NCT02000037终止不适用
Interest in the Medium Term of an Infrared Reflexotherapy on Overweight or Class I Obese People
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Weight changes after 12 months compared to a dietary care (associated with physical activity advice) dispensed by a professional.
研究概览
简要总结
The study aim is to Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 27 and 35 kg/m2 (included),
- •Aged 30 to 60 years old (included),
- •Stable weight: no variation of 3 kg in the las 3 months,
- •Signed the consent form,
- •Able to follow the study,
- •Health insured.
排除标准
- •History of coronary disease (in the last 6 months),
- •Progressive illness at the time of the study (cancer, neurodegenerative disease...),
- •Diabetics (treated or not),
- •Fasting blood total cholesterol equal or over 2.5 g/L (treated or not),
- •Fasting blood triglycerides equal or over 2.0 g/L (treated or not),
- •Fasting blood glucose equal or over 1.26 g/L,
- •Peripheral neuropathy (polyneuritis, diabetic neuropathy) or central neuropathy (hemiplegia),
- •Infectious cutaneous condition or allergies (to the contact point of the device),
- •History of stroke,
- •Severe heart disease,
- •Epilepsy,
- •Reduced motility,
- •Diagnosed eating disorder,
- •Followed a diet in the last 90 days in order to lose weight,
- •Took weight loss assistance drug (Orlistat) in the last month or is likely to take one during the study,
- •Psychiatric disorder incompatible with the study,
- •Mental illness,
- •Neurological disorder,
- •Chronic somatic disease,
- •Addiction or nicotine withdrawal,
- •Under psychoactive drug ,
- •Alcool consumption over 3 glasses a day,
- •Pregnant or breastfeeding women,
- •Women that are likely to get pregnant during the study,
- •Is unable to understand or follow the protocol
- •Is deprived of liberty
- •Is under judicial protection
结局指标
主要结局
Weight changes after 12 months compared to a dietary care (associated with physical activity advice) dispensed by a professional.
时间窗: 12 months
次要结局
- Effect of infrared (IR) reflexotherapy on weight changes.(3, 12 and 18 months)
- Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on the waist siez.(3, 12 and 18 months.)
- Effect of infrared (IR) reflexotherapy on dietary habits.(3, 12 and 18 months)
- Effect of infrared (IR) reflexotherapy on life's quality (anxiety, depression, physical impact, psychosocial, impact on sexual life, eating well-being, feeling about the dietary care).(3, 12 and 18 months)
- Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on blood pressure and heart rate.(3 months.)
- Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on the weight changes.(3, 12 and 18 months.)
- Effect of infrared (IR) reflexotherapy on the salivary cortisol.(3 months)
- Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on dietary habits.(3, 12 and 18 months.)
- Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on the salivary cortisol.(3 months.)
- Effect of infrared (IR) reflexotherapy on waist size.(3, 12 and 18 months)
- Effect of IR reflexotherapy combined with dietary care (and physical activity advises) dispensed by professional on life quality (anxiety, depression, physical impact, psychosocial, impact on sexual life, eating wellbeing, feeling about the dietary care)(3, 12 and 18 months.)
- Effect of infrared (IR) reflexotherapy on blood pressure and heart rate.(3 months)
研究者
Jean-Michel Lecerf
Medical doctor specialized in endocrinology and metabolic diseases
Institut Pasteur de Lille
研究点 (2)
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