合 QC 标准的更新
2015年9月21日
最后验证
2015年9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.
Self-monitoring skills的临床试验
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University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National... 和其他合作者完全的
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Royal Brompton & Harefield NHS Foundation TrustUniversity of Oxford; National Institute for Health Research, United Kingdom完全的