Effects of Self-conditioning Techniques in Promoting Weight Loss in Patients With Severe Obesity. A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- weight loss
研究概览
简要总结
The investigators hypothesized that hypnosis is an alternative technique that could be applied to help patients with obesity to lose weight.
The possibility that a self-conditioning technique (self-hypnosis) added to traditional approach (diet, exercise and behavioral recommendations) will be effective in determining weight loss with respect to the traditional approach in subjects with a body mass index (BMI) between 35 and 50 kg/m2 will be studied.
详细描述
Obesity is a serious health concern. Most lifestyle interventions fail over time; indeed, overeating often involves loss of control and compulsive behaviors.
Hypnosis could increase the ability to control emotional impulses. Self-conditioning techniques borrowed from hypnosis (self-hypnosis) increase self-control and self-management of emotions. Recent hypnosis techniques with a rapid-induction phase allow the trained patients to go into self-hypnosis in a few minutes and to repeat the experience in complete autonomy, employing a short time of the day only.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to give written informed consent
- •BMI between 35 and 50 kg/m2
- •Age 20-70 years
排除标准
- •Current or previous mental disorders and/or on any psychotropic drug
- •Insulin treatment
- •Candidates for bariatric surgery
- •Current (or discontinued for less than 6 months) treatment with anti-obesity drugs
- •Patients at risk of heart failure, edema, ascites (heart diseases, chronic liver diseases, nephrotic syndrome, renal failure)
- •Patients with untreated or uncompensated thyroid diseases
研究组 & 干预措施
Experimental
self-conditioning techniques plus standard care
干预措施: self-conditioning techniques (Other)
Experimental
self-conditioning techniques plus standard care
干预措施: standard care (diet, exercise and behavioral therapy) (Other)
Control
Standard care: dietary recommendations, exercise recommendations, and behavioral recommendations
干预措施: standard care (diet, exercise and behavioral therapy) (Other)
结局指标
主要结局
weight loss
时间窗: 12 months after randomization
次要结局
- Change in body fat percentage(12 months after randomization)
- Change in fasting glucose(12 months after randomization)
- Change in insulin circulating values(12 months after randomization)
- Change in quality of life(12 months after randomization)
研究者
Simona Bo
Associate Professor
University of Turin, Italy