Efficacy of a Web-based Weight Loss Program
2012年7月5日 更新者：Luzia Valentini、Charite University, Berlin, Germany
Is the Support of a Web-based Weight Loss Program Effective in Supporting Self-initiated Weight Loss and Lifestyle Changes?
Since overweight and obesity, a risk factor for various diseases, is a prevalent problem in the modern society, it is important to search for new strategies to counteract this.
In contrast to in person support, the internet provides a low cost opportunity, which is able to reach a large part of the population.
Therefore a web-based weight loss program may be an adequate mean for many people.
Now it is hypothesised that a web-based weight loss program is able to support a reduction of body weight and weight-related cardiovascular risk factors effectively and to promote a healthier lifestyle.
It is expected that program use, compared to a control group, results in greater reductions in body weight and cardiovascular risk.
研究概览
研究类型
介入性
注册 (实际的)
84
阶段
- 阶段2
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。
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
30年 至 65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 30-65 years
- body Mass Index: 27-39,9 kg/m2
- ECOG-Performance status degree 0 or 1
- basal internet skills
- private internet access
- signed informed consent
Exclusion Criteria:
- malign diseases
- major organ diseases
- inflammatory bowel diseases
- insulin - dependent diabetes mellitus
- pregnancy, breast feeding
- treatment of eating disorders (e.g. bulimia, anorexia nervosa) within past 5 years
- parallel participation in other weight loss programs or other trials
- weight loss > 5% within past 6 month
- chronic therapy with glucocorticoids
- subjects treated because of psychiatric disorders (e.g. schizophrenia, bipolar disorder) in the past
- subjects with expected non-compliance to protocol guidelines
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：非随机化
- 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 |
|---|---|
|
实验性的：KiloCoach
Study subjects use the KiloCoach program on at least 4 days per week within the first half of the 6 months intervention period.
In the second half, program usage is ad libitum.
|
Study participants in this arm will use the program to record nutrition and physical activity on at least 4 days per week within the first and ad libitum within the second 3 months of the intervention period. Study visits will be conducted at baseline as well as after 1, 3 and 6 months. After 12 months a follow up visit will be conducted. |
|
无干预：Control
Study subjects try to reduce body weight on their own, without participating in an organized weight loss program, over a period of 6 months.
|
Study subjects try to reduce their body weight on their own. They are free to exercise and/or change nutritional habits. Not allowed is taking part in any structured weight loss program. Study visits will be conducted at baseline as well as after 1,3 and 6 months. A follow up visit will be conducted after 12 months. |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
body weight reduction in %
大体时间：after 3 months
|
after 3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
body weight reduction in %
大体时间：after 6 and 12 months
|
after 6 and 12 months
|
|
|
cardiovascular risk
大体时间：after 3,6 and 12 months
|
Cardiovascular risk is assessed by hsCRP, Fetuin A, LDL/HDL-ratio, waist-to-hip-ratio, HOMA-IR, blood pressure, body mass index, lean body mass (LBM), fat mass (FM), body cell mass (BCM.)
|
after 3,6 and 12 months
|
|
Quality of life
大体时间：after 3,6 and 12 months
|
Quality of life is assessed by "Obesity and Weight-Loss Quality of Life-Instrument" and "Weight related symptom measure".
|
after 3,6 and 12 months
|
|
Nutrition and physical activity
大体时间：after 3,6 and 12 months
|
Nutritional intake (controls) is assessed by 3-day dietary protocols.
Physical activity is assessed by "International physical activity questionnaire" (IPAQ-long), lower limb strength and phase angle.
|
after 3,6 and 12 months
|
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
- Goldstein DJ. Beneficial health effects of modest weight loss. Int J Obes Relat Metab Disord. 1992 Jun;16(6):397-415.
- Truby H, Baic S, deLooy A, Fox KR, Livingstone MB, Logan CM, Macdonald IA, Morgan LM, Taylor MA, Millward DJ. Randomised controlled trial of four commercial weight loss programmes in the UK: initial findings from the BBC "diet trials". BMJ. 2006 Jun 3;332(7553):1309-14. doi: 10.1136/bmj.38833.411204.80. Epub 2006 May 23. Erratum In: BMJ. 2006 Jun 17;332(7555):1418.
- Tate DF, Jackvony EH, Wing RR. A randomized trial comparing human e-mail counseling, computer-automated tailored counseling, and no counseling in an Internet weight loss program. Arch Intern Med. 2006 Aug 14-28;166(15):1620-5. doi: 10.1001/archinte.166.15.1620.
- Harvey-Berino J, Pintauro S, Buzzell P, DiGiulio M, Casey Gold B, Moldovan C, Ramirez E. Does using the Internet facilitate the maintenance of weight loss? Int J Obes Relat Metab Disord. 2002 Sep;26(9):1254-60. doi: 10.1038/sj.ijo.0802051.
- Harvey-Berino J, West D, Krukowski R, Prewitt E, VanBiervliet A, Ashikaga T, Skelly J. Internet delivered behavioral obesity treatment. Prev Med. 2010 Aug;51(2):123-8. doi: 10.1016/j.ypmed.2010.04.018. Epub 2010 May 15.
- Tate DF, Wing RR, Winett RA. Using Internet technology to deliver a behavioral weight loss program. JAMA. 2001 Mar 7;285(9):1172-7. doi: 10.1001/jama.285.9.1172.
- Krukowski RA, Harvey-Berino J, Ashikaga T, Thomas CS, Micco N. Internet-based weight control: the relationship between web features and weight loss. Telemed J E Health. 2008 Oct;14(8):775-82. doi: 10.1089/tmj.2007.0132.
- Galanis DJ, Kolonel LN, Lee J, Le Marchand L. Anthropometric predictors of breast cancer incidence and survival in a multi-ethnic cohort of female residents of Hawaii, United States. Cancer Causes Control. 1998 Mar;9(2):217-24. doi: 10.1023/a:1008842613331.
- Trentham-Dietz A, Newcomb PA, Egan KM, Titus-Ernstoff L, Baron JA, Storer BE, Stampfer M, Willett WC. Weight change and risk of postmenopausal breast cancer (United States). Cancer Causes Control. 2000 Jul;11(6):533-42. doi: 10.1023/a:1008961931534.
- Longin R, Grasse M, Aspalter R, Waldherr K. Effectiveness of the online weight reduction program KiloCoach and comparison with other evaluated commercial direct intervention and online programs. Obes Facts. 2012;5(3):372-83. doi: 10.1159/000339726. Epub 2012 Jun 14.
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9月1日
初级完成 (预期的)
2012年10月1日
研究完成 (预期的)
2013年7月1日
研究注册日期
首次提交
2012年7月3日
首先提交符合 QC 标准的
2012年7月5日
首次发布 (估计)
2012年7月6日
研究记录更新
最后更新发布 (估计)
2012年7月6日
上次提交的符合 QC 标准的更新
2012年7月5日
最后验证
2012年7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.