Preliminary Evaluation Study of Therapeutic Education on Overweight People in Addition to a Hydrotherapeutic Cure at the Thermal Baths of Brides-les-Bains
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Change in the weight between the end of the hydrotherapeutic cure and 5 months after the hydrotherapeutic cure
研究概览
简要总结
The goal of this study is to assess the effect of a therapeutic education program in addition of a hydrotherapeutic cure on obese patients.
The therapeutic education program at the thermal baths of Brides-les-Bains is composed of a dietary follow-up, a physical activities program, working group.
详细描述
The participants are people that come to the thermal baths in order to follow an hydrotherapeutic cure (of about 3 weeks). For the Action group, they also follow a course of therapeutic education where they are given advices on how they should eat and have a regular physical activity.
This therapeutic education in addition of the hydrotherapeutic cure should help them lose weight and not gain in again.
The participants are followed for 18 months (17 months after leaving the thermal baths).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Body Mass Index (BMI) over 27 kg/m² (or equal)
- •Has a valid email address, has access to the internet and to a telephone line
- •Has a domestic scale compatible with its weight
- •Signed the consent form
- •Susceptible to accept the obligations generated by the study
- •Has a health insurance
排除标准
- •Has a progressive illness at the time of the study (cancer, neurodegenerative disease...)
- •Is pregnant
- •Follows the hydro-therapeutic cure in order to cure rheumatism
- •Trying to lose weight prior to a surgery
- •Has a diagnosed eating disorder
- •Has no physical activity due to a handicap or a serious osteoarthritis
- •Has taken a weight-loss drug (Orlistat) in the past month or will likely do so in the future
- •Is taking a Desmopressin-based drug
- •Is unable to understand or follow the protocol
- •Is deprived of liberty
- •Is under judicial protection
结局指标
主要结局
Change in the weight between the end of the hydrotherapeutic cure and 5 months after the hydrotherapeutic cure
时间窗: People's weight in between the end of hydrotherapeutic cure and 5 months after hydrotherapeutic cure
People weight themselves on a domestic scale.
次要结局
- Evolution of the weight.(0 ; 3 weeks ; 6 months ; 12 months ; 18 months)
- Quality of life(0 ; 3 weeks ; 6 months ; 12 months)
- Physical activity(0 ; 3 weeks ; 6 months ; 12 months)
- Individual's readiness to change(0 ; 3 weeks ; 6 months ; 12 months)
- Visual and analogical scale for general and psychological well-being and body discomfort.(0 ; 3 weeks ; 6 months ; 12 months)
- Felling about the body(0 ; 3 weeks ; 6 months ; 12 months)
- Dietary habits(0 ; 3 weeks ; 6 months ; 12 months)
研究者
Jean-Michel Lecerf
medical doctor specializing in endocrinology and metabolic diseases
Institut Pasteur de Lille