此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Long-term Exercise, Weight Loss and Energy Balance

2012年8月8日 更新者:Joseph Donnelly、University of Kansas
In order to examine potential gender differences in the weight loss response to exercise, the investigators propose to compare equal energy expenditure of exercise for overweight men and women using levels of exercise energy expenditure that the investigators have previously shown to prevent weight gain or promote weight loss. The investigators will randomize men and women to an exercise group, 5 days/week, for 9 months, with an energy expenditure of 400 kcal/exercise session, a group with 600 kcal/ exercise session, or a control group. 1)The investigators hypothesize that men and women randomized to sedentary control will gain weight, those randomized to 400 kcal/exercise session will maintain weight (will not gain), and those randomized to 600 kcal/exercise session will lose ~5% of body weight. 2) The investigators hypothesize there will be no differences for weight loss between genders at either 400 or 600 kcal of energy expenditure of exercise since men and women will have equal amounts of energy expenditure of exercise. 3) The investigators hypothesize that men and women randomized to 400 kcal/exercise session will completely compensate for the energy expended during exercise by altering energy intake and/or spontaneous activity and that men and women participants randomized to 600 kcal/exercise session will not completely compensate. The investigators believe the findings from this study could have important implications for exercise guidelines for weight loss.

研究概览

地位

完全的

条件

详细说明

Exercise is recommended by virtually every public health organization; however, the role of exercise is generally considered secondary to energy restriction for the treatment of obesity. Indeed, an argument can be made that suggests exercise is not effective for weight loss. Meta-analytic studies consistently find small amounts of weight loss due to exercise without energy restriction. It is critical to note that there are actually very few randomized controlled trials using exercise alone for weight loss. We believe that there are 3 critical flaws in the vast majority of the literature. 1)Participants are not supervised and is generally recorded by self report and is likely poorly estimated and in general, overestimated. 2)The amount of exercise used is usually prescribed from the guidelines for recommended levels for physical fitness and to diminish cardiovascular disease, not the amount that may be necessary for weight loss. 3)The energy expenditure of the exercise is rarely reported.

Participants will be randomly assigned to expend either 400 or 600kcal per exercise session (or a control group) and will exercise 5 days per week for 9 months. All exercise sessions will be supervised and the length of the exercise session will be based upon energy expenditure (kcal/min) at a give heart rate range. To account for improvements in fitness, energy expenditure will be measured monthly and adjustments to the daily exercise prescription will be altered accordingly.

研究类型

介入性

注册 (实际的)

136

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

    • Kansas
      • Lawrence、Kansas、美国、66045
        • Energy Balance Lab, The University of Kansas

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

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 18 years or greater
  • males & females
  • <500kcal exercise/wk
  • BMI 25-40

Exclusion Criteria:

  • known cardiovascular and metabolic disorders,
  • weight altering product use
  • smoking
  • clinical depression
  • special diets

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: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:400 kcal of exercise/session
To see if there is a variance in weight loss and energy balance between men and women with similar energy expenditure over an extended period of time.
其他名称:
  • 400 kcal of exercise/session
  • 600 kcal of exercise/session
  • No exercise control group
实验性的:600 Kcal of exercise/session
To see if there is a variance in weight loss and energy balance between men and women with similar energy expenditure over an extended period of time.
其他名称:
  • 400 kcal of exercise/session
  • 600 kcal of exercise/session
  • No exercise control group
实验性的:Control, no exercise
No exercise control group
To see if there is a variance in weight loss and energy balance between men and women with similar energy expenditure over an extended period of time.
其他名称:
  • 400 kcal of exercise/session
  • 600 kcal of exercise/session
  • No exercise control group

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Between group weight change at 10 months
大体时间:10 months
10 months

次要结果测量

结果测量
措施说明
大体时间
Body Composition
大体时间:10 months
Changes in body composition will be evaluated by measuring the change in percent body fat, total fat mass, and total lean mass by DEXA.
10 months
Resting Metabolic Rate
大体时间:10 months
Resting metabolic rate will be determined via indirect calorimetry following an overnight fast.
10 months
Total Daily Energy Expenditure
大体时间:10 months
Total daily energy expenditure will be determined using the doubly labeled water procedure
10 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。

调查人员

  • 首席研究员:Joseph E Donnelly, EdD、University of Kansas

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。

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

2005年7月1日

初级完成 (实际的)

2011年7月1日

研究完成 (实际的)

2011年7月1日

研究注册日期

首次提交

2010年8月19日

首先提交符合 QC 标准的

2010年8月20日

首次发布 (估计)

2010年8月23日

研究记录更新

最后更新发布 (估计)

2012年8月9日

上次提交的符合 QC 标准的更新

2012年8月8日

最后验证

2012年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • HSCL15226
  • R01DK049181 (美国 NIH 拨款/合同)

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.

订阅