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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change from baseline to a healthier lifestyle.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from baseline to a healthier lifestyle.
时间窗: 6 Months
Improvement in general health.
次要结局
- Change from baseline in vital signs.(6 Months)
- Change from baseline in laboratory values.(6 Months)
- Change from baseline in stress management.(6 Months)
- Change in baseline on different aspects of eating.(6 Months)