Mindful Eating and Living: A Controlled Study Investigating the Effects of Mindfulness on Weight Loss, Habits, Mood and Biological Markers of Inflammation and Metabolism in Obese Post-Menopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 36
- 主要终点
- Decreases in body mass index
研究概览
简要总结
Background: Mindfulness-based interventions may be effective in reducing the stress that may increase both obesity and inflammation.
Purpose: The purpose of this study was to examine the effects of a mindful eating intervention on weight loss and health-related outcomes.
Methods: Thirty-six obese, postmenopausal women were randomized to a six-week Mindful Eating and Living (MEAL) intervention or an active control group (CONT) consisting of nutritional counseling, goal setting, and group support. Weight, body mass index (BMI), waist-hip ratio (WHR), binge eating, interleukin-6 (IL-6) and C-reactive protein (CRP) were assessed at baseline and four follow-up periods up to one year.
Results: Multilevel analyses showed that the MEAL group had reductions in weight, BMI, WHR, binge eating, IL-6, and CRP; the CONT group had reductions in weight, BMI, and binge eating. The reductions in binge eating, IL-6, and CRP were greater for the MEAL as compared with the CONT group.
Conclusions: This study suggests that a mindfulness-based eating intervention may promote weight loss and reduce a variety of health-related risk factors in post-menopausal women who are obese.
详细描述
Hypothesis A brief mindfulness-based educational program specifically designed for obese individuals will enable them to gain mastery over previously automatic eating and activity habits and will be associated with enhanced mood, decreased inflammation, improved metabolic markers and weight control.
Specific Aims
- To determine if a mindfulness-based educational program for obese persons (BMI ≥30) seeking to gain more control over eating and lifestyle result in significant improvement in BMI compared to a control group.
- To determine if a mindfulness-based educational program for obese persons seeking to gain more control over eating and lifestyle result in significant improvements in insulin resistance and other metabolic and physiologic parameters.
EXPERIMENTAL DESIGN AND METHODS
The final design of this study will be influenced by the results of the pilot study entitled Mindful Eating and Living I (MEAL I), which is currently underway. After completing the analysis of data from MEAL I, 50 post-menopausal women between the ages of 55 and 70 with BMI ≥30 kg/m2 will be recruited and screened to allow for possible screen failures. The goal is to enroll a group of 40 participants (n=20 control, n=20 intervention).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Post-menopausal women between the ages of 55 and 70 without untreated medical illness
- •Fluency in the English language
- •Body mass index (BMI) ≥30 kg/m2
- •Able to walk for at least 10 minutes without needing to stop or without symptom onset
排除标准
- •Significant untreated medical illness as evidenced by abnormal electrolytes or liver function tests
- •Systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than or equal to 95 mmHg with or without treatment
- •Abnormal thyroid stimulating hormone
- •Abnormal late night salivary cortisol
- •Untreated diabetes mellitus
- •Any severe psychiatric condition
- •Loss or gain of greater than or equal to 4 pounds in the past 6 months
- •Pharmacologic treatment for weight loss within three months before screening
- •Treatment with a very low calorie diet within six months before screening
- •Use of systemic corticosteroids within three months
- •Use of neuroleptic agent within three months
- •Treatment for eating disorder within five years
- •Diagnosis of a malignant disease except basal cell carcinoma within five years
- •Change in smoking status within three months or during course of study
- •Any condition that may preclude informed consent
结局指标
主要结局
Decreases in body mass index
时间窗: Baseline, 6 month, 4 months, 9 months, 1 year
次要结局
未报告次要终点
研究者
Brian Shelley
Family Practice Physician
University of New Mexico