Study of the Influence of Erickson's Hypnosis and Self-hypnosis Practice on Food Impulsivity and Weight Loss in Obese Patients: a Pilot Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Evolution of disinhibition score estimated by the TFEQ 51 at the beginning and at the end of the study
研究概览
简要总结
High food impulsiveness, impaired food reward and stress response are involved in the phenomena of weight gain and resistance at weight loss. Henceforth, hypnosis is a complementary medicine which is recognized as effective for defined indications. Complexity and diversity of methodological studies with hypnosis does not allow to conclude on its efficacy in treating this disease.
In obese subjects with high food impulsiveness, it is expected that Erickson's hypnosis and self-hypnosis practice would improve food disinhibition assessed by an adapted questionary (TFEQ 51).
详细描述
Obese failing patients are recruited in an university hospital. Half of the subjects will be randomised to practice hypnosis and will learn to practice self-hypnosis to reduce food impulsivity and specially disinhibition. In the same time, all the included patients will follow therapeutic workshops based on current recommendations of the High Health Authority of France (HAS) for physical activity and the dietetic.
In the hypnosis group, eight workshops are planned during six months. Furthermore, patients have to practice daily self-hypnosis. In the same time, all the patients included will participate in eight dietetic workshops.
It is expected an improvement in patient involvement in personalized care plan, that eating behavior is more suited and consequently a significant decrease in weight.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Evolution of disinhibition score estimated by the TFEQ 51 at the beginning and at the end of the study
时间窗: 8 months
次要结局
- Evolution of waist circumference at the beginning and at the end of study(8 months)
- Evolution of carbohydrate intakes(8 months)
- Evolution of saturated fatty acids intakes at the beginning and at the end of the study.(8 months)
- Evolution of HbA1c at the beginning and the end of the study(8 months)
- Evolution of the physical activity assessed with a pedometer for a week prior to the second and final visits.(8 months)
- Evolution of flexible cognitive restraint at the beginning and at the end of the study(8 months)
- Evolution of weight at the beginning and at the end of study(8 months)
- Evolution of body fat at the beginning and at the end of the study(8 months)
- Evolution of lean mass at the beginning and at the end of the study(8 months)
- Evolution of water mass at the beginning and at the end of the study(8 months)
- Evolution of calories intakes. at the beginning and at the end of the study(8 months)
- Evolution of cognitive restraint at the beginning and at the end of the study(8 months)
- Evolution of rigid cognitive restraint at the beginning and at the end of the study(8 months)
- Evolution of protein intakes.at the beginning and at the end of the study(8 months)
- Evolution of total fat intakes at the beginning and at the end of the study.(8 months)
- Evolution of Total cholesterol at the beginning and the end of the study(8 months)
- Evolution of Low-density lipoprotein (LDL-C) at the beginning and the end of the study(8 months)
- Evolution of Triglyceride at the beginning and the end of the study(8 months)
- Evolution of quality of Live (QoL) estimated by The Short-Form Health Survey (SF-36) at beginning and the end of study at the beginning and the end of the study(8 months)
- Evolution of the food reward evaluated by content analysis of a psychological interview at beginning and the end of study(8 months)
- Evolution of fasting glucose at the beginning and the end of the study(8 months)
- Evolution of the Self-esteem measured by The Self-esteem Inventory (SEI of Coopersmith) at beginning and the end of study(8 months)
- : Evolution of the patient's emotional state evaluated by content analysis of a psychological interview at beginning and the end of study(8 months)
- Evolution of the physical activity assessed with the abridged version of the International Physical Activity Questionnaire (IPAQ) completed online before the inclusion visit and before the final visit(8 months)
- Evolution of High-density lipoprotein-cholesterol (HDL-C) at the beginning and the end of the study(8 months)
- Evolution of stress measured at beginning and the end of study.(8 months)
- Evolution of coping strategies measured by The Coping Inventory for Stressful Situations (CISS) at beginning and the end of study(8 months)
- : Evolution of the patient's involvement in the personalized care project evaluated by content analysis of a psychological interview at beginning and the end of study(8 months)
- Evolution of the self-perception of self-care competence evaluated by content analysis of a psychological interview at beginning and the end of study(8 months)