Effect of Self Regulation With Mindfulness Training on Body Mass Index and Cardiovascular Risk Markers in Obese Adults
2012年4月18日 更新者：Amit Sood、Mayo Clinic
Enhancing Self Regulation With Mindfulness Training and Its Effect on Body Mass Index and Cardiovascular Risk Markers in Obese Adults: A Randomized Pilot Clinical Trial
This study is designed to assess the effect of a mindfulness training program with special focus on diet and nutrition vs. dietary counseling in 40 obese adults (BMI range 30-40) and their partner/spouses (irrespective of their BMI), in a 6-month pilot randomized controlled trial.
研究概览
详细说明
Obesity is associated with deficits in self regulation.
Approaches that foster increased non-judgmental present moment awareness and increased acceptance have been demonstrated to enhance self regulation.
One commonly used approach that synthesizes these concepts is mindfulness training.
This study is designed to assess the effect of a mindfulness training program with special focus on diet and nutrition, on body mass index, cardiovascular risk markers, peripheral blood telomere length and telomerase levels in obese adults.
The mindfulness training program is adapted from the Attention and Interpretation Therapy developed by study investigators at Mayo Clinic.
The study is designed as a 6-month pilot randomized controlled trial involving 40 obese adults and their partners/spouses with standard dietary counseling as the control intervention.
Promising feasibility and efficacy data from the study will prompt us to pursue a larger, multi-center trial to more definitively test this program as well as apply this intervention in clinical practice.
研究类型
介入性
注册 (实际的)
36
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
-
-
Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic in Rochester
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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 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
PRIMARY PARTICIPANT
Inclusion Criteria:
- Obese adults (BMI ≥ 30)
- Currently working at Mayo Clinic Rochester
- Able to provide informed consent
- Stable weight (within + 10 pounds) during the three months prior to enrolling in the study
Exclusion Criteria:
- Currently (in the past six months) attending a weight loss program
- Underlying genetic or endocrine cause for weight gain
- Current cancer
- Medications known to affect weight (corticosteroids, antidepressants, anti psychotics, mood stabilizers, and anti-epileptic medications)
- Musculoskeletal conditions affecting the ability to adequately perform general physical activity
- Active smoking
- Substance abuse
- Quitting smoking within 6 months of enrolling in the study
- Have clinically significant acute unstable neurological, psychiatric, hepatic, renal, cardiovascular or respiratory disease that will prevent participation in the study
- Have an established practice of meditation for three or more months
- Not willing to complete study outcome measures.
PARTNER/SPOUSE
Inclusion Criteria:
- Able to provide informed consent
Exclusion Criteria:
- Have clinically significant acute unstable neurological,Psychiatric, hepatic, renal, cardiovascular or respiratory disease that will prevent participation in the study
- Have an established practice of meditation for three or more months
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Dietary Counseling
The control group will receive two sessions of dietary counseling (with instruction to follow a weight loss program) provided by a clinical dietician, consistent with current routine care for adults with obesity.
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The control group will receive two sessions of dietary counseling (with instruction to follow a weight loss program) provided by a clinical dietician, consistent with current routine care for adults with obesity.
|
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其他：Mindfulness Training Program
The mindfulness training program will be administered over three 90-minute sessions by a physician and clinical dietician with expertise in mind-body medicine and nutrition.
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The mindfulness program will be administered over three 90-minute sessions by a physician and clinical dietician with expertise in mind-body medicine and nutrition.
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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 |
|---|---|---|
|
Change from baseline to a healthier lifestyle.
大体时间：6 Months
|
Improvement in general health.
|
6 Months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in vital signs.
大体时间：6 Months
|
Body mass index (BMI) and absolute and percentage weight loss will be compared.
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6 Months
|
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Change from baseline in laboratory values.
大体时间：6 Months
|
Peripheral blood telomere length and telomerase levels, and cardiovascular risk markers will be compared.
|
6 Months
|
|
Change from baseline in stress management.
大体时间：6 Months
|
Stress, anxiety, and quality of life will be measured on various study questionnaires.
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6 Months
|
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Change in baseline on different aspects of eating.
大体时间：6 Months
|
Mindful eating, self efficacy and self regulation in eating will be compared.
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6 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。
赞助
调查人员
- 首席研究员：Amit Sood, MD、Mayo Clinic
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7月1日
初级完成 (实际的)
2012年4月1日
研究完成 (实际的)
2012年4月1日
研究注册日期
首次提交
2011年6月13日
首先提交符合 QC 标准的
2011年6月16日
首次发布 (估计)
2011年6月17日
研究记录更新
最后更新发布 (估计)
2012年4月19日
上次提交的符合 QC 标准的更新
2012年4月18日
最后验证
2012年4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.