Physiological Factors That Influence Maintenance of Lifestyle Changes and Weight Loss - a Longitudinal Study
2016年1月29日 更新者：Jørn Wulff Helge、University of Copenhagen
In Denmark and the western world, there is an increasing prevalence of obesity probably due to a combination of inadequate daily physical activity and a high energy intake. One approach to achieve weight loss and change life style is to participate in an intensive supervised prolonged life style modification course. The immediate effect is often positive, but over time the overall effect is limited as the majority will not maintain weight loss and a changed life style.
The purpose of this study is therefore to characterize the physiological factors that determine/influence the capacity to maintain weight loss and a healthy lifestyle after a prolonged lifestyle intervention.
We have the following research questions:
- Are there physiological traits and characteristics that mediate better adherence to lifestyle changes and weight loss?
- Does the adaptation in muscle oxidative capacity after lifestyle intervention predict success in maintaining weight loss and lifestyle changes 3, 12 and 39 months after intervention?
- How does gender and age influence the capacity to maintain the lifestyle induced adaptation in muscle and adipose tissue and maintaining weight loss?
The study design is a longitudinal intervention and will be based on a lifestyle intervention, as it is practiced in a real life setting at Ubberup folk high school.
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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Copenhagen、丹麦、2200
- University of Copenhagen, Department of Biomedical Sciences
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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 65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:
- Participants at Ubberup Folk High School
Exclusion Criteria:
- Previous Gastric Bypass Surgery or Gastric Banding
- BMI<25
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：预防
- 分配：不适用
- 介入模型：单组作业
- 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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实验性的：Intensive Lifestyle Intervention
Intensive Lifestyle Intervention at Ubberup Folk High School for 10-14 weeks.
Daily exercise for 1-3hrs.
Calorie restriction (~-700KCal/day).
Education within nutrition, exercise and healthy living in general.
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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 |
|---|---|
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Total body weight
大体时间：Changes from baseline at 3, 6, 15 and 39 months
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Changes from baseline at 3, 6, 15 and 39 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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Maximal fat oxidation during exercise
大体时间：Changes from baseline at 3, 6, 15 and 39 months
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Respiratory Exchange Ratio (RER) is measured and maximal fat oxidation is calculated.
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Changes from baseline at 3, 6, 15 and 39 months
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Anthropometry
大体时间：Changes from baseline at 3, 6, 15 and 39 months
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Body composition measured by dual x-ray absorptiometry or bio-impedance, height, weight, waist circumference.
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Changes from baseline at 3, 6, 15 and 39 months
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Maximal Oxygen Consumption
大体时间：Changes from baseline at 3, 6, 15 and 39 months
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Changes from baseline at 3, 6, 15 and 39 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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Adherence to physical activity
大体时间：Changes from baseline at 3, 6, 15 and 39 months
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International Physical Activity Questionaire (IPAQ) to determine adherence to physical activity.
Furthermore we will use diary and ActiHeart (accelerometer).
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Changes from baseline at 3, 6, 15 and 39 months
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Adherence to healthy diet
大体时间：Changes from baseline at 3, 6, 15 and 39 months
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Questionnaire (24hrs dietary recall) and diary to determine adherence to a healthy diet.
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Changes from baseline at 3, 6, 15 and 39 months
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Mitochondria respiration and efficiency
大体时间：Changes from baseline at 3, 6, 15 and 39 months
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Mitochondria respiration and efficiency is measured by Oreboros Oxygraph.
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Changes from baseline at 3, 6, 15 and 39 months
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Blood and plasma substrates, hormones and metabolites
大体时间：Changes from baseline at 3, 6, 15 and 39 months
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HbA1c, insulin, leptin, glucose, adiponectin, thyroid stimulating hormone (TSH), ghrelin
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Changes from baseline at 3, 6, 15 and 39 months
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Muscle lipid composition
大体时间：Changes from baseline at 3, 6, 15 and 39 months
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Muscle lipid composition will be analysed using a lipidomics approach.
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Changes from baseline at 3, 6, 15 and 39 months
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Expression of muscle lipases
大体时间：Changes from baseline at 3, 6, 15 and 39 months
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Western blot analysis will be applied to analyse expression of muscle lipases; hormone sensitive lipase (HSL), adipose triglyceride lipase (ATGL) and lipoprotein lipase (LPL) as well as muscle PAT proteins; PLIN 2 (ADRP), PLIN 3 (TIP47) and PLIN 5 (OXPAT)
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Changes from baseline at 3, 6, 15 and 39 months
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Intramuscular lipid droplet content and size, glycogen content and ceramide content and location
大体时间：Changes from baseline at 3, 6, 15 and 39 months
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Intramuscular lipid droplet content and size, glycogen content and ceramide content and location will be quantified by immunohistochemical staining of serial cryo-sections of muscle tissue samples that are visualized by confocal microscopy
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Changes from baseline at 3, 6, 15 and 39 months
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Adipose tissue macrophage inflammation and cytokine production
大体时间：Changes from baseline at 3, 6, 15 and 39 months
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Changes from baseline at 3, 6, 15 and 39 months
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Motivation for lifestyle changes and sociological factors involved
大体时间：Changes from baseline at 3, 6, 15 and 39 months
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Questionnaires
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Changes from baseline at 3, 6, 15 and 39 months
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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：Jørn W Helge, PhD、University of Copenhagen, Department of Biomedical Sciences
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
- Karlsen TI, Sohagen M, Hjelmesaeth J. Predictors of weight loss after an intensive lifestyle intervention program in obese patients: a 1-year prospective cohort study. Health Qual Life Outcomes. 2013 Oct 3;11:165. doi: 10.1186/1477-7525-11-165.
- McCormack SE, McCarthy MA, Harrington SG, Farilla L, Hrovat MI, Systrom DM, Thomas BJ, Torriani M, McInnis K, Grinspoon SK, Fleischman A. Effects of exercise and lifestyle modification on fitness, insulin resistance, skeletal muscle oxidative phosphorylation and intramyocellular lipid content in obese children and adolescents. Pediatr Obes. 2014 Aug;9(4):281-91. doi: 10.1111/j.2047-6310.2013.00180.x. Epub 2013 Jun 25.
- Danielsen KK, Svendsen M, Maehlum S, Sundgot-Borgen J. Changes in body composition, cardiovascular disease risk factors, and eating behavior after an intensive lifestyle intervention with high volume of physical activity in severely obese subjects: a prospective clinical controlled trial. J Obes. 2013;2013:325464. doi: 10.1155/2013/325464. Epub 2013 Apr 22.
- Bruun JM, Helge JW, Richelsen B, Stallknecht B. Diet and exercise reduce low-grade inflammation and macrophage infiltration in adipose tissue but not in skeletal muscle in severely obese subjects. Am J Physiol Endocrinol Metab. 2006 May;290(5):E961-7. doi: 10.1152/ajpendo.00506.2005. Epub 2005 Dec 13.
- Pedersen JO, Zimmermann E, Stallknecht BM, Bruun JM, Kroustrup JP, Larsen JF, Helge JW. [Lifestyle intervention in the treatment of severe obesity]. Ugeskr Laeger. 2006 Jan 9;168(2):167-72. Danish.
- Bruun JM, Stallknecht B, Helge JW, Richelsen B. Interleukin-18 in plasma and adipose tissue: effects of obesity, insulin resistance, and weight loss. Eur J Endocrinol. 2007 Oct;157(4):465-71. doi: 10.1530/EJE-07-0206.
- Christiansen T, Bruun JM, Madsen EL, Richelsen B. Weight loss maintenance in severely obese adults after an intensive lifestyle intervention: 2- to 4-year follow-up. Obesity (Silver Spring). 2007 Feb;15(2):413-20. doi: 10.1038/oby.2007.530.
- Elsborg P, Elbe AM. Exercise-specific volition and motivation for weight loss maintenance following an intensive lifestyle intervention. Health Psychol. 2018 Aug;37(8):759-766. doi: 10.1037/hea0000636.
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
2014年1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21日
首先提交符合 QC 标准的
2013年11月21日
首次发布 (估计)
2013年11月27日
研究记录更新
最后更新发布 (估计)
2016年2月1日
上次提交的符合 QC 标准的更新
2016年1月29日
最后验证
2016年1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.