Effectiveness of a Well-being Web-based Intervention
2015年9月22日 更新者:MeYou Health, LLC
A Randomized Controlled Trial of the Effectiveness of the Web-based Well-being Intervention Daily Challenge
The purpose of this study is to determine whether the intervention Daily Challenge (MeYou Health, LLC), a behavioral intervention delivered online, is effective in improving individuals' well-being.
研究概览
研究类型
介入性
注册 (实际的)
1503
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
-
-
Massachusetts
-
Boston、Massachusetts、美国、02116
- MeYou Health office
-
-
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 及以上 (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:
- Adults (18 years of age or older, 19 years of age or older if participant resides in Alabama or Nebraska)
- Provided informed consent to participate in the study
Exclusion Criteria:
- Does not live in the United States of America
- Has a Facebook friend enrolled in the study
- Fails to complete the informed consent and registration process in the allotted time (45 minutes)
- Gender (recruitment will be titrated to ensure a minimum of 30% male ratio)
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 |
|---|---|
|
实验性的:Treatment
Intervention: Daily Challenge
|
Web-based behavioral intervention aiming to improve individuals' well-being.
|
|
无干预:Control
Weekly Well-being, an email-based health information delivery service.
|
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 |
|---|---|---|
|
Well-being score, as determined by the Healthways Well-Being Assessment
大体时间:Baseline, 30 days, 90 days
|
Change in well-being score
|
Baseline, 30 days, 90 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Interpersonal support score, as evaluated with the Interpersonal Support Evaluation List (ISEL)
大体时间:Baseline, 30 days, 90 days
|
Change in interpersonal support score.
|
Baseline, 30 days, 90 days
|
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。
合作者
调查人员
- 首席研究员:Josee Poirier, PhD、MeYou Health, LLC
- 学习椅:Nathan K Cobb, MD、MeYou Health, LLC
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
- Hill JO. Can a small-changes approach help address the obesity epidemic? A report of the Joint Task Force of the American Society for Nutrition, Institute of Food Technologists, and International Food Information Council. Am J Clin Nutr. 2009 Feb;89(2):477-84. doi: 10.3945/ajcn.2008.26566. Epub 2008 Dec 16.
- Harrison PL, Pope JE, Coberley CR, Rula EY. Evaluation of the relationship between individual well-being and future health care utilization and cost. Popul Health Manag. 2012 Dec;15(6):325-30. doi: 10.1089/pop.2011.0089. Epub 2012 Feb 22.
- Prochaska JO, Evers KE, Castle PH, Johnson JL, Prochaska JM, Rula EY, Coberley C, Pope JE. Enhancing multiple domains of well-being by decreasing multiple health risk behaviors: a randomized clinical trial. Popul Health Manag. 2012 Oct;15(5):276-86. doi: 10.1089/pop.2011.0060. Epub 2012 Feb 21.
- Heesch KC, Masse LC, Dunn AL, Frankowski RF, Mullen PD. Does adherence to a lifestyle physical activity intervention predict changes in physical activity? J Behav Med. 2003 Aug;26(4):333-48. doi: 10.1023/a:1024205011001.
- Strecher VJ, McClure J, Alexander G, Chakraborty B, Nair V, Konkel J, Greene S, Couper M, Carlier C, Wiese C, Little R, Pomerleau C, Pomerleau O. The role of engagement in a tailored web-based smoking cessation program: randomized controlled trial. J Med Internet Res. 2008 Nov 4;10(5):e36. doi: 10.2196/jmir.1002.
- Hill JO, Wyatt HR, Reed GW, Peters JC. Obesity and the environment: where do we go from here? Science. 2003 Feb 7;299(5608):853-5. doi: 10.1126/science.1079857.
- Eysenbach G. The law of attrition. J Med Internet Res. 2005 Mar 31;7(1):e11. doi: 10.2196/jmir.7.1.e11.
- Christakis NA. Social networks and collateral health effects. BMJ. 2004 Jul 24;329(7459):184-5. doi: 10.1136/bmj.329.7459.184. No abstract available.
- Christakis NA, Fowler JH. The spread of obesity in a large social network over 32 years. N Engl J Med. 2007 Jul 26;357(4):370-9. doi: 10.1056/NEJMsa066082. Epub 2007 Jul 25.
- Christakis NA. Health care in a web. BMJ. 2008 Jun 28;336(7659):1468. doi: 10.1136/bmj.a452.
- Pew Research Center. Social networking sites and our lives (Report). 2011. http:/pewinternet.org/Reports/2011/Technology-and-social-networks.aspx
- Helliwell JF, Putnam RD. The social context of well-being. Philos Trans R Soc Lond B Biol Sci. 2004 Sep 29;359(1449):1435-46. doi: 10.1098/rstb.2004.1522.
- Stata analysis software. Stata Corporation, College Station, TX.
- Tabachnick, B.G. and Fidell, L.S. Using multivariate statistics, 4th Edition, Allyn & Bacon, Needham, MA. 2001.
- Fleiss, J.L. Design and Analysis of Clinical Experiments.1999. Wiley, New York, NY.
- MacKinnon DP, Fairchild AJ, Fritz MS. Mediation analysis. Annu Rev Psychol. 2007;58:593-614. doi: 10.1146/annurev.psych.58.110405.085542.
- Beasley, T.M. Seemingly unrelated regression (SUR) models as a solution to path analytic models with correlated errors. Multiple Linear Regression Viewpoints. 34(1): 1-7, 2008.
- Zellner, A. An efficient method of estimating seemingly unrelated regressions and tests for aggregation bias. J Am Stat Assoc, 57(348-68), 1962.
- Lin DY, Fleming TR, De Gruttola V. Estimating the proportion of treatment effect explained by a surrogate marker. Stat Med. 1997 Jul 15;16(13):1515-27. doi: 10.1002/(sici)1097-0258(19970715)16:133.0.co;2-1.
- Vittinghoff E, Sen S, McCulloch CE. Sample size calculations for evaluating mediation. Stat Med. 2009 Feb 15;28(4):541-57. doi: 10.1002/sim.3491.
- Gleason, T.C. and Staelin, R. A proposal for handling missing data. Psychometrika, 40(2): 229-252, 1975.
- Little, R.J. and Rubin, D.B. Statistical analysis with missing data, 2nd Edition, Wiley, New York, NY. 2002.
- Schafer, J. L. Analysis of Incomplete Multivariate Data. New York, NY: Chapman & Hall, CRC. 2002.
- Cobb NK, Poirier J. Effectiveness of a multimodal online well-being intervention: a randomized controlled trial. Am J Prev Med. 2014 Jan;46(1):41-8. doi: 10.1016/j.amepre.2013.08.018.
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4月1日
初级完成 (实际的)
2012年9月1日
研究完成 (实际的)
2012年9月1日
研究注册日期
首次提交
2012年4月25日
首先提交符合 QC 标准的
2012年4月25日
首次发布 (估计)
2012年4月27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22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.